Integrating palliative care with usual care of diabetic foot wounds.

PubMed

Dunning, Trisha

2016-01-01

Palliative care is a philosophy and a system for deciding care and can be used alone or integrated with usual chronic disease care. Palliative care encompasses end-of-life care. Palliative care aims to enhance quality of life, optimize function and manage symptoms including early in the course of chronic diseases. The purposes of this article are to outline palliative care and discuss how it can be integrated with usual care of diabetic foot wounds. Many people with diabetes who have foot wounds also have other comorbidities and diabetes complications such as cardiovascular and renal disease and depression, which affect medicine and other treatment choices, functional status, surgical risk and quality of life. Two broad of diabetic foot disease exist: those likely to heal but who could still benefit from integrated palliative care such as managing pain and those where healing is unlikely where palliation can be the primary focus. People with diabetes can die suddenly, although the life course is usually long with periods of stable and unstable disease. Many health professionals are reluctant to discuss palliative care or suggest people to document their end-of-life care preferences. If such preferences are not documented, the person might not achieve their desired death or place of death and health professionals and families can be confronted with difficult decisions. Palliative care can be integrated with usual foot care and is associated with improved function, better quality of life and greater patient and family satisfaction. Copyright © 2016 John Wiley & Sons, Ltd.

Pilot Trial of a Licensed Practical Nurse Intervention for Hypertension and Depression

PubMed Central

Bogner, Hillary R.; de Vries, Heather F.; Kaye, Elise M.; Morales, Knashawn H.

2014-01-01

BACKGROUND AND OBJECTIVES Depression is a risk factor for hypertension, and risk of depression is increased substantially in patients with hypertension. Our objective was to examine whether an intervention carried out by Licensed Practical Nurses (LPNs) integrating depression treatment into care for hypertension improved blood pressure control and depressive symptoms. METHODS In all, 60 patients ages 41 to 92 years with hypertension and depressive symptoms at a large primary care practice in Philadelphia were randomly assigned to an integrated care intervention carried out by LPNs (n=30) or usual care (n=30). Intervention and control groups did not differ statistically on baseline measures. Outcomes assessed at baseline and 12 weeks included standard laboratory procedures to measure blood pressure control and the Patient Health Questionnaire (PHQ-9) to assess depression. RESULTS Patients in the integrated care intervention had lower diastolic blood pressure (intervention 74.2 mmHg versus usual care 82.0 mmHg) and fewer depressive symptoms (PHQ-9 mean scores, intervention 2.4 versus usual care 7.1) compared with patients in the usual care group at 12 weeks after adjustment for baseline values. Patients in the integrated care intervention also had lower systolic blood pressure (intervention 130.0 mmHg versus usual care 140.6 mmHg) compared with patients in the usual care group at 12 weeks although the results approached but did not reach conventional levels of statistical significance. CONCLUSION Training existing primary care practice office staff will facilitate implementation in real world practices with limited resources and competing demands. PMID:23681683

Palliative or Comfort Care

MedlinePlus

... team usually includes: Palliative care doctors and nurses Social workers and chaplains Pharmacists and nutritionists Counselors and others This team works with your doctor and other health care providers ...

Comparative effectiveness research for the clinician researcher: a framework for making a methodological design choice.

PubMed

Williams, Cylie M; Skinner, Elizabeth H; James, Alicia M; Cook, Jill L; McPhail, Steven M; Haines, Terry P

2016-08-17

Comparative effectiveness research compares two active forms of treatment or usual care in comparison with usual care with an additional intervention element. These types of study are commonly conducted following a placebo or no active treatment trial. Research designs with a placebo or non-active treatment arm can be challenging for the clinician researcher when conducted within the healthcare environment with patients attending for treatment.A framework for conducting comparative effectiveness research is needed, particularly for interventions for which there are no strong regulatory requirements that must be met prior to their introduction into usual care. We argue for a broader use of comparative effectiveness research to achieve translatable real-world clinical research. These types of research design also affect the rapid uptake of evidence-based clinical practice within the healthcare setting.This framework includes questions to guide the clinician researcher into the most appropriate trial design to measure treatment effect. These questions include consideration given to current treatment provision during usual care, known treatment effectiveness, side effects of treatments, economic impact, and the setting in which the research is being undertaken.

Impact of universal gowning and gloving on health care worker clothing contamination.

PubMed

Williams, Calvin; McGraw, Patty; Schneck, Elyse E; LaFae, Anna; Jacob, Jesse T; Moreno, Daniela; Reyes, Katherine; Cubillos, G Fernando; Kett, Daniel H; Estrella, Ronald; Morgan, Daniel J; Harris, Anthony D; Drees, Marci

2015-04-01

To determine whether gowning and gloving for all patient care reduces contamination of healthcare worker (HCW) clothing, compared to usual practice. Cross-sectional surveys. Five study sites were recruited from intensive care units (ICUs) randomized to the intervention arm of the Benefits of Universal Gown and Glove (BUGG) study. All HCWs performing direct patient care in the study ICUs were eligible to participate. Surveys were performed first during the BUGG intervention study period (July-September 2012) with universal gowning/gloving and again after BUGG study conclusion (October-December 2012), with resumption of usual care. During each phase, HCW clothing was sampled at the beginning and near the end of each shift. Cultures were performed using broth enrichment followed by selective media. Acquisition was defined as having a negative clothing culture for samples taken at the beginning of a shift and positive clothing culture at for samples taken at the end of the shift. A total of 348 HCWs participated (21-92 per site), including 179 (51%) during the universal gowning/gloving phase. Overall, 51 (15%) HCWs acquired commonly pathogenic bacteria on their clothing: 13 (7.1%) HCWs acquired bacteria during universal gowning/gloving, and 38 (23%) HCWs acquired bacteria during usual care (odds ratio [OR], 0.3; 95% confidence interval [CI], 0.2-0.6). Pathogens identified included S. aureus (25 species, including 7 methicillin-resistant S. aureus [MRSA]), Enterococcus spp. (25, including 1 vancomycin-resistant Enterococcus [VRE]), Pseudomonas spp. (4), Acinetobacter spp. (4), and Klebsiella (2). Nearly 25% of HCWs practicing usual care (gowning and gloving only for patients with known resistant bacteria) contaminate their clothing during their shift. This contamination was reduced by 70% by gowning and gloving for all patient interactions.

Effectiveness and costs of specialised physiotherapy given via ParkinsonNet: a retrospective analysis of medical claims data.

PubMed

Ypinga, Jan H L; de Vries, Nienke M; Boonen, Lieke H H M; Koolman, Xander; Munneke, Marten; Zwinderman, Aeilko H; Bloem, Bastiaan R

2018-02-01

Parkinson's disease is a complex condition that is best managed by specialised professionals. Trials show that specialised allied health interventions are cost-effective, as compared with usual care. We aimed to study the long-term benefits of specialised physiotherapy using the ParkinsonNet approach in real-world practice. We did an observational study, retrospectively analysing a database of health insurance claims that included a representative population of Dutch patients with Parkinson's disease, who were followed for up to 3 years (Jan 1, 2013, to Dec 31, 2015). Eligibility criteria included having both a diagnosis of Parkinson's disease and having received physiotherapy for the disease. Allocation to specialised or usual care physiotherapy was based on the choices of patients and referring physicians. We used a mixed-effects model to compare health-care use and outcomes between patients treated by specialised or usual care physiotherapists. The primary outcome was the percentage of patients with a Parkinson's disease-related complication (ie, visit or admission to hospital because of fracture, other orthopaedic injuries, or pneumonia) adjusted for baseline variables. We compared physiotherapist caseload, the number of physiotherapy sessions, physiotherapy costs, and total health-care costs (including hospital care, but excluding community care, long-term care, and informal care) between the groups, and used a Cox's proportional hazard model for survival time to establish whether mortality was influenced by treatment by a specialised physiotherapist. We analysed 2129 patients (4649 observations) receiving specialised physiotherapy and 2252 patients (5353 observations) receiving usual care physiotherapy. Significantly fewer patients treated by a specialised physiotherapist had a Parkinson's disease-related complication (n=368 [17%]) than patients treated by a usual care physiotherapist (n=480 [21%]; odds ratio 0·67, 95% CI 0·56-0·81, p<0·0001). The annual caseload of patients per therapist was significantly higher for specialised physiotherapists (mean 3·89 patients per therapist [SD 3·91]) than usual care physiotherapists (1·48 [1·24]). Patients who saw specialised physiotherapists received fewer treatment sessions (mean 33·72 [SD 26·70]) than usual care physiotherapists (47·97 [32·11]). Consequently, expenditure was lower for specialised than usual care physiotherapists, both for direct costs (mean €933 [SD 843] vs €1329 [1021]; annual difference €395, 95% CI 358-432, p<0·0001) and total health-care expenditure (€2056 [3272] vs €2586 [3756]; €530, 391-669, p<0·0001). Mortality risk was lower for patients receiving specialised physiotherapy (134 [6%]) compared with patients receiving usual care physiotherapy (205 [9%], p=0·001) before correction for baseline variables, although Cox's survival model showed no significant difference between the two (hazard ratio 0·86, 95% CI 0·69-1·07, p=0·195). These results confirm the findings from controlled trials, and offer evidence that specialised physiotherapy as delivered through ParkinsonNet is associated with fewer Parkinson's disease-related complications and lower costs in real-world practice. Neurologists can facilitate specialised physiotherapy by specific referral to such experts. None. Copyright © 2018 Elsevier Ltd. All rights reserved.

Is home-based palliative care cost-effective? An economic evaluation of the Palliative Care Extended Packages at Home (PEACH) pilot.

PubMed

McCaffrey, Nikki; Agar, Meera; Harlum, Janeane; Karnon, Jonathon; Currow, David; Eckermann, Simon

2013-12-01

The aim of this study was to evaluate the cost-effectiveness of a home-based palliative care model relative to usual care in expediting discharge or enabling patients to remain at home. Economic evaluation of a pilot randomised controlled trial with 28 days follow-up. Mean costs and effectiveness were calculated for the Palliative Care Extended Packages at Home (PEACH) and usual care arms including: days at home; place of death; PEACH intervention costs; specialist palliative care service use; acute hospital and palliative care unit inpatient stays; and outpatient visits. PEACH mean intervention costs per patient ($3489) were largely offset by lower mean inpatient care costs ($2450) and in this arm, participants were at home for one additional day on average. Consequently, PEACH is cost-effective relative to usual care when the threshold value for one extra day at home exceeds $1068, or $2547 if only within-study days of hospital admission are costed. All estimates are high uncertainty. The results of this small pilot study point to the potential of PEACH as a cost-effective end-of-life care model relative to usual care. Findings support the feasibility of conducting a definitive, fully powered study with longer follow-up and comprehensive economic evaluation.

Motivational, reduction and usual care interventions for smokers who are not ready to quit: a randomized controlled trial.

PubMed

Klemperer, Elias M; Hughes, John R; Solomon, Laura J; Callas, Peter W; Fingar, James R

2017-01-01

To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. A parallel-group randomized controlled trial of brief motivational (n = 185), reduction (n = 186) or usual care (n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. United States. A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. © 2016 Society for the Study of Addiction.

A conceptual model: Redesigning how we provide palliative care for patients with chronic obstructive pulmonary disease.

PubMed

Philip, Jennifer; Crawford, Gregory; Brand, Caroline; Gold, Michelle; Miller, Belinda; Hudson, Peter; Smallwood, Natasha; Lau, Rosalind; Sundararajan, Vijaya

2017-05-31

Despite significant needs, patients with chronic obstructive pulmonary disease (COPD) make limited use of palliative care, in part because the current models of palliative care do not address their key concerns. Our aim was to develop a tailored model of palliative care for patients with COPD and their family caregivers. Based on information gathered within a program of studies (qualitative research exploring experiences, a cohort study examining service use), an expert advisory committee evaluated and integrated data, developed responses, formulated principles to inform care, and made recommendations for practice. The informing studies were conducted in two Australian states: Victoria and South Australia. A series of principles underpinning the model were developed, including that it must be: (1) focused on patient and caregiver; (2) equitable, enabling access to components of palliative care for a group with significant needs; (3) accessible; and (4) less resource-intensive than expansion of usual palliative care service delivery. The recommended conceptual model was to have the following features: (a) entry to palliative care occurs routinely triggered by clinical transitions in care; (b) care is embedded in routine ambulatory respiratory care, ensuring that it is regarded as "usual" care by patients and clinicians alike; (c) the tasks include screening for physical and psychological symptoms, social and community support, provision of information, and discussions around goals and preferences for care; and (d) transition to usual palliative care services is facilitated as the patient nears death. Our proposed innovative and conceptual model for provision of palliative care requires future formal testing using rigorous mixed-methods approaches to determine if theoretical propositions translate into effectiveness, feasibility, and benefits (including economic benefits). There is reason to consider adaptation of the model for the palliative care of patients with other nonmalignant conditions.

Effectiveness of an interactive platform, and the ESC/HFA heartfailurematters.org website in patients with heart failure: design of the multicentre randomized e-Vita heart failure trial.

PubMed

Wagenaar, Kim P; Broekhuizen, Berna D L; Dickstein, Kenneth; Jaarsma, Tiny; Hoes, Arno W; Rutten, Frans H

2015-12-01

Electronic health support (e-health) may improve self-care of patients with heart failure (HF). We aim to assess whether an adjusted care pathway with replacement of routine consultations by e-health improves self-care as compared with usual care. In addition, we will determine whether the ESC/HFA (European Society of Cardiology/Heart Failure Association) website heartfailurematters.org (HFM website) improves self-care when added to usual care. Finally, we aim to evaluate the cost-effectiveness of these interventions. A three-arm parallel randomized trial will be conducted. Arm 1 consists of usual care; arm 2 consists of usual care plus the HFM website; and arm 3 is the adjusted care pathway with an interactive platform for disease management (e-Vita platform), with a link to the HFM website, which replaces routine consultations with HF nurses at the outpatient clinic. In total, 414 patients managed in 10 Dutch HF outpatient clinics or in general practice will be included and followed for 12 months. Participants are included if they have had an established diagnosis of HF for at least 3 months. The primary outcome is self-care as measured by the European Heart Failure Self-care Behaviour scale (EHFScB scale). Secondary outcomes are quality of life, cardiovascular- and HF-related mortality, hospitalization, and its duration as captured by hospital and general practitioner registries, use of and user satisfaction with the HFM website, and cost-effectiveness. This study will provide important prospective data on the impact and cost-effectiveness of an interactive platform for disease management and the HFM website. unique identifier: NCT01755988. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.

Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial.

PubMed

Wiles, Nicola; Thomas, Laura; Abel, Anna; Ridgway, Nicola; Turner, Nicholas; Campbell, John; Garland, Anne; Hollinghurst, Sandra; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Turner, Katrina; Williams, Chris; Peters, Tim; Lewis, Glyn

2013-02-02

Only a third of patients with depression respond fully to antidepressant medication but little evidence exists regarding the best next-step treatment for those whose symptoms are treatment resistant. The CoBalT trial aimed to examine the effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment resistant depression compared with usual care alone. This two parallel-group multicentre randomised controlled trial recruited 469 patients aged 18-75 years with treatment resistant depression (on antidepressants for ≥6 weeks, Beck depression inventory [BDI] score ≥14 and international classification of diseases [ICD]-10 criteria for depression) from 73 UK general practices. Participants were randomised, with a computer generated code (stratified by centre and minimised according to baseline BDI score, whether the general practice had a counsellor, previous treatment with antidepressants, and duration of present episode of depression) to one of two groups: usual care or CBT in addition to usual care, and were followed up for 12 months. Because of the nature of the intervention it was not possible to mask participants, general practitioners, CBT therapists, or researchers to the treatment allocation. Analyses were by intention to treat. The primary outcome was response, defined as at least 50% reduction in depressive symptoms (BDI score) at 6 months compared with baseline. This trial is registered, ISRCTN38231611. Between Nov 4, 2008, and Sept 30, 2010, we assigned 235 patients to usual care, and 234 to CBT plus usual care. 422 participants (90%) were followed up at 6 months and 396 (84%) at 12 months, finishing on Oct 31, 2011. 95 participants (46%) in the intervention group met criteria for response at 6 months compared with 46 (22%) in the usual care group (odds ratio 3·26, 95% CI 2·10-5·06, p<0·001). Before this study, no evidence from large-scale randomised controlled trials was available for the effectiveness of augmentation of antidepressant medication with CBT as a next-step for patients whose depression has not responded to pharmacotherapy. Our study has provided robust evidence that CBT as an adjunct to usual care that includes antidepressants is an effective treatment, reducing depressive symptoms in this population. National Institute for Health Research Health Technology Assessment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Impact of advance care planning on the care of patients with heart failure: study protocol for a randomized controlled trial.

PubMed

Malhotra, Chetna; Sim, David Kheng Leng; Jaufeerally, Fazlur; Vikas, Nivedita Nadkarni; Sim, Genevieve Wong Cheng; Tan, Boon Cheng; Ng, Clarice Shu Hwa; Tho, Pei Leng; Lim, Jingfen; Chuang, Claire Ya-Ting; Fong, Florence Hui Mei; Liu, Joy; Finkelstein, Eric A

2016-06-10

Despite the promise and popularity of advance care planning, there is insufficient evidence that advance care planning helps patients to meet their end-of-life care preferences, especially in Asian settings. Thus, the proposed study aims to assess whether patients with advanced heart failure who are receiving advance care planning have a greater likelihood of receiving end-of-life care consistent with their preferences compared to patients receiving usual care. Secondary objectives are to compare differences in health care expenditures, quality of life, anxiety and depression, understanding of own illness, participation in decision-making and concordance with their caregiver's preferences for end-of-life care, between patients with advanced heart failure receiving advance care planning and usual care. This is a two-arm randomized controlled trial of advance care planning versus usual care (control) conducted at two institutions in Singapore. Two hundred and eighty-two patients with advanced heart failure (n = 94 in the advance care planning arm; n = 188 in the control arm receiving usual care) will be recruited from these centers and followed for 1 year or until they die, whichever is earlier. Additionally, the study will include up to one caregiver per patient enrolled. If advance care planning is proven to be effective, the results will help to promote its uptake among health care providers and patients both within Singapore and in other countries. NCT02299180 . Registered on 18 November 2014.

Comparison of group-based outpatient physiotherapy with usual care after total knee replacement: a feasibility study for a randomized controlled trial.

PubMed

Artz, Neil; Dixon, Samantha; Wylde, Vikki; Marques, Elsa; Beswick, Andrew D; Lenguerrand, Erik; Blom, Ashley W; Gooberman-Hill, Rachael

2017-04-01

To evaluate the feasibility of conducting a randomized controlled trial comparing group-based outpatient physiotherapy with usual care in patients following total knee replacement. A feasibility study for a randomized controlled trial. One secondary-care hospital orthopaedic centre, Bristol, UK. A total of 46 participants undergoing primary total knee replacement. The intervention group were offered six group-based exercise sessions after surgery. The usual care group received standard postoperative care. Participants were not blinded to group allocation. Feasibility was assessed by recruitment, reasons for non-participation, attendance, and completion rates of study questionnaires that included the Lower Extremity Functional Scale and Knee Injury and Osteoarthritis Outcome Score. Recruitment rate was 37%. Five patients withdrew or were no longer eligible to participate. Intervention attendance was high (73%) and 84% of group participants reported they were 'very satisfied' with the exercises. Return of study questionnaires at six months was lower in the usual care (75%) than in the intervention group (100%). Mean (standard deviation) Lower Extremity Functional Scale scores at six months were 45.0 (20.8) in the usual care and 57.8 (15.2) in the intervention groups. Recruitment and retention of participants in this feasibility study was good. Group-based physiotherapy was acceptable to participants. Questionnaire return rates were lower in the usual care group, but might be enhanced by telephone follow-up. The Lower Extremity Functional Scale had high responsiveness and completion rates. Using this outcome measure, 256 participants would be required in a full-scale randomized controlled trial.

Impact of Primary Care Intensive Management on High-Risk Veterans' Costs and Utilization: A Randomized Quality Improvement Trial.

PubMed

Yoon, Jean; Chang, Evelyn; Rubenstein, Lisa V; Park, Angel; Zulman, Donna M; Stockdale, Susan; Ong, Michael K; Atkins, David; Schectman, Gordon; Asch, Steven M

2018-06-05

Primary care models that offer comprehensive, accessible care to all patients may provide insufficient resources to meet the needs of patients with complex conditions who have the greatest risk for hospitalization. To assess whether augmenting usual primary care with team-based intensive management lowers utilization and costs for high-risk patients. Randomized quality improvement trial. (ClinicalTrials.gov: NCT03100526). 5 U.S. Department of Veterans Affairs (VA) medical centers. Primary care patients at high risk for hospitalization who had a recent acute care episode. Locally tailored intensive management programs providing care coordination, goals assessment, health coaching, medication reconciliation, and home visits through an interdisciplinary team, including a physician or nurse practitioner, a nurse, and psychosocial experts. Utilization and costs (including intensive management program expenses) 12 months before and after randomization. 2210 patients were randomly assigned, 1105 to intensive management and 1105 to usual care. Patients had a mean age of 63 years and an average of 7 chronic conditions; 90% were men. Of the patients assigned to intensive management, 487 (44%) received intensive outpatient care (that is, ≥3 encounters in person or by telephone) and 204 (18%) received limited intervention. From the pre- to postrandomization periods, mean inpatient costs decreased more for the intensive management than the usual care group (-$2164 [95% CI, -$7916 to $3587]). Outpatient costs increased more for the intensive management than the usual care group ($2636 [CI, $524 to $4748]), driven by greater use of primary care, home care, telephone care, and telehealth. Mean total costs were similar in the 2 groups before and after randomization. Sites took up to several months to contact eligible patients, limiting the time between treatment and outcome assessment. Only VA costs were assessed. High-risk patients with access to an intensive management program received more outpatient care with no increase in total costs. Veterans Health Administration Primary Care Services.

Usual Primary Care Provider Characteristics of a Patient-Centered Medical Home and Mental Health Service Use.

PubMed

Jones, Audrey L; Cochran, Susan D; Leibowitz, Arleen; Wells, Kenneth B; Kominski, Gerald; Mays, Vickie M

2015-12-01

The benefits of the patient-centered medical home (PCMH) over and above that of a usual source of medical care have yet to be determined, particularly for adults with mental health disorders. To examine qualities of a usual provider that align with PCMH goals of access, comprehensiveness, and patient-centered care, and to determine whether PCMH qualities in a usual provider are associated with the use of mental health services (MHS). Using national data from the Medical Expenditure Panel Survey, we conducted a lagged cross-sectional study of MHS use subsequent to participant reports of psychological distress and usual provider and practice characteristics. A total of 2,358 adults, aged 18-64 years, met the criteria for serious psychological distress and reported on their usual provider and practice characteristics. We defined "usual provider" as a primary care provider/practice, and "PCMH provider" as a usual provider that delivered accessible, comprehensive, patient-centered care as determined by patient self-reporting. The dependent variable, MHS, included self-reported mental health visits to a primary care provider or mental health specialist, counseling, and psychiatric medication treatment over a period of 1 year. Participants with a usual provider were significantly more likely than those with no usual provider to have experienced a primary care mental health visit (marginal effect [ME] = 8.5, 95 % CI = 3.2-13.8) and to have received psychiatric medication (ME = 15.5, 95 % CI = 9.4-21.5). Participants with a PCMH were additionally more likely than those with no usual provider to visit a mental health specialist (ME = 7.6, 95 % CI = 0.7-14.4) and receive mental health counseling (ME = 8.5, 95 % CI = 1.5-15.6). Among those who reported having had any type of mental health visit, participants with a PCMH were more likely to have received mental health counseling than those with only a usual provider (ME = 10.0, 95 % CI = 1.0-19.0). Access to a usual provider is associated with increased receipt of needed MHS. Patients who have a usual provider with PCMH qualities are more likely to receive mental health counseling.

Terminal patients in Belgian nursing homes: a cost analysis.

PubMed

Simoens, Steven; Kutten, Betty; Keirse, Emmanuel; Vanden Berghe, Paul; Beguin, Claire; Desmedt, Marianne; Deveugele, Myriam; Léonard, Christian; Paulus, Dominique; Menten, Johan

2013-06-01

Policy makers and health care payers are concerned about the costs of treating terminal patients. This study was done to measure the costs of treating terminal patients during the final month of life in a sample of Belgian nursing homes from the health care payer perspective. Also, this study compares the costs of palliative care with those of usual care. This multicenter, retrospective cohort study enrolled terminal patients from a representative sample of nursing homes. Health care costs included fixed nursing home costs, medical fees, pharmacy charges, other charges, and eventual hospitalization costs. Data sources consisted of accountancy and invoice data. The analysis calculated costs per patient during the final month of life at 2007/2008 prices. Nineteen nursing homes participated in the study, generating a total of 181 patients. Total mean nursing home costs amounted to 3,243 € per patient during the final month of life. Total mean nursing home costs per patient of 3,822 € for patients receiving usual care were higher than costs of 2,456 € for patients receiving palliative care (p = 0.068). Higher costs of usual care were driven by higher hospitalization costs (p < 0.001). This study suggests that palliative care models in nursing homes need to be supported because such care models appear to be less expensive than usual care and because such care models are likely to better reflect the needs of terminal patients.

Does Physician Education on Depression Management Improve Treatment in Primary Care?

PubMed Central

Lin, Elizabeth H B; Simon, Gregory E; Katzelnick, David J; Pearson, Steven D

2001-01-01

OBJECTIVE To assess the effect of physician training on management of depression. DESIGN Primary care physicians were randomly assigned to a depression management intervention that included an educational program. A before-and-after design evaluated physician practices for patients not enrolled in the intervention trial. SETTING One hundred nine primary care physicians in 2 health maintenance organizations located in the Midwest and Northwest regions of the United States. PATIENTS/PARTICIPANTS Computerized pharmacy and visit data from a group of 124,893 patients who received visits or prescriptions from intervention and usual care physicians. INTERVENTIONS Primary care physicians received education on diagnosis and optimal management of depression over a 3-month training period. Methods of education included small group interactive discussions, expert demonstrations, role-play, and academic detailing of pharmacotherapy, criteria for urgent psychiatric referrals, and case reviews with psychiatric consultants. MEASUREMENTS AND MAIN RESULTS Pharmacy and visit data provided indicators of physician management of depression: rate of newly diagnosed depression, new prescription of antidepressant medication, and duration of pharmacotherapy. One year after the training period, intervention and usual care physicians did not differ significantly in the rate of new depression diagnosis (P = .95) or new prescription of antidepressant medicines (P = .10). Meanwhile, patients of intervention physicians did not differ from patients of usual care physicians in adequacy of pharmacotherapy (P = .53) as measured by 12 weeks of continuous antidepressant treatment. CONCLUSIONS After education on optimal management of depression, intervention physicians did not differ from their usual care colleagues in depression diagnosis or pharmacotherapy. PMID:11556942

Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness.

PubMed

Abbott, J H; Robertson, M C; Chapple, C; Pinto, D; Wright, A A; Leon de la Barra, S; Baxter, G D; Theis, J-C; Campbell, A J

2013-04-01

To evaluate the clinical effectiveness of manual physiotherapy and/or exercise physiotherapy in addition to usual care for patients with osteoarthritis (OA) of the hip or knee. In this 2 × 2 factorial randomized controlled trial, 206 adults (mean age 66 years) who met the American College of Rheumatology criteria for hip or knee OA were randomly allocated to receive manual physiotherapy (n = 54), multi-modal exercise physiotherapy (n = 51), combined exercise and manual physiotherapy (n = 50), or no trial physiotherapy (n = 51). The primary outcome was change in the Western Ontario and McMaster osteoarthritis index (WOMAC) after 1 year. Secondary outcomes included physical performance tests. Outcome assessors were blinded to group allocation. Of 206 participants recruited, 193 (93.2%) were retained at follow-up. Mean (SD) baseline WOMAC score was 100.8 (53.8) on a scale of 0-240. Intention to treat analysis showed adjusted reductions in WOMAC scores at 1 year compared with the usual care group of 28.5 (95% confidence interval (CI) 9.2-47.8) for usual care plus manual therapy, 16.4 (-3.2 to 35.9) for usual care plus exercise therapy, and 14.5 (-5.2 to 34.1) for usual care plus combined exercise therapy and manual therapy. There was an antagonistic interaction between exercise therapy and manual therapy (P = 0.027). Physical performance test outcomes favoured the exercise therapy group. Manual physiotherapy provided benefits over usual care, that were sustained to 1 year. Exercise physiotherapy also provided physical performance benefits over usual care. There was no added benefit from a combination of the two therapies. Australian New Zealand Clinical Trials Registry ACTRN12608000130369. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Improving quality of care and long-term health outcomes through continuity of care with the use of an electronic or paper patient-held portable health file (COMMUNICATE): study protocol for a randomized controlled trial.

PubMed

Lassere, Marissa Nichole; Baker, Sue; Parle, Andrew; Sara, Anthony; Johnson, Kent Robert

2015-06-04

The advantages of patient-held portable health files (PHF) and personal health records (PHR), paper or electronic, are said to include improved health-care provider continuity-of-care and patient empowerment in maintaining health. Top-down approaches are favored by public sector government and health managers. Bottom-up approaches include systems developed directly by health-care providers, consumers and industry, implemented locally on devices carried by patient-consumers or shared via web-based portals. These allow individuals to access, manage and share their health information, and that of others for whom they are authorized, in a private, secure and confidential environment. Few medical record technologies have been evaluated in randomized trials to determine whether there are important clinical benefits of these interventions. The COMMUNICATE trial will assess the acceptability and long-term clinical outcomes of an electronic and paper patient-held PHF. This is a 48-month, open-label pragmatic, superiority, parallel-group design randomized controlled trial. Subjects (n = 792) will be randomized in a 1:1:1 ratio to each of the trial arms: the electronic PHF added to usual care, the paper PHF added to usual care and usual care alone (no PHF). Inclusion criteria include those 60 years or older living independently in the community, but who have two or more chronic medical conditions that require prescription medication and regular care by at least three medical practitioners (general and specialist care). The primary objective is whether use of a PHF compared to usual care reduces a combined endpoint of deaths, overnight hospitalizations and blindly adjudicated serious out-of-hospital events. All primary analyses will be undertaken masked to randomized arm allocation using intention-to-treat principles. Secondary outcomes include quality of life and health literacy improvements. Lack of blinding creates potential for bias in trial conduct and ascertainment of clinical outcomes. Mechanisms are provided to reduce bias, including balanced study contact with all participants, a blinded adjudication committee determining which out-of-hospital events are serious and endpoints that are objective (overnight hospitalizations and mortality). The PRECIS tool provides a summary of the trial's design on the Pragmatic-Explanatory Continuum. Registered with Clinicaltrials.gov (identifier: NCT01082978) on 8 March 2010.

Early rehabilitation after total knee replacement surgery: a multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.

PubMed

Han, Annie S Y; Nairn, Lillias; Harmer, Alison R; Crosbie, Jack; March, Lyn; Parker, David; Crawford, Ross; Fransen, Marlene

2015-02-01

To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis. We conducted a multicenter, randomized clinical trial. Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation (n = 196) or the HEP (n = 194). Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales, knee range of motion, and the 50-foot walk time. The upper bound of the 95% confidence interval (95% CI) mean difference favoring usual care was used to determine noninferiority. At 6 weeks after surgery there were no significant differences between usual care and HEP, respectively, for pain (7.4 and 7.2; 95% CI mean difference [MD] -0.7, 0.9), physical function (22.5 and 22.4; 95% CI MD -2.5, 2.6), knee flexion (96° and 97°; 95% CI MD -4°, 2°), knee extension (-7° and -6°; 95% CI MD -2°, 1°), or the 50-foot walk time (12.9 and 12.9 seconds; 95% CI MD -0.8, 0.7 seconds). At 6 weeks, 18 patients (9%) allocated to usual care and 11 (6%) to the HEP did not achieve 80° knee flexion. There was no difference between the treatment allocations in the number of hospital readmissions. The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR. Copyright © 2015 by the American College of Rheumatology.

The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes’ Effects on Moms (GEM) Cluster Randomized Controlled Trial

PubMed Central

Hedderson, Monique M.; Brown, Susan D.; Albright, Cheryl L.; Ehrlich, Samantha F.; Tsai, Ai-Lin; Caan, Bette J.; Sternfeld, Barbara; Gordon, Nancy P.; Schmittdiel, Julie A.; Gunderson, Erica P.; Mevi, Ashley A.; Herman, William H.; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P.

2016-01-01

OBJECTIVE To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)–derived lifestyle intervention. RESEARCH DESIGN AND METHODS This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m2 or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m2; and pregravid to postpartum weight change. RESULTS On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference −0.64 kg [95% CI −1.13, −0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). CONCLUSIONS A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. PMID:26657945

The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial.

PubMed

Ferrara, Assiamira; Hedderson, Monique M; Brown, Susan D; Albright, Cheryl L; Ehrlich, Samantha F; Tsai, Ai-Lin; Caan, Bette J; Sternfeld, Barbara; Gordon, Nancy P; Schmittdiel, Julie A; Gunderson, Erica P; Mevi, Ashley A; Herman, William H; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P

2016-01-01

To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention. This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m(2) or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m(2); and pregravid to postpartum weight change. On average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference -0.64 kg [95% CI -1.13, -0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]). A DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity. © 2016 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

Design of a randomized controlled trial to assess the comparative effectiveness of a multifaceted intervention to improve adherence to colorectal cancer screening among patients cared for in a community health center.

PubMed

Baker, David W; Brown, Tiffany; Buchanan, David R; Weil, Jordan; Cameron, Kenzie A; Ranalli, Lauren; Ferreira, M Rosario; Stephens, Quinn; Balsley, Kate; Goldman, Shira N; Wolf, Michael S

2013-04-29

Colorectal cancer (CRC) is common and leads to significant morbidity and mortality. Although screening with fecal occult blood testing (FOBT) or endoscopy has been shown to decrease CRC mortality, screening rates remain suboptimal. Screening rates are particularly low for people with low incomes and members of underrepresented minority groups. FOBT should be done annually to detect CRC early and to reduce CRC mortality, but this often does not occur. This paper describes the design of a multifaceted intervention to increase long-term adherence to FOBT among poor, predominantly Latino patients, and the design of a randomized controlled trial (RCT) to test the efficacy of this intervention compared to usual care. In this RCT, patients who are due for repeat FOBT are identified in the electronic health record (EHR) and randomized to receive either usual care or a multifaceted intervention. The usual care group includes multiple point-of-care interventions (e.g., standing orders, EHR reminders), performance measurement, and financial incentives to improve CRC screening rates. The intervention augments usual care through mailed CRC screening test kits, low literacy patient education materials, automated phone and text message reminders, in-person follow up calls from a CRC Screening Coordinator, and communication of results to patients along with a reminder card highlighting when the patient is next due for screening. The primary outcome is completion of FOBT within 6 months of becoming due. The main goal of the study is to determine the comparative effectiveness of the intervention compared to usual care. Additionally, we want to assess whether or not it is possible to achieve high rates of adherence to CRC screening with annual FOBT, which is necessary for reducing CRC mortality. The intervention relies on technology that is increasingly widespread and declining in cost, including EHR systems, automated phone and text messaging, and FOBTs for CRC screening. We took this approach to ensure generalizability and allow us to rapidly disseminate the intervention through networks of community health centers (CHCs) if the RCT shows the intervention to be superior to usual care. ClinicalTrials.gov NCT01453894.

Protocolized fluid therapy in brain-dead donors: The multi-center randomized MOnIToR trial

PubMed Central

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S.; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-01-01

BACKGROUND Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multi-center randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases organs transplanted. METHODS We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A “protocol-guided fluid therapy” algorithm targeting cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor and our primary analysis was intention-to-treat. Secondary analyses included: 1) modified intention-to-treat where only subjects able to receive the intervention were included, and 2) twelve-month survival in transplant recipients. The study was stopped early. RESULTS We enrolled 556 donors; 279 protocolized care, 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76% of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor, (95%CI: 3.14-3.63) with protocolized care, compared to usual care 3.29 (95%CI: 3.04-3.54) (mean difference, 0.1, 95%CI: -0.25 to 0.45; p=0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95%CI: 3.23-3.8) but was not statistically significant (mean difference, 0.23, 95%CI: -0.15-0.61; p=0.23). Among the 1430 recipients of organs from study subjects, with data available, 56 deaths (7.8%) occurred in the protocolized care arm and 56 (7.9%) in the usual care arm in the first year (Hazard Ratio: 0.97, p=0.86). CONCLUSIONS In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor. PMID:25583616

Clinical effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: the CoBalT randomised controlled trial.

PubMed

Wiles, Nicola; Thomas, Laura; Abel, Anna; Barnes, Maria; Carroll, Fran; Ridgway, Nicola; Sherlock, Sofie; Turner, Nicholas; Button, Katherine; Odondi, Lang'o; Metcalfe, Chris; Owen-Smith, Amanda; Campbell, John; Garland, Anne; Hollinghurst, Sandra; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Turner, Katrina; Williams, Chris; Peters, Tim; Lewis, Glyn

2014-05-01

Only one-third of patients with depression respond fully to treatment with antidepressant medication. However, there is little robust evidence to guide the management of those whose symptoms are 'treatment resistant'. The CoBalT trial examined the clinical effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment-resistant depression (TRD) compared with usual care alone. Pragmatic, multicentre individually randomised controlled trial with follow-up at 3, 6, 9 and 12 months. A subset took part in a qualitative study investigating views and experiences of CBT, reasons for completing/not completing therapy, and usual care for TRD. General practices in Bristol, Exeter and Glasgow, and surrounding areas. Patients aged 18-75 years who had TRD [on antidepressants for ≥ 6 weeks, had adhered to medication, Beck Depression Inventory, 2nd version (BDI-II) score of ≥ 14 and fulfilled the International Classification of Diseases and Related Health Problems, Tenth edition criteria for depression]. Individuals were excluded who (1) had bipolar disorder/psychosis or major alcohol/substance abuse problems; (2) were unable to complete the questionnaires; or (3) were pregnant, as were those currently receiving CBT/other psychotherapy/secondary care for depression, or who had received CBT in the past 3 years. Participants were randomised, using a computer-generated code, to usual care or CBT (12-18 sessions) in addition to usual care. The primary outcome was 'response', defined as ≥ 50% reduction in depressive symptoms (BDI-II score) at 6 months compared with baseline. Secondary outcomes included BDI-II score as a continuous variable, remission of symptoms (BDI-II score of < 10), quality of life, anxiety and antidepressant use at 6 and 12 months. Data on health and social care use, personal costs, and time off work were collected at 6 and 12 months. Costs from these three perspectives were reported using a cost-consequence analysis. A cost-utility analysis compared health and social care costs with quality adjusted life-years. A total of 469 patients were randomised (intervention: n = 234; usual care: n = 235), with 422 participants (90%) and 396 (84%) followed up at 6 and 12 months. Ninety-five participants (46.1%) in the intervention group met criteria for 'response' at 6 months compared with 46 (21.6%) in the usual-care group {odds ratio [OR] 3.26 [95% confidence interval (CI) 2.10 to 5.06], p < 0.001}. In repeated measures analyses using data from 6 and 12 months, the OR for 'response' was 2.89 (95% CI 2.03 to 4.10, p < 0.001) and for a secondary 'remission' outcome (BDI-II score of < 10) 2.74 (95% CI 1.82 to 4.13, p < 0.001). The mean cost of CBT per participant was £ 910, the incremental health and social care cost £ 850, the incremental QALY gain 0.057 and incremental cost-effectiveness ratio £ 14,911. Forty participants were interviewed. Patients described CBT as challenging but helping them to manage their depression; listed social, emotional and practical reasons for not completing treatment; and described usual care as mainly taking medication. Among patients who have not responded to antidepressants, augmenting usual care with CBT is effective in reducing depressive symptoms, and these effects, including outcomes reflecting remission, are maintained over 12 months. The intervention was cost-effective based on the National Institute for Health and Care Excellence threshold. Patients may experience CBT as difficult but effective. Further research should evaluate long-term effectiveness, as this would have major implications for the recommended treatment of depression. Current Controlled Trials ISRCTN38231611.

Effect of Endobronchial Coils vs Usual Care on Exercise Tolerance in Patients With Severe Emphysema: The RENEW Randomized Clinical Trial.

PubMed

Sciurba, Frank C; Criner, Gerard J; Strange, Charlie; Shah, Pallav L; Michaud, Gaetane; Connolly, Timothy A; Deslée, Gaëtan; Tillis, William P; Delage, Antoine; Marquette, Charles-Hugo; Krishna, Ganesh; Kalhan, Ravi; Ferguson, J Scott; Jantz, Michael; Maldonado, Fabien; McKenna, Robert; Majid, Adnan; Rai, Navdeep; Gay, Steven; Dransfield, Mark T; Angel, Luis; Maxfield, Roger; Herth, Felix J F; Wahidi, Momen M; Mehta, Atul; Slebos, Dirk-Jan

Preliminary clinical trials have demonstrated that endobronchial coils compress emphysematous lung tissue and may improve lung function, exercise tolerance, and symptoms in patients with emphysema and severe lung hyperinflation. To determine the effectiveness and safety of endobronchial coil treatment. Randomized clinical trial conducted among 315 patients with emphysema and severe air trapping recruited from 21 North American and 5 European sites from December 2012 through November 2015. Participants were randomly assigned to continue usual care alone (guideline based, including pulmonary rehabilitation and bronchodilators; n = 157) vs usual care plus bilateral coil treatment (n = 158) involving 2 sequential procedures 4 months apart in which 10 to 14 coils were bronchoscopically placed in a single lobe of each lung. The primary effectiveness outcome was difference in absolute change in 6-minute-walk distance between baseline and 12 months (minimal clinically important difference [MCID], 25 m). Secondary end points included the difference between groups in 6-minute walk distance responder rate, absolute change in quality of life using the St George's Respiratory Questionnaire (MCID, 4) and change in forced expiratory volume in the first second (FEV1; MCID, 10%). The primary safety analysis compared the proportion of participants experiencing at least 1 of 7 prespecified major complications. Among 315 participants (mean age, 64 years; 52% women), 90% completed the 12-month follow-up. Median change in 6-minute walk distance at 12 months was 10.3 m with coil treatment vs -7.6 m with usual care, with a between-group difference of 14.6 m (Hodges-Lehmann 97.5% CI, 0.4 m to ∞; 1-sided P = .02). Improvement of at least 25 m occurred in 40.0% of patients in the coil group vs 26.9% with usual care (odds ratio, 1.8 [97.5% CI, 1.1 to ∞]; unadjusted between-group difference, 11.8% [97.5% CI, 1.0% to ∞]; 1-sided P = .01). The between-group difference in median change in FEV1 was 7.0% (97.5% CI, 3.4% to ∞; 1-sided P < .001), and the between-group St George's Respiratory Questionnaire score improved -8.9 points (97.5% CI, -∞ to -6.3 points; 1-sided P < .001), each favoring the coil group. Major complications (including pneumonia requiring hospitalization and other potentially life-threatening or fatal events) occurred in 34.8% of coil participants vs 19.1% of usual care (P = .002). Other serious adverse events including pneumonia (20% coil vs 4.5% usual care) and pneumothorax (9.7% vs 0.6%, respectively) occurred more frequently in the coil group. Among patients with emphysema and severe hyperinflation treated for 12 months, the use of endobronchial coils compared with usual care resulted in an improvement in median exercise tolerance that was modest and of uncertain clinical importance, with a higher likelihood of major complications. Further follow-up is needed to assess long-term effects on health outcomes. clinicaltrials.gov Identifier: NCT01608490.

Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial.

PubMed

McManus, Richard J; Mant, Jonathan; Franssen, Marloes; Nickless, Alecia; Schwartz, Claire; Hodgkinson, James; Bradburn, Peter; Farmer, Andrew; Grant, Sabrina; Greenfield, Sheila M; Heneghan, Carl; Jowett, Susan; Martin, Una; Milner, Siobhan; Monahan, Mark; Mort, Sam; Ogburn, Emma; Perera-Salazar, Rafael; Shah, Syed Ahmar; Yu, Ly-Mee; Tarassenko, Lionel; Hobbs, F D Richard

2018-03-10

Studies evaluating titration of antihypertensive medication using self-monitoring give contradictory findings and the precise place of telemonitoring over self-monitoring alone is unclear. The TASMINH4 trial aimed to assess the efficacy of self-monitored blood pressure, with or without telemonitoring, for antihypertensive titration in primary care, compared with usual care. This study was a parallel randomised controlled trial done in 142 general practices in the UK, and included hypertensive patients older than 35 years, with blood pressure higher than 140/90 mm Hg, who were willing to self-monitor their blood pressure. Patients were randomly assigned (1:1:1) to self-monitoring blood pressure (self-montoring group), to self-monitoring blood pressure with telemonitoring (telemonitoring group), or to usual care (clinic blood pressure; usual care group). Randomisation was by a secure web-based system. Neither participants nor investigators were masked to group assignment. The primary outcome was clinic measured systolic blood pressure at 12 months from randomisation. Primary analysis was of available cases. The trial is registered with ISRCTN, number ISRCTN 83571366. 1182 participants were randomly assigned to the self-monitoring group (n=395), the telemonitoring group (n=393), or the usual care group (n=394), of whom 1003 (85%) were included in the primary analysis. After 12 months, systolic blood pressure was lower in both intervention groups compared with usual care (self-monitoring, 137·0 [SD 16·7] mm Hg and telemonitoring, 136·0 [16·1] mm Hg vs usual care, 140·4 [16·5]; adjusted mean differences vs usual care: self-monitoring alone, -3·5 mm Hg [95% CI -5·8 to -1·2]; telemonitoring, -4·7 mm Hg [-7·0 to -2·4]). No difference between the self-monitoring and telemonitoring groups was recorded (adjusted mean difference -1·2 mm Hg [95% CI -3·5 to 1·2]). Results were similar in sensitivity analyses including multiple imputation. Adverse events were similar between all three groups. Self-monitoring, with or without telemonitoring, when used by general practitioners to titrate antihypertensive medication in individuals with poorly controlled blood pressure, leads to significantly lower blood pressure than titration guided by clinic readings. With most general practitioners and many patients using self-monitoring, it could become the cornerstone of hypertension management in primary care. National Institute for Health Research via Programme Grant for Applied Health Research (RP-PG-1209-10051), Professorship to RJM (NIHR-RP-R2-12-015), Oxford Collaboration for Leadership in Applied Health Research and Care, and Omron Healthcare UK. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Quasi-experimental evaluation of a multifaceted intervention to improve quality of end-of-life care and quality of dying for patients with advanced dementia in long-term care institutions.

PubMed

Verreault, René; Arcand, Marcel; Misson, Lucie; Durand, Pierre J; Kroger, Edeltraut; Aubin, Michèle; Savoie, Maryse; Hadjistavropoulos, Thomas; Kaasalainen, Sharon; Bédard, Annick; Grégoire, Annie; Carmichael, Pierre-Hughes

2018-03-01

Improvement in the quality of end-of-life care for advanced dementia is increasingly recognized as a priority in palliative care. To evaluate the impact of a multidimensional intervention to improve quality of care and quality of dying in advanced dementia in long-term care facilities. Quasi-experimental study with the intervention taking place in two long-term care facilities versus usual care in two others over a 1-year period. The intervention had five components: (1) training program to physicians and nursing staff, (2) clinical monitoring of pain using an observational pain scale, (3) implementation of a regular mouth care routine, (4) early and systematic communication with families about end-of-life care issues with provision of an information booklet, and (5) involvement of a nurse facilitator to implement and monitor the intervention. Quality of care was assessed with the Family Perception of Care Scale. The Symptom Management for End-of-Life Care in Dementia and the Comfort Assessment in Dying scales were used to assess the quality of dying. A total of 193 residents with advanced dementia and their close family members were included (97 in the intervention group and 96 in the usual care group). The Family Perception of Care score was significantly higher in the intervention group than in the usual care group (157.3 vs 149.1; p = 0.04). The Comfort Assessment and Symptom Management scores were also significantly higher in the intervention group. Our multidimensional intervention in long-term care facilities for patients with terminal dementia resulted in improved quality of care and quality of dying when compared to usual care.

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer.

PubMed

Emery, Jon D; Jefford, Michael; King, Madeleine; Hayne, Dickon; Martin, Andrew; Doorey, Juanita; Hyatt, Amelia; Habgood, Emily; Lim, Tee; Hawks, Cynthia; Pirotta, Marie; Trevena, Lyndal; Schofield, Penelope

2017-03-01

To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer. Men who had completed treatment for low- to moderate-risk prostate cancer within the previous 8 weeks were eligible. Participants were randomized to usual care or shared care. Shared care entailed substituting two hospital visits with three visits in primary care, a survivorship care plan, recall and reminders, and screening for distress and unmet needs. Outcome measures included psychological distress, prostate cancer-specific quality of life, satisfaction and preferences for care and healthcare resource use. A total of 88 men were randomized (shared care n = 45; usual care n = 43). There were no clinically important or statistically significant differences between groups with regard to distress, prostate cancer-specific quality of life or satisfaction with care. At the end of the trial, men in the intervention group were significantly more likely to prefer a shared care model to hospital follow-up than those in the control group (intervention 63% vs control 24%; P<0.001). There was high compliance with prostate-specific antigen monitoring in both groups. The shared care model was cheaper than usual care (shared care AUS$1411; usual care AUS$1728; difference AUS$323 [plausible range AUS$91-554]). Well-structured shared care for men with low- to moderate-risk prostate cancer is feasible and appears to produce clinically similar outcomes to those of standard care, at a lower cost. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Supplemental parenteral nutrition versus usual care in critically ill adults: a pilot randomized controlled study.

PubMed

Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, D James; McGuinness, Shay

2018-01-23

In the critically ill, energy delivery from enteral nutrition (EN) is often less than the estimated energy requirement. Parenteral nutrition (PN) as a supplement to EN may increase energy delivery. We aimed to determine if an individually titrated supplemental PN strategy commenced 48-72 hours following ICU admission and continued for up to 7 days would increase energy delivery to critically ill adults compared to usual care EN delivery. This study was a prospective, parallel group, phase II pilot trial conducted in six intensive care units in Australia and New Zealand. Mechanically ventilated adults with at least one organ failure and EN delivery below 80% of estimated energy requirement in the previous 24 hours received either a supplemental PN strategy (intervention group) or usual care EN delivery. EN in the usual care group could be supplemented with PN if EN remained insufficient after usual methods to optimise delivery were attempted. There were 100 patients included in the study and 99 analysed. Overall, 71% of the study population were male, with a mean (SD) age of 59 (17) years, Acute Physiology and Chronic Health Evaluation II score of 18.2 (6.7) and body mass index of 29.6 (5.8) kg/m 2 . Significantly greater energy (mean (SD) 1712 (511) calories vs. 1130 (601) calories, p < 0.0001) and proportion of estimated energy requirement (mean (SD) 83 (25) % vs. 53 (29) %, p < 0.0001) from EN and/or PN was delivered to the intervention group compared to usual care. Delivery of protein and proportion of estimated protein requirements were also greater in the intervention group (mean (SD) 86 (25) g, 86 (23) %) compared to usual care (mean (SD) 53 (29) g, 51 (25) %, p < 0.0001). Antibiotic use, ICU and hospital length of stay, mortality and functional outcomes were similar between the two groups. This individually titrated supplemental PN strategy applied over 7 days significantly increased energy delivery when compared to usual care delivery. Clinical and functional outcomes were similar between the two patient groups. Clinical Trial registry details: NCT01847534 (First registered 22 April 2013, last updated 31 July 2016).

Palliative Care Questions and Answers (Hospice Care Comparison)

MedlinePlus

... usually there is a team including doctors, nurses, social workers and chaplains, similar to the hospice team. A team – doctor, nurse, social worker, chaplain, volunteer, home health aide and others. For ...

Pharmacotherapy after myocardial infarction: disease management versus usual care.

PubMed

Chan, Vicky; Cooke, Catherine E

2008-06-01

To evaluate the effectiveness of a disease management (DM) program compared with usual care on utilization of and adherence to key evidence-based therapies (angiotensin-converting enzyme [ACE] inhibitors/angiotensin II receptor blockers [ARBs], beta-blockers, and statins) after hospital discharge for patients with myocardial infarction (MI) in a managed care organization. Retrospective case-control cohort. Members were included if they were 18 years of age or older and had any medical claims for hospitalization for MI, defined as International Classification of Diseases, Ninth Revision, Clinical Modification, codes 410.xx, from January 1, 2002, to December 31, 2002. The index date was the first date of discharge for members with an MI diagnosis. Members were categorized into the active group (automatically enrolled in the DM program) or the control group (not enrolled in the program because their employer group did not purchase the benefit). Pharmacy claims were obtained for 12 months after the index date for ACE inhibitors, ARBs, beta-blockers, and statins. The study cohort included 250 members in the active group and 137 members in the control group. There were no statistical differences in utilization or time to first prescription fill of ACE inhibitors, ARBs, beta-blockers, and statins between the DM and usual care groups. Adherence to each of these therapies, as measured by medication possession ratio, was not statistically different between the 2 groups. Compared with usual care, participation in the DM program did not improve ACE inhibitor, ARB, statin, or beta-blocker utilization or adherence in members post-MI.

Impact of a pharmacist-physician collaborative care model on patient outcomes and health services utilization.

PubMed

Matzke, Gary R; Moczygemba, Leticia R; Williams, Karen J; Czar, Michael J; Lee, William T

2018-05-22

The impact of a pharmacist-physician collaborative care model on patient outcomes and health services utilization is described. Six hospitals from the Carilion Clinic health system in southwest Virginia, along with 22 patient-centered medical home (PCMH) practices affiliated with Carilion Clinic, participated in this project. Eligibility criteria included documented diagnosis of 2 or more of the 7 targeted chronic conditions (congestive heart failure, hypertension, hyperlipidemia, diabetes mellitus, asthma, chronic obstructive pulmonary disease, and depression), prescriptions for 4 or more medications, and having a primary care physician in the Carilion Clinic health system. A total of 2,480 evaluable patients were included in both the collaborative care group and the usual care group. The primary clinical outcomes measured were the absolute change in values associated with diabetes mellitus, hypertension, and hyperlipidemia management from baseline within and between the collaborative care and usual care groups. Significant improvements ( p < 0.01) in glycosylated hemoglobin, blood pressure, low-density-lipoprotein cholesterol, and total cholesterol were observed in the collaborative care group compared with the usual care group. Hospitalizations declined significantly in the collaborative care group (23.4%), yielding an estimated cost savings of $2,619 per patient. The return on investment (net savings divided by program cost) was 504%. Inclusion of clinical pharmacists in this physician-pharmacist collaborative care-based PCMH model was associated with significant improvements in patients' medication-related clinical health outcomes and a reduction in hospitalizations. Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Cost-Effectiveness Analysis: Risk Stratification of Nonalcoholic Fatty Liver Disease (NAFLD) by the Primary Care Physician Using the NAFLD Fibrosis Score.

PubMed

Tapper, Elliot B; Hunink, M G Myriam; Afdhal, Nezam H; Lai, Michelle; Sengupta, Neil

2016-01-01

The complications of Nonalcoholic Fatty Liver Disease (NAFLD) are dependent on the presence of advanced fibrosis. Given the high prevalence of NAFLD in the US, the optimal evaluation of NAFLD likely involves triage by a primary care physician (PCP) with advanced disease managed by gastroenterologists. We compared the cost-effectiveness of fibrosis risk-assessment strategies in a cohort of 10,000 simulated American patients with NAFLD performed in either PCP or referral clinics using a decision analytical microsimulation state-transition model. The strategies included use of vibration-controlled transient elastography (VCTE), the NAFLD fibrosis score (NFS), combination testing with NFS and VCTE, and liver biopsy (usual care by a specialist only). NFS and VCTE performance was obtained from a prospective cohort of 164 patients with NAFLD. Outcomes included cost per quality adjusted life year (QALY) and correct classification of fibrosis. Risk-stratification by the PCP using the NFS alone costs $5,985 per QALY while usual care costs $7,229/QALY. In the microsimulation, at a willingness-to-pay threshold of $100,000, the NFS alone in PCP clinic was the most cost-effective strategy in 94.2% of samples, followed by combination NFS/VCTE in the PCP clinic (5.6%) and usual care in 0.2%. The NFS based strategies yield the best biopsy-correct classification ratios (3.5) while the NFS/VCTE and usual care strategies yield more correct-classifications of advanced fibrosis at the cost of 3 and 37 additional biopsies per classification. Risk-stratification of patients with NAFLD primary care clinic is a cost-effective strategy that should be formally explored in clinical practice.

Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial.

PubMed

Bekelman, David B; Plomondon, Mary E; Carey, Evan P; Sullivan, Mark D; Nelson, Karin M; Hattler, Brack; McBryde, Connor F; Lehmann, Kenneth G; Gianola, Katherine; Heidenreich, Paul A; Rumsfeld, John S

2015-05-01

Heart failure (HF) has a major effect on patients' health status, including their symptom burden, functional status, and health-related quality of life. To determine the effectiveness of a collaborative care patient-centered disease management (PCDM) intervention to improve the health status of patients with HF. The Patient-Centered Disease Management (PCDM) trial was a multisite randomized clinical trial comparing a collaborative care PCDM intervention with usual care in patients with HF. A population-based sample of 392 patients with an HF diagnosis from 4 Veterans Affairs centers who had a Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of less than 60 (heavy symptom burden and impaired functional status and quality of life) were enrolled between May 2009 and June 2011. The PCDM intervention included collaborative care by a multidisciplinary care team consisting of a nurse coordinator, cardiologist, psychiatrist, and primary care physician; home telemonitoring and patient self-management support; and screening and treatment for comorbid depression. The primary outcome was change in the KCCQ overall summary score at 1 year (a 5-point change is clinically significant). Mortality, hospitalization, and depressive symptoms (Patient Health Questionnaire 9) were secondary outcomes. There were no significant differences in baseline characteristics between patients randomized to the PCDM intervention (n=187) vs usual care (n=197); baseline mean KCCQ overall summary scores were 37.9 vs 36.9 (P=.48). There was significant improvement in the KCCQ overall summary scores in both groups after 1 year (mean change, 13.5 points in each group), with no significant difference between groups (P=.97). The intervention was not associated with greater improvement in the KCCQ overall summary scores when the effect over time was estimated using 3-month, 6-month, and 12-month data (P=.74). Among secondary outcomes, there were significantly fewer deaths at 1 year in the intervention arm (8 of 187 [4.3%]) than in the usual care arm (19 of 197 [9.6%]) (P = .04). Among those who screened positive for depression, there was a greater improvement in the Patient Health Questionnaire 9 scores after 1 year in the intervention arm than in the usual care arm (2.1 points lower, P=.01). There was no significant difference in 1-year hospitalization rates between the intervention arm and the usual care arm (29.4% vs 29.9%, P=.87). This multisite randomized trial of a multifaceted HF PCDM intervention did not demonstrate improved patient health status compared with usual care. clinicaltrials.gov Identifier: NCT00461513.

Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial.

PubMed

Kalter-Leibovici, Ofra; Freimark, Dov; Freedman, Laurence S; Kaufman, Galit; Ziv, Arnona; Murad, Havi; Benderly, Michal; Silverman, Barbara G; Friedman, Nurit; Cukierman-Yaffe, Tali; Asher, Elad; Grupper, Avishay; Goldman, Dorit; Amitai, Miriam; Matetzky, Shlomi; Shani, Mordechai; Silber, Haim

2017-05-01

The efficacy of disease management programs in improving the outcome of heart failure patients remains uncertain and may vary across health systems. This study explores whether a countrywide disease management program is superior to usual care in reducing adverse health outcomes and improving well-being among community-dwelling adult patients with moderate-to-severe chronic heart failure who have universal access to advanced health-care services and technologies. In this multicenter open-label trial, 1,360 patients recruited after hospitalization for heart failure exacerbation (38%) or from the community (62%) were randomly assigned to either disease management or usual care. Disease management, delivered by multi-disciplinary teams, included coordination of care, patient education, monitoring disease symptoms and patient adherence to medication regimen, titration of drug therapy, and home tele-monitoring of body weight, blood pressure and heart rate. Patients assigned to usual care were treated by primary care practitioners and consultant cardiologists. The primary composite endpoint was the time elapsed till first hospital admission for heart failure exacerbation or death from any cause. Secondary endpoints included the number of all hospital admissions, health-related quality of life and depression during follow-up. Intention-to-treat comparisons between treatments were adjusted for baseline patient data and study center. During the follow-up, 388 (56.9%) patients assigned to disease management and 387 (57.1%) assigned to usual care had a primary endpoint event. The median (range) time elapsed until the primary endpoint event or end of study was 2.0 (0-5.0) years among patients assigned to disease management, and 1.8 (0-5.0) years among patients assigned to usual care (adjusted hazard ratio, 0.908; 95% confidence interval, 0.788 to 1.047). Hospital admissions were mostly (70%) unrelated to heart failure. Patients assigned to disease management had a better health-related quality of life and a lower depression score during follow-up. This comprehensive disease management intervention was not superior to usual care with respect to the primary composite endpoint, but it improved health-related quality of life and depression. A disease-centered approach may not suffice to make a significant impact on hospital admissions and mortality in patients with chronic heart failure who have universal access to health care. Clinicaltrials.gov identifier: NCT00533013 . Trial registration date: 9 August 2007. Initial protocol release date: 20 September 2007.

Improving Care for Depression in Obstetrics and Gynecology: A Randomized Controlled Trial

PubMed Central

Melville, Jennifer L.; Reed, Susan D.; Russo, Joan; Croicu, Carmen A.; Ludman, Evette; LaRocco-Cockburn, Anna; Katon, Wayne

2014-01-01

OBJECTIVE To evaluate an evidence-based collaborative depression care intervention adapted to obstetrics and gynecology clinics compared with usual care. METHODS Two-site randomized controlled trial included screen-positive women (Patient Health Questionnaire-9 of at least 10) who then met criteria for major depression, dysthymia or both (Mini-International Neuropsychiatric Interview). Women were randomized to 12-months of collaborative depression management or usual care; 6, 12 and 18-month outcomes were compared. The primary outcomes were change from baseline to 12-months on depression symptoms and functional status. Secondary outcomes included at least 50% decrease and remission in depressive symptoms, global improvement, treatment satisfaction, and quality of care. RESULTS Participants were on average 39 years old, 44% were non-white and 56% had posttraumatic stress disorder. Intervention (n= 102) compared to usual care (n=103) patients had greater improvement in depressive symptoms at 12 months (P< .001) and 18 months (P=.004). The intervention group compared with usual care had improved functioning over 18 months (P< .05), were more likely to have an at least 50% decrease in depressive symptoms at 12 months (relative risk [RR]=1.74, 95% confidence interval [CI] 1.11–2.73), greater likelihood of at least 4 specialty mental health visits (6 month RR=2.70, 95% CI1.73–4.20; 12 month RR=2.53, 95% CI 1.63–3.94), adequate dose of antidepressant (6-month RR=1.64, 95% CI 1.03–2.60; 12-month RR=1.71, 95%CI 1.08 2.73), and greater satisfaction with care (6-month RR=1.70, 95% CI 1.19–2.44; 12-month RR=2.26, 95% CI 1.52–3.36). CONCLUSION Collaborative depression care adapted to women’s health settings improved depressive and functional outcomes and quality of depression care. PMID:24807320

Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial

PubMed Central

Littlewood, Elizabeth; Hewitt, Catherine; Brierley, Gwen; Tharmanathan, Puvan; Araya, Ricardo; Barkham, Michael; Bower, Peter; Cooper, Cindy; Gask, Linda; Kessler, David; Lester, Helen; Lovell, Karina; Parry, Glenys; Richards, David A; Andersen, Phil; Brabyn, Sally; Knowles, Sarah; Shepherd, Charles; Tallon, Debbie; White, David

2015-01-01

Study question How effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression? Methods This was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score ≥10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme (“Beating the Blues”) or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months. Study answer and limitations Participants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support. What this study adds Supported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care. Funding, competing interests, data sharing Commissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management group Trial registration Current Controlled Trials ISRCTN91947481. PMID:26559241

TRUST-tPA trial: Telemedicine for remote collaboration with urgentists for stroke-tPA treatment.

PubMed

Mazighi, Mikael; Meseguer, Elena; Labreuche, Julien; Miroux, Patrick; Le Gall, Catherine; Roy, Patricia; Tubach, Florence; Amarenco, Pierre

2017-01-01

Background Previous observational studies have shown that telemedicine is feasible and safe to deliver intravenous (IV) recombinant tissue plasminogen activator (rt-PA). However, implementation of telemedicine may be challenging. To illustrate this fact, we report a study showing that telemedicine failed to improve clinical outcome and analyze the reasons for this shortcoming. Methods We established a tele-stroke network of 10 emergency rooms (ERs) of community hospitals connected to a stroke center to perform a randomized, open-label clinical trial with blinded outcome evaluation. Eligible patients were randomly assigned to either a usual care arm (i.e. immediate transfer to the stroke center and administration of IV rt-PA if indication was confirmed upon stroke arrival) or tele-thrombolysis arm (i.e. immediate administration of IV rt-PA in ER and transfer to the stroke center). The primary efficacy outcome was an excellent outcome (modified Rankin scale (mRS) 0-1 at 90 days). Secondary endpoints included favorable outcome (90-day mRS 0-2) and early neurological improvement (NIHSS score 0-1 at 24 hours or a decrease of ≥ 4 points within 24 hours). Safety outcomes included symptomatic intracerebral hemorrhage (ICH) per ECASS II definition, any ICH and all-cause mortality. Results During an accrual time of 48 months, because of a slow enrollment rate, only 49 of 270 patients initially planned for inclusion were randomized into usual care ( n = 23) and tele-thrombolysis ( n = 26). Despite random assignment, patients allocated to tele-thrombolysis were older and had more severe stroke than patients allocated to usual care. The median duration of video-conference was 23 minutes in the usual care arm and 73 minutes in the tele-thrombolysis arm. Eighty-four percent of patients in the tele-thrombolysis arm were treated by IV rt-PA in comparison to 18% in the usual care arm. In univariate analysis but not after adjustment for age and baseline NIHSS, patients allocated in the usual care arm had a higher rate of excellent or favorable outcome. There were no differences in safety outcomes, with only one symptomatic ICH occurring in the tele-thrombolysis arm. Conclusions Stroke patients included in the telemedicine arm of the TRUST-tPA trial increased their rt-PA eligibility five-fold. However, the efficacy and safety remains to be determined (ClinicalTrials.org, NCT00279149).

Comparative Effectiveness of Fecal Immunochemical Test Outreach, Colonoscopy Outreach, and Usual Care for Boosting Colorectal Cancer Screening Among the Underserved

PubMed Central

Gupta, Samir; Halm, Ethan A.; Rockey, Don C.; Hammons, Marcia; Koch, Mark; Carter, Elizabeth; Valdez, Luisa; Tong, Liyue; Ahn, Chul; Kashner, Michael; Argenbright, Keith; Tiro, Jasmin; Geng, Zhuo; Pruitt, Sandi; Skinner, Celette Sugg

2017-01-01

IMPORTANCE Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited. OBJECTIVE To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population. DESIGN, SETTING, AND PARTICIPANTS We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system. INTERVENTIONS Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n = 1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n = 479). The third group was assigned to usual care, consisting of opportunistic primary care visit-based screening (n = 3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion. MAIN OUTCOME MEASURES Screening participation in any CRC test within 1 year after randomization. RESULTS Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P < .001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P < .001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P < .005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P < .05 for colonoscopy vs usual care advanced adenoma comparison; P > .05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy. CONCLUSIONS AND REVELANCE Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01191411 PMID:23921906

Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial

PubMed Central

Lauche, Romy; Spitzer, Julia; Schwahn, Barbara; Ostermann, Thomas; Bernardy, Kathrin; Cramer, Holger; Dobos, Gustav; Langhorst, Jost

2016-01-01

This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference −12.4; 95% CI: −18.9; −5.9, p < 0.001) but not compared to sham (difference −3.0; 95% CI: −9.9, 3.9, p = 0.396). Further effects were found for quality of life compared to usual care. Patients were mildly satisfied with cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time. PMID:27853272

Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial.

PubMed

Lauche, Romy; Spitzer, Julia; Schwahn, Barbara; Ostermann, Thomas; Bernardy, Kathrin; Cramer, Holger; Dobos, Gustav; Langhorst, Jost

2016-11-17

This study aimed to test the efficacy of cupping therapy to improve symptoms and quality of life in patients diagnosed with the fibromyalgia syndrome. Participants were randomly assigned to cupping therapy, sham or usual care. Cupping was administered five times at twice weekly intervals on the upper and lower back. The primary outcome measure was pain intensity at day 18. Secondary outcomes included functional disability, quality of life, fatigue and sleep quality as well as pressure pain sensitivity, satisfaction and safety at day 18 and 6 months. Altogether 141 patients were included in this study (139 females, 55.8 ± 9.1 years). After 18 days patients reported significant less pain after cupping compared to usual care (difference -12.4; 95% CI: -18.9; -5.9, p < 0.001) but not compared to sham (difference -3.0; 95% CI: -9.9, 3.9, p = 0.396). Further effects were found for quality of life compared to usual care. Patients were mildly satisfied with cupping and sham cupping; and only minor side effects were observed. Despite cupping therapy being more effective than usual care to improve pain intensity and quality of life, effects of cupping therapy were small and comparable to those of a sham treatment, and as such cupping cannot be recommended for fibromyalgia at the current time.

Method‐of‐use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity

PubMed Central

Shan, Kevin; Walsh, Brandon; Gilder, Kye; Fujioka, Ken

2016-01-01

Objective This study assessed the effects of 32 mg naltrexone sustained release (SR)/360 mg bupropion SR (NB) on body weight in adults with obesity, with comprehensive lifestyle intervention (CLI), for 78 weeks. Methods In this phase 3b, randomized, open‐label, controlled study, subjects received NB + CLI or usual care (standard diet/exercise advice) for 26 weeks. NB subjects not achieving 5% weight loss at week 16 were discontinued, as indicated by product labeling. After week 26, usual care subjects began NB + CLI. Assessments continued through week 78. The primary end point was percent change in weight from baseline to week 26 in the per protocol population. Other end points included percentage of subjects achieving ≥5%, ≥10%, and ≥15% weight loss, percent change in weight at week 78, and adverse events (AEs) necessitating study medication discontinuation. Results NB + CLI subjects lost significantly more weight than usual care subjects at week 26 (8.52% difference; P < 0.0001). Weight loss persisted through 78 weeks. In total, 20.7% of subjects discontinued medication for AEs, including 7.0% for nausea. Conclusions Treatment with NB, used as indicated by prescribing information and with CLI, significantly improved weight loss over usual care alone. NB‐facilitated weight loss was sustained for 78 weeks and was deemed safe and well tolerated. PMID:28026920

Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial.

PubMed

Buys, Saundra S; Partridge, Edward; Black, Amanda; Johnson, Christine C; Lamerato, Lois; Isaacs, Claudine; Reding, Douglas J; Greenlee, Robert T; Yokochi, Lance A; Kessel, Bruce; Crawford, E David; Church, Timothy R; Andriole, Gerald L; Weissfeld, Joel L; Fouad, Mona N; Chia, David; O'Brien, Barbara; Ragard, Lawrence R; Clapp, Jonathan D; Rathmell, Joshua M; Riley, Thomas L; Hartge, Patricia; Pinsky, Paul F; Zhu, Claire S; Izmirlian, Grant; Kramer, Barnett S; Miller, Anthony B; Xu, Jian-Lun; Prorok, Philip C; Gohagan, John K; Berg, Christine D

2011-06-08

Screening for ovarian cancer with cancer antigen 125 (CA-125) and transvaginal ultrasound has an unknown effect on mortality. To evaluate the effect of screening for ovarian cancer on mortality in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial. Randomized controlled trial of 78,216 women aged 55 to 74 years assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. Intervention The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years (median [range], 12.4 years [10.9-13.0 years]) for cancer diagnoses and death until February 28, 2010. Mortality from ovarian cancer, including primary peritoneal and fallopian tube cancers. Secondary outcomes included ovarian cancer incidence and complications associated with screening examinations and diagnostic procedures. Ovarian cancer was diagnosed in 212 women (5.7 per 10,000 person-years) in the intervention group and 176 (4.7 per 10,000 person-years) in the usual care group (rate ratio [RR], 1.21; 95% confidence interval [CI], 0.99-1.48). There were 118 deaths caused by ovarian cancer (3.1 per 10,000 person-years) in the intervention group and 100 deaths (2.6 per 10,000 person-years) in the usual care group (mortality RR, 1.18; 95% CI, 0.82-1.71). Of 3285 women with false-positive results, 1080 underwent surgical follow-up; of whom, 163 women experienced at least 1 serious complication (15%). There were 2924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10,000 person-years) in the intervention group and 2914 deaths (76.2 per 10,000 person-years) in the usual care group (RR, 1.01; 95% CI, 0.96-1.06). Among women in the general US population, simultaneous screening with CA-125 and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality. Diagnostic evaluation following a false-positive screening test result was associated with complications. Trial Registration clinicaltrials.gov Identifier: NCT00002540.

Specialist mental health consultation for depression in Australian aged care residents with dementia: a cluster randomized trial.

PubMed

McSweeney, Kate; Jeffreys, Aimee; Griffith, Joanne; Plakiotis, Chris; Kharsas, Renee; O'Connor, Daniel W

2012-11-01

This cluster randomized controlled trial sought to determine whether multidisciplinary specialist mental health consultation was more effective than care as usual in treating the depression of aged care residents with dementia. Three hundred and eighty nine aged care residents were screened for dementia and major depression. Forty four were ultimately included in the intervention sample, selected from 20 aged care facilities located in Melbourne, Australia. Facilities were randomly allocated to an intervention condition involving the provision of multidisciplinary specialist consultation regarding the best-practice management of depression in dementia, or to a care as usual condition. Consultations involved individually tailored medical and psychosocial recommendations provided to care staff and general practitioners. All residents participated in a comprehensive pre-intervention diagnostic assessment, including the administration of the Cornell Scale for Depression in Dementia. This assessment was repeated approximately 15 weeks post-intervention by a rater blind to study condition. Multidisciplinary specialist mental health consultation was significantly more effective than care as usual in treating the clinical depression of aged care residents with dementia (p < 0.05, partial η(2)  = 0.16). At follow-up, the mean Cornell Scale for Depression in Dementia score for the intervention group was 9.47, compared with 14.23 for the control group. In addition, 77% of the intervention group no longer met criteria for major depression. The results of this study suggest that the psychosocial and medical management of depressed aged care residents can be improved by increasing access to specialist mental health consultation. Copyright © 2012 John Wiley & Sons, Ltd.

Protocolized fluid therapy in brain-dead donors: the multicenter randomized MOnIToR trial.

PubMed

Al-Khafaji, Ali; Elder, Michele; Lebovitz, Daniel J; Murugan, Raghavan; Souter, Michael; Stuart, Susan; Wahed, Abdus S; Keebler, Ben; Dils, Dorrie; Mitchell, Stephanie; Shutterly, Kurt; Wilkerson, Dawn; Pearse, Rupert; Kellum, John A

2015-03-01

Critical shortages of organs for transplantation jeopardize many lives. Observational data suggest that better fluid management for deceased organ donors could increase organ recovery. We conducted the first large multicenter randomized trial in brain-dead donors to determine whether protocolized fluid therapy increases the number of organs transplanted. We randomly assigned donors to either protocolized or usual care in eight organ procurement organizations. A "protocol-guided fluid therapy" algorithm targeting the cardiac index, mean arterial pressure and pulse pressure variation was used. Our primary outcome was the number of organs transplanted per donor, and our primary analysis was intention to treat. Secondary analyses included: (1) modified intention to treat where only subjects able to receive the intervention were included and (2) 12-month survival in transplant recipients. The study was stopped early. We enrolled 556 donors: 279 protocolized care and 277 usual care. Groups had similar characteristics at baseline. The study protocol could be implemented in 76 % of subjects randomized to the intervention. There was no significant difference in mean number of organs transplanted per donor: 3.39 organs per donor (95 % CI 3.14-3.63) with protocolized care compared to 3.29 usual care (95 % CI 3.04-3.54; mean difference, 0.1, 95 % CI -0.25 to 0.45; p = 0.56). In modified intention-to-treat analysis the mean number of organs increased (3.52 organs per donor, 95 % CI 3.23-3.8), but not statistically significantly (mean difference, 0.23, 95 % CI -0.15 to 0.61; p = 0.23). Among the 1,430 recipients of organs from study subjects with data available, 56 deaths (7.8 %) occurred in the protocolized care arm and 56 (7.9 %) in the usual care arm in the first year (hazard ratio: 0.97, p = 0.86). In brain-dead organ donors, protocol-guided fluid therapy compared to usual care may not increase the number of organs transplanted per donor.

Expert patient self-management program versus usual care in bronchiectasis: a randomized controlled trial.

PubMed

Lavery, Katherine A; O'Neill, Brenda; Parker, Michael; Elborn, J Stuart; Bradley, Judy M

2011-08-01

To investigate the efficacy of a disease-specific Expert Patient Programme (EPP) compared with usual care in patients with bronchiectasis. Proof-of-concept randomized controlled trial. Regional respiratory center. Adult patients (N=64; age, >18y) with a primary diagnosis of bronchiectasis based on a respiratory physician's assessment including a computed tomographic scan. Patients were randomly assigned to an intervention (usual care plus EPP; n=32) or control group (usual care only; n=32). The primary outcome measure was the Chronic Disease Self-efficacy Scale (CDSS). Other outcome measures included the Revised Illness Perception Questionnaire (IPQ-R), the St Georges Respiratory Questionnaire, and standard EPP questionnaires. Data were collected at baseline, postintervention, and 3 and 6 months postintervention. This disease-specific EPP for patients with bronchiectasis significantly improved self-efficacy in 6 of 10 subscales (CDSS subscales: exercise regularly [P=.02]; get information about disease [P=.03]; obtain help from community, family, and friends [P=.06]; communicate with physician [P=.85]; manage disease in general [P=.05]; do chores [P=.04]; social/recreational activities [P=.03]; manage symptoms [P<.01]; manage shortness of breath [P=.08]; control/manage depression [P=.01]) compared with usual care. There was no improvement on IPQ-R score. Patients who received the intervention reported more symptoms and decreased quality of life between 3 and 6 months postintervention and an increase in some components of self reported health care use. Patients receiving the disease-specific EPP indicated they were satisfied with the intervention and learned new self-management techniques. There were no significant differences in lung function over time. This original study indicates that a disease-specific EPP results in short-term improvements in self-efficacy. Based on these positive preliminary findings, a larger adequately powered study is justified to investigate the efficacy of a disease-specific EPP in patients with bronchiectasis. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Weight gain in preterm infants following parent-administered Vimala massage: a randomized controlled trial.

PubMed

Gonzalez, Alma Patricia; Vasquez-Mendoza, Guadalupe; García-Vela, Alfonso; Guzmán-Ramirez, Andres; Salazar-Torres, Marcos; Romero-Gutierrez, Gustavo

2009-04-01

Massage has been proposed as a way of facilitating development and growth of newborns through its effects on increasing blood flow, heart rate, digestion, and immunity. Massage might increase basal metabolism and nutrient absorption through endocrine effects such as increase in insulin and adrenaline and decrease in cortisol. Preliminary studies have suggested significant impact on weight gain with shortening of in-hospital stays of up to 6 days. We compared weight gain among preterm infants receiving Vimala massage plus usual care versus usual care alone. A randomized controlled trial was conducted. Sixty clinically stable preterm newborns with a corrected gestational age of 30 to 35 weeks receiving enteral nutrition in the hospital nursery were included. Half of them were assigned at random to receive Vimala massage twice daily for 10 days plus usual nursery care; the others received usual nursery care. Weight, head circumference, caloric intake, and nutritional method were recorded daily. Group characteristics were compared with analysis of variance, T test, and chi (2) test as appropriate. There were no differences between groups in gender, gestational age, initial weight, head circumference, and caloric intake and type of nutrition at baseline. Infants receiving massage had a larger weight gain versus the control group since the third day (188.2 +/- 41.20 g/kg versus 146.7 +/- 56.43 g/kg, P < 0.001). Hospital stay was shorter in infants receiving massage and usual nursery care (15.63 +/- 5.41 days versus 19.33 +/- 7.92 days, P = 0.03). The addition of parent-administered Vimala massage to usual nursery care resulted in increased weight gain and shorter hospital stay among clinically stable preterm newborns.

Patients’ and Clinicians’ Views of the Psychological Components of Tinnitus Treatment That Could Inform Audiologists’ Usual Care: A Delphi Survey

PubMed Central

Taylor, John; Hall, Deborah A.; Walker, Dawn-Marie; McMurran, Mary; Casey, Amanda; Stockdale, David; Featherstone, Debbie; Hoare, Derek J.

2018-01-01

Objectives: The aim of this study was to determine which components of psychological therapies are most important and appropriate to inform audiologists’ usual care for people with tinnitus. Design: A 39-member panel of patients, audiologists, hearing therapists, and psychologists completed a three-round Delphi survey to reach consensus on essential components of audiologist-delivered psychologically informed care for tinnitus. Results: Consensus (≥80% agreement) was reached on including 76 of 160 components. No components reached consensus for exclusion. The components reaching consensus were predominantly common therapeutic skills such as Socratic questioning and active listening, rather than specific techniques, for example, graded exposure therapy or cognitive restructuring. Consensus on educational components to include largely concerned psychological models of tinnitus rather than neurophysiological information. Conclusions: The results of this Delphi survey provide a tool to develop audiologists’ usual tinnitus care using components that both patients and clinicians agree are important and appropriate to be delivered by an audiologist for adults with tinnitus-related distress. Research is now necessary to test the added effects of these components when delivered by audiologists. PMID:28930785

Pursuing cost-effectiveness in mental health service delivery for youth with complex needs.

PubMed

Grimes, Katherine E; Schulz, Margaret F; Cohen, Steven A; Mullin, Brian O; Lehar, Sophie E; Tien, Shelly

2011-06-01

Mental health advocates seek to expand children's services, noting widespread failure to meet the needs of public sector youth suffering from serious emotional disturbance (SED). However, state and national budgets face deepening cuts, with rising health care costs taking the blame. As the gap between needs and finances widens, identification of cost-effective treatments that will benefit children with SED and their families is of increasing importance. Community-based interventions for this population, such as the wraparound approach and systems-of-care, are being disseminated but literature is scant regarding effects on expense. The Mental Health Services Program for Youth (MHSPY) model is aligned philosophically with wraparound and systems-of-care but unique in blending public agency dollars to deliver integrated medical, mental health and social services. MHSPY's linked clinical and expense data is useful to study community-based treatment cost-effectiveness. To examine the cost-effectiveness of an intensively integrated, family and community-based clinical intervention for youth with mental health needs in comparison to "usual care.'' Study and reference populations were matched on age, gender, community, psychiatric diagnosis, morbidity and insurance type. Claims analyses included patterns of service utilization and medical expense for both groups. Using propensity score matching, results for study youth are compared with results for the population receiving "usual care.'' Clinical functioning was measured for the intervention group at baseline and 12 months. The intervention group used lower intensity services and had substantially lower claims expense (e.g. 32% lower for emergency room, 74% lower for inpatient psychiatry) than their matched counterparts in the "usual care'' group. Intervention youth were consistently maintained in least restrictive settings, with over 88% of days spent at home and showed improved clinical functioning on standard measures. The intensive MHSPY model of service delivery offers potential as a cost-effective intervention for complex youth. Its integrated approach, recognizing needs across multiple life domains, appears to enhance engagement and the effectiveness of mental health treatment, resulting in statistically significant clinical improvements. Functional measures are not collected in "usual care,'' limiting comparisons. However, claims expense for intervention youth was substantially lower than claims expense for Medicaid comparison youth, suggesting clinical needs for intervention youth post-enrollment were lower than for those receiving "usual care.'' The MHSPY model, which intentionally engages families in "clustered'' traditional and non-traditional services, represents a replicable strategy for enhancing the impact of clinical interventions, thereby reducing medical expense. Blending categorical state agency dollars and insurance funds creates flexibility to support community-based care, including individualized services for high-risk youth. Resulting expenses total no more, and are often less, than "treatment as usual'' but yield greater clinical benefits. Further research is needed regarding which intervention elements contribute the most towards improved clinical functioning, as well as which patients are most likely to benefit. A randomized trial of MHSPY vs. "usual care,'' including examination of the sustainability of effects post-disenrollment, would provide a chance to further test this innovative model.

Impact of discharge planning decision support on time to readmission among older adult medical patients.

PubMed

Bowles, Kathryn H; Hanlon, Alexandra; Holland, Diane; Potashnik, Sheryl L; Topaz, Maxim

2014-01-01

Hospital clinicians are overwhelmed with the volume of patients churning through the health care systems. The study purpose was to determine whether alerting case managers about high-risk patients by supplying decision support results in better discharge plans as evidenced by time to first hospital readmission. Four medical units at one urban, university medical center. A quasi-experimental study including a usual care and experimental phase with hospitalized English-speaking patients aged 55 years and older. The intervention included using an evidence-based screening tool, the Discharge Decision Support System (D2S2), that supports clinicians' discharge referral decision making by identifying high-risk patients upon admission who need a referral for post-acute care. The usual care phase included collection of the D2S2 information, but not sharing the information with case managers. The experimental phase included data collection and then sharing the results with the case managers. The study compared time to readmission between index discharge date and 30 and 60 days in patients in both groups (usual care vs. experimental). After sharing the D2S2 results, the percentage of referral or high-risk patients readmitted by 30 and 60 days decreased by 6% and 9%, respectively, representing a 26% relative reduction in readmissions for both periods. Supplying decision support to identify high-risk patients recommended for postacute referral is associated with better discharge plans as evidenced by an increase in time to first hospital readmission. The tool supplies standardized information upon admission allowing more time to work with high-risk admissions.

Cost-Effectiveness Analysis of Interventions to Reduce Risk of Aspiration in Elderly Cancer Survivors Residing in Skilled Nursing Facilities.

PubMed

Mantravadi, S

2017-04-01

Aspiration can occur in patients of any age group, but it can be prevented. The primary population at risk is made up of survivors of cancer because of their increased risk of mucositis, mucosal atrophy, and dysphagia associated with chemotherapy, radiotherapy, and the disease process itself. The rate of incidence of aspiration cannot be quantified, because minor cases of aspiration often go unreported. Sequelae ensuing from aspirations can include pneumonia, end-stage kidney disease, dialysis, and death. Analyses of cost, decision-tree modeling, and cost effectiveness were performed to compare a hypothetical, interventional model based on best practices with usual (standard) care. A societal perspective was used as the economic view point. Direct costs, caregiver time, and market values for wages were estimated for the 2 interventions. Effectiveness values for the cost-effectiveness and decision-tree analyses were obtained from the literature. The incremental-cost-effectiveness ratio was calculated and used to compare the intervention with usual care. The interventional method was more costly but more effective than usual care. A sensitivity analysis considered the uncertainty of event probability (aspiration vs no aspiration). The interventional protocol for aspiration reduction continued to be more cost effective than usual care. Aspiration takes a financial toll on all facets of health care, including on nurses, skilled nursing facilities, patients, their families, and insurers, among others. Implementing guidelines that describe best practices for aspiration appears to be a cost-effective strategy for reducing aspirations among cancer survivors - especially elderly patients - who live in skilled nursing facilities.

Physical conditioning as part of a return to work strategy to reduce sickness absence for workers with back pain.

PubMed

Schaafsma, Frederieke G; Whelan, Karyn; van der Beek, Allard J; van der Es-Lambeek, Ludeke C; Ojajärvi, Anneli; Verbeek, Jos H

2013-08-30

Physical conditioning as part of a return to work strategy aims to improve work status for workers on sick leave due to back pain. This is the second update of a Cochrane Review (originally titled 'Work conditioning, work hardening and functional restoration for workers with back and neck pain') first published in 2003, updated in 2010, and updated again in 2013. To assess the effectiveness of physical conditioning as part of a return to work strategy in reducing time lost from work and improving work status for workers with back pain. Further, to assess which aspects of physical conditioning are related to a faster return to work for workers with back pain. We searched the following databases to March 2012: CENTRAL, MEDLINE (from 1966), EMBASE (from 1980), CINAHL (from 1982), PsycINFO (from 1967), and PEDro. Randomized controlled trials (RCTs) and cluster RCTs that studied workers with work disability related to back pain and who were included in physical conditioning programmes. Two review authors independently extracted data and assessed risk of bias. We used standard methodological procedures expected by The Cochrane Collaboration. We included 41 articles reporting on 25 RCTs with 4404 participants. Risk of bias was low in 16 studies.Three studies involved workers with acute back pain, eight studies workers with subacute back pain, and 14 studies workers with chronic back pain.In 14 studies, physical conditioning as part of a return to work strategy was compared to usual care. The physical conditioning mostly consisted of graded activity with work-related exercises aimed at increasing back strength and flexibility, together with a set date for return to work. The programmes were divided into a light version with a maximum of five sessions, or an intense version with more than five sessions up to full time or as inpatient treatment.For acute back pain, there was low quality evidence that both light and intense physical conditioning programmes made little or no difference in sickness absence duration compared with care as usual at three to 12 months follow-up (3 studies with 340 workers).For subacute back pain, the evidence on the effectiveness of intense physical conditioning combined with care as usual compared to usual care alone was conflicting (four studies with 395 workers). However, subgroup analysis showed low quality evidence that if the intervention was executed at the workplace, or included a workplace visit, it may have reduced sickness absence duration at 12 months follow-up (3 studies with 283 workers; SMD -0.42, 95% CI -0.65 to -0.18).For chronic back pain, there was low quality evidence that physical conditioning as part of integrated care management in addition to usual care may have reduced sickness absence days compared to usual care at 12 months follow-up (1 study, 134 workers; SMD -4.42, 95% CI -5.06 to -3.79). What part of the integrated care management was most effective remained unclear. There was moderate quality evidence that intense physical conditioning probably reduced sickness absence duration only slightly compared with usual care at 12 months follow-up (5 studies, 1093 workers; SMD -0.23, 95% CI -0.42 to -0.03).Physical conditioning compared to exercise therapy showed conflicting results for workers with subacute and chronic back pain. Cognitive behavioural therapy was probably not superior to physical conditioning as an alternative or in addition to physical conditioning. The effectiveness of physical conditioning as part of a return to work strategy in reducing sick leave for workers with back pain, compared to usual care or exercise therapy, remains uncertain. For workers with acute back pain, physical conditioning may have no effect on sickness absence duration. There is conflicting evidence regarding the reduction of sickness absence duration with intense physical conditioning versus usual care for workers with subacute back pain. It may be that including workplace visits or execution of the intervention at the workplace is the component that renders a physical conditioning programme effective. For workers with chronic back pain physical conditioning has a small effect on reducing sick leave compared to care as usual after 12 months follow-up. To what extent physical conditioning as part of integrated care management may alter the effect on sick leave for workers with chronic back pain needs further research.

Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial.

PubMed

Richards, David A; Bower, Peter; Chew-Graham, Carolyn; Gask, Linda; Lovell, Karina; Cape, John; Pilling, Stephen; Araya, Ricardo; Kessler, David; Barkham, Michael; Bland, J Martin; Gilbody, Simon; Green, Colin; Lewis, Glyn; Manning, Chris; Kontopantelis, Evangelos; Hill, Jacqueline J; Hughes-Morley, Adwoa; Russell, Abigail

2016-02-01

Collaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness. To determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression. Cluster randomised controlled trial. UK primary care practices (n = 51) in three UK primary care districts. A total of 581 adults aged ≥ 18 years in general practice with a current International Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment. Collaborative care: 14 weeks of 6-12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice. Blinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months. In total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31; p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64; p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for recovery 1.88, 95% CI 1.28 to 2.75; number needed to treat 6.5). Quality of mental health but not physical health was significantly better for collaborative care at 4 months but not at 12 months. There was no difference for anxiety. Participants receiving collaborative care were significantly more satisfied with treatment. Differences between groups had disappeared at 36 months. Collaborative care had a mean cost of £272.50 per participant with similar health and social care service use between collaborative care and usual care. Collaborative care offered a mean incremental gain of 0.02 (95% CI -0.02 to 0.06) quality-adjusted life-years (QALYs) over 12 months at a mean incremental cost of £270.72 (95% CI -£202.98 to £886.04) and had an estimated mean cost per QALY of £14,248, which is below current UK willingness-to-pay thresholds. Sensitivity analyses including informal care costs indicated that collaborative care is expected to be less costly and more effective. The amount of participant behavioural activation was the only effect mediator. Collaborative care improves depression up to 12 months after initiation of the intervention, is preferred by patients over usual care, offers health gains at a relatively low cost, is cost-effective compared with usual care and is mediated by patient activation. Supervision was by expert clinicians and of short duration and more intensive therapy may have improved outcomes. In addition, one participant requiring inpatient treatment incurred very significant costs and substantially inflated our cost per QALY estimate. Future work should test enhanced intervention content not collaborative care per se. Current Controlled Trials ISRCTN32829227. This project was funded by the Medical Research Council (MRC) (G0701013) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

Rates of detection of developmental problems at the 18-month well-baby visit by family physicians' using four evidence-based screening tools compared to usual care: a randomized controlled trial.

PubMed

Thomas, R E; Spragins, W; Mazloum, G; Cronkhite, M; Maru, G

2016-05-01

Early and regular developmental screening can improve children's development through early intervention but is insufficiently used. Most developmental problems are readily evident at the 18-month well-baby visit. This trial's purpose is to: (1) compare identification rates of developmental problems by GPs/family physicians using four evidence-based tools with non-evidence based screening, and (2) ascertain whether the four tools can be completed in 10-min pre-visit on a computer. We compared two approaches to early identification via random assignment of 54 families to either: 'usual care' (informal judgment including ad-hoc milestones, n = 25); or (2) 'Evidence-based' care (use of four validated, accurate screening tools, n = 29), including: the Parents' Evaluation of Developmental Status (PEDS), the PEDS-Developmental Milestones (PEDS-DM), the Modified Checklist for Autism in Toddlers (M-CHAT) and PHQ9 (maternal depression). In the 'usual care' group four (16%) and in the evidence-based tools group 18 (62%) were identified as having a possible developmental problem. In the evidence-based tools group three infants were to be recalled at 24 months for language checks (no specialist referrals made). In the 'usual care' group four problems were identified: one child was referred for speech therapy, two to return to check language at 24 months and a mother to discuss depression. All forms were completed on-line within 10 min. Despite higher early detection rates in the evidence-based care group, there were no differences in referral rates between evidence-based and usual-care groups. This suggests that clinicians: (1) override evidence-based screening results with informal judgment; and/or (2) need assistance understanding test results and making referrals. Possible solutions are improve the quality of information obtained from the screening process, improved training of physicians, improved support for individual practices and acceptance by the regional health authority for overall responsibility for screening and creation of a comprehensive network. © 2016 John Wiley & Sons Ltd.

Acute care research: is it ethical?

PubMed

Iserson, K V; Mahowald, M B

1992-07-01

Research in acute care is a troubling area for Institutional Review Board (IRB) approval and informed consent. Confusion about ethical and legal requirements has hampered research efforts and subsequent patient benefits. Acute care patients are the relatively few critical care patients who have suffered unexpected events that carry a high probability of mortality or severe morbidity unless immediate medical intervention is provided. We argue that acute care research is justified if the usual ethical requirements for research are modified to reflect the uniqueness of the situation. Our recommendations are to: a) use an explicit definition of acute care as distinct from other modes of critical care; b) eliminate the requirement for informed consent (as it is usually understood); and c) require stringent IRB oversight, regarding the unique ethical problems raised by this area of research. We further suggest that IRB oversight includes review of the protocol by a panel of individuals who represent possible enrollees in the proposed study.

The Economic Impact of the Child Care Industry in Southeast Wisconsin

ERIC Educational Resources Information Center

Kovach, Melissa; Lam, Eva; Dickman, Anneliese

2009-01-01

Discussions of early childhood care and education usually focus on its social and educational value, and how it helps children and families. More recently, the focus in many states, including Wisconsin, has been on potential investments in child care quality improvements as strategies for improving long-term educational outcomes for disadvantaged…

Comparing Dutch case management care models for people with dementia and their caregivers: The design of the COMPAS study.

PubMed

MacNeil Vroomen, Janet; Van Mierlo, Lisa D; van de Ven, Peter M; Bosmans, Judith E; van den Dungen, Pim; Meiland, Franka J M; Dröes, Rose-Marie; Moll van Charante, Eric P; van der Horst, Henriëtte E; de Rooij, Sophia E; van Hout, Hein P J

2012-05-28

Dementia care in the Netherlands is shifting from fragmented, ad hoc care to more coordinated and personalised care. Case management contributes to this shift. The linkage model and a combination of intensive case management and joint agency care models were selected based on their emerging prominence in the Netherlands. It is unclear if these different forms of case management are more effective than usual care in improving or preserving the functioning and well-being at the patient and caregiver level and at the societal cost. The objective of this article is to describe the design of a study comparing these two case management care models against usual care. Clinical and cost outcomes are investigated while care processes and the facilitators and barriers for implementation of these models are considered. Mixed methods include a prospective, observational, controlled, cohort study among persons with dementia and their primary informal caregiver in regions of the Netherlands with and without case management including a qualitative process evaluation. Inclusion criteria for the cohort study are: community-dwelling individuals with a dementia diagnosis who are not terminally-ill or anticipate admission to a nursing home within 6 months and with an informal caregiver who speaks fluent Dutch. Person with dementia-informal caregiver dyads are followed for two years. The primary outcome measure is the Neuropsychiatric Inventory for the people with dementia and the General Health Questionnaire for their caregivers. Secondary outcomes include: quality of life and needs assessment in both persons with dementia and caregivers, activity of daily living, competence of care, and number of crises. Costs are measured from a societal perspective using cost diaries. Process indicators measure the quality of care from the participant's perspective. The qualitative study uses purposive sampling methods to ensure a wide variation of respondents. Semi-structured interviews with stakeholders based on the theoretical model of adaptive implementation are planned. This study provides relevant insights into care processes, description of two case management models along with clinical and economic data from persons with dementia and caregivers to clarify important differences in two case management care models compared to usual care.

Comparing Dutch Case management care models for people with dementia and their caregivers: The design of the COMPAS study

PubMed Central

2012-01-01

Background Dementia care in the Netherlands is shifting from fragmented, ad hoc care to more coordinated and personalised care. Case management contributes to this shift. The linkage model and a combination of intensive case management and joint agency care models were selected based on their emerging prominence in the Netherlands. It is unclear if these different forms of case management are more effective than usual care in improving or preserving the functioning and well-being at the patient and caregiver level and at the societal cost. The objective of this article is to describe the design of a study comparing these two case management care models against usual care. Clinical and cost outcomes are investigated while care processes and the facilitators and barriers for implementation of these models are considered. Design Mixed methods include a prospective, observational, controlled, cohort study among persons with dementia and their primary informal caregiver in regions of the Netherlands with and without case management including a qualitative process evaluation. Inclusion criteria for the cohort study are: community-dwelling individuals with a dementia diagnosis who are not terminally-ill or anticipate admission to a nursing home within 6 months and with an informal caregiver who speaks fluent Dutch. Person with dementia-informal caregiver dyads are followed for two years. The primary outcome measure is the Neuropsychiatric Inventory for the people with dementia and the General Health Questionnaire for their caregivers. Secondary outcomes include: quality of life and needs assessment in both persons with dementia and caregivers, activity of daily living, competence of care, and number of crises. Costs are measured from a societal perspective using cost diaries. Process indicators measure the quality of care from the participant’s perspective. The qualitative study uses purposive sampling methods to ensure a wide variation of respondents. Semi-structured interviews with stakeholders based on the theoretical model of adaptive implementation are planned. Discussion This study provides relevant insights into care processes, description of two case management models along with clinical and economic data from persons with dementia and caregivers to clarify important differences in two case management care models compared to usual care. PMID:22640695

The Costs and Cost-effectiveness of Collaborative Care for Adolescents With Depression in Primary Care Settings: A Randomized Clinical Trial.

PubMed

Wright, Davene R; Haaland, Wren L; Ludman, Evette; McCauley, Elizabeth; Lindenbaum, Jeffrey; Richardson, Laura P

2016-11-01

Depression is one of the most common adolescent chronic health conditions and can lead to increased health care use. Collaborative care models have been shown to be effective in improving adolescent depressive symptoms, but there are few data on the effect of such a model on costs. To evaluate the costs and cost-effectiveness of a collaborative care model for treatment of adolescent major depressive disorder in primary care settings. This randomized clinical trial was conducted between April 1, 2010, and April 30, 2013, at 9 primary care clinics in the Group Health system in Washington State. Participants were adolescents (age range, 13-17 years) with depression who participated in the Reaching Out to Adolescents in Distress (ROAD) collaborative care intervention trial. A 12-month collaborative care intervention included an initial in-person engagement session, delivery of evidence-based treatments, and regular follow-up by master's level clinicians. Youth in the usual care control condition received depression screening results and could access mental health services and obtain medications through Group Health. Cost outcomes included intervention costs and per capita health plan costs, calculated from the payer perspective using administrative records. The primary effectiveness outcome was the difference in quality-adjusted life-years (QALYs) between groups from baseline to 12 months. The QALYs were calculated using Child Depression Rating Scale-Revised scores measured during the clinical trial. Cost and QALYs were used to calculate an incremental cost-effectiveness ratio. Of those screened, 105 youths met criteria for entry into the study, and 101 were randomized to the intervention (n = 50) and usual care (n = 51) groups. Overall health plan costs were not significantly different between the intervention ($5161; 95% CI, $3564-$7070) and usual care ($5752; 95% CI, $3814-$7952) groups. Intervention delivery cost an additional $1475 (95% CI, $1230-$1695) per person. The intervention group had a mean daily utility value of 0.78 (95% CI, 0.75-0.80) vs 0.73 (95% CI, 0.71-0.76) for the usual care group. The net mean difference in effectiveness was 0.04 (95% CI, 0.02-0.09) QALY at $883 above usual care. The mean incremental cost-effectiveness ratio was $18 239 (95% CI, dominant to $24 408) per QALY gained, with dominant indicating that the intervention resulted in both a net cost savings and a net increase in QALYs. Collaborative care for adolescent depression appears to be cost-effective, with 95% CIs far below the strictest willingness-to-pay thresholds. These findings support the use of collaborative care interventions to treat depression among adolescent youth. clinicaltrials.gov Identifier: NCT01140464.

PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. Methods/Design PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant’s optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. Discussion This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life. The impact of this research may allow the future development of a cost-effective conservative treatment strategy for patients with sciatica. Trial registration ClinicalTrial.gov, ACTRN 12613000530729 PMID:23845078

PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial.

PubMed

Mathieson, Stephanie; Maher, Christopher G; McLachlan, Andrew J; Latimer, Jane; Koes, Bart W; Hancock, Mark J; Harris, Ian; Day, Richard O; Pik, Justin; Jan, Stephen; Billot, Laurent; Lin, Chung-Wei Christine

2013-07-11

Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant's optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life. The impact of this research may allow the future development of a cost-effective conservative treatment strategy for patients with sciatica. ClinicalTrial.gov, ACTRN 12613000530729.

[Violent acts against health care providers].

PubMed

Irinyi, Tamás; Németh, Anikó

2016-07-01

Violence against health care providers is getting more awareness nowadays. These are usually deliberate actions committed by patients or family members of them resulting in short and long term physical or psychological debilitating harm in the staff members. The causes of the violent acts are usually rooted in patient-related factors, although some characteristics of the professionals and of the workplace may also play some role. The present article presents different definitions of violence and possible reasons for violence against health care providers based on relevant international and national literature. The paper discusses the different forms and frequency of violence, furthermore, details about the effects, consequences and some options for prevention in health care settings are also included. Orv. Hetil., 2016, 157(28), 1105-1109.

A pragmatic randomised controlled trial of the effectiveness and cost-effectiveness of 'PhysioDirect' telephone assessment and advice services for physiotherapy.

PubMed

Salisbury, C; Foster, N E; Hopper, C; Bishop, A; Hollinghurst, S; Coast, J; Kaur, S; Pearson, J; Franchini, A; Hall, J; Grove, S; Calnan, M; Busby, J; Montgomery, A A

2013-01-01

As a result of long delays for physiotherapy for musculoskeletal problems, several areas in the UK have introduced PhysioDirect services in which patients telephone a physiotherapist for initial assessment and treatment advice. However, there is no robust evidence about the effectiveness, cost-effectiveness or acceptability to patients of PhysioDirect. To investigate whether or not PhysioDirect is equally as clinically effective as and more cost-effective than usual care for patients with musculoskeletal (MSK) problems in primary care. Pragmatic randomised controlled trial to assess equivalence, incorporating economic evaluation and nested qualitative research. Patients were randomised in 2 : 1 ratio to PhysioDirect or usual care using a remote automated allocation system at the level of the individual, stratifying by physiotherapy site and minimising by sex, age group and site of MSK problem. For the economic analysis, cost consequences included NHS and patient costs, and the cost of lost production. Cost-effectiveness analysis was carried out from the perspective of the NHS. Interviews were conducted with patients, physiotherapists and their managers. Four community physiotherapy services in England. Adults referred by general practitioners or self-referred for physiotherapy for a MSK problem. Patients allocated to PhysioDirect were invited to telephone a senior physiotherapist for initial assessment and advice using a computerised template, followed by face-to-face care when necessary. Patients allocated to usual care were put on to a waiting list for face-to-face care. Primary outcome was the Short Form questionnaire-36 items, version 2 (SF-36v2) Physical Component Score (PCS) at 6 months after randomisation. Secondary outcomes included other measures of health outcome [Measure Yourself Medical Outcomes Profile, European Quality of Life-5 Dimensions (EuroQol health utility measure, EQ-5D), global improvement, response to treatment], wait for treatment, time lost from work and usual activities, patient satisfaction. Data were collected by postal questionnaires at baseline, 6 weeks and 6 months, and from routine records by researchers blind to allocation. A total of 1506 patients were allocated to PhysioDirect and 743 to usual care. Patients allocated to PhysioDirect had a shorter wait for treatment than those allocated to usual care [median 7 days vs 34 days; arm-time ratio 0.32, 95% confidence interval (CI) 0.29 to 0.35] and had fewer non-attended face-to-face appointments [incidence rate ratio 0.55 (95% CI 0.41 to 0.73)]. The primary outcome at 6 months' follow-up was equivalent between PhysioDirect and usual care [mean PCS 43.50 vs 44.18, adjusted difference in means -0.01 (95% CI -0.80 to 0.79)]. The secondary measures of health outcome all demonstrated equivalence at 6 months, with slightly greater improvement in the PhysioDirect arm at 6 weeks' follow-up. Patients were equally satisfied with access to care but slightly less satisfied overall with PhysioDirect compared with usual care. NHS costs (physiotherapy plus other relevant NHS costs) per patient were similar in the two arms [PhysioDirect £ 198.98 vs usual care £ 179.68, difference in means £ 19.30 (95% CI -£ 37.60 to £ 76.19)], while QALYs gained were also similar [difference in means 0.007 (95% CI -0.003 to 0.016)]. Incremental cost per QALY gained was £ 2889. The probability that PhysioDirect was cost-effective at a £ 20,000 willingness-to-pay threshold was 88%. These conclusions about cost-effectiveness were robust to sensitivity analyses. There was no evidence of difference between trial arms in cost to patients or value of lost production. No adverse events were detected. Providing physiotherapy via PhysioDirect is equally clinically effective compared with usual waiting list-based care, provides faster access to treatment, appears to be safe, and is broadly acceptable to patients. PhysioDirect is probably cost-effective compared with usual care.

Electrical stimulation for chronic non-specific low back pain in a working-age population: a 12-week double blinded randomized controlled trial.

PubMed

Thiese, Matthew S; Hughes, Matthew; Biggs, Jeremy

2013-03-28

Non-invasive electrotherapy is commonly used for treatment of chronic low back pain. Evidence for efficacy of most electrotherapy modalities is weak or lacking. This study aims to execute a high-quality, double-blinded randomized controlled clinical trial comparing 1) H-Wave(®) Device stimulation plus usual care with 2) transcutaneous electrical nerve stimulation (TENS) plus usual care, and 3) Sham electrotherapy plus usual care to determine comparative efficacy for treatment of chronic non-specific low back pain patients. Chronic non-specific low back pain patients between ages of 18-65 years, with pain of at least 3 months duration and minimal current 5/10 VAS pain. Patients will have no significant signs or symptoms of lumbosacral nerve impingement, malignancy, spinal stenosis, or mood disorders. Double blind RCT with 3 arms and 38 subjects per arm. Randomization by permuted blocks of random length, stratified by Workers Compensation claim (yes vs. no), and use of opioids. The null hypothesis of this study is that there are no statistically significant differences in functional improvement between treatment types during and at the end of a 12-week week treatment period. Subjective data will be collected using Filemaker Pro™ database management collection tools. Objective data will be obtained through functional assessments. Data will be collected at enrollment and at 1, 4, 8, and 12 weeks for each participant by a blinded assessor. H-Wave(®) device stimulation (Intervention A) plus usual care, transcutaneous electrical nerve stimulation (TENS) (Intervention B) plus usual care, and sham electrotherapy plus usual care (control). Each treatment arm will have identical numbers of visits (4) and researcher contact time (approximately 15 hours). Oswestry Disability Index. Secondary measures include: Rowland Morris Instrument, VAS pain score, functional evaluation including strength when pushing and pulling, pain free range of motion in flexion and extension. Outcome measures assessed at baseline, 1, 4, 8, and 12 weeks. Treatment failure will be defined if patient terminates assigned treatment arm for non-efficacy or undergoes invasive procedure or other excluded cointerventions. Data will be analyzed using intention-to-treat analysis and adjusted for covariates related to LBP (e.g. age) as needed. Study strengths include complex randomization, treatment group allocation concealment, double blinding, controlling for co-interventions, rigorous inclusion criteria, assessment of compliance, plans for limiting dropout, identical assessment methods and timing for each treatment arm, and planned intention-to-treat analyses.

The 24-month metabolic benefits of the healthy living partnerships to prevent diabetes: A community-based translational study.

PubMed

Pedley, Carolyn F; Case, L Douglas; Blackwell, Caroline S; Katula, Jeffrey A; Vitolins, Mara Z

2018-05-01

Large-scale clinical trials and translational studies have demonstrated that weight loss achieved through diet and physical activity reduced the development of diabetes in overweight individuals with prediabetes. These interventions also reduced the occurrence of metabolic syndrome and risk factors linked to other chronic conditions including obesity-driven cancers and cardiovascular disease. The Healthy Living Partnerships to Prevent Diabetes (HELP PD) was a clinical trial in which participants were randomized to receive a community-based lifestyle intervention translated from the Diabetes Prevention Program (DPP) or an enhanced usual care condition. The objective of this study is to compare the 12 and 24 month prevalence of metabolic syndrome in the two treatment arms of HELP PD. The intervention involved a group-based, behavioral weight-loss program led by community health workers monitored by personnel from a local diabetes education program. The enhanced usual care condition included dietary counseling and written materials. HELP PD included 301 overweight or obese participants (BMI 25-39.9kg/m 2 ) with elevated fasting glucose levels (95-125mg/dl). At 12 and 24 months of follow-up there were significant improvements in individual components of the metabolic syndrome: fasting blood glucose, waist circumference, HDL, triglycerides and blood pressure and the occurrence of the metabolic syndrome in the intervention group compared to the usual care group. This study demonstrates that a community diabetes prevention program in participants with prediabetes results in metabolic benefits and a reduction in the occurrence of the metabolic syndrome in the intervention group compared to the enhanced usual care group. Copyright © 2017 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders.

PubMed

Harbourne, Regina T; Dusing, Stacey C; Lobo, Michele A; Westcott-McCoy, Sarah; Bovaird, James; Sheridan, Susan; Galloway, James C; Chang, Hui-Ju; Hsu, Lin-Ya; Koziol, Natalie; Marcinowski, Emily C; Babik, Iryna

2018-06-01

There is limited research examining the efficacy of early physical therapy on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the clear association between motor activity and cognition during infancy. The aim of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to advance global development in infants with motor delays or neuromotor dysfunction. This study is a longitudinal multisite randomized controlled trial. Infants in the START-Play group are compared to infants receiving usual care in early intervention (EI). The research takes place in homes in Pennsylvania, Delaware, Washington, and Virginia. There will be 140 infants with neuromotor dysfunction participating, beginning between 7 to 16 months of age. Infants will have motor delays and emerging sitting skill. START-Play provides individualized twice-weekly home intervention for 12 weeks with families to enhance cognition through sitting, reaching, and problem-solving activities for infants. Ten interventionists provide the intervention, with each child assigned 1 therapist. The primary outcome measure is the Bayley III Scales of Infant Development. Secondary measures include change in the Early Problem Solving Indicator, change in the Gross Motor Function Measure, and change in the type and duration of toy contacts during reaching. Additional measures include sitting posture control and parent-child interaction. Limitations include variability in usual EI care and the lack of blinding for interventionists and families. This study describes usual care in EI across 4 US regions and compares outcomes of the START-Play intervention to usual care.

Preliminary efficacy of service dogs as a complementary treatment for posttraumatic stress disorder in military members and veterans.

PubMed

O'Haire, Marguerite E; Rodriguez, Kerri E

2018-02-01

Psychiatric service dogs are an emerging complementary treatment for military members and veterans with posttraumatic stress disorder (PTSD). Yet despite anecdotal accounts of their value, there is a lack of empirical research on their efficacy. The current proof-of-concept study assessed the effects of this practice. A nonrandomized efficacy trial was conducted with 141 post-9/11 military members and veterans with PTSD to compare usual care alone (n = 66) with usual care plus a trained service dog (n = 75). The primary outcome was longitudinal change on The PTSD Checklist (PCL; Weathers, Litz, Herman, Huska, & Keane, 1993), including data points from a cross-sectional assessment and a longitudinal record review. Secondary outcomes included cross-sectional differences in depression, quality of life, and social and work functioning. Mixed-model analyses revealed clinically significant reductions in PTSD symptoms from baseline following the receipt of a service dog, but not while receiving usual care alone. Though clinically meaningful, average reductions were not below the diagnostic cutoff on the PCL. Regression analyses revealed significant differences with medium to large effect sizes among those with service dogs compared with those on the waitlist, including lower depression, higher quality of life, and higher social functioning. There were no differences in employment status, but there was lower absenteeism because of health among those who were employed. The addition of trained service dogs to usual care may confer clinically meaningful improvements in PTSD symptomology for military members and veterans with PTSD, though it does not appear to be associated with a loss of diagnosis. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Internet-based self-management plus education compared with usual care in asthma: a randomized trial.

PubMed

van der Meer, Victor; Bakker, Moira J; van den Hout, Wilbert B; Rabe, Klaus F; Sterk, Peter J; Kievit, Job; Assendelft, Willem J J; Sont, Jacob K

2009-07-21

The Internet may support patient self-management of chronic conditions, such as asthma. To evaluate the effectiveness of Internet-based asthma self-management. Randomized, controlled trial. 37 general practices and 1 academic outpatient department in the Netherlands. 200 adults with asthma who were treated with inhaled corticosteroids for 3 months or more during the previous year and had access to the Internet. Asthma-related quality of life at 12 months (minimal clinically significant difference of 0.5 on the 7-point scale), asthma control, symptom-free days, lung function, and exacerbations. Participants were randomly assigned by using a computer-generated permuted block scheme to Internet-based self-management (n = 101) or usual care (n = 99). The Internet-based self-management program included weekly asthma control monitoring and treatment advice, online and group education, and remote Web communications. Asthma-related quality of life improved by 0.56 and 0.18 points in the Internet and usual care groups, respectively (adjusted between-group difference, 0.38 [95% CI, 0.20 to 0.56]). An improvement of 0.5 point or more occurred in 54% and 27% of Internet and usual care patients, respectively (adjusted relative risk, 2.00 [CI, 1.38 to 3.04]). Asthma control improved more in the Internet group than in the usual care group (adjusted difference, -0.47 [CI, -0.64 to -0.30]). At 12 months, 63% of Internet patients and 52% of usual care patients reported symptom-free days in the previous 2 weeks (adjusted absolute difference, 10.9% [CI, 0.05% to 21.3%]). Prebronchodilator FEV1 changed with 0.24 L and -0.01 L for Internet and usual care patients, respectively (adjusted difference, 0.25 L [CI, 0.03 to 0.46 L]). Exacerbations did not differ between groups. The study was unblinded and lasted only 12 months. Internet-based self-management resulted in improvements in asthma control and lung function but did not reduce exacerbations, and improvement in asthma-related quality of life was slightly less than clinically significant. Netherlands Organization for Health Research and Development, ZonMw, and Netherlands Asthma Foundation.

Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan.

PubMed

Jarab, Anan Sadeq; Alqudah, Salam Ghazi; Mukattash, Tareq Lewis; Shattat, Ghassan; Al-Qirim, Tariq

2012-09-01

Glycemic goals (hemoglobin A1c < 7%) are often not achieved in patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications. Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes. Diabetes prevalence and mortality are increasing rapidly in Jordan. Nevertheless, clinical pharmacists in Jordan do not typically provide pharmaceutical care; instead, the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians. To assess the primary clinical outcome of glycemic control (A1c) and secondary outcomes, including blood pressure, lipid values, self-reported medication adherence, and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic randomly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program. Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and randomly assigned to intervention and usual care groups using the Minim software technique. The intervention group at baseline received face-to-face objective-directed education from a clinical pharmacist about type 2 diabetes, prescription medications, and necessary lifestyle changes, followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns. The primary outcome measure was glycemic control (A1c), and secondary measures included systolic and diastolic blood pressure, complete lipid profile (i.e., total cholesterol, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], serum triglycerides), and self-reported medication adherence (4-item Morisky Scale) and self-care activities (Summary of Diabetes Self-Care Activities questionnaire). Data were collected at baseline and at 6 months follow-up. Changes from baseline to follow-up were calculated for biomarker values, and between-group differences in the change amounts were tested using the t test for independent samples. A P value of < 0.05 was considered statistically significant. A total of 77 of 85 patients (90.6%) randomly assigned to the intervention group and 79 of 86 patients (91.9%) assigned to usual care had baseline and 6-month follow-up values. Compared with baseline values, patients in the intervention group had a mean reduction of 0.8% in A1c versus a mean increase of 0.1% from baseline in the usual care group (P = 0.019). The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose, systolic and diastolic blood pressure, total cholesterol, LDL-C, serum triglycerides, self-reported medication adherence, and self-care activities. Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant. Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group. Six of 8 secondary biomarkers were improved in the intervention group compared with usual care. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.

Cost-effectiveness of a Primary Care Intervention to Treat Obesity

PubMed Central

Tsai, Adam G.; Wadden, Thomas A.; Volger, Sheri; Sarwer, David B.; Vetter, Marion; Kumanyika, Shiriki; Berkowitz, Robert I.; Diewald, Lisa; Perez, Joanna; Lavenberg, Jeffrey; Panigrahi, Eva R.; Glick, Henry A.

2013-01-01

Background Data on the cost-effectiveness of the behavioral treatment of obesity are not conclusive. The cost-effectiveness of treatment in primary care settings is particularly relevant. Methods We conducted a within-trial cost-effectiveness analysis of a primary care-based obesity intervention. Study participants were randomized to: Usual Care (quarterly visits with their primary care provider); Brief Lifestyle Counseling (Brief LC; quarterly provider visits plus monthly weight loss counseling visits; or Enhanced Brief Lifestyle Counseling (Enhanced Brief LC; all above interventions, plus choice of meal replacements or weight loss medication). A health care payer perspective was used. Intervention costs were estimated from tracking data obtained prospectively. Quality adjusted life years (QALYs) were estimated with the EuroQol-5D. We estimated cost per kilogram-year of weight loss and cost per QALY. Results Weight losses after 2 years were 1.7, 2.9, and 4.6 kg for Usual Care, Brief LC, and Enhanced Brief LC, respectively (p = 0.003 for comparison of Enhanced Brief LC vs. Usual Care). The incremental cost per kilogram-year lost was $292 for Enhanced Brief LC compared to Usual Care (95% CI $38 to $394). The incremental cost per QALY was $115,397, but the 95% CI were undefined. Comparison of short term cost per kg with published estimates of longer term cost per QALYs suggested that the intervention could be cost-effective over the long term (≥ 10 years). Conclusions A primary care intervention that included monthly counseling visits and a choice of meal replacements or weight loss medication could be a cost-effective treatment for obesity over the long term. However, additional studies are needed on the cost-effectiveness of behavioral treatment of obesity. PMID:23921780

Cryotherapy and ankle motion in chronic venous disorders

PubMed Central

Kelechi, Teresa J.; Mueller, Martina; Zapka, Jane G.; King, Dana E.

2013-01-01

This study compared ankle range of motion (AROM) including dorsiflexion, plantar flexion, inversion and eversion, and venous refill time (VRT) in leg skin inflamed by venous disorders, before and after a new cryotherapy ulcer prevention treatment. Fifty-seven-individuals participated in the randomized clinical trial; 28 in the experimental group and 29 received usual care only. Results revealed no statistically significant differences between the experimental and usual care groups although AROM measures in the experimental group showed a consistent, non-clinically relevant decrease compared to the usual care group except for dorsiflexion. Within treatment group comparisons of VRT results showed a statistically significant increase in both dorsiflexion and plantar flexion for patients with severe VRT in the experimental group (6.9 ± 6.8; p = 0.002 and 5.8 ± 12.6; p = 0.02, respectively). Cryotherapy did not further restrict already compromised AROM, and in some cases, there were minor improvements. PMID:23516043

The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

PubMed

Thompson, E A; Shaw, A; Nichol, J; Hollinghurst, S; Henderson, A J; Thompson, T; Sharp, D

2011-07-01

To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Virtual house calls for Parkinson disease (Connect.Parkinson): study protocol for a randomized, controlled trial.

PubMed

Achey, Meredith A; Beck, Christopher A; Beran, Denise B; Boyd, Cynthia M; Schmidt, Peter N; Willis, Allison W; Riggare, Sara S; Simone, Richard B; Biglan, Kevin M; Dorsey, E Ray

2014-11-27

Interest in improving care for the growing number of individuals with chronic conditions is rising. However, access to care is limited by distance, disability, and distribution of doctors. Small-scale studies in Parkinson disease, a prototypical chronic condition, have suggested that delivering care using video house calls is feasible, offers similar clinical outcomes to in-person care, and reduces travel burden. We are conducting a randomized comparative effectiveness study (Connect.Parkinson) comparing usual care in the community to usual care augmented by virtual house calls with a Parkinson disease specialist. Recruitment is completed centrally using online advertisements and emails and by contacting physicians, support groups, and allied health professionals. Efforts target areas with a high proportion of individuals not receiving care from neurologists. Approximately 200 individuals with Parkinson disease and their care partners will be enrolled at 20 centers throughout the United States and followed for one year. Participants receive educational materials, then are randomized in a 1:1 ratio to continue their usual care (control arm) or usual care and specialty care delivered virtually (intervention arm). Care partners are surveyed about their time and travel burden and their perceived caregiver burden. Participants are evaluated via electronic survey forms and videoconferencing with a blinded independent rater at baseline and at 12 months. All study activities are completed remotely.The primary outcomes are: (1) feasibility, as measured by the proportion of visits completed, and (2) quality of life, as measured by the 39-item Parkinson's Disease Questionnaire. Secondary outcomes include measures of clinical benefit, quality of care, time and travel burden, and caregiver burden. Connect.Parkinson will evaluate the feasibility and effectiveness of using technology to deliver care into the homes of individuals with Parkinson disease. The trial may serve as a model for increasing access and delivering patient-centered care at home for individuals with chronic conditions. This trial was registered on clinicaltrials.gov on January 8, 2014 [NCT02038959].

A review of recent literature - nurse case managers in diabetes care: equivalent or better outcomes compared to primary care providers.

PubMed

Watts, Sharon A; Lucatorto, Michelle

2014-07-01

Primary care has changed remarkably with chronic disease burden growth. Nurse case managers assist with this chronic disease by providing if not significantly better care, than equivalent care to that provided by usual primary care providers. Chronic disease management requires patient-centered skills and tools, such as registries, panel management, review of home data, communicating with patients outside of face-to-face care, and coordinating multiple services. Evidence reviewed in this article demonstrates that registered nurse care managers (RNCM) perform many actions required for diabetes chronic disease management including initiation and titration of medications with similar or improved physiologic and patient satisfaction outcomes over usual care providers. Selection and training of the nurse case managers is of utmost importance for implementation of a successful chronic disease management program. Evidence based guidelines, algorithms, protocols, and adequate ongoing education and mentoring are generally cited as necessary support tools for the nurse case managers.

An enriched medical home intervention using community health workers improves adherence to immunization schedules.

PubMed

Pati, Susmita; Ladowski, Kristi L; Wong, Angie T; Huang, Jiayu; Yang, Jie

2015-11-17

Disparities in childhood vaccination rates persist. To evaluate the impact of an enriched medical home intervention using community health workers on improving immunization adherence among young children. The intervention group received home visits from trained community health workers to support families in adhering to recommended care while the comparison group received usual care (i.e. no home visits/reminders). Immunization history and socio-demographic data were collected using medical records and a validated questionnaire. The doubly robust estimation of risk difference, which combines weighting via propensity score and outcome regression model, was used to compare immunization adherence rates between two groups. Primary care practices affiliated with a suburban tertiary care academic medical center serving a socioeconomically diverse population. The study sample included children ≤ 2 years of age at enrollment who crossed at least one age time point of 3, 7, 15, or 24 months during their 6 months post-enrollment period. The primary outcome was age-specific immunization up-to-date status defined by CDC guidelines. The primary predictor was participation in the intervention. The analysis included 201 children in the usual care group and 110 children in the intervention group. The usual care and intervention groups were divided into subgroups of newborn and infant/toddler to account for prior immunization history. After adjusting for differences in group characteristics, we found a significant absolute increase in the up-to-date immunization likelihood for both newborns (20.9%, p=0.01) and infants/toddlers (16.8%, p=0.01) receiving the intervention when compared to their peers receiving usual clinical care. Our findings demonstrate the positive impact of an enriched medical home intervention using community health worker home visitation on early childhood immunization up-to-date status. With further study, this model may provide a cost-effective approach to improving childhood vaccination rates, especially for vulnerable groups. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effectiveness of Collaborative Care for Depression in Public-Sector Primary Care Clinics Serving Latinos.

PubMed

Lagomasino, Isabel T; Dwight-Johnson, Megan; Green, Jennifer M; Tang, Lingqi; Zhang, Lily; Duan, Naihua; Miranda, Jeanne

2017-04-01

Quality improvement interventions for depression care have been shown to be effective for improving quality of care and depression outcomes in settings with primarily insured patients. The aim of this study was to determine the impact of a collaborative care intervention for depression that was tailored for low-income Latino patients seen in public-sector clinics. A total of 400 depressed patients from three public-sector primary care clinics were enrolled in a randomized controlled trial of a tailored collaborative care intervention versus enhanced usual care. Social workers without previous mental health experience served as depression care specialists for the intervention patients (N=196). Depending on patient preference, they delivered a cognitive-behavioral therapy (CBT) intervention or facilitated antidepressant medication given by primary care providers or both. In enhanced usual care, patients (N=204) received a pamphlet about depression, a letter for their primary care provider stating that they had a positive depression screen, and a list of local mental health resources. Intent-to-treat analyses examined clinical and process-of-care outcomes at 16 weeks. Compared with patients in the enhanced usual care group, patients in the intervention group had significantly improved depression, quality of life, and satisfaction outcomes (p<.001 for all). Intervention patients also had significantly improved quality-of-care indicators, including the proportion of patients receiving either psychotherapy or antidepressant medication (77% versus 21%, p<.001). Collaborative care for depression can greatly improve care and outcomes in public-sector clinics. Social workers without prior mental health experience can effectively provide CBT and manage depression care.

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial.

PubMed

van der Heijden, Amber A W A; de Bruijne, Martine C; Feenstra, Talitha L; Dekker, Jacqueline M; Baan, Caroline A; Bosmans, Judith E; Bot, Sandra D M; Donker, Gé A; Nijpels, Giel

2014-06-25

The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€ 758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Current Controlled trials: ISRCTN66124817.

Resource use and costs of type 2 diabetes patients receiving managed or protocolized primary care: a controlled clinical trial

PubMed Central

2014-01-01

Background The increasing prevalence of diabetes is associated with increased health care use and costs. Innovations to improve the quality of care, manage the increasing demand for health care and control the growth of health care costs are needed. The aim of this study is to evaluate the care process and costs of managed, protocolized and usual care for type 2 diabetes patients from a societal perspective. Methods In two distinct regions of the Netherlands, both managed and protocolized diabetes care were implemented. Managed care was characterized by centralized organization, coordination, responsibility and centralized annual assessment. Protocolized care had a partly centralized organizational structure. Usual care was characterized by a decentralized organizational structure. Using a quasi-experimental control group pretest-posttest design, the care process (guideline adherence) and costs were compared between managed (n = 253), protocolized (n = 197), and usual care (n = 333). We made a distinction between direct health care costs, direct non-health care costs and indirect costs. Multivariate regression models were used to estimate differences in costs adjusted for confounding factors. Because of the skewed distribution of the costs, bootstrapping methods (5000 replications) with a bias-corrected and accelerated approach were used to estimate 95% confidence intervals (CI) around the differences in costs. Results Compared to usual and protocolized care, in managed care more patients were treated according to diabetes guidelines. Secondary health care use was higher in patients under usual care compared to managed and protocolized care. Compared to usual care, direct costs were significantly lower in managed care (€-1.181 (95% CI: -2.597 to -334)) while indirect costs were higher (€758 (95% CI: -353 to 2.701), although not significant. Direct, indirect and total costs were lower in protocolized care compared to usual care (though not significantly). Conclusions Compared to usual care, managed care was significantly associated with better process in terms of diabetes care, fewer secondary care consultations and lower health care costs. The same trends were seen for protocolized care, however they were not statistically significant. Trial registration Current Controlled trials: ISRCTN66124817. PMID:24966055

Cost-benefit and cost-savings analyses of antiarrhythmic medication monitoring.

PubMed

Snider, Melissa; Carnes, Cynthia; Grover, Janel; Davis, Rich; Kalbfleisch, Steven

2012-09-15

The economic impact of pharmacist-managed antiarrhythmic drug therapy monitoring on an academic medical center's electrophysiology (EP) program was investigated. Data were collected for the initial two years of patient visits (n = 816) to a pharmacist-run clinic for antiarrhythmic drug therapy monitoring. A retrospective cost analysis was conducted to assess the direct costs associated with three appointment models: (1) a clinic office visit only, (2) a clinic visit involving electrocardiography and basic laboratory tests, and (3) a clinic visit including pulmonary function testing and chest x-rays in addition to electrocardiography and laboratory testing. A subset of patient cases (n = 18) were included in a crossover analysis comparing pharmacist clinic care and usual care in an EP physician clinic. The primary endpoints were the cost benefits and cost savings associated with pharmacy-clinic care versus usual care. A secondary endpoint was improvement of overall EP program efficiency. The payer mix was 61.6% (n = 498) Medicare, 33.2% (n = 268) managed care, and 5.2% (n = 42) other. Positive contribution margins were demonstrated for all appointment models. The pharmacist-managed clinic also yielded cost savings by reducing overall patient care charges by 21% relative to usual care. By the second year, the pharmacy clinic improved EP program efficiency by scheduling an average of 24 patients per week, in effect freeing up one day per week of EP physician time to spend on other clinical activities. Pharmacist monitoring of antiarrhythmic drug therapy in an out-patient clinic provided cost benefits, cost savings, and improved overall EP program efficiency.

The economic and clinical impact of an inpatient palliative care consultation service: a multifaceted approach.

PubMed

Ciemins, Elizabeth L; Blum, Linda; Nunley, Marsha; Lasher, Andrew; Newman, Jeffrey M

2007-12-01

While there has been a rapid increase of inpatient palliative care (PC) programs, the financial and clinical benefits have not been well established. Determine the effect of an inpatient PC consultation service on costs and clinical outcomes. Multifaceted study included: (1) interrupted time-series design utilizing mean daily costs preintervention and postintervention; (2) matched cohort analysis comparing PC to usual care patients; and (3) analysis of symptom control after consultation. Large private, not-for-profit, academic medical center in San Francisco, California, 2004-2006. Time series analysis included 282 PC patients; matched cohorts included 27 PC with 128 usual care patients; clinical outcome analysis of 48 PC patients. Mean daily patient costs and length of stay (LOS); pain, dyspnea, and secretions assessment scores. Mean daily costs were reduced 33% (p < 0.01) from preintervention to postintervention period. Mean length of stay (LOS) was reduced 30%. Mean daily costs for PC patients were 14.5% lower compared to usual care patients (p < 0.01). Pain, dyspnea, and secretions scores were reduced by 86%, 64%, and 87%, respectively. Over the study period, time to PC referral as well as overall ALOS were reduced by 50%. The large reduction in mean daily costs and LOS resulted in an estimated annual savings of $2.2 million in the study hospital. Our results extend the evidence base of financial and clinical benefits associated with inpatient PC programs. We recommend additional study of best practices for identifying patients and providing consultation services, in addition to progressive management support and reimbursement policy.

Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial.

PubMed

Pouw, Maaike A; Calf, Agneta H; van Munster, Barbara C; Ter Maaten, Jan C; Smidt, Nynke; de Rooij, Sophia E

2018-03-27

An acute hospital admission is a stressful life event for older people, particularly for those with cognitive impairment. The hospitalisation is often complicated by hospital-associated geriatric syndromes, including delirium and functional loss, leading to functional decline and nursing home admission. Hospital at Home care aims to avoid hospitalisation-associated adverse outcomes in older patients with cognitive impairment by providing hospital care in the patient's own environment. This randomised, non-blinded feasibility trial aims to assess the feasibility of conducting a randomised controlled trial in terms of the recruitment, use and acceptability of Hospital at Home care for older patients with cognitive impairment. The quality of care will be evaluated and the advantages and disadvantages of the Hospital at Home care programme compared with usual hospital care. Eligible patients will be randomised either to Hospital at Home care in their own environment or usual hospital care. The intervention consists of hospital level care provided at patients' homes, including visits from healthcare professionals, diagnostics (laboratory tests, blood cultures) and treatment. The control group will receive usual hospital care. Measurements will be conducted at baseline, during admission, at discharge and at 3 and 6 months after the baseline assessment. Institutional ethics approval has been granted. The findings will be disseminated through public lectures, professional and scientific conferences, as well as peer-reviewed journal articles. The study findings will contribute to knowledge on the implementation of Hospital at Home care for older patients with cognitive disorders. The results will be used to inform and support strategies to deliver eligible care to older patients with cognitive impairment. e020313; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer.

PubMed

Walker, Jane; Hansen, Christian Holm; Martin, Paul; Symeonides, Stefan; Gourley, Charlie; Wall, Lucy; Weller, David; Murray, Gordon; Sharpe, Michael

2014-09-01

The management of depression in patients with poor prognosis cancers, such as lung cancer, creates specific challenges. We aimed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care. Symptom Management Research Trials (SMaRT) Oncology-3 is a parallel-group, multicentre, randomised controlled trial. We enrolled patients with lung cancer and major depression from three cancer centres and their associated clinics in Scotland, UK. Participants were randomly assigned in a 1:1 ratio to the depression care for people with lung cancer treatment programme or usual care by a database software algorithm that used stratification (by trial centre) and minimisation (by age, sex, and cancer type) with allocation concealment. Depression care for people with lung cancer is a manualised, multicomponent collaborative care treatment that is systematically delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. The primary outcome was depression severity (on the Symptom Checklist Depression Scale [SCL-20], range 0-4) averaged over the patient's time in the trial (up to a maximum of 32 weeks). Trial statisticians and data collection staff were masked to treatment allocation, but patients and clinicians could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN75905964. 142 participants were recruited between Jan 5, 2009, and Sept 9, 2011; 68 were randomly allocated to depression care for people with lung cancer and 74 to usual care. 43 (30%) of 142 patients had died by 32 weeks, all of which were cancer-related deaths. No intervention-related serious adverse events occurred. 131 (92%) of 142 patients provided outcome data (59 in the depression care for people with lung cancer group and 72 in the usual care group) and were included in the intention-to-treat primary analysis. Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer (mean score on the SCL-20 1·24 [SD 0·64]) than in those allocated to usual care (mean score 1·61 [SD 0·58]); difference -0·38 (95% CI -0·58 to -0·18); standardised mean difference -0·62 (95% CI -0·94 to -0·29). Self-rated depression improvement, anxiety, quality of life, role functioning, perceived quality of care, and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group. Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer; integrated depression care for people with lung cancer was substantially more efficacious than was usual care. Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population, and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy. Cancer Research UK and Chief Scientist Office of the Scottish Government. Copyright © 2014 Elsevier Ltd. All rights reserved.

Counselling for depression in primary care.

PubMed

Rowland, N; Bower, P; Mellor, C; Heywood, P; Godfrey, C

2001-01-01

There is wide clinician and patient support for counselling in primary care, particularly in the UK. This review examines the effectiveness and cost effectiveness of counselling for psychological and psychosocial problems in the primary care setting. To assess the effects of counselling in primary care by reviewing cost and outcome data for patients with psychological and psychosocial problems considered suitable for counselling. The search strategy included electronic searching of databases (including the CCDAN Register of RCTs and CCTs) along with handsearching of a specialist journal. Published and unpublished sources (clinical trials, books, dissertations, agency reports etc.) were searched, and their reference lists scanned. Contact was made with subject experts and CCDAN members. Randomised and controlled patient preference trials comparing counselling in primary care with usual general practitioner care for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of April 1998 were included in the review. Trials were independently assessed by at least two reviewers for appropriateness of inclusion and methdological quality. Four trials, involving 678 participants, of whom 487 were followed up, were included. Data for psychological symptom levels (four trials) were pooled statistically. Patients receiving counselling had significantly better psychological symptom levels post intervention than patients receiving usual general practitioner care (standardised mean difference -0.30, 95% CI, (-0.49 to - 0.11). The effect remained statistically significant when the results from studies with less rigorous methodology were excluded in a sensitivity analysis. Patients who received counselling tended to be more satisfied with their treatment (three trials). Health service utilisation data were reported in all trials reviewed, but only one trial undertook a cost analysis. No clear cost advantage was associated with either counselling or usual general practice care. Patients who received counselling were more likely to have improved psychological symptom levels than those who did not receive counselling. Levels of satisfaction with counselling were high. There is limited information about the cost effectiveness of counselling, with one study reporting no clear cost advantage with either counselling or general practice care. The four trials included in this review were all pragmatic trials of counselling in primary care in the UK, which reflect the reality of clinical provision in this context. There were methdological weaknesses identified in the studies, which should be taken into account when considering the results. The evidence base will be extended by trials of counselling which are nearing completion.

Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City.

PubMed

Martínez-Andrade, Gloria Oliva; Cespedes, Elizabeth M; Rifas-Shiman, Sheryl L; Romero-Quechol, Guillermina; González-Unzaga, Marco Aurelio; Benítez-Trejo, María Amalia; Flores-Huerta, Samuel; Horan, Chrissy; Haines, Jess; Taveras, Elsie M; Pérez-Cuevas, Ricardo; Gillman, Matthew W

2014-03-20

Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children <5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics. We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We recruited 306 parent-child pairs: 168 intervention, 138 usual care. Children were 2-5 years old with WHO body mass index (BMI) z-score 0-3. We measured children's height and weight and parents reported children's diet and physical activity at baseline and 3 and 6-month follow-up. We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values. 93 (55%) intervention and 96 (70%) usual care families completed 3 and 6-month follow-up. At 3 months, intervention v. usual care children increased vegetables by 6.3 servings/week (95% CI, 1.8, 10.8). In stratified analyses, intervention participants with high program adherence (5-6 sessions) decreased snacks and screen time and increased vegetables v. usual care. No further effects on behavioral outcomes or BMI were observed. Transportation time and expenses were barriers to adherence. 90% of parents who completed the post-intervention survey were satisfied with the program. Although satisfaction was high among participants, barriers to participation and retention included transportation cost and time. In intention to treat analyses, we found intervention effects on vegetable intake, but not other behaviors or BMI. ClinicalTrials.gov NCT01539070.Comisión Nacional de Investigación Científica del IMSS: 2009-785-120.

An observational study of emergency department utilization among enrollees of Minnesota Health Care Programs: financial and non-financial barriers have different associations.

PubMed

Shippee, Nathan D; Shippee, Tetyana P; Hess, Erik P; Beebe, Timothy J

2014-02-08

Emergency department (ED) use is costly, and especially frequent among publicly insured populations in the US, who also disproportionately encounter financial (cost/coverage-related) and non-financial/practical barriers to care. The present study examines the distinct associations financial and non-financial barriers to care have with patterns of ED use among a publicly insured population. This observational study uses linked administrative-survey data for enrollees of Minnesota Health Care Programs to examine patterns in ED use-specifically, enrollee self-report of the ED as usual source of care, and past-year count of 0, 1, or 2+ ED visits from administrative data. Main independent variables included a count of seven enrollee-reported financial concerns about healthcare costs and coverage, and a count of seven enrollee-reported non-financial, practical barriers to access (e.g., limited office hours, problems with childcare). Covariates included health, health care, and demographic measures. In multivariate regression models, only financial concerns were positively associated with reporting ED as usual source of care, but only non-financial barriers were significantly associated with greater ED visits. Regression-adjusted values indicated notable differences in ED visits by number of non-financial barriers: zero non-financial barriers meant an adjusted 78% chance of having zero ED visits (95% C.I.: 70.5%-85.5%), 15.9% chance of 1(95% C.I.: 10.4%-21.3%), and 6.2% chance (95% C.I.: 3.5%-8.8%) of 2+ visits, whereas having all seven non-financial barriers meant a 48.2% adjusted chance of zero visits (95% C.I.: 30.9%-65.6%), 31.8% chance of 1 visit (95% C.I.: 24.2%-39.5%), and 20% chance (95% C.I.: 8.4%-31.6%) of 2+ visits. Financial barriers were associated with identifying the ED as one's usual source of care but non-financial barriers were associated with actual ED visits. Outreach/literacy efforts may help reduce reliance on/perception of ED as usual source of care, whereas improved targeting/availability of covered services may help curb frequent actual visits, among publicly insured individuals.

Usual source of care and the quality of medical care experiences: a cross-sectional survey of patients from a Taiwanese community.

PubMed

Tsai, Jenna; Shi, Leiyu; Yu, Wei-Lung; Lebrun, Lydie A

2010-07-01

This study used a recent patient survey to examine the relationship between having a usual source of care (USC) and the quality of ambulatory medical care experiences in Taiwan, where there is universal health insurance coverage. The study design was a cross-sectional survey of 879 patients in Taichung County, Taiwan. Children and adults visiting hospital-based physicians were included. Quality of care was measured using items from the Primary Care Assessment Tool (PCAT), representing 7 ambulatory medical care domains: first contact (ie, access and utilization), longitudinality (ie, ongoing care), coordination (ie, referrals and information systems), comprehensiveness (ie, services available and provided), family centeredness, community orientation, and cultural competence. USC was defined based on responses to 3 survey items from the PCAT. Having a USC was significantly associated with higher quality of medical care experiences. Specifically, having a USC was associated with improved accessibility and utilization, ongoing care, coordination of referrals, and healthcare providers' family centeredness and cultural competence. However, having a USC was not strongly related with comprehensiveness of services, coordination of information systems, or healthcare providers' community orientation. In a region with universal health insurance, patients with a USC reported higher quality of medical care experiences compared with those without a USC. Beyond the provision of health insurance coverage, efforts to improve quality of care should include policies promoting USC.

Web-based collaborative care intervention to manage cancer-related symptoms in the palliative care setting.

PubMed

Steel, Jennifer L; Geller, David A; Kim, Kevin H; Butterfield, Lisa H; Spring, Michael; Grady, Jonathan; Sun, Weiing; Marsh, Wallis; Antoni, Michael; Dew, Mary Amanda; Helgeson, Vicki; Schulz, Richard; Tsung, Allan

2016-04-15

The aim of this study was to examine the efficacy of a collaborative care intervention in reducing depression, pain, and fatigue and improve quality of life. A total of 261 patients with advanced cancer and 179 family caregivers were randomized to a web-based collaborative care intervention or enhanced usual care. The intervention included the following: 1) a web site with written and audiovisual self-management strategies, a bulletin board, and other resources; 2) visits with a care coordinator during a physician's appointment every 2 months; and 3) telephone follow-up every 2 weeks. Primary patient outcomes included measures of depression, pain, fatigue, and health-related quality of life. Secondary outcomes included Interleukin (IL)-1α, IL-1β, IL-6, and IL-8 levels, Natural Killer (NK) cell numbers, and caregiver stress and depression. At the baseline, 51% of the patients reported 1 or more symptoms in the clinical range. For patients who presented with clinical levels of symptoms and were randomized to the intervention, reductions in depression (Cohen's d = 0.71), pain (Cohen's d = 0.62), and fatigue (Cohen's d = 0.26) and improvements in quality of life (Cohen's d = 0.99) were observed when compared to those in the enhanced usual car arm at 6 months. Reductions in IL-6 (φ = 0.18), IL-1β (φ = 0.35), IL-1α (φ = 0.19), and IL-8 (φ = 0.15) and increases in NK cell numbers (φ = 0.23) were observed in comparison with enhanced usual care arm at 6 months. Reductions in caregiver stress (Cohen's d = 0.75) and depression (Cohen's d = 0.37) were observed at 6 months for caregivers whose loved ones were randomized to the intervention arm. The integration of screening and symptom management into cancer care is recommended. © 2016 American Cancer Society.

Proactive tobacco treatment and population-level cessation: a pragmatic randomized clinical trial.

PubMed

Fu, Steven S; van Ryn, Michelle; Sherman, Scott E; Burgess, Diana J; Noorbaloochi, Siamak; Clothier, Barbara; Taylor, Brent C; Schlede, Carolyn M; Burke, Randy S; Joseph, Anne M

2014-05-01

Current tobacco use treatment approaches require smokers to request treatment or depend on the provider to initiate smoking cessation care and are therefore reactive. Most smokers do not receive evidence-based treatments for tobacco use that include both behavioral counseling and pharmacotherapy. To assess the effect of a proactive, population-based tobacco cessation care model on use of evidence-based tobacco cessation treatments and on population-level smoking cessation rates (ie, abstinence among all smokers including those who use and do not use treatment) compared with usual care among a diverse population of current smokers. The Veterans Victory Over Tobacco Study, a pragmatic randomized clinical trial involving a population-based registry of current smokers aged 18 to 80 years. A total of 6400 current smokers, identified using the Department of Veterans Affairs (VA) electronic medical record, were randomized prior to contact to evaluate both the reach and effectiveness of the proactive care intervention. Current smokers were randomized to usual care or proactive care. Proactive care combined (1) proactive outreach and (2) offer of choice of smoking cessation services (telephone or in-person). Proactive outreach included mailed invitations followed by telephone outreach to motivate smokers to seek treatment with choice of services. The primary outcome was 6-month prolonged smoking abstinence at 1 year and was assessed by a follow-up survey among all current smokers regardless of interest in quitting or treatment utilization. A total of 5123 participants were included in the primary analysis. The follow-up survey response rate was 66%. The population-level, 6-month prolonged smoking abstinence rate at 1 year was 13.5% for proactive care compared with 10.9% for usual care (P = .02). Logistic regression mixed model analysis showed a significant effect of the proactive care intervention on 6-month prolonged abstinence (odds ratio [OR], 1.27 [95% CI, 1.03-1.57]). In analyses accounting for nonresponse using likelihood-based not-missing-at-random models, the effect of proactive care on 6-month prolonged abstinence persisted (OR, 1.33 [95% CI, 1.17-1.51]). Proactive, population-based tobacco cessation care using proactive outreach to connect smokers to evidence-based telephone or in-person smoking cessation services is effective for increasing long-term population-level cessation rates. clinicaltrials.gov Identifier: NCT00608426.

Cost-effectiveness analysis of a collaborative care programme for depression in primary care.

PubMed

Aragonès, Enric; López-Cortacans, Germán; Sánchez-Iriso, Eduardo; Piñol, Josep-Lluís; Caballero, Antonia; Salvador-Carulla, Luis; Cabasés, Juan

2014-04-01

Collaborative care programmes lead to better outcomes in the management of depression. A programme of this nature has demonstrated its effectiveness in primary care in Spain. Our objective was to evaluate the cost-effectiveness of this programme compared to usual care. A bottom-up cost-effectiveness analysis was conducted within a randomized controlled trial (2007-2010). The intervention consisted of a collaborative care programme with clinical, educational and organizational procedures. Outcomes were monitored over a 12 months period. Primary outcomes were incremental cost-effectiveness ratios (ICER): mean differences in costs divided by quality-adjusted life years (QALY) and mean differences in costs divided by depression-free days (DFD). Analyses were performed from a healthcare system perspective (considering healthcare costs) and from a society perspective (including healthcare costs plus loss of productivity costs). Three hundred and thirty-eight adult patients with major depression were assessed at baseline. Only patients with complete data were included in the primary analysis (166 in the intervention group and 126 in the control group). From a healthcare perspective, the average incremental cost of the programme compared to usual care was €182.53 (p<0.001). Incremental effectiveness was 0.045 QALY (p=0.017) and 40.09 DFD (p=0.011). ICERs were €4,056/QALY and €4.55/DFD. These estimates and their uncertainty are graphically represented in the cost-effectiveness plane. The amount of 13.6% of patients with incomplete data may have introduced a bias. Available data about non-healthcare costs were limited, although they may represent most of the total cost of depression. The intervention yields better outcomes than usual care with a modest increase in costs, resulting in favourable ICERs. This supports the recommendation for its implementation. Copyright © 2014 Elsevier B.V. All rights reserved.

An intervention study exploring the effects of providing older adult hip fracture patients with an information booklet in the early postoperative period.

PubMed

Murphy, Siobhan; Conway, Col; McGrath, Niamh B; O'Leary, Breda; O'Sullivan, Mary P; O'Sullivan, Dawn

2011-12-01

To determine whether the provision of an information booklet on mobilisation improves early mobility postsurgical repair of hip fracture. Hip fracture among older people can have long-lasting consequences with the majority of patients failing to achieve their prefracture functional status. Early postoperative mobility may have a positive effect on long-term recovery. The importance of providing postoperative information on mobility has been highlighted. It is suggested that patients remain passive in their recovery when they do not understand the importance of mobilisation. The study used a pretest-post-test design of two treatments and a usual care control group. Eighty-three adults postsurgical repair of hip fracture, aged 65 years and older, were recruited to the study. Participants were assigned to one of three groups, a usual care group, treatment group 1 (T(1)) usual care plus basic information booklet or treatment group 2 (T(2)) usual care plus detailed information booklet. Data collection three days postsurgery and prior to discharge included the Mini-Mental State Examination, a Demographic Questionnaire, the Elderly Mobility Scale and a Numerical Pain Scale. Greatest improvements in Elderly Mobility Scale scores occurred in T(1), with least changes observed in T(2). Changes did not reach significance level (p=0·105). The results of the study suggest that the provision of basic information is preferable and highlights a deficiency of education in usual care. Hip fracture patients should be provided with an educational booklet containing basic information on mobility to promote optimal recovery. © 2011 Blackwell Publishing Ltd.

Cost analysis of strategies to reduce blood culture contamination in the emergency department: sterile collection kits and phlebotomy teams.

PubMed

Self, Wesley H; Talbot, Thomas R; Paul, Barbara R; Collins, Sean P; Ward, Michael J

2014-08-01

Blood culture collection practices that reduce contamination, such as sterile blood culture collection kits and phlebotomy teams, increase up-front costs for collecting cultures but may lead to net savings by eliminating downstream costs associated with contamination. The study objective was to compare overall hospital costs associated with 3 collection strategies: usual care, sterile kits, and phlebotomy teams. Cost analysis. This analysis was conducted from the perspective of a hospital leadership team selecting a blood culture collection strategy for an adult emergency department (ED) with 8,000 cultures drawn annually. Total hospital costs associated with 3 strategies were compared: (1) usual care, with nurses collecting cultures without a standardized protocol; (2) sterile kits, with nurses using a dedicated sterile collection kit; and (3) phlebotomy teams, with cultures collected by laboratory-based phlebotomists. In the base case, contamination rates associated with usual care, sterile kits, and phlebotomy teams were assumed to be 4.34%, 1.68%, and 1.10%, respectively. Total hospital costs included costs of collecting cultures and hospitalization costs according to culture results (negative, true positive, and contaminated). Compared with usual care, annual net savings using the sterile kit and phlebotomy team strategies were $483,219 and $288,980, respectively. Both strategies remained less costly than usual care across a broad range of sensitivity analyses. EDs with high blood culture contamination rates should strongly consider evidence-based strategies to reduce contamination. In addition to improving quality, implementing a sterile collection kit or phlebotomy team strategy is likely to result in net cost savings.

Enhanced rehabilitation and care models for adults with dementia following hip fracture surgery.

PubMed

Smith, Toby O; Hameed, Yasir A; Cross, Jane L; Henderson, Catherine; Sahota, Opinder; Fox, Chris

2015-06-15

Hip fracture is a major fall-related injury which causes significant problems for individuals, their family and carers. Over 40% of people with hip fracture have dementia or cognitive impairment, and their outcomes after surgery are poorer than those without dementia. It is not clear which care and rehabilitation interventions achieve the best outcomes for these people. (a) To assess the effectiveness of models of care including enhanced rehabilitation strategies designed specifically for people with dementia following hip fracture surgery compared to usual care.(b) To assess the effectiveness for people with dementia of models of care including enhanced rehabilitation strategies which are designed for all older people, regardless of cognitive status, following hip fracture surgery compared to usual care. We searched ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group Specialised Register, up to and including week 1 June 2014 using the terms hip OR fracture OR surgery OR operation OR femur OR femoral. We include randomised and quasi-randomised controlled clinical trials (RCTs) evaluating the effectiveness for people with dementia of any model of enhanced care and rehabilitation following hip fracture surgery compared to usual care. Two review authors working independently selected studies for inclusion and extracted data. We assessed the risk of bias of included studies. We synthesised data only if we considered studies sufficiently homogeneous in terms of participants, interventions and outcomes. We used the GRADE approach to rate the overall quality of evidence for each outcome. We included five trials with a total of 316 participants. Four trials evaluated models of enhanced interdisciplinary rehabilitation and care, two of these for inpatients only and two for inpatients and at home after discharge. All were compared with usual rehabilitation and care in the trial settings. The fifth trial compared outcomes of geriatrician-led care in hospital to conventional care led by the orthopaedic team. All papers analysed subgroups of people with dementia/cognitive impairment from larger RCTs of older people following hip fracture. Trial follow-up periods ranged from acute hospital discharge to 24 months post-discharge.We considered all of the studies to be at high risk of bias in more than one domain. As subgroups of larger studies, the analyses lacked power to detect differences between the intervention groups. Further, there were some important differences in the baseline characteristics of the participants in experimental and control groups. Using the GRADE approach, we downgraded the quality of the evidence for all outcomes to 'low' or 'very low'.No study assessed our primary outcome (cognitive function) nor other important dementia-related outcomes including behaviour and quality of life. The effect estimates for most comparisons were very imprecise, so it was not possible to draw firm conclusions from the data. There was low-quality evidence that enhanced care and rehabilitation in hospital led to lower rates of some complications and that enhanced care provided across hospital and home settings reduced the chance of being in institutional care at three months post-discharge (Odds Ratio (OR) 0.46, 95% confidence interval (CI) 0.22 to 0.95, 2 trials, n = 184), but this effect was more uncertain at 12 months (OR 0.90, 95% CI 0.40 to 2.03, 2 trials, n = 177). The effect of enhanced care and rehabilitation in hospital and at home on functional outcomes was very uncertain because the quality of evidence was very low from one small trial. Results on functional outcomes from other trials were inconclusive. The effect of geriatrician-led compared to orthopaedic-led management on the cumulative incidence of delirium was very uncertain (OR 0.73, 95% CI 0.22 to 2.38, 1 trial, n = 126, very low-quality evidence). There is currently insufficient evidence to draw conclusions about how effective the models of enhanced rehabilitation and care after hip fracture used in these trials are for people with dementia above active usual care. The current evidence base derives from a small number of studies with quality limitations. This should be addressed as a research priority to determine the optimal strategies to improve outcomes for this growing population of patients.

Effectiveness of app-based relaxation for patients with chronic low back pain (Relaxback) and chronic neck pain (Relaxneck): study protocol for two randomized pragmatic trials.

PubMed

Blödt, Susanne; Pach, Daniel; Roll, Stephanie; Witt, Claudia M

2014-12-15

Chronic low back pain (LBP) and neck pain (NP) are highly prevalent conditions resulting in high economic costs. Treatment guidelines recommend relaxation techniques, such as progressive muscle relaxation, as adjuvant therapies. Self-care interventions could have the potential to reduce costs in the health care system, but their effectiveness, especially in a usual care setting, is unclear. The aim of these two pragmatic randomized studies is to evaluate whether an additional app-delivered relaxation is more effective in the reduction of chronic LBP or NP than usual care alone. Each pragmatic randomized two-armed study aims to include a total of 220 patients aged 18 to 65 years with chronic (>12 weeks) LBP or NP and an average pain intensity of ≥ 4 on a numeric rating scale (NRS) in the 7 days before recruitment. The participants will be randomized into an intervention and a usual care group. The intervention group will be instructed to practice one of these 3 relaxation techniques on at least 5 days/week for 15 minutes/day over a period of 6 months starting on the day of randomization: autogenic training, mindfulness meditation, or guided imagery. Instructions and exercises will be provided using a smartphone app, baseline information will be collected using paper and pencil. Follow-up information (daily, weekly, and after 3 and 6 months) will be collected using electronic diaries and questionnaires included in the app. The primary outcome measure will be the mean LBP or NP intensity during the first 3 months of intervention based on daily pain intensity measurements on a NRS (0 = no pain, 10 = worst possible pain). The secondary outcome parameters will include the mean pain intensity during the first 6 months after randomization based on daily measurements, the mean pain intensity measured weekly as the average pain intensity of the previous 7 days over 3 and 6 months, pain acceptance, 'LBP- and NP-related' stress, sick leave days, pain medication intake, adherence, suspected adverse reaction, and serious adverse events. The designed studies reflect a usual self-care setting and will provide evidence on a pragmatic self-care intervention that is easy to combine with care provided by medical professionals. ClinicalTrials.gov identifier Relaxback NCT02019498, Relaxneck NCT02019134 registered on 18 December 2013.

Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

PubMed

Matthews, Paul A; Scammell, Brigitte E; Ali, Arfan; Coughlin, Timothy; Nightingale, Jessica; Khan, Tanvir; Ollivere, Ben J

2018-05-31

Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisation in a below-knee cast. We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are demonstrated, EMADE should become a worthwhile treatment option. A larger-scale, multicentre trial may be required to influence national guidelines. ISRCTN, ID: ISRCTN11212729 . Registered retrospectively on 20 March 2017.

Improving inhaler adherence in patients with chronic obstructive pulmonary disease: a cost-effectiveness analysis.

PubMed

van Boven, Job Fm; Tommelein, Eline; Boussery, Koen; Mehuys, Els; Vegter, Stefan; Brusselle, Guy Go; Rutten-van Mölken, Maureen Pmh; Postma, Maarten J

2014-06-14

The PHARMACOP-intervention significantly improved medication adherence and inhalation technique for patients with COPD compared with usual care. This study aimed to evaluate its cost-effectiveness. An economic analysis was performed from the Belgian healthcare payer's perspective. A Markov model was constructed in which a representative group of patients with COPD (mean age of 70 years, 66% male, 43% current smokers and mean Forced Expiratory Volume in 1 second of % predicted of 50), was followed for either receiving the 3-month PHARMACOP-intervention or usual care. Three types of costs were calculated: intervention costs, medication costs and exacerbation costs. Outcome measures included the number of hospital-treated exacerbations, cost per prevented hospital-treated exacerbation and cost per Quality Adjusted Life-Year. Follow-up was 1 year in the basecase analysis. Sensitivity and scenario analyses (including long-term follow-up) were performed to assess uncertainty. In the basecase analysis, the average overall costs per patient for the PHARMACOP-intervention and usual care were €2,221 and €2,448, respectively within the 1-year time horizon. This reflects cost savings of €227 for the PHARMACOP-intervention. The PHARMACOP-intervention resulted in the prevention of 0.07 hospital-treated exacerbations per patient (0.177 for PHARMACOP versus 0.244 for usual care). Results showed robust cost-savings in various sensitivity analyses. Optimization of current pharmacotherapy (e.g. close monitoring of inhalation technique and medication adherence) has been shown to be cost-saving and should be considered before adding new therapies.

Improving inhaler adherence in patients with Chronic Obstructive Pulmonary Disease: a cost-effectiveness analysis

PubMed Central

2014-01-01

Background The PHARMACOP-intervention significantly improved medication adherence and inhalation technique for patients with COPD compared with usual care. This study aimed to evaluate its cost-effectiveness. Methods An economic analysis was performed from the Belgian healthcare payer’s perspective. A Markov model was constructed in which a representative group of patients with COPD (mean age of 70 years, 66% male, 43% current smokers and mean Forced Expiratory Volume in 1 second of % predicted of 50), was followed for either receiving the 3-month PHARMACOP-intervention or usual care. Three types of costs were calculated: intervention costs, medication costs and exacerbation costs. Outcome measures included the number of hospital-treated exacerbations, cost per prevented hospital-treated exacerbation and cost per Quality Adjusted Life-Year. Follow-up was 1 year in the basecase analysis. Sensitivity and scenario analyses (including long-term follow-up) were performed to assess uncertainty. Results In the basecase analysis, the average overall costs per patient for the PHARMACOP-intervention and usual care were €2,221 and €2,448, respectively within the 1-year time horizon. This reflects cost savings of €227 for the PHARMACOP-intervention. The PHARMACOP-intervention resulted in the prevention of 0.07 hospital-treated exacerbations per patient (0.177 for PHARMACOP versus 0.244 for usual care). Results showed robust cost-savings in various sensitivity analyses. Conclusions Optimization of current pharmacotherapy (e.g. close monitoring of inhalation technique and medication adherence) has been shown to be cost-saving and should be considered before adding new therapies. PMID:24929799

Impact of pretest on posttest knowledge scores with a Solomon Four research design.

PubMed

Weinrich, Sally P; Seger, Rachelle; Curtsinger, Tim; Pumphrey, Gwen; NeSmith, Elizabeth G; Weinrich, Martin C

2007-01-01

There is a paucity of research on the effects of pretest measurement with prostate cancer screening. What effect does a pretest measurement have on posttest outcomes? This research reports knowledge of prostate cancer screening among men randomized to an Enhanced decision aid versus an Usual Care decision aid. Using a Solomon Four research design, there were a total of 198 men in 4 groups. Most of the sample was African American (78%), with a mean age of 52 years. The greatest posttest knowledge occurred with the Enhanced decision aid in contrast to the Usual Care. The Enhanced/Usual Care groups that had both a pretest and posttest and had received a previous digital rectal examination had the highest means (P = .015), with means of 9.1 and 7.0, respectively. Among men who had a previous digital rectal examination, the greatest increase in score occurred among men randomized to the Enhanced decision aid in contrast to the Usual Care decision aid, 2.9 versus 0.4 (P = .008). The outcome varied based on the status of (1) random group assignment of the Solomon Four design and (2) status of previous digital rectal examination. Implications for nurses include consideration 1 of a pretest to increase posttest knowledge scores.

Managed Care

MedlinePlus

... three types of managed care plans: Health Maintenance Organizations (HMO) usually only pay for care within the ... who coordinates most of your care. Preferred Provider Organizations (PPO) usually pay more if you get care ...

A Capabilities Based Assessment of the United States Air Force Critical Care Air Transport Team

DTIC Science & Technology

2013-09-01

usually consist of a critical care physician, critical care nurse , and respiratory therapist. A Front-end Analysis has found several problems within...critically ill and wounded. This life-saving mission is executed by CCAT teams, which usually consist of a critical care physician, critical care nurse ...ill and wounded. This life-saving mission is executed by CCAT teams, which usually consist of a critical care physician, critical care nurse , and

Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study.

PubMed

Douglas, Pamela S; Pontone, Gianluca; Hlatky, Mark A; Patel, Manesh R; Norgaard, Bjarne L; Byrne, Robert A; Curzen, Nick; Purcell, Ian; Gutberlet, Matthias; Rioufol, Gilles; Hink, Ulrich; Schuchlenz, Herwig Walter; Feuchtner, Gudrun; Gilard, Martine; Andreini, Daniele; Jensen, Jesper M; Hadamitzky, Martin; Chiswell, Karen; Cyr, Derek; Wilk, Alan; Wang, Furong; Rogers, Campbell; De Bruyne, Bernard

2015-12-14

In symptomatic patients with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) improves patient selection for invasive coronary angiography (ICA) compared with functional testing. The impact of measuring fractional flow reserve by CTA (FFRCT) is unknown. At 11 sites, 584 patients with new onset chest pain were prospectively assigned to receive either usual testing (n = 287) or CTA/FFR(CT) (n = 297). Test interpretation and care decisions were made by the clinical care team. The primary endpoint was the percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis ≥50% by core laboratory quantitative analysis or invasive FFR < 0.80) was found at ICA within 90 days. Secondary endpoints including death, myocardial infarction, and unplanned revascularization were independently and blindly adjudicated. Subjects averaged 61 ± 11 years of age, 40% were female, and the mean pre-test probability of obstructive CAD was 49 ± 17%. Among those with intended ICA (FFR(CT)-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFR(CT) arm and 137 (73%) in the usual care arm (risk difference 61%, 95% confidence interval 53-69, P< 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4 mSv, P = 0.20). Invasive coronary angiography was cancelled in 61% after receiving CTA/FFR(CT) results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFR(CT)) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFR(CT) arms. Computed tomographic angiography/fractional flow reserve by CTA was a feasible and safe alternative to ICA and was associated with a significantly lower rate of invasive angiography showing no obstructive CAD. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

A randomized trial of protocol-based care for early septic shock.

PubMed

Yealy, Donald M; Kellum, John A; Huang, David T; Barnato, Amber E; Weissfeld, Lisa A; Pike, Francis; Terndrup, Thomas; Wang, Henry E; Hou, Peter C; LoVecchio, Frank; Filbin, Michael R; Shapiro, Nathan I; Angus, Derek C

2014-05-01

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).

Racial Differences in Outcomes of an Advance Care Planning Intervention for Dialysis Patients and Their Surrogates.

PubMed

Song, Mi-Kyung; Ward, Sandra E; Lin, Feng-Chang; Hamilton, Jill B; Hanson, Laura C; Hladik, Gerald A; Fine, Jason P

2016-02-01

African Americans' beliefs about end-of-life care may differ from those of whites, but racial differences in advance care planning (ACP) outcomes are unknown. The aim of this study was to compare the efficacy of an ACP intervention on preparation for end-of-life decision making and post-bereavement outcomes for African Americans and whites on dialysis. A secondary analysis of data from a randomized trial comparing an ACP intervention (Sharing Patient's Illness Representations to Increase Trust [SPIRIT]) with usual care was conducted. There were 420 participants, 210 patient-surrogate dyads (67.4% African Americans), recruited from 20 dialysis centers in North Carolina. The outcomes of preparation for end-of-life decision making included dyad congruence on goals of care, surrogate decision-making confidence, a composite of the two, and patient decisional conflict assessed at 2, 6, and 12 months post-intervention. Surrogate bereavement outcomes included anxiety, depression, and post-traumatic distress symptoms assessed at 2 weeks, and at 3 and 6 months after the patient's death. SPIRIT was superior to usual care in improving dyad congruence (odds ration [OR] = 2.31, p = 0.018), surrogate decision-making confidence (β = 0.18, p = 0.021), and the composite (OR = 2.19, p = 0.028) 2 months post-intervention, but only for African Americans. SPIRIT reduced patient decisional conflict at 6 months for whites and at 12 months for African Americans. Finally, SPIRIT was superior to usual care in reducing surrogates' bereavement depressive symptoms for African Americans but not for whites (β = -3.49, p = 0.003). SPIRIT was effective in improving preparation for end-of-life decision-making and post-bereavement outcomes in African Americans.

Care manager to control cardiovascular risk factors in primary care: the Raffaello cluster randomized trial.

PubMed

Deales, A; Fratini, M; Romano, S; Rappelli, A; Penco, M; Perna, G Piero; Beccaceci, G; Borgia, R; Palumbo, W; Magi, M; Vespasiani, G; Bronzini, M; Musilli, A; Nocciolini, M; Mezzetti, A; Manzoli, L

2014-05-01

This cluster randomized trial evaluated the efficacy of a disease and care management (D&CM) model in cardiovascular (CVD) prevention in primary care. Eligible subjects had ≥ 1 among: blood pressure ≥ 140/90 mmHg; glycated hemoglobin ≥ 7%; LDL-cholesterol ≥ 160 or ≥ 100 mg/dL (primary or secondary prevention, respectively); BMI ≥ 30; current smoking. The D&CM intervention included a teamwork including nurses as care managers for the implementation of tailored care plans. Control group was allocated to usual-care. The main outcome was the proportion of subjects achieving recommended clinical targets for ≥ 1 of uncontrolled CVD risk factors at 12-month. During 2008-2009 we enrolled 920 subjects in the Abruzzo/Marche regions, Italy. Following the exclusion of L'Aquila due to 2009 earthquake, final analyses included 762 subjects. The primary outcome was achieved by 39.1% (95%CI: 34.2-44.2) and 25.2% (95%CI: 20.9-29.9) of subjects in the intervention and usual-care group, respectively (p < 0.001). The D&CM intervention significantly increased the proportion of subjects who achieved clinical targets for both diabetes and hypertension, with no differences in hypercholesterolemia, smoking status and obesity. The D&CM intervention was effective in controlling cardiovascular risk factors, in particular hypertension and diabetes. Numbers needed to treat were small. Such intervention may deserve further consideration in clinical practice. ACTRN12611000813987. Copyright © 2013 Elsevier B.V. All rights reserved.

Usual source of care and the quality of primary care: a survey of patients in Guangdong province, China.

PubMed

Du, Zhicheng; Liao, Yu; Chen, Chien-Chou; Hao, Yuantao; Hu, Ruwei

2015-07-31

Usual source of care (USC) refers to the provider or place a patient consults when sick or in need of medical advice. No studies have been conducted in China to compare the quality of primary care provided with or without USC. The purpose of this study was to fill this gap in the literature by examining the quality of primary care provided between those having a USC and those without. Results of the study would provide implications for policymakers in terms of improving primary care performance in China, and help guide patients in their health care seeking behaviors. A cross-sectional survey with patients was conducted in Guangdong province of China, using the Chinese validated Primary Care Assessment Tool (PCAT). ANOVA was performed to compare the overall and ten domains of primary care quality for patients with and without USC. Multivariate analyses were used to assess the association between USC and quality of primary care attributes while controlling for sociodemographic and health care characteristics. The study added evidence that having a USC can provide higher quality of primary care to patients than those without a USC. Results of this study showed that the PCAT score associated with those having a USC was significantly higher than those not having a USC. Moreover, the study showed that having a usual provider of care was also independently and significantly associated with patients' satisfaction with care. This study added evidence that in China, patients with a USC reported higher quality of medical care experiences compared with those without a USC. The efforts to improve quality of care should include policies promoting USC.

Disease activity guided dose reduction and withdrawal of adalimumab or etanercept compared with usual care in rheumatoid arthritis: open label, randomised controlled, non-inferiority trial.

PubMed

van Herwaarden, Noortje; van der Maas, Aatke; Minten, Michiel J M; van den Hoogen, Frank H J; Kievit, Wietske; van Vollenhoven, Ronald F; Bijlsma, Johannes W J; van den Bemt, Bart J F; den Broeder, Alfons A

2015-04-09

To evaluate whether a disease activity guided strategy of dose reduction of two tumour necrosis factor (TNF) inhibitors, adalimumab or etanercept, is non-inferior in maintaining disease control in patients with rheumatoid arthritis compared with usual care. Randomised controlled, open label, non-inferiority strategy trial. Two rheumatology outpatient clinics in the Netherlands, from December 2011 to May 2014. 180 patients with rheumatoid arthritis and low disease activity using adalimumab or etanercept; 121 allocated to the dose reduction strategy, 59 to usual care. Disease activity guided dose reduction (advice to stepwise increase the injection interval every three months, until flare of disease activity or discontinuation) or usual care (no dose reduction advice). Flare was defined as increase in DAS28-CRP (a composite score measuring disease activity) greater than 1.2, or increase greater than 0.6 and current score of at least 3.2. In the case of flare, TNF inhibitor use was restarted or escalated. Difference in proportions of patients with major flare (DAS28-CRP based flare longer than three months) between the two groups at 18 months, compared against a non-inferiority margin of 20%. Secondary outcomes included TNF inhibitor use at study end, functioning, quality of life, radiographic progression, and adverse events. Dose reduction of adalimumab or etanercept was non-inferior to usual care (proportion of patients with major flare at 18 months, 12% v 10%; difference 2%, 95% confidence interval -12% to 12%). In the dose reduction group, TNF inhibitor use could successfully be stopped in 20% (95% confidence interval 13% to 28%), the injection interval successfully increased in 43% (34% to 53%), but no dose reduction was possible in 37% (28% to 46%). Functional status, quality of life, relevant radiographic progression, and adverse events did not differ between the groups, although short lived flares (73% v 27%) and minimal radiographic progression (32% v 15%) were more frequent in dose reduction than usual care. A disease activity guided, dose reduction strategy of adalimumab or etanercept to treat rheumatoid arthritis is non-inferior to usual care with regard to major flaring, while resulting in the successful dose reduction or stopping in two thirds of patients.Trial registration Dutch trial register (www.trialregister.nl), NTR 3216. © van Herwaarden et al 2015.

Characteristics of Office-based Physician Visits, 2015.

PubMed

Ashman, Jill J; Rui, Pinyao; Okeyode, Titilayo

2018-06-01

In 2015, most Americans had a usual place to receive health care (85% of adults and 96% of children) (1,2). The majority of children and adults listed a doctor's office as the usual place they received care (1,2). In 2015, there were an estimated 990.8 million office-based physician visits in the United States (3,4). This report examines visit rates by age and sex. It also examines visit characteristics-including insurance status, reason for visit, and services-by age. Estimates use data from the 2015 National Ambulatory Medical Care Survey (NAMCS). All material appearing in this report is in the public domain and may be reproduced or copied without permission; citation as to source, however, is appreciated.

Primary care ... where?

PubMed

Adcock, G B

1999-07-01

Corporate-based nurse managed centers are not the national norm. More prevalent is the use of an occupational health or physician-directed medical model of care. The author describes how a 14-year-old primary care center at a North Carolina computer software company is just "business as usual" when viewed in the context of the company's philosophy, goals, and culture. Included are considerations for nurse practitioners interested in the successful transplantation of this primary care model to other settings.

After-hours care and its coordination with primary care in the U.S.

PubMed

O'Malley, Ann S; Samuel, Divya; Bond, Amelia M; Carrier, Emily

2012-11-01

Despite expectations that medical homes provide "24 × 7 coverage" there is little to guide primary care practices in developing sustainable models for accessible and coordinated after-hours care. To identify and describe models of after-hours care in the U.S. that are delivered in primary care sites or coordinated with a patient's usual primary care provider. Qualitative analysis of data from in-depth telephone interviews. Primary care practices in 16 states and the organizations they partner with to provide after-hours coverage. Forty-four primary care physicians, practice managers, nurses and health plan representatives from 28 organizations. Analyses examined after-hours care models, facilitators, barriers and lessons learned. Based on 28 organizations interviewed, five broad models of after-hours care were identified, ranging in the extent to which they provide continuity and patient access. Key themes included: 1) The feasibility of a model varies for many reasons, including patient preferences and needs, the local health care market supply, and financial compensation; 2) A shared electronic health record and systematic notification procedures were extremely helpful in maintaining information continuity between providers; and 3) after-hours care is best implemented as part of a larger practice approach to access and continuity. After-hours care coordinated with a patient's usual primary care provider is facilitated by consideration of patient demand, provider capacity, a shared electronic health record, systematic notification procedures and a broader practice approach to improving primary care access and continuity. Payer support is important to increasing patients' access to after-hours care.

Randomized controlled trial of a health plan-level mood disorders psychosocial intervention for solo or small practices.

PubMed

Kilbourne, Amy M; Nord, Kristina M; Kyle, Julia; Van Poppelen, Celeste; Goodrich, David E; Kim, Hyungjin Myra; Eisenberg, Daniel; Un, Hyong; Bauer, Mark S

2014-01-01

Mood disorders represent the most expensive mental disorders for employer-based commercial health plans. Collaborative care models are effective in treating chronic physical and mental illnesses at little to no net healthcare cost, but to date have primarily been implemented by larger healthcare organizations in facility-based models. The majority of practices providing commercially insured care are far too small to implement such models. Health plan-level collaborative care treatment can address this unmet need. The goal of this study is to implement at the national commercial health plan level a collaborative care model to improve outcomes for persons with mood disorders. A randomized controlled trial of a collaborative care model versus usual care will be conducted among beneficiaries of a large national health plan from across the country seen by primary care or behavioral health practices. At discharge 344 patients identified by health plan claims as hospitalized for unipolar depression or bipolar disorder will be randomized to receive collaborative care (patient phone-based self-management support, care management, and guideline dissemination to practices delivered by a plan-level care manager) or usual care from their provider. Primary outcomes are changes in mood symptoms and mental health-related quality of life at 12 months. Secondary outcomes include rehospitalization, receipt of guideline-concordant care, and work productivity. This study will determine whether a collaborative care model for mood disorders delivered at the national health plan level improves outcomes compared to usual care, and will inform a business case for collaborative care models for these settings that can reach patients wherever they receive treatment. ClinicalTrials.gov Identifier: NCT02041962; registered January 3, 2014.

Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial.

PubMed

Goertz, Christine M; Long, Cynthia R; Vining, Robert D; Pohlman, Katherine A; Kane, Bridget; Corber, Lance; Walter, Joan; Coulter, Ian

2016-02-09

Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone. This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation. Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability. The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.

Tackling psychosocial maladjustment in Parkinson's disease patients following subthalamic deep-brain stimulation: A randomised clinical trial.

PubMed

Flores Alves Dos Santos, Joao; Tezenas du Montcel, Sophie; Gargiulo, Marcella; Behar, Cecile; Montel, Sébastien; Hergueta, Thierry; Navarro, Soledad; Belaid, Hayat; Cloitre, Pauline; Karachi, Carine; Mallet, Luc; Welter, Marie-Laure

2017-01-01

Subthalamic nucleus deep brain stimulation (STN-DBS) is an effective treatment for the motor and non-motor signs of Parkinson's disease (PD), however, psychological disorders and social maladjustment have been reported in about one third of patients after STN-DBS. We propose here a perioperative psychoeducation programme to limit such social and familial disruption. Nineteen PD patients and carers were included in a randomised single blind study. Social adjustment scale (SAS) scores from patients and carers that received the psychoeducation programme (n = 9) were compared, both 1 and 2 years after surgery, with patients and carers with usual care (n = 10). Depression, anxiety, cognitive status, apathy, coping, parkinsonian disability, quality-of-life, carers' anxiety and burden were also analysed. Seventeen patients completed the study, 2 were excluded from the final analysis because of adverse events. At 1 year, 2/7 patients with psychoeducation and 8/10 with usual care had an aggravation in at least one domain of the SAS (p = .058). At 2 years, only 1 patient with psychoeducation suffered persistent aggravated social adjustment as compared to 8 patients with usual care (p = .015). At 1 year, anxiety, depression and instrumental coping ratings improved more in the psychoeducation than in the usual care group (p = .038, p = .050 and p = .050, respectively). No significant differences were found between groups for quality of life, cognitive status, apathy or motor disability. Our results suggest that a perioperative psychoeducation programme prevents social maladjustment in PD patients following STN-DBS and improves anxiety and depression compared to usual care. These preliminary data need to be confirmed in larger studies.

Tackling psychosocial maladjustment in Parkinson’s disease patients following subthalamic deep-brain stimulation: A randomised clinical trial

PubMed Central

Flores Alves Dos Santos, Joao; Tezenas du Montcel, Sophie; Gargiulo, Marcella; Behar, Cecile; Montel, Sébastien; Hergueta, Thierry; Navarro, Soledad; Belaid, Hayat; Cloitre, Pauline; Karachi, Carine; Mallet, Luc

2017-01-01

Background Subthalamic nucleus deep brain stimulation (STN-DBS) is an effective treatment for the motor and non-motor signs of Parkinson’s disease (PD), however, psychological disorders and social maladjustment have been reported in about one third of patients after STN-DBS. We propose here a perioperative psychoeducation programme to limit such social and familial disruption. Methods Nineteen PD patients and carers were included in a randomised single blind study. Social adjustment scale (SAS) scores from patients and carers that received the psychoeducation programme (n = 9) were compared, both 1 and 2 years after surgery, with patients and carers with usual care (n = 10). Depression, anxiety, cognitive status, apathy, coping, parkinsonian disability, quality-of-life, carers’ anxiety and burden were also analysed. Results Seventeen patients completed the study, 2 were excluded from the final analysis because of adverse events. At 1 year, 2/7 patients with psychoeducation and 8/10 with usual care had an aggravation in at least one domain of the SAS (p = .058). At 2 years, only 1 patient with psychoeducation suffered persistent aggravated social adjustment as compared to 8 patients with usual care (p = .015). At 1 year, anxiety, depression and instrumental coping ratings improved more in the psychoeducation than in the usual care group (p = .038, p = .050 and p = .050, respectively). No significant differences were found between groups for quality of life, cognitive status, apathy or motor disability. Conclusions Our results suggest that a perioperative psychoeducation programme prevents social maladjustment in PD patients following STN-DBS and improves anxiety and depression compared to usual care. These preliminary data need to be confirmed in larger studies. PMID:28399152

Efficacy of the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program among patients with mild cognitive impairment: a randomized controlled crossover trial.

PubMed

Han, Ji Won; Son, Kyung Lak; Byun, Hye Jin; Ko, Ji Won; Kim, Kayoung; Hong, Jong Woo; Kim, Tae Hyun; Kim, Ki Woong

2017-06-06

Spaced retrieval training (SRT) is a nonpharmacological intervention for mild cognitive impairment (MCI) and dementia that trains the learning and retention of target information by recalling it over increasingly long intervals. We recently developed the Ubiquitous Spaced Retrieval-based Memory Advancement and Rehabilitation Training (USMART) program as a convenient, self-administered tablet-based SRT program. We also demonstrated the utility of USMART for improving memory in individuals with MCI through an open-label uncontrolled trial. This study had an open-label, single-blind, randomized, controlled, two-period crossover design. Fifty patients with MCI were randomized into USMART-usual care and usual care-USMART treatment sequences. USMART was completed or usual care was provided biweekly over a 4-week treatment period with a 2-week washout period between treatment periods. Primary outcome measures included the Word List Memory Test, Word List Recall Test (WLRT), and Word List Recognition Test. Outcomes were measured at baseline, week 5, and week 11 by raters who were blinded to intervention type. An intention-to-treat analysis and linear mixed modeling were used. Of 50 randomized participants, 41 completed the study (18% dropout rate). The USMART group had larger improvements in WLRT score (effect size = 0.49, p = 0.031) than the usual care group. There were no significant differences in other primary or secondary measures between the USMART and usual care groups. Moreover, no USMART-related adverse events were reported. The 4-week USMART modestly improved information retrieval in older people with MCI, and was well accepted with minimal technical support. ClinicalTrials.gov NCT01688128 . Registered 12 September 2012.

Cost-effectiveness of a classification-based system for sub-acute and chronic low back pain.

PubMed

Apeldoorn, Adri T; Bosmans, Judith E; Ostelo, Raymond W; de Vet, Henrica C W; van Tulder, Maurits W

2012-07-01

Identifying relevant subgroups in patients with low back pain (LBP) is considered important to guide physical therapy practice and to improve outcomes. The aim of the present study was to assess the cost-effectiveness of a modified version of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with sub-acute and chronic LBP with 1 year follow-up. All patients were classified using the modified version of Delitto's classification-based system and then randomly assigned to receive either classification-based treatment or usual physical therapy care. The main clinical outcomes measured were; global perceived effect, intensity of pain, functional disability and quality of life. Costs were measured from a societal perspective. Multiple imputations were used for missing data. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated. In total, 156 patients were included. The outcome analyses showed a significantly better outcome on global perceived effect favoring the classification-based approach, and no differences between the groups on pain, disability and quality-adjusted life-years. Mean total societal costs for the classification-based group were 2,287, and for the usual physical therapy care group 2,020. The difference was 266 (95% CI -720 to 1,612) and not statistically significant. Cost-effectiveness analyses showed that the classification-based approach was not cost-effective in comparison with usual physical therapy care for any clinical outcome measure. The classification-based treatment approach as used in this study was not cost-effective in comparison with usual physical therapy care in a population of patients with sub-acute and chronic LBP.

In-shoe plantar pressure measurements for the evaluation and adaptation of foot orthoses in patients with rheumatoid arthritis: A proof of concept study.

PubMed

Tenten-Diepenmaat, Marloes; Dekker, Joost; Steenbergen, Menno; Huybrechts, Elleke; Roorda, Leo D; van Schaardenburg, Dirkjan; Bus, Sicco A; van der Leeden, Marike

2016-03-01

Improving foot orthoses (FOs) in patients with rheumatoid arthritis (RA) by using in-shoe plantar pressure measurements seems promising. The objectives of this study were to evaluate (1) the outcome on plantar pressure distribution of FOs that were adapted using in-shoe plantar pressure measurements according to a protocol and (2) the protocol feasibility. Forty-five RA patients with foot problems were included in this observational proof-of concept study. FOs were custom-made by a podiatrist according to usual care. Regions of Interest (ROIs) for plantar pressure reduction were selected. According to a protocol, usual care FOs were evaluated using in-shoe plantar pressure measurements and, if necessary, adapted. Plantar pressure-time integrals at the ROIs were compared between the following conditions: (1) no-FO versus usual care FO and (2) usual care FO versus adapted FO. Semi-structured interviews were held with patients and podiatrists to evaluate the feasibility of the protocol. Adapted FOs were developed in 70% of the patients. In these patients, usual care FOs showed a mean 9% reduction in pressure-time integral at forefoot ROIs compared to no-FOs (p=0.01). FO adaptation led to an additional mean 3% reduction in pressure-time integral (p=0.05). The protocol was considered feasible by patients. Podiatrists considered the protocol more useful to achieve individual rather than general treatment goals. A final protocol was proposed. Using in-shoe plantar pressure measurements for adapting foot orthoses for patients with RA leads to a small additional plantar pressure reduction in the forefoot. Further research on the clinical relevance of this outcome is required. Copyright © 2016. Published by Elsevier B.V.

System Transformation under the California Mental Health Services Act: Implementation of Full Service Partnerships in Los Angeles County

PubMed Central

Starks, Sarah L.; Arns, Paul G.; Padwa, Howard; Friedman, Jack R.; Marrow, Jocelyn; Meldrum, Marcia L.; Bromley, Elizabeth; Kelly, Erin Lee; Brekke, John; Braslow, Joel T.

2018-01-01

Objective The objective is to evaluate the effect of California’s Mental Health Services Act on the structure, volume, location, and patient-centeredness of Los Angeles County public mental health services. Methods This prospective mixed-methods study (2006-2013) is based in 5 Los Angeles County public mental health clinics, all with usual care and 3 with Full Service Partnerships (FSP): new MHSA-funded programs designed to “do whatever it takes” to provide intensive, recovery-oriented, team-based, integrated services for clients with severe mental illness. Study participants include treatment providers (42 FSP, 130 usual care) and clients (174 FSP, 298 usual care). FSPs were compared to usual care on outpatient services received (claims data) and organizational climate, recovery orientation, and provider-client working alliance (surveys; semi-structured interviews), with regression adjustment for client and provider characteristics. Results FSP clients received significantly more (5,238 vs. 1,643 minutes, p<.001), and more-frequently field-based (22% vs. 2%, p<.001), outpatient services than usual care clients in the first year post-admission. FSP clients reported more recovery-oriented services (RSA-R 3.8 vs. 3.5, p<.001) and better provider-client working alliance (WAI-S 3.8 vs. 3.6, p=.01). FSP providers reported more stress (55.0 vs. 51.3, p<.001) and lower morale (48.1 vs. 49.6, p<.001). Conclusions Los Angeles County’s public mental health system was able to transform service delivery in response to well-funded policy mandates. For providers, a structure emphasizing accountability and patient-centeredness was associated with greater stress, despite smaller caseloads. For clients, service structure and volume created opportunities to build stronger provider-client relationships and address client needs and goals. PMID:28142386

Costs and Outcomes Evaluation of Patient Navigation Following Abnormal Cancer Screening: Evidence from the Patient Navigation Research Program

PubMed Central

Bensink, Mark E.; Ramsey, Scott D.; Battaglia, Tracy; Fiscella, Kevin; Hurd, Thelma C.; McKoy, June M.; Patierno, Steven R.; Raich, Peter C.; Seiber, Eric E.; Mears, Victoria Warren; Whitley, Elizabeth; Paskett, Electra D.; Mandelblatt, Jeanne S.

2013-01-01

Background Navigators can facilitate timely access to cancer services but there are little data on their economic impact. Methods We conduct a cost-consequence analysis of navigation vs. usual care among 10,521 individuals with abnormal breast, cervix, colorectal or prostate cancer screening results who enrolled in the Patient Navigation Research Program study from January 1 2006 to March 31 2010. Navigation costs included diagnostic evaluation, patient and staff time, materials, and overhead. Consequences or outcomes were time to diagnostic resolution and probability of resolution. Differences in costs and outcomes were evaluated using multi-level, mixed-effects regression adjusting for age, race/ethnicity, language, marital status, insurance, cancer, and site clustering. Results Most individuals were minority (70.7%) and un- or publically-insured (72.7%). Diagnostic resolution was higher for navigation vs. usual care at 180 (56.2% vs. 53.8%, p=0.008) and 270 days: 70.0% vs. 68.2%, p<0.001). While there were no differences in average days to resolution (110 vs. 109 days, p=.63), the probability of ever having diagnostic resolution was higher for navigation vs. usual care (84.5% vs. 79.6%, p <0.001). The added cost of navigation vs. usual care was $275 per patient (95% CI $260 – $290, p <0.001). There was no significant difference in stage distribution among the 12.4% of navigated vs. 11% of usual care patients diagnosed with cancer. Conclusions Navigation adds costs and modestly increases the probability of diagnostic resolution among patients with abnormal screening tests. Navigation is only likely to be cost-effective if improved resolution translates into earlier cancer stage at diagnosis. PMID:24166217

Relationship Between Continuity of Care and Diabetes Control: Evidence From the Third National Health and Nutrition Examination Survey

PubMed Central

Mainous, Arch G.; Koopman, Richelle J.; Gill, James M.; Baker, Richard; Pearson, William S.

2004-01-01

Objectives. We examined the relationship between continuity of care and diabetes control. Methods. We analyzed data on 1400 adults with diabetes who took part in the Third National Health and Nutrition Examination Survey. We examined the relationship of continuity of care with glycemic, blood pressure, and lipid control. Results. Continuity of care was associated with both acceptable and optimal levels of glycemic control. Continuity was not associated with blood pressure or lipid control. There was no difference between having a usual site but no usual provider and having a usual provider in any of the investigated outcomes. Conclusions. Continuity of care is associated with better glycemic control among people with diabetes. Our results do not support a benefit of having a usual provider above having a usual site of care. PMID:14713700

Targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR): protocol for a randomised controlled trial.

PubMed

O'Brien, Claire; Bray, Emma P; Bryan, Stirling; Greenfield, Sheila M; Haque, M Sayeed; Hobbs, F D Richard; Jones, Miren I; Jowett, Sue; Kaambwa, Billingsley; Little, Paul; Mant, Jonathan; Penaloza, Cristina; Schwartz, Claire; Shackleford, Helen; Varghese, Jinu; Williams, Bryan; McManus, Richard J

2013-03-23

Self-monitoring of hypertension with self-titration of antihypertensives (self-management) results in lower systolic blood pressure for at least one year. However, few people in high risk groups have been evaluated to date and previous work suggests a smaller effect size in these groups. This trial therefore aims to assess the added value of self-management in high risk groups over and above usual care. The targets and self-management for the control of blood pressure in stroke and at risk groups (TASMIN-SR) trial will be a pragmatic primary care based, unblinded, randomised controlled trial of self-management of blood pressure (BP) compared to usual care. Eligible patients will have a history of stroke, coronary heart disease, diabetes or chronic kidney disease and will be recruited from primary care. Participants will be individually randomised to either usual care or self-management. The primary outcome of the trial will be difference in office SBP between intervention and control groups at 12 months adjusted for baseline SBP and covariates. 540 patients will be sufficient to detect a difference in SBP between self-management and usual care of 5 mmHg with 90% power. Secondary outcomes will include self-efficacy, lifestyle behaviours, health-related quality of life and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative analysis will gain insights into patients' views, experiences and decision making processes. The results of the trial will be directly applicable to primary care in the UK. If successful, self-management of blood pressure in people with stroke and other high risk conditions would be applicable to many hundreds of thousands of individuals in the UK and beyond. ISRCTN87171227.

Patients' experiences with navigation for cancer care.

PubMed

Carroll, Jennifer K; Humiston, Sharon G; Meldrum, Sean C; Salamone, Charcy M; Jean-Pierre, Pascal; Epstein, Ronald M; Fiscella, Kevin

2010-08-01

We examined how navigation, defined as the assessment and alleviation of barriers to adequate health care, influences patients' perspectives on the quality of their cancer care. We conducted post-study patient interviews from a randomized controlled trial (usual care vs. patient navigation services) from cancer diagnosis through treatment completion. Patients were recruited from 11 primary care, hospital and community oncology practices in New York. We interviewed patients about their expectations and experience of patient navigation or, for non-navigated patients, other sources of assistance. Thirty-five patients newly diagnosed with breast or colorectal cancer. Valued aspects of navigation included emotional support, assistance with information needs and problem-solving, and logistical coordination of cancer care. Unmet cancer care needs expressed by patients randomized to usual care consisted of lack of assistance or support with childcare, household responsibilities, coordination of care, and emotional support. Cancer patients value navigation. Instrumental benefits were the most important expectations for navigation from navigated and non-navigated patients. Navigated patients received emotional support and assistance with information needs, problem-solving, and logistical aspects of cancer care coordination. Navigation services may help improve cancer care outcomes important to patients by addressing fragmented, confusing, uncoordinated, or inefficient care. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Patients' Experiences with Navigation for Cancer Care

PubMed Central

Carroll, Jennifer K.; Humiston, Sharon G.; Meldrum, Sean C.; Salamone, Charcy M.; Jean-Pierre, Pascal; Epstein, Ronald M.; Fiscella, Kevin

2010-01-01

Objective We examined how navigation, defined as the assessment and alleviation of barriers to adequate health care, influences patients' perspectives on the quality of their cancer care. Methods We conducted post-study patient interviews from a randomized controlled trial (usual care vs. patient navigation services) from cancer diagnosis through treatment completion. Patients were recruited from 11 primary care, hospital and community oncology practices in New York. We interviewed patients about their expectations and experience of patient navigation or, for non-navigated patients, other sources of assistance. Results Thirty-five patients newly diagnosed with breast or colorectal cancer. Valued aspects of navigation included emotional support, assistance with information needs and problem-solving, and logistical coordination of cancer care. Unmet cancer care needs expressed by patients randomized to usual care consisted of lack of assistance or support with childcare, household responsibilities, coordination of care, and emotional support. Conclusion Cancer patients value navigation. Instrumental benefits were the most important expectations for navigation from navigated and non-navigated patients. Navigated patients received emotional support and assistance with information needs, problem-solving, and logistical aspects of cancer care coordination. Practice Implications Navigation services may help improve cancer care outcomes important to patients by addressing fragmented, confusing, uncoordinated, or inefficient care. PMID:20006459

Quality of life in patients receiving telemedicine enhanced chronic heart failure disease management: A meta-analysis.

PubMed

Knox, Liam; Rahman, Rachel J; Beedie, Chris

2017-08-01

Background Previous reviews have investigated the effectiveness of telemedicine in the treatment of heart failure (HF). Dependent variables have included hospitalisations, mortality rates, disease knowledge and health costs. Few reviews, however, have examined the variable of health-related quality of life (QoL). Methods Randomised controlled trials comparing the delivery methods of any form of telemedicine with usual care for the provision of HF disease-management were identified via searches of all relevant databases and reference lists. Studies had to report a quantitative measure for mental, physical or overall QoL in order to be included. Results A total of 33 studies were identified. However, poor reporting of data resulted in the exclusion of seven, leaving 26 studies with 7066 participants. Three separate, random effects meta-analyses were conducted for mental, physical and overall QoL. Telemedicine was not significantly more effective than usual care on mental and physical QoL (standardised mean difference (SMD) 0.03, (95% confidence interval (CI) -0.05-0.12), p = 0.45 and SMD 0.24, (95% CI -0.08-0.56), p = 0.14, respectively). However, when compared to usual care, telemedicine was associated with a small significant increase in overall QoL (SMD 0.23, (95% CI 0.09-0.37), p = 0.001). Moderator analyses indicated that telemedicine delivered over a long-duration (≥52 weeks) and via telemonitoring was most beneficial. Conclusion Compared to usual care, telemedicine significantly increases overall QoL in patients receiving HF disease management. Statistically non-significant but nonetheless positive trends were also observed for physical QoL. These findings provide preliminary support for the use of telemedicine in the management of heart failure without jeopardising patient well-being.

Comparative Effectiveness of Usual Source of Care Approaches to Improve End-of-Life Outcomes for Children With Intellectual Disability.

PubMed

Lindley, Lisa C; Cozad, Melanie J

2017-09-01

Children with intellectual disability (ID) are at risk for adverse end-of-life outcomes including high emergency room utilization and hospital readmissions, along with low hospice enrollment. The objective of this study was to compare the effectiveness of usual source of care approaches to improve end-of-life outcomes for children with ID. We used longitudinal California Medicaid claims data. Children were included who were 21 years with fee-for-service Medicaid claims, died between January 1, 2007, and December 31, 2010, and had a moderate-to-profound ID diagnosis. End-of-life outcomes (i.e., hospice enrollment, emergency room utilization, hospital readmissions) were measured via claims data. Our treatments were usual source of care (USC) only vs. usual source of care plus targeted case management (USC plus TCM). Using instrumental variable analysis, we compared the effectiveness of treatments on end-of-life outcomes. Ten percent of children with ID enrolled in hospice, 73% used the emergency room, and 20% had three or more hospital admissions in their last year of life. USC plus TCM relative to USC only had no effect on hospice enrollment; however, it significantly reduced the probability of emergency room utilization (B = -1.29, P < 0.05) and hospital readmissions (B = -1.71, P < 0.001). Our findings demonstrated that USC plus TCM was more effective at improving end-of-life outcomes for children with ID. Further study of the extent of UCS and TCM involvement in reducing emergency room utilization and hospital readmissions at end of life is needed. Copyright © 2017 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department: A Stepped-Wedge, Cluster Randomized Trial.

PubMed

Poldervaart, Judith M; Reitsma, Johannes B; Backus, Barbra E; Koffijberg, Hendrik; Veldkamp, Rolf F; Ten Haaf, Monique E; Appelman, Yolande; Mannaerts, Herman F J; van Dantzig, Jan-Melle; van den Heuvel, Madelon; El Farissi, Mohamed; Rensing, Bernard J W M; Ernst, Nicolette M S K J; Dekker, Ineke M C; den Hartog, Frank R; Oosterhof, Thomas; Lagerweij, Ghizelda R; Buijs, Eugene M; van Hessen, Maarten W J; Landman, Marcel A J; van Kimmenade, Roland R J; Cozijnsen, Luc; Bucx, Jeroen J J; van Ofwegen-Hanekamp, Clara E E; Cramer, Maarten-Jan; Six, A Jacob; Doevendans, Pieter A; Hoes, Arno W

2017-05-16

The HEART (History, Electrocardiogram, Age, Risk factors, and initial Troponin) score is an easy-to-apply instrument to stratify patients with chest pain according to their short-term risk for major adverse cardiac events (MACEs), but its effect on daily practice is unknown. To measure the effect of use of the HEART score on patient outcomes and use of health care resources. Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT01756846). Emergency departments in 9 Dutch hospitals. Unselected patients with chest pain presenting at emergency departments in 2013 and 2014. All hospitals started with usual care. Every 6 weeks, 1 hospital was randomly assigned to switch to "HEART care," during which physicians calculated the HEART score to guide patient management. For safety, a noninferiority margin of a 3.0% absolute increase in MACEs within 6 weeks was set. Other outcomes included use of health care resources, quality of life, and cost-effectiveness. A total of 3648 patients were included (1827 receiving usual care and 1821 receiving HEART care). Six-week incidence of MACEs during HEART care was 1.3% lower than during usual care (upper limit of the 1-sided 95% CI, 2.1% [within the noninferiority margin of 3.0%]). In low-risk patients, incidence of MACEs was 2.0% (95% CI, 1.2% to 3.3%). No statistically significant differences in early discharge, readmissions, recurrent emergency department visits, outpatient visits, or visits to general practitioners were observed. Physicians were hesitant to refrain from admission and diagnostic tests in patients classified as low risk by the HEART score. Using the HEART score during initial assessment of patients with chest pain is safe, but the effect on health care resources is limited, possibly due to nonadherence to management recommendations. Netherlands Organisation for Health Research and Development.

Multistrategy childcare-based intervention to improve compliance with nutrition guidelines versus usual care in long day care services: a study protocol for a randomised controlled trial

PubMed Central

Seward, Kirsty; Finch, Meghan; Wiggers, John; Wyse, Rebecca; Jones, Jannah; Gillham, Karen; Yoong, Sze Lin

2016-01-01

Introduction Interventions to improve child diet are recommended as dietary patterns developed in childhood track into adulthood and influence the risk of chronic disease. For child health, childcare services are required to provide foods to children consistent with nutrition guidelines. Research suggests that foods and beverages provided by services to children are often inconsistent with nutrition guidelines. The primary aim of this study is to assess, relative to a usual care control group, the effectiveness of a multistrategy childcare-based intervention in improving compliance with nutrition guidelines in long day care services. Methods and analysis The study will employ a parallel group randomised controlled trial design. A sample of 58 long day care services that provide all meals (typically includes 1 main and 2 mid-meals) to children while they are in care, in the Hunter New England region of New South Wales, Australia, will be randomly allocated to a 6-month intervention to support implementation of nutrition guidelines or a usual care control group in a 1:1 ratio. The intervention was designed to overcome barriers to the implementation of nutrition guidelines assessed using the theoretical domains framework. Intervention strategies will include the provision of staff training and resources, audit and feedback, ongoing support and securing executive support. The primary outcome of the trial will be the change in the proportion of long day care services that have a 2-week menu compliant with childcare nutrition guidelines, measured by comprehensive menu assessments. As a secondary outcome, child dietary intake while in care will also be assessed. To assess the effectiveness of the intervention, the measures will be undertaken at baseline and ∼6 months postbaseline. Ethics and dissemination The study was approved by the Hunter New England Human Research Ethics Committee. Study findings will be disseminated widely through peer-reviewed publications. PMID:27301484

Effectiveness and cost effectiveness of counselling in primary care.

PubMed

Rowland, N; Bower, P; Mellor, C; Heywood, P; Godfrey, C

2001-01-01

There is wide clinician and patient support for counselling in primary care, particularly in the UK. This review examines the effectiveness and cost effectiveness of counselling for psychological and psychosocial problems in the primary care setting. To assess the effects of counselling in primary care by reviewing cost and outcome data for patients with psychological and psychosocial problems considered suitable for counselling. The search strategy included electronic searching of databases (including the CCDAN Register of RCTs and CCTs) along with handsearching of a specialist journal. Published and unpublished sources (clinical trials, books, dissertations, agency reports etc.) were searched, and their reference lists scanned. Contact was made with subject experts and CCDAN members. Randomised and controlled patient preference trials comparing counselling in primary care with usual general practitioner care for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of April 1998 were included in the review. Trials were independently assessed by at least two reviewers for appropriateness of inclusion and methdological quality. Four trials, involving 678 participants, of whom 487 were followed up, were included. Data for psychological symptom levels (four trials) were pooled statistically. Patients receiving counselling had significantly better psychological symptom levels post intervention than patients receiving usual general practitioner care (standardised mean difference -0.30, 95% CI, (-0.49 to - 0.11). The effect remained statistically significant when the results from studies with less rigorous methodology were excluded in a sensitivity analysis. Patients who received counselling tended to be more satisfied with their treatment (three trials). Health service utilisation data were reported in all trials reviewed, but only one trial undertook a cost analysis. No clear cost advantage was associated with either counselling or usual general practice care. Patients who received counselling were more likely to have improved psychological symptom levels than those who did not receive counselling. Levels of satisfaction with counselling were high. There is limited information about the cost effectiveness of counselling, with one study reporting no clear cost advantage with either counselling or general practice care. The four trials included in this review were all pragmatic trials of counselling in primary care in the UK, which reflect the reality of clinical provision in this context. There were methdological weaknesses identified in the studies, which should be taken into account when considering the results. The evidence base will be extended by trials of counselling which are nearing completion.

A clustered controlled trial of the implementation and effectiveness of a medical home to improve health care of people with serious mental illness: study protocol.

PubMed

Young, Alexander S; Cohen, Amy N; Chang, Evelyn T; Flynn, Anthony W P; Hamilton, Alison B; Oberman, Rebecca; Vinzon, Merlyn

2018-06-07

People with serious mental illness (SMI) die many years prematurely, with rates of premature mortality two to three times greater than the general population. Most premature deaths are due to "natural causes," especially cardiovascular disease and cancer. Often, people with SMI are not well engaged in primary care treatment and do not receive high-value preventative and medical services. There have been numerous efforts to improve this care, and few controlled trials, with inconsistent results. While people with SMI often do poorly with usual primary care arrangements, research suggests that integrated care and medical care management may improve treatment and outcomes, and reduce treatment costs. This hybrid implementation-effectiveness study is a prospective, cluster controlled trial of a medical home, the SMI Patient-Aligned Care Team (SMI PACT), to improve the healthcare of patients with SMI enrolled with the Veterans Health Administration. The SMI PACT team includes proactive medical nurse care management, and integrated mental health treatment through regular psychiatry consultation and a collaborative care model. Patients are recruited to receive primary care through SMI PACT based on having a serious mental illness that is manageable with treatment, and elevated risk for hospitalization or death. In a site-level prospective controlled trial, this project studies the effect, relative to usual care, of SMI PACT on provision of appropriate preventive and medical treatments, health-related quality of life, satisfaction with care, and medical and mental health treatment utilization and costs. Research includes mixed-methods formative evaluation of usual care and SMI PACT implementation to strengthen the intervention and assess barriers and facilitators. Investigators examine relationships among organizational context, intervention factors, and patient and clinician outcomes, and identify patient factors related to successful patient outcomes. This will be one of the first controlled trials of the implementation and effectiveness of a patient centered medical home for people with serious mental illness. It will provide information regarding the value of this strategy, and processes and tools for implementing this model in community healthcare settings. ClinicalTrials.gov, NCT01668355 . Registered August 20, 2012.

Effectiveness of a Geriatric Care Model for frail older adults in primary care: Results from a stepped wedge cluster randomized trial.

PubMed

Hoogendijk, Emiel O; van der Horst, Henriëtte E; van de Ven, Peter M; Twisk, Jos W R; Deeg, Dorly J H; Frijters, Dinnus H M; van Leeuwen, Karen M; van Campen, Jos P C M; Nijpels, Giel; Jansen, Aaltje P D; van Hout, Hein P J

2016-03-01

Primary care-based comprehensive care programs have the potential to improve outcomes in frail older adults. We evaluated the impact of the Geriatric Care Model (GCM) on the quality of life of community-dwelling frail older adults. A 24-month stepped wedge cluster randomized controlled trial was conducted between May 2010 and March 2013 in 35 primary care practices in the Netherlands, and included 1147 frail older adults. The intervention consisted of a geriatric in-home assessment by a practice nurse, followed by a tailored care plan. Reassessment occurred every six months. Nurses worked together with primary care physicians and were supervised and trained by geriatric expert teams. Complex patients were reviewed in multidisciplinary consultations. The primary outcome was quality of life (SF-12). Secondary outcomes were health-related quality of life, functional limitations, self-rated health, psychological wellbeing, social functioning and hospitalizations. Intention-to-treat analyses based on multilevel modeling showed no significant differences between the intervention group and usual care regarding SF-12 and most secondary outcomes. Only for IADL limitations we found a small intervention effect in patients who received the intervention for 18months (B=-0.25, 95%CI=-0.43 to -0.06, p=0.007), but this effect was not statistically significant after correction for multiple comparisons. The GCM did not show beneficial effects on quality of life in frail older adults in primary care, compared to usual care. This study strengthens the idea that comprehensive care programs add very little to usual primary care for this population. The Netherlands National Trial Register NTR2160. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

The impact of health coaching on medication adherence in patients with poorly controlled diabetes, hypertension, and/or hyperlipidemia: a randomized controlled trial.

PubMed

Thom, David H; Willard-Grace, Rachel; Hessler, Danielle; DeVore, Denise; Prado, Camille; Bodenheimer, Thomas; Chen, Ellen

2015-01-01

Lack of concordance between medications listed in the medical record and taken by the patient contributes to poor outcomes. We sought to determine whether patients who received health coaching by medical assistants improved their medication concordance and adherence. This was a nonblinded, randomized, controlled, pragmatic intervention trial. English- or Spanish-speaking patients, age 18 to 75 years, with poorly controlled type 2 diabetes, hypertension, and/or hyperlipidemia were enrolled from 2 urban safety net clinics and randomized to receive 12 months of health coaching versus usual care. Outcomes included concordance between medications documented in the medical record and those reported by the patient and adherence based on the patient-reported number of days (of the last 7) on which patient took all prescribed medications. The proportion of medications completely concordant increased in the coached group versus the usual care group (difference in change, 10%; P = .05). The proportion of medications listed in the chart but not taken significantly decreased in the coached group compared with the usual care group (difference in change, 17%; P = .013). The mean number of adherent days increased in the coached but not in the usual care group (difference in change, 1.08; P < .001). Health coaching by medical assistants significantly increases medication concordance and adherence. © Copyright 2015 by the American Board of Family Medicine.

An observational study of emergency department utilization among enrollees of Minnesota Health Care Programs: financial and non-financial barriers have different associations

PubMed Central

2014-01-01

Background Emergency department (ED) use is costly, and especially frequent among publicly insured populations in the US, who also disproportionately encounter financial (cost/coverage-related) and non-financial/practical barriers to care. The present study examines the distinct associations financial and non-financial barriers to care have with patterns of ED use among a publicly insured population. Methods This observational study uses linked administrative-survey data for enrollees of Minnesota Health Care Programs to examine patterns in ED use—specifically, enrollee self-report of the ED as usual source of care, and past-year count of 0, 1, or 2+ ED visits from administrative data. Main independent variables included a count of seven enrollee-reported financial concerns about healthcare costs and coverage, and a count of seven enrollee-reported non-financial, practical barriers to access (e.g., limited office hours, problems with childcare). Covariates included health, health care, and demographic measures. Results In multivariate regression models, only financial concerns were positively associated with reporting ED as usual source of care, but only non-financial barriers were significantly associated with greater ED visits. Regression-adjusted values indicated notable differences in ED visits by number of non-financial barriers: zero non-financial barriers meant an adjusted 78% chance of having zero ED visits (95% C.I.: 70.5%-85.5%), 15.9% chance of 1(95% C.I.: 10.4%-21.3%), and 6.2% chance (95% C.I.: 3.5%-8.8%) of 2+ visits, whereas having all seven non-financial barriers meant a 48.2% adjusted chance of zero visits (95% C.I.: 30.9%-65.6%), 31.8% chance of 1 visit (95% C.I.: 24.2%-39.5%), and 20% chance (95% C.I.: 8.4%-31.6%) of 2+ visits. Conclusions Financial barriers were associated with identifying the ED as one’s usual source of care but non-financial barriers were associated with actual ED visits. Outreach/literacy efforts may help reduce reliance on/perception of ED as usual source of care, whereas improved targeting/availability of covered services may help curb frequent actual visits, among publicly insured individuals. PMID:24507761

One size fits some: the impact of patient treatment attitudes on the cost-effectiveness of a depression primary-care intervention.

PubMed

Pyne, Jeffrey M; Rost, Kathryn M; Farahati, Farah; Tripathi, Shanti P; Smith, Jeffrey; Williams, D Keith; Fortney, John; Coyne, James C

2005-06-01

Despite their impact on outcomes, the effect of patient treatment attitudes on the cost-effectiveness of health-care interventions is not widely studied. This study estimated the impact of patient receptivity to antidepressant medication on the cost-effectiveness of an evidence-based primary-care depression intervention. Twelve community primary-care practices were stratified and then randomized to enhanced (intervention) or usual care. Subjects included 211 patients beginning a new treatment episode for major depression. At baseline, 111 (52.6%) and 145 (68.7%) reported receptivity to antidepressant medication and counseling respectively. The intervention trained the primary-care teams to assess, educate, and monitor depressed patients. Twelve-month incremental (enhanced minus usual care) total costs and quality-adjusted life years (QALYs) were calculated. Among patients receptive to antidepressants, the mean incremental cost-effectiveness ratio was dollar 5,864 per QALY (sensitivity analyses up to dollar 14,689 per QALY). For patients not receptive to antidepressants, the mean incremental QALY score was negative (for both main and sensitivity analyses), or the intervention was at least no more effective than usual care. These findings suggest a re-thinking of the 'one size fits all' depression intervention, given that half of depressed primary-care patients may be non-receptive to antidepressant medication treatment. A brief assessment of treatment receptivity should occur early in the treatment process to identify patients most likely to benefit from primary-care quality improvement efforts for depression treatment. Patient treatment preferences are also important for the development, design, and analysis of depression interventions.

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

PubMed Central

Geraghty, Adam W A; Stanford, Rosie; Stuart, Beth; Little, Paul; Roberts, Lisa C; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine M; Turner, David; Malakan, Wansida; Leigh, Linda; Yardley, Lucy

2018-01-01

Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. Trial registration number ISRCTN31034004; Results. PMID:29525768

A randomized controlled trial of the effect of intrapartum intravenous fluid management on breastfed newborn weight loss.

PubMed

Watson, Jo; Hodnett, Ellen; Armson, B Anthony; Davies, Barbara; Watt-Watson, Judy

2012-01-01

To determine the effect of conservative versus usual intrapartum intravenous (IV) fluid management for low-risk women receiving epidural analgesia on weight loss in breastfed newborns. A randomized controlled trial. A tertiary perinatal center in a large urban setting. Women experiencing uncomplicated pregnancies who planned to have epidural analgesia and to breastfeed. Healthy pregnant women were randomized to receive an IV epidural preload volume of <500 mLs continuing at an hourly rate of 75-100 mL/h (conservative care) or an epidural preload volume of ≥500 mLs and an hourly rate >125 mL/h (usual care). The primary study outcome was breastfed newborn weight loss >7% prior to hospital discharge. Secondary study outcomes included breastfeeding exclusivity, referral to outpatient breastfeeding clinic support, and delayed discharge. Other outcomes were admission to the neonatal intensive care unit and cord blood pH <7.25. Two hundred women participated (100 in the conservative care and 100 in the usual care groups). Forty-eight of 100 infants in the usual care group and 44 of the 100 infants in the conservative care group lost >7% of their birth weight prior to discharge, p < 0.52 RR 0.92 [0.68-1.24]. A policy of restricted IV fluids did not affect newborn weight loss. Women and their care providers should be reassured that the volumes of IV fluid <2500 mLs are unlikely to have a clinically meaningful effect on breastfed newborn weight loss >7%. Exploratory analyses suggest that breastfed newborn weight loss increases when intrapartum volumes infused are >2500 mLs. Care providers are encouraged to consider volumes of IV fluid infused intrapartum as a factor that may have contributed to early newborn weight loss in the first 48 h of life. © 2012 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Effectiveness of certified diabetes educators following pre-approved protocols to redesign diabetes care delivery in primary care: Results of the REMEDIES 4D trial.

PubMed

Zgibor, Janice C; Maloney, Maura A; Malmi, Markku; Fabio, Anthony; Kuo, Shihchen; Solano, Francis X; Tilves, Debra; Tu, Lichuan; Davidson, Mayer B

2018-01-01

To evaluate changes in HbA1c, blood pressure, and LDLc levels in participants from practices where certified diabetes educators (CDEs) implemented standardized protocols to intensify treatment compared with those receiving usual care. This clustered, randomized, clinical trial was implemented in community-based primary care practices. Fifteen primary care practices and 240 patients with type 2 diabetes were randomized to the intervention (n=175) or usual care (n=65). Participants had uncontrolled HbA1c, blood pressure, or LDLc. The one-year intervention included CDEs implementing pre-approved protocols to intensify treatment. Diabetes self-management education was also provided in both study groups. The population was 50.8% male with a mean age of 61years. The HbA1c in the intervention group decreased from 8.8% to 7.8%, (p=0.001) while the HbA1c in the usual care group increased slightly from 8.2% to 8.3%. There was also a significant difference in HbA1c between the two groups (p=0.004). There was not a significant difference between groups for systolic blood pressure (SBP) or LDLc at the end of the intervention. Those in the intervention group were more likely to have glucose-lowering medications intensified and were more likely to have their HbA1c (35% vs 15%), SBP (80% vs 77%) and HbA1c, SBP, and LDLc at goal (11% vs 1.5%) compared with the usual care group. There was no significant difference in intensification of blood pressure or cholesterol medication. Findings suggest that CDEs following standardized protocols in primary care is feasible and can effectively intensify treatment and improve glycemic control. Copyright © 2017 Elsevier Inc. All rights reserved.

CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea.

PubMed

McEvoy, R Doug; Antic, Nick A; Heeley, Emma; Luo, Yuanming; Ou, Qiong; Zhang, Xilong; Mediano, Olga; Chen, Rui; Drager, Luciano F; Liu, Zhihong; Chen, Guofang; Du, Baoliang; McArdle, Nigel; Mukherjee, Sutapa; Tripathi, Manjari; Billot, Laurent; Li, Qiang; Lorenzi-Filho, Geraldo; Barbe, Ferran; Redline, Susan; Wang, Jiguang; Arima, Hisatomi; Neal, Bruce; White, David P; Grunstein, Ron R; Zhong, Nanshan; Anderson, Craig S

2016-09-08

Obstructive sleep apnea is associated with an increased risk of cardiovascular events; whether treatment with continuous positive airway pressure (CPAP) prevents major cardiovascular events is uncertain. After a 1-week run-in period during which the participants used sham CPAP, we randomly assigned 2717 eligible adults between 45 and 75 years of age who had moderate-to-severe obstructive sleep apnea and coronary or cerebrovascular disease to receive CPAP treatment plus usual care (CPAP group) or usual care alone (usual-care group). The primary composite end point was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack. Secondary end points included other cardiovascular outcomes, health-related quality of life, snoring symptoms, daytime sleepiness, and mood. Most of the participants were men who had moderate-to-severe obstructive sleep apnea and minimal sleepiness. In the CPAP group, the mean duration of adherence to CPAP therapy was 3.3 hours per night, and the mean apnea-hypopnea index (the number of apnea or hypopnea events per hour of recording) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up. After a mean follow-up of 3.7 years, a primary end-point event had occurred in 229 participants in the CPAP group (17.0%) and in 207 participants in the usual-care group (15.4%) (hazard ratio with CPAP, 1.10; 95% confidence interval, 0.91 to 1.32; P=0.34). No significant effect on any individual or other composite cardiovascular end point was observed. CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood. Therapy with CPAP plus usual care, as compared with usual care alone, did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease. (Funded by the National Health and Medical Research Council of Australia and others; SAVE ClinicalTrials.gov number, NCT00738179 ; Australian New Zealand Clinical Trials Registry number, ACTRN12608000409370 .).

Comparison of interactive voice response, patient mailing, and mailed registry to encourage screening for osteoporosis: a randomized controlled trial.

PubMed

Heyworth, L; Kleinman, K; Oddleifson, S; Bernstein, L; Frampton, J; Lehrer, M; Salvato, K; Weiss, T W; Simon, S R; Connelly, M

2014-05-01

Guidelines recommend screening for osteoporosis with bone mineral density (BMD) testing in menopausal women, particularly those with additional risk factors for fracture. Many eligible women remain unscreened. This randomized study demonstrates that a single outreach interactive voice response phone call improves rates of BMD screening among high-risk women age 50-64. Osteoporotic fractures are a major cause of disability and mortality. Guidelines recommend screening with BMD for menopausal women, particularly those with additional risk factors for fracture. However, many women remain unscreened. We examined whether telephonic interactive voice response (IVR) or patient mailing could increase rates of BMD testing in high risk, menopausal women. We studied 4,685 women age 50-64 years within a not-for-profit health plan in the United States. All women had risk factors for developing osteoporosis and no prior BMD testing or treatment for osteoporosis. Patients were randomly allocated to usual care, usual care plus IVR, or usual care plus mailed educational materials. To avoid contamination, patients within a single primary care physician practice were randomized to receive the same intervention. The primary endpoint was BMD testing at 12 months. Secondary outcomes included BMD testing at 6 months and medication use at 12 months. Mean age was 57 years. Baseline demographic and clinical characteristics were similar across the three study groups. In adjusted analyses, the incidence of BMD screening was 24.6% in the IVR group compared with 18.6% in the usual care group (P < 0.001). There was no difference between the patient mailing group and the usual care group (P = 0.3). In this large community-based randomized trial of high risk, menopausal women age 50-64, IVR, but not patient mailing, improved rates of BMD screening. IVR remains a viable strategy to incorporate in population screening interventions.

Feasibility and impact of Creciendo Sanos, a clinic-based pilot intervention to prevent obesity among preschool children in Mexico City

PubMed Central

2014-01-01

Background Mexico has the highest adult overweight and obesity prevalence in the Americas; 23.8% of children <5 years old are at risk for overweight and 9.7% are already overweight or obese. Creciendo Sanos was a pilot intervention to prevent obesity among preschoolers in Instituto Mexicano del Seguro Social (IMSS) clinics. Methods We randomized 4 IMSS primary care clinics to either 6 weekly educational sessions promoting healthful nutrition and physical activity or usual care. We recruited 306 parent-child pairs: 168 intervention, 138 usual care. Children were 2-5 years old with WHO body mass index (BMI) z-score 0-3. We measured children’s height and weight and parents reported children’s diet and physical activity at baseline and 3 and 6-month follow-up. We analyzed behavioral and BMI outcomes with generalized mixed models incorporating multiple imputation for missing values. Results 93 (55%) intervention and 96 (70%) usual care families completed 3 and 6-month follow-up. At 3 months, intervention v. usual care children increased vegetables by 6.3 servings/week (95% CI, 1.8, 10.8). In stratified analyses, intervention participants with high program adherence (5-6 sessions) decreased snacks and screen time and increased vegetables v. usual care. No further effects on behavioral outcomes or BMI were observed. Transportation time and expenses were barriers to adherence. 90% of parents who completed the post-intervention survey were satisfied with the program. Conclusions Although satisfaction was high among participants, barriers to participation and retention included transportation cost and time. In intention to treat analyses, we found intervention effects on vegetable intake, but not other behaviors or BMI. Trial registration ClinicalTrials.gov NCT01539070. Comisión Nacional de Investigación Científica del IMSS: 2009-785-120. PMID:24649831

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Spillover effects of community uninsurance on working-age adults and seniors: an instrumental variables analysis.

PubMed

Gresenz, Carole Roan; Escarce, José J

2011-09-01

: Previous research suggests, but does not definitively establish, that a high level of uninsurance in a community may negatively affect access to and quality of health care for insured persons. : To assess the effect of the level of uninsurance in a community on access to and satisfaction with care-an important dimension of quality-among insured persons. : The 1996 to 2006 Medical Expenditure Panel Survey Household Component data linked to data from the Current Population Survey, Area Resource File, and the InterStudy Competitive Edge. Analyses include 86,928 insured adult respondents living in approximately 200 large metropolitan areas. : Measures of whether an individual had a usual source of care, had any delay/difficulty obtaining needed care, used office-based services, used prescription drug services, and used any medical services, and measures of satisfaction with care. : Among privately insured adults, a higher community uninsurance rate resulted in a lower probability of having a usual source of care, having an office-based visit, having any medical expenditures, and reporting being satisfied with the quality of care provided by the usual source of care. A higher community uninsurance rate also led to a higher probability of reporting difficulty obtaining needed care. Among Medicare enrollees, a higher community uninsurance rate resulted in lower reported satisfaction with care and higher probability of experiencing difficulty or delay in getting needed care. : Our results suggest substantial spillover effects of the community uninsurance rate on access to and satisfaction with health care among insured working-age adults and seniors. Consequently, new efforts to address the problem of the uninsured may bring significant benefits to persons who already have insurance.

Rhythmic artifact of physiotherapy in intensive care unit EEG recordings.

PubMed

Young, Bryan; Raihan, Syed; Ladak, H; Kelly, Martin

2007-06-01

Intensive care unit EEG recordings are often contaminated by artifacts that are unseen elsewhere and are usually not documented. One is the rhythmic artifact of physiotherapy (RAP), which can follow the frequency of chest percussion or vibration with either fundamental or harmonic sinusoidal wave forms, affecting single or multiple channels. The occipital electrodes are the most commonly affected, but others can be involved separately or in combination. RAP can easily be mistaken for cerebrally originating rhythms, including seizures. RAP is most easily detected by examining the ECG channel, which usually captures the artifact, but video EEG provides another means, at least for chest percussion.

Effectiveness and cost effectiveness of counselling in primary care.

PubMed

Bower, P; Rowland, N; Mellor, C l; Heywood, P; Godfrey, C; Hardy, R

2002-01-01

Counsellors are prevalent in primary care settings. However, there are concerns about the clinical and cost-effectiveness of the treatments they provide, compared with alternatives such as usual care from the general practitioner, medication or other psychological therapies. To assess the effectiveness and cost effectiveness of counselling in primary care by reviewing cost and outcome data in randomised controlled trials, controlled clinical trials and controlled patient preference trials of counselling interventions in primary care, for patients with psychological and psychosocial problems considered suitable for counselling. The original search strategy included electronic searching of databases (including the CCDAN Register of RCTs and CCTs) along with handsearching of a specialist journal. Published and unpublished sources (clinical trials, books, dissertations, agency reports etc.) were searched, and their reference lists scanned to uncover further controlled trials. Contact was made with subject experts and CCDAN members in order to uncover further trials. For the updated review, searches were restricted to those databases judged to be high yield in the first version of the review: MEDLINE, EMBASE, PSYCLIT and CINAHL, the Cochrane Controlled Trials register and the CCDAN trials register. All controlled trials comparing counselling in primary care with other treatments for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of June 2001 were included in the review. Data were extracted using a standardised data extraction sheet. The relevant data were entered into the Review Manager software. Trials were quality rated, using CCDAN criteria, to assess the extent to which their design and conduct were likely to have prevented systematic error. Continuous measures of outcome were combined using standardised mean differences. An overall effect size was calculated for each outcome with 95% confidence intervals. Continuous data from different measuring instruments were transformed into a standard effect size by dividing mean values by standard deviations. In view of the diversity of counselling services in primary care (the range of treatments, patients and practitioners) tests of heterogeneity were done to assess the feasibility of aggregating measures of outcome from trials. Sensitivity analyses were undertaken to test the robustness of the results. Seven trials were included in the review. The main analyses showed significantly greater clinical effectiveness in the counselling group compared with 'usual care' in the short-term (standardised mean difference -0.28, 95% CI -0.43 to -0.13, n=772, 6 trials) but not the long-term (standardised mean difference -0.09, 95% CI -0.27 to 0.10, n=475, 4 trials). Levels of satisfaction with counselling were high. Four studies reported similar total costs associated with counselling and usual care over the long-term. However, the economic analyses were likely to be underpowered. Counselling is associated with modest improvement in short-term outcome compared to 'usual care', but provides no additional advantages in the long-term. Patients are satisfied with counselling, and it may not be associated with increased costs.

Tobacco Cessation via Public Dental Clinics: Results of a Randomized Trial

PubMed Central

Andrews, Judy A.; Albert, David A.; Crews, Karen M.; Payne, Thomas J.; Severson, Herbert H.

2010-01-01

Objectives. We sought to compare the effectiveness of a dental practitioner advice and brief counseling intervention to quit tobacco use versus usual care for patients in community health centers on tobacco cessation, reduction in tobacco use, number of quit attempts, and change in readiness to quit. Methods. We randomized 14 federally funded community health center dental clinics that serve diverse racial/ethnic groups in 3 states (Mississippi, New York, and Oregon) to the intervention (brief advice and assistance, including nicotine replacement therapy) or usual care group. Results. We enrolled 2549 smokers. Participants in the intervention group reported significantly higher abstinence rates at the 7.5-month follow-up, for both point prevalence (F1,12 = 6.84; P < .05) and prolonged abstinence (F1,12 = 14.62; P < .01) than did those in the usual care group. Conclusions. The results of our study suggest the viability and effectiveness of tobacco cessation services delivered to low-income smokers via their dental health care practitioner in community health centers. Tobacco cessation services delivered in public dental clinics have the potential to improve the health and well-being of millions of Americans. PMID:20466951

Time-limited home-care reablement services for maintaining and improving the functional independence of older adults.

PubMed

Cochrane, Andy; Furlong, Mairead; McGilloway, Sinead; Molloy, David W; Stevenson, Michael; Donnelly, Michael

2016-10-11

Reablement, also known as restorative care, is one possible approach to home-care services for older adults at risk of functional decline. Unlike traditional home-care services, reablement is frequently time-limited (usually six to 12 weeks) and aims to maximise independence by offering an intensive multidisciplinary, person-centred and goal-directed intervention. To assess the effects of time-limited home-care reablement services (up to 12 weeks) for maintaining and improving the functional independence of older adults (aged 65 years or more) when compared to usual home-care or wait-list control group. We searched the following databases with no language restrictions during April to June 2015: the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (OvidSP); Embase (OvidSP); PsycINFO (OvidSP); ERIC; Sociological Abstracts; ProQuest Dissertations and Theses; CINAHL (EBSCOhost); SIGLE (OpenGrey); AgeLine and Social Care Online. We also searched the reference lists of relevant studies and reviews as well as contacting authors in the field. We included randomised controlled trials (RCTs), cluster randomised or quasi-randomised trials of time-limited reablement services for older adults (aged 65 years or more) delivered in their home; and incorporated a usual home-care or wait-list control group. Two authors independently assessed studies for inclusion, extracted data, assessed the risk of bias of individual studies and considered quality of the evidence using GRADE. We contacted study authors for additional information where needed. Two studies, comparing reablement with usual home-care services with 811 participants, met our eligibility criteria for inclusion; we also identified three potentially eligible studies, but findings were not yet available. One included study was conducted in Western Australia with 750 participants (mean age 82.29 years). The second study was conducted in Norway (61 participants; mean age 79 years).We are very uncertain as to the effects of reablement compared with usual care as the evidence was of very low quality for all of the outcomes reported. The main findings were as follows.Functional status: very low quality evidence suggested that reablement may be slightly more effective than usual care in improving function at nine to 12 months (lower scores reflect greater independence; standardised mean difference (SMD) -0.30; 95% confidence interval (CI) -0.53 to -0.06; 2 studies with 249 participants).Adverse events: reablement may make little or no difference to mortality at 12 months' follow-up (RR 0.97; 95% CI 0.74 to 1.29; 2 studies with 811 participants) or rates of unplanned hospital admission at 24 months (RR 0.94; 95% CI 0.85 to 1.03; 1 study with 750 participants).The very low quality evidence also means we are uncertain whether reablement may influence quality of life (SMD -0.23; 95% CI -0.48 to 0.02; 2 trials with 249 participants) or living arrangements (RR 0.92, 95% CI 0.62 to 1.34; 1 study with 750 participants) at time points up to 12 months. People receiving reablement may be slightly less likely to have been approved for a higher level of personal care than people receiving usual care over the 24 months' follow-up (RR 0.87; 95% CI 0.77 to 0.98; 1 trial, 750 participants). Similarly, although there may be a small reduction in total aggregated home and healthcare costs over the 24-month follow-up (reablement: AUD 19,888; usual care: AUD 22,757; 1 trial with 750 participants), we are uncertain about the size and importance of these effects as the results were based on very low quality evidence.Neither study reported user satisfaction with the service. There is considerable uncertainty regarding the effects of reablement as the evidence was of very low quality according to our GRADE ratings. Therefore, the effectiveness of reablement services cannot be supported or refuted until more robust evidence becomes available. There is an urgent need for high quality trials across different health and social care systems due to the increasingly high profile of reablement services in policy and practice in several countries.

Effectiveness of chronic care models for the management of type 2 diabetes mellitus in Europe: a systematic review and meta-analysis

PubMed Central

Bongaerts, Brenda W C; Müssig, Karsten; Wens, Johan; Lang, Caroline; Schwarz, Peter; Roden, Michael; Rathmann, Wolfgang

2017-01-01

Objectives We evaluated the effectiveness of European chronic care programmes for type 2 diabetes mellitus (characterised by integrative care and a multicomponent framework for enhancing healthcare delivery), compared with usual diabetes care. Design Systematic review and meta-analysis. Data sources MEDLINE, Embase, CENTRAL and CINAHL from January 2000 to July 2015. Eligibility criteria Randomised controlled trials focussing on (1) adults with type 2 diabetes, (2) multifaceted diabetes care interventions specifically designed for type 2 diabetes and delivered in primary or secondary care, targeting patient, physician and healthcare organisation and (3) usual diabetes care as the control intervention. Data extraction Study characteristics, characteristics of the intervention, data on baseline demographics and changes in patient outcomes. Data analysis Weighted mean differences in change in HbA1c and total cholesterol levels between intervention and control patients (95% CI) were estimated using a random-effects model. Results Eight cluster randomised controlled trials were identified for inclusion (9529 patients). One year of multifaceted care improved HbA1c levels in patients with screen-detected and newly diagnosed diabetes, but not in patients with prevalent diabetes, compared to usual diabetes care. Across all seven included trials, the weighted mean difference in HbA1c change was −0.07% (95% CI −0.10 to −0.04) (−0.8 mmol/mol (95% CI −1.1 to −0.4)); I2=21%. The findings for total cholesterol, LDL-cholesterol and blood pressure were similar to HbA1c, albeit statistical heterogeneity between studies was considerably larger. Compared to usual care, multifaceted care did not significantly change quality of life of the diabetes patient. Finally, measured for screen-detected diabetes only, the risk of macrovascular and mircovascular complications at follow-up was not significantly different between intervention and control patients. Conclusions Effects of European multifaceted diabetes care patient outcomes are only small. Improvements are somewhat larger for screen-detected and newly diagnosed diabetes patients than for patients with prevalent diabetes. PMID:28320788

Effectiveness of chronic care models for the management of type 2 diabetes mellitus in Europe: a systematic review and meta-analysis.

PubMed

Bongaerts, Brenda W C; Müssig, Karsten; Wens, Johan; Lang, Caroline; Schwarz, Peter; Roden, Michael; Rathmann, Wolfgang

2017-03-20

We evaluated the effectiveness of European chronic care programmes for type 2 diabetes mellitus (characterised by integrative care and a multicomponent framework for enhancing healthcare delivery), compared with usual diabetes care. Systematic review and meta-analysis. MEDLINE, Embase, CENTRAL and CINAHL from January 2000 to July 2015. Randomised controlled trials focussing on (1) adults with type 2 diabetes, (2) multifaceted diabetes care interventions specifically designed for type 2 diabetes and delivered in primary or secondary care, targeting patient, physician and healthcare organisation and (3) usual diabetes care as the control intervention. Study characteristics, characteristics of the intervention, data on baseline demographics and changes in patient outcomes. Weighted mean differences in change in HbA1c and total cholesterol levels between intervention and control patients (95% CI) were estimated using a random-effects model. Eight cluster randomised controlled trials were identified for inclusion (9529 patients). One year of multifaceted care improved HbA1c levels in patients with screen-detected and newly diagnosed diabetes, but not in patients with prevalent diabetes, compared to usual diabetes care. Across all seven included trials, the weighted mean difference in HbA1c change was -0.07% (95% CI -0.10 to -0.04) (-0.8 mmol/mol (95% CI -1.1 to -0.4)); I 2 =21%. The findings for total cholesterol, LDL-cholesterol and blood pressure were similar to HbA1c, albeit statistical heterogeneity between studies was considerably larger. Compared to usual care, multifaceted care did not significantly change quality of life of the diabetes patient. Finally, measured for screen-detected diabetes only, the risk of macrovascular and mircovascular complications at follow-up was not significantly different between intervention and control patients. Effects of European multifaceted diabetes care patient outcomes are only small. Improvements are somewhat larger for screen-detected and newly diagnosed diabetes patients than for patients with prevalent diabetes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Effectiveness of an Integrated Multidisciplinary Osteoarthritis Outpatient Program versus Outpatient Clinic as Usual: A Randomized Controlled Trial.

PubMed

Moe, Rikke Helene; Grotle, Margreth; Kjeken, Ingvild; Olsen, Inge Christoffer; Mowinckel, Petter; Haavardsholm, Espen A; Hagen, Kåre Birger; Kvien, Tore K; Uhlig, Till

2016-02-01

Osteoarthritis (OA) is one of the leading causes of pain and disability. Given the constraint in the provision of care, there is a need to develop and assess effectiveness of new treatment models. The objective was to compare satisfaction with and effectiveness of a new integrated multidisciplinary outpatient program with usual care in an outpatient clinic for patients with OA. Patients with clinical OA referred to a rheumatology outpatient clinic were randomized to a 3.5-h multidisciplinary group-based educational program followed by individual consultations, or to usual care. The primary outcome was satisfaction with the health service evaluated on a numerical rating scale (0 = extremely unsatisfied, 10 = extremely satisfied) after 4 months. Secondary outcomes included health-related quality of life measures. Of 391 patients, 86.4% (n = 338) were women, and mean age was 61.2 (SD 8.0) years. At 4 months, patients who received integrated multidisciplinary care were significantly more satisfied with the health service compared with controls, with a mean difference of -1.05 (95% CI -1.68 to -0.43, p < 0.001). Among secondary outcomes, only self-efficacy with other symptoms scale (10-100) improved significantly in the multidisciplinary group compared with controls at 4 months (3.59, 95% CI 0.69-6.5, p = 0.02). At 12 months, the Australian/Canadian Hand Osteoarthritis Index pain (0-10) and fatigue scores (0-10) were slightly worse in the multidisciplinary group with differences of 0.38 (95% CI 0.06-0.71, p = 0.02) and 0.55 (95% CI 0.02-1.07, p = 0.04), respectively. Patients receiving an integrated multidisciplinary care model were more satisfied with healthcare than those receiving usual care, whereas there were no clinically relevant improvements in health outcomes.

Collaborative Interventions for Circulation and Depression (COINCIDE): study protocol for a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease

PubMed Central

2012-01-01

Background Depression is up to two to three times as common in people with long-term conditions. It negatively affects medical management of disease and self-care behaviors, and leads to poorer quality of life and high costs in primary care. Screening and treatment of depression is increasingly prioritized, but despite initiatives to improve access and quality of care, depression remains under-detected and under-treated, especially in people with long-term conditions. Collaborative care is known to positively affect the process and outcome of care for people with depression and long-term conditions, but its effectiveness outside the USA is still relatively unknown. Furthermore, collaborative care has yet to be tested in settings that resemble more naturalistic settings that include patient choice and the usual care providers. The aim of this study was to test the effectiveness of a collaborative-care intervention, for people with depression and diabetes/coronary heart disease in National Health Service (NHS) primary care, in which low-intensity psychological treatment services are delivered by the usual care provider - Increasing Access to Psychological Therapies (IAPT) services. The study also aimed to evaluate the cost-effectiveness of the intervention over 6 months, and to assess qualitatively the extent to which collaborative care was implemented in the intervention general practices. Methods This is a cluster randomized controlled trial of 30 general practices allocated to either collaborative care or usual care. Fifteen patients per practice will be recruited after a screening exercise to detect patients with recognized depression (≥10 on the nine-symptom Patient Health Questionnaire; PHQ-9). Patients in the collaborative-care arm with recognized depression will be offered a choice of evidence-based low-intensity psychological treatments based on cognitive and behavioral approaches. Patients will be case managed by psychological well-being practitioners employed by IAPT in partnership with a practice nurse and/or general practitioner. The primary outcome will be change in depressive symptoms at 6 months on the 90-item Symptoms Checklist (SCL-90). Secondary outcomes include change in health status, self-care behaviors, and self-efficacy. A qualitative process evaluation will be undertaken with patients and health practitioners to gauge the extent to which the collaborative-care model is implemented, and to explore sustainability beyond the clinical trial. Discussion COINCIDE will assess whether collaborative care can improve patient-centered outcomes, and evaluate access to and quality of care of co-morbid depression of varying intensity in people with diabetes/coronary heart disease. Additionally, by working with usual care providers such as IAPT, and by identifying and evaluating interventions that are effective and appropriate for routine use in the NHS, the COINCIDE trial offers opportunities to address translational gaps between research and implementation. Trial Registration Number ISRCTN80309252 Trial Status Open PMID:22906179

DIABETES, DEPRESSION, AND DEATH: A RANDOMIZED CONTROLLED TRIAL OF A DEPRESSION TREATMENT PROGRAM FOR OLDER ADULTS BASED IN PRIMARY CARE (PROSPECT)

PubMed Central

Bogner, Hillary R; Morales, Knashawn H; Post, Edward P; Bruce, Martha L

2009-01-01

OBJECTIVE Our a priori hypothesis was that depressed patients with diabetes in practices implementing a depression management program would have a decreased risk of mortality compared to depressed patients with diabetes in usual care practices. RESEARCH DESIGN AND METHODS Multi-site practice-randomized controlled trial PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 5/99-8/01 and supplemented with a search of the National Death Index. Twenty primary care practices participated from New York City, Philadelphia, and Pittsburgh. In all, 584 participants who were identified though a two-stage, age-stratified (60-74; 75+) depression screening of randomly sampled patients and were classified as depressed with complete information on diabetes status are included in these analyses. Of all the 584 participants, 123 (21.2%) reported a history of diabetes. A depression care manager worked with primary care physicians to provide algorithm-based care. Vital status was assessed at 5 years. RESULTS After a median follow-up of 52.0 months, 110 depressed patients had died. Depressed patients with diabetes in the Intervention Condition were less likely to have died during the 5-year follow-up interval than were depressed persons with diabetes in Usual Care after accounting for baseline differences among patients (adjusted hazard ratio 0.49, 95% CI [0.24, 0.98]). CONCLUSIONS Older depressed primary care patients with diabetes in practices implementing depression care management were less likely to die over the course of a 5-year interval than were depressed patients with diabetes in usual care practices. PMID:17717284

The effect of donepezil on the cognitive ability early in the course of recovery from traumatic brain injury.

PubMed

Campbell, Kelsey A; Kennedy, Richard E; Brunner, Robert C; Hollis, Sean D; Lumsden, Ross A; Novack, Thomas A

2018-05-08

To investigate the effect of donepezil on cognitive ability in patients who have sustained a traumatic brain injury (TBI). We hypothesized that donepezil, an acetylcholinesterase inhibitor, would enhance cognitive recovery beyond that of usual care in an acute rehabilitation facility. This retrospective, longitudinal analysis included 55 patients who were non-randomly prescribed donepezil during acute care and compared them to 74 patients who received usual rehabilitation treatment. All 129 patients completed neuropsychological assessment at two time points. Donepezil was increased from 5 to 10 mg 7-10 days after initiation and maintained until follow-up cognitive assessment. Primary cognitive abilities of interest included processing speed, attention and memory. Cognitive and functional abilities were assessed by a standard neuropsychological battery for TBI. Propensity scores were used to adjust for differences between groups. Mixed effect model analysis showed no significant differences between treatment and control groups on all neuropsychological subtests over time. Acute administration of donepezil did not significantly improve measures of cognitive or functional ability beyond that of treatment as usual in patients with moderate-to-severe TBI.

Very high volume hemofiltration with the Cascade system in septic shock patients.

PubMed

Quenot, Jean-Pierre; Binquet, Christine; Vinsonneau, Christophe; Barbar, Saber-David; Vinault, Sandrine; Deckert, Valerie; Lemaire, Stéphanie; Hassain, Ali Ait; Bruyère, Rémi; Souweine, Bertrand; Lagrost, Laurent; Adrie, Christophe

2015-12-01

We compared hemodynamic and biological effects of the Cascade system, which uses very high volume hemofiltration (HVHF) (120 mL kg(-1) h(-1)), with those of usual care in patients with septic shock. Multicenter, prospective, randomized, open-label trial in three intensive care units (ICU). Adults with septic shock with administration of epinephrine/norepinephrine were eligible. Patients were randomized to usual care plus HVHF (Cascade group), or usual care alone (control group). Primary end point was the number of catecholamine-free days up to 28 days after randomization. Secondary end points were number of days free of mechanical ventilation, renal replacement therapy (RRT) or ICU up to 90 days, and 7-, 28-, and 90-day mortality. We included 60 patients (29 Cascade, 31 usual care). Baseline characteristics were comparable. Median number of catecholamine-free days was 22 [IQR 11-23] vs 20 [0-25] for Cascade vs control; there was no significant difference even after adjustment. There was no significant difference in number of mechanical ventilation-free days or ICU requirement. Median number of RRT-free days was 85 [46-90] vs 74 [0-90] for Cascade vs control groups, p = 0.42. By multivariate analysis, the number of RRT-free days was significantly higher in the Cascade group (up to 25 days higher after adjustment). There was no difference in mortality at 7, 28, or 90 days. Very HVHF using the Cascade system can safely be used in patients presenting with septic shock, but it was not associated with a reduction in the need for catecholamines during the first 28 days.

Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial.

PubMed

Labhardt, Niklaus D; Ringera, Isaac; Lejone, Thabo I; Klimkait, Thomas; Muhairwe, Josephine; Amstutz, Alain; Glass, Tracy R

2018-03-20

Home-based HIV testing is a frequently used strategy to increase awareness of HIV status in sub-Saharan Africa. However, with referral to health facilities, less than half of those who test HIV positive link to care and initiate antiretroviral therapy (ART). To determine whether offering same-day home-based ART to patients with HIV improves linkage to care and viral suppression in a rural, high-prevalence setting in sub-Saharan Africa. Open-label, 2-group, randomized clinical trial (February 22, 2016-September 17, 2017), involving 6 health care facilities in northern Lesotho. During home-based HIV testing in 6655 households from 60 rural villages and 17 urban areas, 278 individuals aged 18 years or older who tested HIV positive and were ART naive from 268 households consented and enrolled. Individuals from the same household were randomized into the same group. Participants were randomly assigned to be offered same-day home-based ART initiation (n = 138) and subsequent follow-up intervals of 1.5, 3, 6, 9, and 12 months after treatment initiation at the health facility or to receive usual care (n = 140) with referral to the nearest health facility for preparatory counseling followed by ART initiation and monthly follow-up visits thereafter. Primary end points were rates of linkage to care within 3 months (presenting at the health facility within 90 days after the home visit) and viral suppression at 12 months, defined as a viral load of less than 100 copies/mL from 11 through 14 months after enrollment. Among 278 randomized individuals (median age, 39 years [interquartile range, 28.0-52.0]; 180 women [65.7%]), 274 (98.6%) were included in the analysis (137 in the same-day group and 137 in the usual care group). In the same-day group, 134 (97.8%) indicated readiness to start ART that day and 2 (1.5%) within the next few days and were given a 1-month supply of ART. At 3 months, 68.6% (94) in same-day group vs 43.1% (59) in usual care group had linked to care (absolute difference, 25.6%; 95% CI, 13.8% to 36.3%; P < .001). At 12 months, 50.4% (69) in the same-day group vs 34.3% (47) in usual care group achieved viral suppression (absolute difference, 16.0%; 4.4%-27.2%; P = .007). Two deaths (1.5%) were reported in the same-day group, none in usual care group. Among adults in rural Lesotho, a setting of high HIV prevalence, offering same-day home-based ART initiation to individuals who tested positive during home-based HIV testing, compared with usual care and standard clinic referral, significantly increased linkage to care at 3 months and HIV viral suppression at 12 months. These findings support the practice of offering same-day ART initiation during home-based HIV testing. clinicaltrials.gov Identifier: NCT02692027.

The integration of a Podiatrist into an orthopaedic department: a cost-consequences analysis.

PubMed

Walsh, Tom P; Ferris, Linda R; Cullen, Nancy C; Brown, Christopher H; Loughry, Cathy J; McCaffrey, Nikki M

2017-01-01

The aim of this study was to evaluate the cost-consequences of a podiatry-led triage clinic provided in an orthopaedic department relative to usual care for non-urgent foot and ankle complaints in an Australian tertiary care hospital. All new, non-urgent foot and ankle patients seen in an outpatient orthopaedic department were included in this study. The patients seen between 2014 and 2015 by Orthopaedic Surgeons were considered 'usual care', the patients seen between 2015 and 2016 by a Podiatrist were considered the 'Podiatry Triage Clinic'. Data on new and review patient appointments; the number of new patients / session; the number of appointments / patient; the number of patients discharged; the surgical conversion rate; staff time; and imaging use were collected. A cost-consequences analysis, undertaken from a healthcare provider perspective (hospital) estimated the incremental resource use, costs and effects of the Podiatry Triage Clinic relative to usual care over a 12-month period. The Orthopaedic Surgeons and Podiatrist consulted with 72 and 212 new patients during the usual care and triage periods, respectively. The Podiatrist consulted with more new patients / session, mean (SD) of 3.6 (1.0) versus 0.7 (0.8), p  < 0.001 and utilised less appointments / patient than the Orthopaedic Surgeons, mean (SD) of 1.3 (0.6) versus 1.9 (1.1), p  < 0.001. The percentage of patients discharged without surgery was similar in the Podiatry Triage Clinic and usual care, 80.3% and 87.5% p  = 0.135, respectively, but the surgical conversion rate was higher in the Podiatry Triage Clinic, 76.1% versus 12.5% p  < 0.001. The total integrated appointment cost for the 12-month usual care period was $32,744, which represented a cost of $454.78 / patient. The total appointment and imaging cost during the triage period was $19,999, representing $94.34 / patient. Further analysis, suggests that the projected annual saving of integrating a Podiatry Triage Clinic versus an orthopaedic clinic alone is $50,441. The integration of a Podiatrist into an orthopaedic department significantly increases the number of patients seen, is cost-effective, improves the surgical conversion rate and improves the utilisation of Orthopaedic Surgeons.

Aerobic or Resistance Training and Pulse Wave Velocity in Kidney Transplant Recipients: A 12-Week Pilot Randomized Controlled Trial (the Exercise in Renal Transplant [ExeRT] Trial).

PubMed

Greenwood, Sharlene A; Koufaki, Pelagia; Mercer, Thomas H; Rush, Robert; O'Connor, Ellen; Tuffnell, Rachel; Lindup, Herolin; Haggis, Lynda; Dew, Tracy; Abdulnassir, Lyndsey; Nugent, Eilish; Goldsmith, David; Macdougall, Iain C

2015-10-01

Cardiovascular disease remains the leading cause of death in kidney transplant recipients. This pilot study examined the potential effect of aerobic training or resistance training on vascular health and indexes of cardiovascular risk in kidney transplant recipients. Single-blind, randomized, controlled, parallel trial. 60 participants (mean age, 54 years; 34 men) were randomly assigned to aerobic training (n=20), resistance training (n=20), or usual care (n=20). Participants were included if they had a kidney transplant within 12 months prior to baseline assessment. Patients were excluded if they had unstable medical conditions or had recently started regular exercise. Aerobic training and resistance training were delivered 3 days per week for a 12-week period. The usual-care group received standard care. Pulse wave velocity, peak oxygen uptake (Vo2peak), sit-to-stand 60, isometric quadriceps force, and inflammatory biomarkers were assessed at 0 and 12 weeks. The anticipated 60 participants were recruited within 12 months. 46 participants completed the study (aerobic training, n=13; resistance training, n=13; and usual care, n=20), resulting in a 23% attrition rate. Analyses of covariance, adjusted for baseline values, age, and dialysis vintage pretransplantation, revealed significant mean differences between aerobic training and usual care in pulse wave velocity of -2.2±0.4 (95% CI, -3.1 to -1.3) m/s (P<0.001) and between resistance training and usual care of -2.6±0.4 (95% CI, -3.4 to -1.7) m/s (P<0.001) at 12 weeks. Secondary analyses indicated significant improvements in Vo2peak in the aerobic training group and in Vo2peak, sit-to-stand 60, and isometric muscle force in the resistance training group compared with usual care at 12 weeks. There were no reported adverse events, cardiovascular events, or hospitalizations as a result of the intervention. Pilot study, small sample size, no measure of endothelial function. Both aerobic training and resistance training interventions appear to be feasible and clinically beneficial in this patient population. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Inpatient Palliative Care Consultation and 30-Day Readmissions in Oncology.

PubMed

DiMartino, Lisa D; Weiner, Bryan J; Hanson, Laura C; Weinberger, Morris; Birken, Sarah A; Reeder-Hayes, Katherine; Trogdon, Justin G

2018-01-01

Prior research indicates that hospice and palliative care delivered in outpatient settings are associated with reduced hospital readmissions for cancer patients. However, little is known about how inpatient palliative care affects readmissions in oncology. To examine associations among inpatient palliative care consultation, hospice use (discharge), and 30-day readmissions among patients with solid tumor cancers. We identified all live discharges from a large tertiary cancer hospital between 2010 and 2016. Palliative care consult data were abstracted from medical charts and linked to hospital encounter data. Propensity scores were used to match palliative care consult to usual care encounters. Modified Poisson regression models estimated adjusted relative risk (aRR) and 95% confidence intervals (CI) of 30-day readmissions and hospice discharge. We compared predicted probabilities of readmission for palliative care consultation with hospice discharge, without hospice discharge, and usual care. Of 8085 eligible encounters, 753 involved a palliative care consult. The likelihood of having a 30-day readmission did not differ between palliative care consult and usual care groups (p > 0.05). However, the palliative care consult group was more likely than usual care to have a hospice discharge (aRR = 4.09, 95% CI: 3.07-5.44). The predicted probability of 30-day readmission was lower when palliative care consultation was combined with hospice discharge compared to usual care or consultation with discharge to nonhospice postacute care (p < 0.001). The effect of inpatient palliative care on readmissions in oncology is largely driven by hospice enrollment. Strategies that combine palliative care consultation with hospice discharge may decrease hospital readmissions and improve cancer care quality.

The cost of a primary care-based childhood obesity prevention intervention

PubMed Central

2014-01-01

Background United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting. Primary care-based interventions can be effective in improving health behaviors, but also costly. The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity, measured against usual care. Methods High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children’s nutrition and TV viewing habits through a motivational interviewing intervention. We assessed visit-related costs from a societal perspective, including provider-incurred direct medical costs, provider-incurred equipment costs, parent time costs and parent out-of-pocket costs, in 2011 dollars for the intervention (n = 253) and usual care (n = 192) groups. We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results. Results The total costs for the intervention group and usual care groups in the first year of the intervention were $65,643 (95% CI [$64,522, $66,842]) and $12,192 (95% CI [$11,393, $13,174]). The mean costs for the intervention and usual care groups were $259 (95% CI [$255, $264]) and $63 (95% CI [$59, $69]) per child, respectively, for a incremental difference of $196 (95% CI [$191, $202]) per child. Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls. Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses. Conclusions High Five for Kids was a resource-intensive intervention. Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions. Trial registration ClinicalTrials.gov Identifier: NCT00377767. PMID:24472122

The cost of a primary care-based childhood obesity prevention intervention.

PubMed

Wright, Davene R; Taveras, Elsie M; Gillman, Matthew W; Horan, Christine M; Hohman, Katherine H; Gortmaker, Steven L; Prosser, Lisa A

2014-01-29

United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting. Primary care-based interventions can be effective in improving health behaviors, but also costly. The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity, measured against usual care. High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children's nutrition and TV viewing habits through a motivational interviewing intervention. We assessed visit-related costs from a societal perspective, including provider-incurred direct medical costs, provider-incurred equipment costs, parent time costs and parent out-of-pocket costs, in 2011 dollars for the intervention (n = 253) and usual care (n =192) groups. We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results. The total costs for the intervention group and usual care groups in the first year of the intervention were $65,643 (95% CI [$64,522, $66,842]) and $12,192 (95% CI [$11,393, $13,174]). The mean costs for the intervention and usual care groups were $259 (95% CI [$255, $264]) and $63 (95% CI [$59, $69]) per child, respectively, for a incremental difference of $196 (95% CI [$191, $202]) per child. Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls. Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses. High Five for Kids was a resource-intensive intervention. Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions.

Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial.

PubMed

Lambeek, Ludeke C; Bosmans, Judith E; Van Royen, Barend J; Van Tulder, Maurits W; Van Mechelen, Willem; Anema, Johannes R

2010-11-30

To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain. Economic evaluation alongside a randomised controlled trial with 12 months' follow-up. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9. 134 adults aged 18-65 sick listed because of chronic low back pain: 66 were randomised to integrated care and 68 to usual care. Integrated care consisted of a workplace intervention based on participatory ergonomics, with involvement of a supervisor, and a graded activity programme based on cognitive behavioural principles. Usual care was provided by general practitioners and occupational physicians according to Dutch guidelines. The primary outcome was duration until sustainable return to work. The secondary outcome was quality adjusted life years (QALYs), measured using EuroQol. Total costs in the integrated care group (£13 165, SD £13 600) were significantly lower than in the usual care group (£18 475, SD £13 616). Cost effectiveness planes and acceptability curves showed that integrated care was cost effective compared with usual care for return to work and QALYs gained. The cost-benefit analyses showed that every £1 invested in integrated care would return an estimated £26. The net societal benefit of integrated care compared with usual care was £5744. Implementation of an integrated care programme for patients sick listed with chronic low back pain has a large potential to significantly reduce societal costs, increase effectiveness of care, improve quality of life, and improve function on a broad scale. Integrated care therefore has large gains for patients and society as well as for employers.

Design of a multicentre randomized controlled trial to evaluate the effectiveness of a tailored clinical support intervention to enhance return to work for gastrointestinal cancer patients.

PubMed

Zaman, AnneClaire G N M; Tytgat, Kristien M A J; Klinkenbijl, Jean H G; Frings-Dresen, Monique H W; de Boer, Angela G E M

2016-05-10

Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work. We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs. The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and occupational care in a clinical setting, early in the cancer treatment process. METC protocol number NL51444.018.14/Netherlands Trial Register number NTR5022 . Registered 6 March 2015.

Effect of reversal of neuromuscular blockade with sugammadex versus usual care on bleeding risk in a randomized study of surgical patients.

PubMed

Rahe-Meyer, Niels; Fennema, Hein; Schulman, Sam; Klimscha, Walter; Przemeck, Michael; Blobner, Manfred; Wulf, Hinnerk; Speek, Marcel; McCrary Sisk, Christine; Williams-Herman, Debora; Woo, Tiffany; Szegedi, Armin

2014-11-01

Previous studies show a prolongation of activated partial thromboplastin time and prothrombin time in healthy volunteers after treatment with sugammadex. The authors investigated the effect of sugammadex on postsurgical bleeding and coagulation variables. This randomized, double-blind trial enrolled patients receiving thromboprophylaxis and undergoing hip or knee joint replacement or hip fracture surgery. Patients received sugammadex 4 mg/kg or usual care (neostigmine or spontaneous recovery) for reversal of rocuronium- or vecuronium-induced neuromuscular blockade. The Cochran-Mantel-Haenszel method, stratified by thromboprophylaxis and renal status, was used to estimate relative risk and 95% confidence interval (CI) of bleeding events with sugammadex versus usual care. Safety was further evaluated by prespecified endpoints and adverse event reporting. Of 1,198 patients randomized, 1,184 were treated (sugammadex n = 596, usual care n = 588). Bleeding events within 24 h (classified by an independent, blinded Adjudication Committee) were reported in 17 (2.9%) sugammadex and 24 (4.1%) usual care patients (relative risk [95% CI], 0.70 [0.38 to 1.29]). Compared with usual care, increases of 5.5% in activated partial thromboplastin time (P < 0.001) and 3.0% in prothrombin time (P < 0.001) from baseline with sugammadex occurred 10 min after administration and resolved within 60 min. There were no significant differences between sugammadex and usual care for other blood loss measures (transfusion, 24-h drain volume, drop in hemoglobin, and anemia), or risk of venous thromboembolism, and no cases of anaphylaxis. Sugammadex produced limited, transient (<1 h) increases in activated partial thromboplastin time and prothrombin time but was not associated with increased risk of bleeding versus usual care.

Effectiveness of an integrated telehealth service for patients with depression: a pragmatic randomised controlled trial of a complex intervention.

PubMed

Salisbury, Chris; O'Cathain, Alicia; Edwards, Louisa; Thomas, Clare; Gaunt, Daisy; Hollinghurst, Sandra; Nicholl, Jon; Large, Shirley; Yardley, Lucy; Lewis, Glyn; Foster, Alexis; Garner, Katy; Horspool, Kimberley; Man, Mei-See; Rogers, Anne; Pope, Catherine; Dixon, Padraig; Montgomery, Alan A

2016-06-01

Many countries are exploring the potential of telehealth interventions to manage the rising number of people with chronic disorders. However, evidence of the effectiveness of telehealth is ambiguous. Based on an evidence-based conceptual framework, we developed an integrated telehealth service (the Healthlines Service) for chronic disorders and assessed its effectiveness in patients with depression. We aimed to compare the Healthlines Depression Service plus usual care with usual care alone. This study was a pragmatic, multicentre, randomised controlled trial with participants recruited from 43 general practices in three areas of England. To be eligible, participants needed to have access to the internet and email, a Patient Health Questionnaire 9 (PHQ-9) score of at least 10, and a confirmed diagnosis of depression. Participants were individually assigned (1:1) to either the Healthlines Depression Service plus usual care or usual care alone. Random assignment was done by use of a web-based automated randomisation system, stratified by site and minimised by practice and PHQ-9 score. Participants were aware of their allocation, but outcomes were analysed masked. The Healthlines Service consisted of regular telephone calls from non-clinical, trained health advisers who followed standardised scripts generated by interactive software. After an initial assessment and goal-setting telephone call, the advisers called each participant on six occasions over 4 months, and then made up to three more calls at intervals of roughly 2 months to provide reinforcement and to detect relapse. Advisers supported participants in the use of online resources (including computerised cognitive behavioural therapy) and sought to encourage healthier lifestyles, optimise medication, and improve treatment adherence. The primary outcome was the proportion of participants responding to the intervention (defined as PHQ-9 <10 and reduction in PHQ-9 of ≥5 points) at 4 months after randomisation. The primary analysis was based on the intention-to-treat principle without imputation and all serious adverse events were investigated. This trial is registered with Current Controlled Trials, number ISRCTN 14172341. Between July 24, 2012, and July 31, 2013, we recruited 609 participants, randomly assigning 307 to the Healthlines Service plus usual care and 302 to usual care. Primary outcome data were available for 525 (86%) participants. At 4 months, 68 (27%) of 255 individuals in the intervention group had a treatment response compared with 50 (19%) of 270 individuals in the usual care group (adjusted odds ratio 1·7, 95% CI 1·1-2·5, p=0·019). Compared with usual care alone, intervention participants reported improvements in anxiety, better access to support and advice, greater satisfaction with the support they received, and improvements in self-management and health literacy. During the trial, 70 adverse events were reported by participants, one of which was related to the intervention (increased anxiety from discussing depression) and was not serious. This telehealth service based on non-clinically trained health advisers supporting patients in use of internet resources was both acceptable and effective compared with usual care. Our results provide support for the development and assessment of similar interventions in other chronic disorders to expand care provision. National Institute for Health Research (NIHR). Copyright © 2016 Salisbury et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

Mindfulness-based stress reduction added to care as usual for lung cancer patients and/or their partners: A multicentre randomized controlled trial.

PubMed

Schellekens, M P J; van den Hurk, D G M; Prins, J B; Donders, A R T; Molema, J; Dekhuijzen, R; van der Drift, M A; Speckens, A E M

2017-12-01

Lung cancer patients report among the highest distress rates of all cancer patients. Partners report similar distress rates. The present study examined the effectiveness of additional mindfulness-based stress reduction (care as usual [CAU] + MBSR) versus solely CAU to reduce psychological distress in lung cancer patients and/or their partners. We performed a multicentre, parallel-group, randomized controlled trial. Mindfulness-based stress reduction is an 8-week group-based intervention, including mindfulness practice and teachings on stress. Care as usual included anticancer treatment, medical consultations, and supportive care. The primary outcome was psychological distress. Secondary outcomes included quality of life, caregiver burden, relationship satisfaction, mindfulness skills, self-compassion, rumination, and posttraumatic stress symptoms. Outcomes were assessed at baseline, post-intervention, and 3-month follow-up. Linear mixed modeling was conducted on an intention-to-treat sample. Moderation (gender, disease stage, baseline distress, participation with/without partner) and mediation analyses were performed. A total of 31 patients and 21 partners were randomized to CAU + MBSR and 32 patients and 23 partners to CAU. After CAU + MBSR patients reported significantly less psychological distress (p = .008, d = .69) than after CAU. Baseline distress moderated outcome: those with more distress benefitted most from MBSR. Additionally, after CAU + MBSR patients showed more improvements in quality of life, mindfulness skills, self-compassion, and rumination than after CAU. In partners, no differences were found between groups. Our findings suggest that psychological distress in lung cancer patients can be effectively treated with MBSR. No effect was found in partners, possibly because they were more focused on patients' well-being rather than their own. Copyright © 2017 John Wiley & Sons, Ltd.

The role of a behavioural medicine intervention in physiotherapy for the effects of rehabilitation outcomes in exercise-based cardiac rehabilitation (ECRA) - the study protocol of a randomised, controlled trial.

PubMed

Borg, Sabina; Öberg, Birgitta; Nilsson, Lennart; Söderlund, Anne; Bäck, Maria

2017-05-25

To help patients with coronary artery disease (CAD) benefit from the positive health effects attained by exercise-based cardiac rehabilitation (CR), adherence to these programmes according to international guidelines is important. Strategies to increase adherence to exercise-based CR are mainly an unexplored area. The objective of this study is to investigate the effects of a behavioural medicine intervention in physiotherapy, containing goal-setting, self-monitoring and feedback, with the aim of improving rehabilitation outcomes for exercise-based CR, compared with usual care. This is a randomised, controlled trial. A total of 160 patients with CAD will be included consecutively at the Coronary Care Unit at a university hospital in Sweden. Patients are randomised 1:1 using sealed envelopes to usual care or a behavioural medicine intervention in physiotherapy, in addition to usual care for 4 months. Outcome assessment at baseline, 4 and 12 months includes submaximal aerobic capacity (primary outcome), exercise adherence, muscle endurance, level of physical activity, biomarkers, anxiety and depression, health-related quality of life, patient enablement and self-efficacy (secondary outcomes). This is the first study to evaluate the role of an integrated behavioural medicine intervention in exercise-based CR in the effects of rehabilitation outcomes. The results of this study will provide valuable information about the effect of these interventions in exercise-based CR and it has the potential to inform and assist in further treatment in secondary prevention for patients with CAD. The study include all items from the World Health Organization Trial Registration Data Set. NCT02895451, 2016-08-16, retrospectively registered.

Selling the OR: strategies to compete in the marketplace.

PubMed

Lee, M G

1989-07-01

1. OR directors are expected to be successful business managers in addition to their usual management responsibilities. 2. To complete with other health-care facilities, it is essential to incorporate marketing as part of the management strategy. 3. Marketing includes developing the skill level of all staff members, including middle managers, staff nurses, and ancillary personnel. 4. OR directors must create a work environment where the physician and staff are partners in providing quality patient care.

The costs and benefits of technology-enabled, home-based cardiac rehabilitation measured in a randomised controlled trial.

PubMed

Whittaker, Frank; Wade, Victoria

2014-10-01

We conducted a cost benefit analysis of a home telehealth-based cardiac rehabilitation programme compared to the standard hospital-based programme. A total of 120 participants were enrolled in a trial, with 60 randomised to the telehealth group and 60 randomised to usual care. Participants in the telehealth group received a mobile phone, Wellness Diary and a Wellness web portal, with daily text messaging. Participants in the usual care group received the standard 6-week hospital-based outpatient cardiac rehabilitation programme, including gym sessions. The cost of delivery by telehealth was slightly lower than for patients attending a rehabilitation service in person. From the provider's perspective, the telehealth intervention could be delivered for $1633 per patient, compared to $1845 for the usual care group. From the participant's perspective, patient travel costs for home rehabilitation were substantially less than for hospital attendance ($80 vs $400). Cardiac rehabilitation by telehealth offers obvious advantages and the option should be available to all patients who are eligible for cardiac rehabilitation. © The Author(s) 2014 Reprints and permissions:]br]sagepub.co.uk/journalsPermissions.nav.

Should we reconsider the routine use of placebo controls in clinical research?

PubMed

Avins, Andrew L; Cherkin, Daniel C; Sherman, Karen J; Goldberg, Harley; Pressman, Alice

2012-04-27

Modern clinical-research practice favors placebo controls over usual-care controls whenever a credible placebo exists. An unrecognized consequence of this preference is that clinicians are more limited in their ability to provide the benefits of the non-specific healing effects of placebos in clinical practice. We examined the issues in choosing between placebo and usual-care controls. We considered why placebo controls place constraints on clinicians and the trade-offs involved in the choice of control groups. We find that, for certain studies, investigators should consider usual-care controls, even if an adequate placebo is available. Employing usual-care controls would be of greatest value for pragmatic trials evaluating treatments to improve clinical care and for which threats to internal validity can be adequately managed without a placebo-control condition. Intentionally choosing usual-care controls, even when a satisfactory placebo exists, would allow clinicians to capture the value of non-specific therapeutic benefits that are common to all interventions. The result could be more effective, patient-centered care that makes the best use of both specific and non-specific benefits of medical interventions.

Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.

PubMed

Kruis, Annemarije L; Boland, Melinde R S; Assendelft, Willem J J; Gussekloo, Jacobijn; Tsiachristas, Apostolos; Stijnen, Theo; Blom, Coert; Sont, Jacob K; Rutten-van Mölken, Maureen P H M; Chavannes, Niels H

2014-09-10

To investigate the long term effectiveness of integrated disease management delivered in primary care on quality of life in patients with chronic obstructive pulmonary disease (COPD) compared with usual care. 24 month, multicentre, pragmatic cluster randomised controlled trial 40 general practices in the western part of the Netherlands Patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse, and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. General practitioners, practice nurses, and specialised physiotherapists in the intervention group received a two day training course on incorporating integrated disease management in practice, including early recognition of exacerbations and self management, smoking cessation, physiotherapeutic reactivation, optimal diagnosis, and drug adherence. Additionally, the course served as a network platform and collaborating healthcare providers designed an individual practice plan to integrate integrated disease management into daily practice. The control group continued usual care (based on international guidelines). The primary outcome was difference in health status at 12 months, measured by the Clinical COPD Questionnaire (CCQ); quality of life, Medical Research Council dyspnoea, exacerbation related outcomes, self management, physical activity, and level of integrated care (PACIC) were also assessed as secondary outcomes. Of a total of 1086 patients from 40 clusters, 20 practices (554 patients) were randomly assigned to the intervention group and 20 clusters (532 patients) to the usual care group. No difference was seen between groups in the CCQ at 12 months (mean difference -0.01, 95% confidence interval -0.10 to 0.08; P=0.8). After 12 months, no differences were seen in secondary outcomes between groups, except for the PACIC domain "follow-up/coordination" (indicating improved integration of care) and proportion of physically active patients. Exacerbation rates as well as number of days in hospital did not differ between groups. After 24 months, no differences were seen in outcomes, except for the PACIC follow-up/coordination domain. In this pragmatic study, an integrated disease management approach delivered in primary care showed no additional benefit compared with usual care, except improved level of integrated care and a self reported higher degree of daily activities. The contradictory findings to earlier positive studies could be explained by differences between interventions (provider versus patient targeted), selective reporting of positive trials, or little room for improvement in the already well developed Dutch healthcare system. Netherlands Trial Register NTR2268. © Kruis et al 2014.

Primary care physician assistant and advance practice nurses roles: Patient healthcare utilization, unmet need, and satisfaction.

PubMed

Everett, Christine M; Morgan, Perri; Jackson, George L

2016-12-01

Team-based care involving physician assistants (PAs) and advance practice nurses (APNs) is one strategy for improving access and quality of care. PA/APNs perform a variety of roles on primary care teams. However, limited research describes the relationship between PA/APN role and patient outcomes. We examined multiple outcomes associated with primary care PA/APN roles. In this cross-sectional survey analysis, we studied adult respondents to the 2010 Health Tracking Household Survey. Outcomes included primary care and emergency department visits, hospitalizations, unmet need, and satisfaction. PA/APN role was categorized as physician only (no PA/APN visits; reference), usual provider (PA/APN provide majority of primary care visits) or supplemental provider (physician as usual provider, PA/APN provide a subset of visits). Multivariable logistic and multinomial logistic regressions were performed. Compared to people with physician only care, patients with PA/APNs as usual providers [5-9 visits RRR=2.4 (CI 1.8-3.4), 10+ visits RRR=3.0 (CI 2.0-4.5): reference 2-4 visits] and supplemental providers had increased risk of having 5 or more primary care visits [5-9 visits RRR=1.3 (CI 1.0-1.6)]. Patients reporting PA/APN as supplemental providers had increased risk of emergency department utilization [2+ visits: RRR 1.8 (CI 1.3, 2.5)], and lower satisfaction [very dissatisfied: RRR 1.8 (CI 1.03-3.0)]. No differences were seen for hospitalizations or unmet need. Healthcare utilization patterns and satisfaction varied between adults with PA/APN in different roles, but reported unmet need did not. These findings suggest a wide range of outcomes should be considered when identifying the best PA/APN role on primary care teams. Copyright © 2016 Elsevier Inc. All rights reserved.

Efficacy of a Chronic Care-Based Intervention on Secondary Stroke Prevention Among Vulnerable Stroke Survivors: A Randomized Controlled Trial.

PubMed

Cheng, Eric M; Cunningham, William E; Towfighi, Amytis; Sanossian, Nerses; Bryg, Robert J; Anderson, Thomas L; Barry, Frances; Douglas, Susan M; Hudson, Lillie; Ayala-Rivera, Monica; Guterman, Jeffrey J; Gross-Schulman, Sandra; Beanes, Sylvia; Jones, Andrea S; Liu, Honghu; Vickrey, Barbara G

2018-01-01

Disparities of care among stroke survivors are well documented. Effective interventions to improve recurrent stroke preventative care in vulnerable populations are lacking. In a randomized controlled trial, we tested the efficacy of components of a chronic care model-based intervention versus usual care among 404 subjects having an ischemic stroke or transient ischemic attack within 90 days of enrollment and receiving care within the Los Angeles public healthcare system. Subjects had baseline systolic blood pressure (SBP) ≥120 mm Hg. The intervention included a nurse practitioner/physician assistant care manager, group clinics, self-management support, report cards, decision support, and ongoing care coordination. Outcomes were collected at 3, 8, and 12 months, analyzed as intention-to-treat, and used repeated-measures mixed-effects models. Change in SBP was the primary outcome. Low-density lipoprotein reduction, antithrombotic medication use, smoking cessation, and physical activity were secondary outcomes. Average age was 57 years; 18% were of black race; 69% were of Hispanic ethnicity. Mean baseline SBP was 150 mm Hg in both arms. SBP decreased to 17 mm Hg in the intervention arm and 14 mm Hg in the usual care arm; the between-arm difference was not significant (-3.6 mm Hg; 95% confidence interval, -9.2 to 2.2). Among secondary outcomes, the only significant difference was that persons in the intervention arm were more likely to lower their low-density lipoprotein <100 md/dL (2.0 odds ratio; 95% confidence interval, 1.1-3.5). This intervention did not improve SBP control beyond that attained in usual care among vulnerable stroke survivors. A community-centered component could strengthen the intervention impact. URL: https://clinicaltrials.gov. Unique identifier: NCT00861081. © 2017 American Heart Association, Inc.

Self-management interventions including action plans for exacerbations versus usual care in patients with chronic obstructive pulmonary disease.

PubMed

Lenferink, Anke; Brusse-Keizer, Marjolein; van der Valk, Paul Dlpm; Frith, Peter A; Zwerink, Marlies; Monninkhof, Evelyn M; van der Palen, Job; Effing, Tanja W

2017-08-04

Chronic Obstructive Pulmonary Disease (COPD) self-management interventions should be structured but personalised and often multi-component, with goals of motivating, engaging and supporting the patients to positively adapt their behaviour(s) and develop skills to better manage disease. Exacerbation action plans are considered to be a key component of COPD self-management interventions. Studies assessing these interventions show contradictory results. In this Cochrane Review, we compared the effectiveness of COPD self-management interventions that include action plans for acute exacerbations of COPD (AECOPD) with usual care. To evaluate the efficacy of COPD-specific self-management interventions that include an action plan for exacerbations of COPD compared with usual care in terms of health-related quality of life, respiratory-related hospital admissions and other health outcomes. We searched the Cochrane Airways Group Specialised Register of trials, trials registries, and the reference lists of included studies to May 2016. We included randomised controlled trials evaluating a self-management intervention for people with COPD published since 1995. To be eligible for inclusion, the self-management intervention included a written action plan for AECOPD and an iterative process between participant and healthcare provider(s) in which feedback was provided. We excluded disease management programmes classified as pulmonary rehabilitation or exercise classes offered in a hospital, at a rehabilitation centre, or in a community-based setting to avoid overlap with pulmonary rehabilitation as much as possible. Two review authors independently assessed trial quality and extracted data. We resolved disagreements by reaching consensus or by involving a third review author. Study authors were contacted to obtain additional information and missing outcome data where possible. When appropriate, study results were pooled using a random-effects modelling meta-analysis. The primary outcomes of the review were health-related quality of life (HRQoL) and number of respiratory-related hospital admissions. We included 22 studies that involved 3,854 participants with COPD. The studies compared the effectiveness of COPD self-management interventions that included an action plan for AECOPD with usual care. The follow-up time ranged from two to 24 months and the content of the interventions was diverse.Over 12 months, there was a statistically significant beneficial effect of self-management interventions with action plans on HRQoL, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score, where a lower score represents better HRQoL. We found a mean difference from usual care of -2.69 points (95% CI -4.49 to -0.90; 1,582 participants; 10 studies; high-quality evidence). Intervention participants were at a statistically significant lower risk for at least one respiratory-related hospital admission compared with participants who received usual care (OR 0.69, 95% CI 0.51 to 0.94; 3,157 participants; 14 studies; moderate-quality evidence). The number needed to treat to prevent one respiratory-related hospital admission over one year was 12 (95% CI 7 to 69) for participants with high baseline risk and 17 (95% CI 11 to 93) for participants with low baseline risk (based on the seven studies with the highest and lowest baseline risk respectively).There was no statistically significant difference in the probability of at least one all-cause hospital admission in the self-management intervention group compared to the usual care group (OR 0.74, 95% CI 0.54 to 1.03; 2467 participants; 14 studies; moderate-quality evidence). Furthermore, we observed no statistically significant difference in the number of all-cause hospitalisation days, emergency department visits, General Practitioner visits, and dyspnoea scores as measured by the (modified) Medical Research Council questionnaire for self-management intervention participants compared to usual care participants. There was no statistically significant effect observed from self-management on the number of COPD exacerbations and no difference in all-cause mortality observed (RD 0.0019, 95% CI -0.0225 to 0.0263; 3296 participants; 16 studies; moderate-quality evidence). Exploratory analysis showed a very small, but significantly higher respiratory-related mortality rate in the self-management intervention group compared to the usual care group (RD 0.028, 95% CI 0.0049 to 0.0511; 1219 participants; 7 studies; very low-quality evidence).Subgroup analyses showed significant improvements in HRQoL in self-management interventions with a smoking cessation programme (MD -4.98, 95% CI -7.17 to -2.78) compared to studies without a smoking cessation programme (MD -1.33, 95% CI -2.94 to 0.27, test for subgroup differences: Chi² = 6.89, df = 1, P = 0.009, I² = 85.5%). The number of behavioural change techniques clusters integrated in the self-management intervention, the duration of the intervention and adaptation of maintenance medication as part of the action plan did not affect HRQoL. Subgroup analyses did not detect any potential variables to explain differences in respiratory-related hospital admissions among studies. Self-management interventions that include a COPD exacerbation action plan are associated with improvements in HRQoL, as measured with the SGRQ, and lower probability of respiratory-related hospital admissions. No excess all-cause mortality risk was observed, but exploratory analysis showed a small, but significantly higher respiratory-related mortality rate for self-management compared to usual care.For future studies, we would like to urge only using action plans together with self-management interventions that meet the requirements of the most recent COPD self-management intervention definition. To increase transparency, future study authors should provide more detailed information regarding interventions provided. This would help inform further subgroup analyses and increase the ability to provide stronger recommendations regarding effective self-management interventions that include action plans for AECOPD. For safety reasons, COPD self-management action plans should take into account comorbidities when used in the wider population of people with COPD who have comorbidities. Although we were unable to evaluate this strategy in this review, it can be expected to further increase the safety of self-management interventions. We also advise to involve Data and Safety Monitoring Boards for future COPD self-management studies.

Home and Online Management and Evaluation of Blood Pressure (HOME BP) digital intervention for self-management of uncontrolled, essential hypertension: a protocol for the randomised controlled HOME BP trial

PubMed Central

Morton, Katherine; Stuart, Beth; Raftery, James; Bradbury, Katherine; Yao, Guiqing Lily; Zhu, Shihua; Little, Paul; Yardley, Lucy

2016-01-01

Introduction Self-management of hypertension, including self-monitoring and antihypertensive medication titration, lowers blood pressure (BP) at 1 year compared to usual care. The aim of the current trial is to assess the effectiveness of the Home and Online Management and Evaluation of Blood Pressure (HOME BP) intervention for the self-management of hypertension in primary care. Methods and analysis The HOME BP trial will be a randomised controlled trial comparing BP self-management—consisting of the HOME BP online digital intervention with self-monitoring, lifestyle advice and antihypertensive drug titration—with usual care for people with uncontrolled essential hypertension. Eligible patients will be recruited from primary care and randomised to usual care or to self-management using HOME BP. The primary outcome will be the difference in mean systolic BP (mm Hg) at 12-month follow-up between the intervention and control groups adjusting for baseline BP and covariates. Secondary outcomes (also adjusted for baseline and covariates where appropriate) will be differences in mean BP at 6 months and diastolic BP at 12 months; patient enablement; quality of life, and economic analyses including all key resources associated with the intervention and related services, adopting a broad societal perspective to include NHS, social care and patient costs, considered within trial and modelled with a lifetime horizon. Medication beliefs, adherence and changes; self-efficacy; perceived side effects and lifestyle changes will be measured for process analyses. Qualitative analyses will explore patient and healthcare professional experiences of HOME BP to gain insights into the factors affecting acceptability, feasibility and adherence. Ethics and dissemination This study has received NHS ethical approval (REC reference 15/SC/0082). The findings from HOME BP will be disseminated widely through peer-reviewed publications, scientific conferences and workshops. If successful, HOME BP will be directly applicable to UK primary care management of hypertension. Trial registration number ISRCTN13790648; pre-results. PMID:27821598

Using Behavioral Economic Theory to Increase Use of Effective Contraceptives among Opioid-maintained Women at Risk of Unintended Pregnancy

PubMed Central

Heil, Sarah H.; Hand, Dennis J.; Sigmon, Stacey C.; Badger, Gary J.; Meyer, Marjorie C.; Higgins, Stephen T.

2016-01-01

Objective An unsettling aspect of the US opioid epidemic is the high rate of in utero exposure, especially since most of these pregnancies are unintended, due in part to low rates of effective contraceptive use among opioid-using women. This study tested an intervention informed by behavioral economic theory and aimed at promoting effective contraceptive use among opioid-maintained women at risk of unintended pregnancy in the Burlington, VT area between 2011–2013. Methods Thirty-one women were assigned (initial 5 consecutively, subsequent 26 randomly) to either usual care or an experimental intervention. Participants in usual care received condoms, a dose of emergency contraception, and referral to local providers. Participants in the experimental condition received usual care plus the World Health Organization’s contraception initiation protocol, including free prescription contraceptives, and financial incentives for attending 13 follow-up visits over 6 months to help manage side effects and other issues. Results Significantly more women in the experimental vs. usual care control conditions initiated prescription contraceptive use (100% vs. 29%) and reported prescription contraceptive use at 1-month (63% vs. 13%), 3-month (88% vs. 20%), and 6-month (94% vs. 13%) assessments. None of the experimental condition participants became pregnant during the 6-month protocol vs. three women (20%) in the control condition. Conclusions These results provide the first experimental evidence supporting the efficacy of an intervention for increasing prescription contraceptive use among opioid-maintained women at risk of unintended pregnancy. PMID:27346756

Reducing suicidal ideation and depressive symptoms in depressed older primary care patients: a randomized controlled trial.

PubMed

Bruce, Martha L; Ten Have, Thomas R; Reynolds, Charles F; Katz, Ira I; Schulberg, Herbert C; Mulsant, Benoit H; Brown, Gregory K; McAvay, Gail J; Pearson, Jane L; Alexopoulos, George S

2004-03-03

Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation. To determine the effect of a primary care intervention on suicidal ideation and depression in older patients. Randomized controlled trial known as PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 20 primary care practices in New York City, Philadelphia, and Pittsburgh regions, May 1999 through August 2001. Two-stage, age-stratified (60-74, > or =75 years) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of screened negative patients. This analysis included patients with a depression diagnosis (N = 598). Treatment guidelines tailored for the elderly with care management compared with usual care. Assessment of suicidal ideation and depression severity at baseline, 4 months, 8 months, and 12 months. Rates of suicidal ideation declined faster (P =.01) in intervention patients compared with usual care patients; at 4 months, in the intervention group, raw rates of suicidal ideation declined 12.9% points (29.4% to 16.5%) compared with 3.0% points (20.1% to 17.1% in usual care [P =.01]). Among patients reporting suicidal ideation, resolution of ideation was faster among intervention patients (P =.03); differences peaked at 8 months (70.7% vs 43.9% resolution; P =.005). Intervention patients had a more favorable course of depression in both degree and speed of symptom reduction; group difference peaked at 4 months. The effects on depression were not significant among patients with minor depression unless suicidal ideation was present. Evidence of the intervention's effectiveness in community-based primary care with a heterogeneous sample of depressed patients introduces new challenges related to its sustainability and dissemination. The intervention's effectiveness in reducing suicidal ideation, regardless of depression severity, reinforces its role as a prevention strategy to reduce risk factors for suicide in late life.

Heat-Related Illnesses

MedlinePlus

... Share this! EmergencyCareForYou » Emergency 101 » Heat-Related Illnesses Heat-Related Illnesses Dr. Glenn Mitchell , Emergency physician at ... about heat cramps and heat stroke and exhaustion. Heat Cramps Symptoms include muscle spasms, usually in the ...

Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care alone: using stakeholder engagement to design a pragmatic randomized trial and study protocol.

PubMed

Blödt, Susanne; Schützler, Lena; Huang, Wenjing; Pach, Daniel; Brinkhaus, Benno; Hummelsberger, Josef; Kirschbaum, Barbara; Kuhlmann, Kirsten; Lao, Lixing; Liang, Fanrong; Mietzner, Anna; Mittring, Nadine; Müller, Sabine; Paul, Anna; Pimpao-Niederle, Carolina; Roll, Stephanie; Wu, Huangan; Zhu, Jiang; Witt, Claudia M

2013-04-11

Self-care acupressure might be successful in treating menstrual pain, which is common among young women. There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers. Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement. The study was designed using multiple mixed methods for stakeholder engagement. Based on the results of a survey and focus group discussion, a stakeholder advisory group developed the study design. Stakeholder engagement resulted in a two-arm pragmatic randomized trial. Two hundred and twenty women aged 18 to 25 years with menstrual pain will be included in the study. Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application (App). Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start. Stakeholder engagement helped to develop a study design that better serves the needs of decision makers, including an App as a modern tool for both intervention and data collection in a young target group. Clinicaltrials.gov identifier http://NCT01582724.

Cost-effectiveness of a primary care treatment program for depression in low-income women in Santiago, Chile.

PubMed

Araya, Ricardo; Flynn, Terry; Rojas, Graciela; Fritsch, Rosemarie; Simon, Greg

2006-08-01

The authors compared the incremental cost-effectiveness of a stepped-care, multicomponent program with usual care for the treatment of depressed women in primary care in Santiago, Chile. A cost-effectiveness study was conducted of a previous randomized controlled trial involving 240 eligible women with DSM-IV major depression who were selected from a consecutive sample of adult women attending primary care clinics. The patients were randomly allocated to usual care or a multicomponent stepped-care program led by a nonmedical health care worker. Depression-free days and health care costs derived from local sources were assessed after 3 and 6 months. A health service perspective was used in the economic analysis. Complete data were determined for 80% of the randomly assigned patients. After we adjusted for initial severity, women receiving the stepped-care program had a mean of 50 additional depression-free days over 6 months relative to patients allocated to usual care. The stepped-care program was marginally more expensive than usual care (an extra 216 Chilean pesos per depression-free day). There was a 90% probability that the incremental cost of obtaining an extra depression-free day with the intervention would not exceed 300 pesos (1.04 US dollars). The stepped-care program was significantly more effective and marginally more expensive than usual care for the treatment of depressed women in primary care. Small investments to improve depression appear to yield larger gains in poorer environments. Simple and inexpensive treatment programs tested in developing countries might provide good study models for developed countries.

Does Motivation Matter? Analysis of a Randomized Trial of Proactive Outreach to VA Smokers.

PubMed

Danan, Elisheva R; Joseph, Anne M; Sherman, Scott E; Burgess, Diana J; Noorbaloochi, Siamak; Clothier, Barbara; Japuntich, Sandra J; Taylor, Brent C; Fu, Steven S

2016-08-01

Current guidelines advise providers to assess smokers' readiness to quit, then offer cessation therapies to smokers planning to quit and motivational interventions to smokers not planning to quit. We examined the relationship between baseline stage of change (SOC), treatment utilization, and smoking cessation to determine whether the effect of a proactive smoking cessation intervention was dependent on smokers' level of motivation to quit. Secondary analysis of a multicenter randomized controlled trial. A total of 3006 current smokers, aged 18-80 years, at four Veterans Affairs (VA) medical centers. Proactive care included proactive outreach (mailed invitation followed by telephone outreach), offer of smoking cessation services (telephone or face-to-face), and access to pharmacotherapy. Usual care participants had access to VA smoking cessation services and state telephone quitlines. Baseline SOC measured with Readiness to Quit Ladder, and 6-month prolonged abstinence self-reported at 1 year. At baseline, 35.8 % of smokers were in preparation, 38.2 % in contemplation, and 26.0 % in precontemplation. The overall interaction between SOC and treatment arm was not statistically significant (p = 0.30). Among smokers in preparation, 21.1 % of proactive care participants achieved 6-month prolonged abstinence, compared to 13.1 % of usual care participants (OR, 1.8 [95 % CI, 1.2-2.6]). Similarly, proactive care increased abstinence among smokers in contemplation (11.0 % vs. 6.5 %; OR, 1.8 [95 % CI, 1.1-2.8]). Smokers in precontemplation quit smoking at similar rates (5.3 % vs. 5.6 %; OR, 0.9 [95 % CI, 0.5-1.9]). Within each stage, uptake of smoking cessation treatments increased with higher SOC and with proactive care as compared with usual care. Mostly male participants limits generalizability. Randomization was not stratified by SOC. Proactive care increased treatment uptake compared to usual care across all SOC. Proactive care increased smoking cessation among smokers in preparation and contemplation but not in precontemplation. Proactively offering cessation therapies to smokers at all SOC will increase treatment utilization and population-level smoking cessation.

Feasibility of an ED-to-Home Intervention to Engage Patients: A Mixed-Methods Investigation.

PubMed

Schumacher, Jessica R; Lutz, Barbara J; Hall, Allyson G; Pines, Jesse M; Jones, Andrea L; Hendry, Phyllis; Kalynych, Colleen; Carden, Donna L

2017-06-01

Older, chronically ill patients with limited health literacy are often under-engaged in managing their health and turn to the emergency department (ED) for healthcare needs. We tested the impact of an ED-initiated coaching intervention on patient engagement and follow-up doctor visits in this high-risk population. We also explored patients' care-seeking decisions. We conducted a mixed-methods study including a randomized controlled trial and in-depth interviews in two EDs in northern Florida. Participants were chronically ill older ED patients with limited health literacy and Medicare as a payer source. Patients were assigned to an evidence-based coaching intervention (n= 35) or usual post-ED care (n= 34). Qualitative interviews (n=9) explored patients' reasons for ED use. We assessed average between-group differences in patient engagement over time with the Patient Activation Measure (PAM) tool, using logistic regression and a difference-in-difference approach. Between-group differences in follow-up doctor visits were determined. We analyzed qualitative data using open coding and thematic analysis. PAM scores fell in both groups after the ED visit but fell significantly more in "usual care" (average decline -4.64) than "intervention" participants (average decline -2.77) (β=1.87, p=0.043). There were no between-group differences in doctor visits. Patients described well-informed reasons for ED visits including onset and severity of symptoms, lack of timely provider access, and immediate and comprehensive ED care. The coaching intervention significantly reduced declines in patient engagement observed after usual post-ED care. Patients reported well-informed reasons for ED use and will likely continue to make ED visits unless strategies, such as ED-initiated coaching, are implemented to help vulnerable patients better manage their health and healthcare.

Dexmedetomidine Use in Critically-Ill Children with Acute Respiratory Failure

PubMed Central

Grant, Mary Jo C.; Schneider, James B.; Asaro, Lisa A.; Dodson, Brenda L.; Hall, Brent A.; Simone, Shari L.; Cowl, Allison S.; Munkwitz, Michele M.; Wypij, David; Curley, Martha A.Q.

2016-01-01

Objective Care of critically-ill children includes sedation but current therapies are suboptimal. To describe dexmedetomidine (DEX) use in children supported on mechanical ventilation for acute respiratory failure. Design Secondary analysis of data from the RESTORE clinical trial. Setting Thirty-one pediatric ICUs. Patients Data from 2449 children; 2 weeks to 17 years old. Interventions Sedation practices were unrestrained in the usual care arm. Patients were categorized as receiving dexmedetomidine as a primary sedative (DEXp), secondary sedative (DEXs), periextubation agent (DEXe), or never prescribed. DEX exposure and sedation and clinical profiles are described. Measurements and Main Results Of 1224 usual care patients, 596 (49%) received DEX. DEXp patients (N=138; 11%) were less critically ill (PRISM III-12 score median 6 [IQR 3–11]) and when compared to all other cohorts, experienced more episodic agitation. In the intervention group, time in sedation target improved from 28% to 50% within one day of initiating DEXp. DEXs usual care patients (N=280; 23%) included more children with severe PARDS or organ failure. DEXs patients experienced more inadequate pain (22% vs 11%) and sedation (31% vs 16%) events. DEXe patients (N=178; 15%) were those known to not tolerate an awake, intubated state and experienced a shorter ventilator weaning process (2.1 vs 2.3 days). Conclusions Our data support the use of dexmedetomidine as a primary agent in low criticality patients offering the benefit of rapid achievement of targeted sedation levels. Dexmedetomidine as a secondary agent does not appear to add benefit. The use of dexmedetomidine to facilitate extubation in children intolerant of an awake, intubated state may abbreviate ventilator weaning. These data support a broader armamentarium of pediatric critical care sedation. PMID:27654816

Circuit class or seven-day therapy for increasing intensity of rehabilitation after stroke: protocol of the CIRCIT trial.

PubMed

Hillier, Susan; English, Coralie; Crotty, Maria; Segal, Leonie; Bernhardt, Julie; Esterman, Adrian

2011-12-01

There is strong evidence for a dose-response relationship between physical therapy early after stroke and recovery of function. The optimal method of maximizing physical therapy within finite health care resources is unknown. To determine the effectiveness and cost-effectiveness of two alternative models of physical therapy service delivery (seven-days per week therapy services or group circuit class therapy over five-days a week) to usual care for people receiving inpatient rehabilitation after stroke. Multicenter, three-armed randomized controlled trial with blinded assessment of outcomes. A total of 282 people admitted to inpatient rehabilitation facilities after stroke with an admission functional independence measure (FIM) score within the moderate range (total 40-80 points or motor 38-62 points) will be randomized to receive one of three interventions: • usual care therapy over five-days a week • standard care therapy over seven-days a week, or • group circuit class therapy over five-days a week. Participants will receive the allocated intervention for the length of their hospital stay. Analysis will be by intention-to-treat. The primary outcome measure is walking ability (six-minute walk test) at four-week postintervention with three- and six-month follow-up. Economic analysis will include a costing analysis based on length of hospital stay and staffing/resource costs and a cost-utility analysis (incremental quality of life per incremental cost, relative to usual care). Secondary outcomes include walking speed and independence, ability to perform activities of daily living, arm function, quality of life and participant satisfaction. © 2011 The Authors. International Journal of Stroke © 2011 World Stroke Organization.

Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the alliance study.

PubMed

Koren, Michael J; Hunninghake, Donald B

2004-11-02

This study sought to determine if an aggressive, focused low-density lipoprotein cholesterol (LDL-C)-lowering strategy was superior to usual care for coronary heart disease (CHD) patients enrolled in health maintenance organization or Veterans Administration settings. Statin therapy benefits are well established. No prospective, randomized studies have tested strategies to optimize these benefits in a "real-world" setting. A total of 2,442 CHD patients with hyperlipidemia were randomized to either an aggressive treatment arm using atorvastatin or usual care and followed for 51.5 months on average. Atorvastatin-group patients were titrated to LDL-C goals of <80 mg/dl (2.1 mmol/l) or a maximum atorvastatin dose of 80 mg/day. Usual-care patients received any treatment deemed appropriate by their regular physicians. End point assessments were complete in 958 atorvastatin-group and 941 usual-care patients. Partial assessments occurred in 259 patients in the atorvastatin group and 284 patients in the usual care group who did not complete four years of study participation because of adverse events, withdrawn consent, or follow-up loss. The primary efficacy parameter was time to first cardiovascular event. A total of 289 (23.7%) patients in the atorvastatin group compared with 333 (27.7%) patients in the usual care group experienced a primary outcome (hazard ratio, 0.83; 95% confidence interval 0.71 to 0.97, p = 0.02). This reduction in morbidity was largely due to fewer non-fatal myocardial infarctions (4.3% vs. 7.7%, p = 0.0002). Levels of LDL-C were reduced more (34.3% vs. 23.3%, p < 0.0001) and National Cholesterol Education Program goals (LDL-C <100 mg/dl) more likely met at end-of-study visits (72.4% vs. 40.0%) in patients receiving atorvastatin compared with those receiving usual care. An aggressive, focused statin therapy management strategy outperformed usual care in health maintenance organization and Veterans Administration clinic patients with CHD.

Workflow standardization of a novel team care model to improve chronic care: a quasi-experimental study.

PubMed

Panattoni, Laura; Hurlimann, Lily; Wilson, Caroline; Durbin, Meg; Tai-Seale, Ming

2017-04-19

Team-based chronic care models have not been widely adopted in community settings, partly due to their varying effectiveness in randomized control trials, implementation challenges, and concerns about physician acceptance. The Palo Alto Medical Foundation designed and implemented "Champion," a novel team-based model that includes new standard work (e.g. proactive patient outreach, pre-visit schedule grooming, depression screening, care planning, health coaching) to support patients' self-management of hypertension and diabetes. We investigated whether Champion improved clinical outcomes. We conducted a quasi-experimental study comparing the Champion clinic-level intervention (n = 38 physicians) with a usual care clinic (n = 37 physicians) in Northern California. The primary outcomes, blood pressure and glycohemoglobin (A1c), were analyzed using a piecewise linear growth curve model for patients exposed to a Champion physician visit (n = 3156) or usual care visit (n = 8034) in the two years prior and one year post implementation. Secondary outcomes were provider experience, compared at baseline and 12 months in both the intervention and usual care clinics using multi-level ordered logistic modeling, and electronic health record based fidelity measures. Compared to usual care, in the first 6 months after a Champion physician visit, diabetes patients aged 18-75 experienced an additional -1.13 mm Hg (95% CI: -2.23 to -0.04) decline in diastolic blood pressure and -0.47 (95% CI: -0.61 to -0.33) decline in A1c. There were no additional improvements in blood pressure or A1c 6 to 12 months post physician visit. At 12 months, Champion physicians reported improved experience with managing chronic care patients in 6 of 7 survey items (p < 0.05), but compared to usual, this difference was only statistically significant for one item (p < 0.05). Fidelity to standard work was uneven; depression screening was the most commonly documented element (85% of patients), while care plans were the least (30.8% of patients). Champion standard work improved glycemic control over the first 6 months and physicians' experience with managing chronic care; changes in blood pressure were not clinically meaningful. Our results suggest the need to understand the relationship between the intervention, the contextual features of implementation, and fidelity to further improve chronic disease outcomes. This study was retrospectively registered with the ISRCTN Registry on March 15, 2017 (ISRCTN11341906).

The Effects of Alternative Resuscitation Strategies on Acute Kidney Injury in Patients with Septic Shock.

PubMed

Kellum, John A; Chawla, Lakhmir S; Keener, Christopher; Singbartl, Kai; Palevsky, Paul M; Pike, Francis L; Yealy, Donald M; Huang, David T; Angus, Derek C

2016-02-01

Septic shock is a common cause of acute kidney injury (AKI), and fluid resuscitation is a major part of therapy. To determine if structured resuscitation designed to alter fluid, blood, and vasopressor use affects the development or severity of AKI or outcomes. Ancillary study to the ProCESS (Protocolized Care for Early Septic Shock) trial of alternative resuscitation strategies (two protocols vs. usual care) for septic shock. We studied 1,243 patients and classified AKI using serum creatinine and urine output. We determined recovery status at hospital discharge, examined rates of renal replacement therapy and fluid overload, and measured biomarkers of kidney damage. Among patients without evidence of AKI at enrollment, 37.6% of protocolized care and 38.1% of usual care patients developed kidney injury (P = 0.90). AKI duration (P = 0.59) and rates of renal replacement therapy did not differ between study arms (6.9% for protocolized care and 4.3% for usual care; P = 0.08). Fluid overload occurred in 8.3% of protocolized care and 6.3% of usual care patients (P = 0.26). Among patients with severe AKI, complete and partial recovery was 50.7 and 13.2% for protocolized patients and 49.1 and 13.4% for usual care patients (P = 0.93). Sixty-day hospital mortality was 6.2% for patients without AKI, 16.8% for those with stage 1, and 27.7% for stages 2 to 3. In patients with septic shock, AKI is common and associated with adverse outcomes, but it is not influenced by protocolized resuscitation compared with usual care.

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol

PubMed Central

Chow, Clara K; Thiagalingam, Aravinda; Rogers, Kris; Chalmers, John; Redfern, Julie

2017-01-01

Introduction The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. Methods and analysis Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. Ethics and dissemination Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. Trial registration number ACTRN12616000661471; Pre-results PMID:28993388

Electroacupuncture as a complement to usual care for patients with non-acute pain after back surgery: a study protocol for a pilot randomised controlled trial.

PubMed

Hwang, Man-Suk; Heo, Kwang-Ho; Cho, Hyun-Woo; Shin, Byung-Cheul; Lee, Hyeon-Yeop; Heo, In; Kim, Nam-Kwen; Choi, Byung-Kwan; Son, Dong-Wuk; Hwang, Eui-Hyoung

2015-02-04

Recurrent or persistent low back pain is common after back surgery but is typically not well controlled. Previous randomised controlled trials on non-acute pain after back surgery were flawed. In this article, the design and protocol of a randomised controlled trial to treat pain and improve function after back surgery are described. This study is a pilot randomised, active-controlled, assessor-blinded trial. Patients with recurring or persistent low back pain after back surgery, defined as a visual analogue scale value of ≥50 mm, with or without leg pain, will be randomly assigned to an electroacupuncture-plus-usual-care group or to a usual-care-only group. Patients assigned to both groups will have usual care management, including physical therapy and patient education, twice a week during a 4-week treatment period that would begin at randomisation. Patients assigned to the electroacupuncture-plus-usual-care group will also have electroacupuncture twice a week during the 4-week treatment period. The primary outcome will be measured with the 100 mm pain visual analogue scale of low back pain by a blinded evaluator. Secondary outcomes will be measured with the EuroQol 5-Dimension and the Oswestry Disability Index. The primary and secondary outcomes will be measured at 4 and 8 weeks after treatment. Written informed consent will be obtained from all participants. This study was approved by the Institutional Review Board (IRB) of Pusan National University Korean Hospital in September 2013 (IRB approval number 2013012). The study findings will be published in peer-reviewed journals and presented at national and international conferences. This trial was registered with the US National Institutes of Health Clinical Trials Registry: NCT01966250. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Effects of Telephone Counseling Intervention by Pharmacists (TelCIP) on Medication Adherence; Results of a Cluster Randomized Trial

PubMed Central

Kooij, Marcel J.; Heerdink, Eibert R.; van Dijk, Liset; van Geffen, Erica C. G.; Belitser, Svetlana V.; Bouvy, Marcel L.

2016-01-01

Objectives: To assess the effect of a pharmacist telephone counseling intervention on patients' medication adherence. Design: Pragmatic cluster randomized controlled trial. Setting: 53 Community pharmacies in The Netherlands. Participants: Patients ≥18 years initiating treatment with antidepressants, bisphosphonates, Renin-Angiotensin System (RAS)-inhibitors, or statins (lipid lowering drugs). Pharmacies in arm A provided the intervention for antidepressants and bisphosphonates and usual care for RAS-inhibitors and statins. Pharmacies in arm B provided the intervention for RAS-inhibitors and statins and usual care for antidepressants and bisphosphonates. Intervention: Intervention consisted of a telephone counseling intervention 7–21 days after the start of therapy. Counseling included assessment of practical and perceptual barriers and provision of information and motivation. Main outcome measure: Primary outcome was refill adherence measured over 1 year expressed as continuous outcome and dichotomous (refill rate≥80%). Secondary outcome was discontinuation within 1 year. Results: In the control arms 3627 patients were eligible and in the intervention arms 3094 patients. Of the latter, 1054 patients (34%) received the intervention. Intention to treat analysis showed no difference in adherence rates between the intervention and the usual care arm (74.7%, SD 37.5 respectively 74.5%, 37.9). More patients starting with RAS-inhibitors had a refill ratio ≥80% in the intervention arm compared to usual care (81.4 vs. 74.9% with odds ratio (OR) 1.43, 95%CI 1.11–1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically significant higher for patients starting with RAS-inhibitors, statins and bisphosphonates. Patients initiating antidepressants did not benefit from the intervention. Conclusions: Telephone counseling at start of therapy improved adherence in patients initiating RAS-inhibitors. The per protocol analysis indicated an improvement for lipid lowering drugs and bisphosphonates. No effect for on adherence in patients initiating antidepressants was found. The trial was registered at www.trialregister.nl under the identifier NTR3237. PMID:27625605

Costs and outcomes evaluation of patient navigation after abnormal cancer screening: evidence from the Patient Navigation Research Program.

PubMed

Bensink, Mark E; Ramsey, Scott D; Battaglia, Tracy; Fiscella, Kevin; Hurd, Thelma C; McKoy, June M; Patierno, Steven R; Raich, Peter C; Seiber, Eric E; Warren-Mears, Victoria; Whitley, Elizabeth; Paskett, Electra D; Mandelblatt, S

2014-02-15

Navigators can facilitate timely access to cancer services, but to the authors' knowledge there are little data available regarding their economic impact. The authors conducted a cost-consequence analysis of navigation versus usual care among 10,521 individuals with abnormal breast, cervical, colorectal, or prostate cancer screening results who enrolled in the Patient Navigation Research Program study from January 1, 2006 to March 31, 2010. Navigation costs included diagnostic evaluation, patient and staff time, materials, and overhead. Consequences or outcomes were time to diagnostic resolution and probability of resolution. Differences in costs and outcomes were evaluated using multilevel, mixed-effects regression modeling adjusting for age, race/ethnicity, language, marital status, insurance status, cancer, and site clustering. The majority of individuals were members of a minority (70.7%) and uninsured or publically insured (72.7%). Diagnostic resolution was higher for navigation versus usual care at 180 days (56.2% vs 53.8%; P = .008) and 270 days (70.0% vs 68.2%; P < .001). Although there were no differences in the average number of days to resolution between the 2 groups (110 days vs 109 days; P = .63), the probability of ever having diagnostic resolution was higher for the navigation group versus the usual-care group (84.5% vs 79.6%; P < .001). The added cost of navigation versus usual care was $275 per patient (95% confidence interval, $260-$290; P < .001). There was no significant difference in stage distribution among the 12.4% of patients in the navigation group vs 11% of the usual-care patients diagnosed with cancer. Navigation adds costs and modestly increases the probability of diagnostic resolution among patients with abnormal screening test results. Navigation is only likely to be cost-effective if improved resolution translates into an earlier cancer stage at the time of diagnosis. © 2013 American Cancer Society.

A Randomized Trial of Acceptability and Effects of Values-Based Advance Care Planning in Outpatient Oncology: Person-Centered Oncologic Care and Choices (P-COCC).

PubMed

Epstein, Andrew S; O'Reilly, Eileen M; Shuk, Elyse; Romano, Danielle; Li, Yuelin; Breitbart, William; Volandes, Angelo E

2018-05-02

No standard advance care planning (ACP) process exists in oncology. We previously developed and validated the values questions for Person-Centered Oncologic Care and Choices (P-COCC), a novel ACP intervention combining a patient values interview with an informational care goals video. To pilot study acceptability, and, using randomization, explore potential utility of P-COCC. Eligibility included patients with advanced gastrointestinal cancer cared for at a comprehensive cancer center. Participants were randomized 2:2:1 to P-COCC vs. video alone vs. usual care. Validated assessments of wellbeing and decisional conflict were completed. Participants in the P-COCC arm also completed 3 Likert scales (was the intervention helpful, comfortable, and recommended to others); a positive score on at least 1 of 3 indicated acceptability. Patients were screened from 9/2014-11/2016; 151 were consented and randomized, 99 whom completed study measures (most common attrition reason: disease progression or death). The primary aim was met: Among 33 participants, P-COCC was acceptable to 32 (97%, 95%CI: 0.84-0.99, p<0.001). Mean distress scores (0-10) increased (0.43) in the P-COCC arm but decreased in the video alone (-0.04) and usual care (-0.21) arms (p=0.03 and 0.04, P-COCC versus video alone and usual care arms, respectively). There were no significant pre-post change scores on other measures of wellbeing (e.g., anxiety, depression, stress), or intergroup differences in decisional conflict. Our values-based ACP paradigm is acceptable but may increase distress in cancer outpatients. Further studies are investigating the underpinnings of these effects and ways to best support cancer patients in ACP. Copyright © 2018. Published by Elsevier Inc.

A systematic review of integrated use of disease-management interventions in asthma and COPD.

PubMed

Lemmens, Karin M M; Nieboer, Anna P; Huijsman, Robbert

2009-05-01

The effectiveness of multiple interventions in asthma and chronic obstructive pulmonary disease (COPD) is unclear. To examine the effectiveness of multiple interventions as compared to single interventions or usual care on health outcomes and health care utilisation within the context of integrated disease management in asthma and COPD. MEDLINE and the Cochrane Library (1995-May 2008) were searched for controlled trials. Two reviewers independently extracted data and assessed study quality. Meta-analyses were performed on quality of life and health care utilisation data. Furthermore, the effects of multiple interventions versus single interventions and usual care were assessed qualitatively. Of the 36 studies included, 17 targeted double interventions (patient-related and organisational interventions); 19 studies performed triple interventions (patient-related, professional-directed and organisational interventions). They were heterogeneous in terms of (combinations of) interventions, outcomes measured, study design and setting. Pooled data showed that studied disease management programmes significantly improved quality of life on several domains. Patients within triple intervention programmes had less chance of at least one hospital admission compared with usual care. No significant effects were found in number of emergency department visits. Qualitative analyses revealed positive trends on process improvements and satisfaction. Inconclusive results were reported on symptoms; no effects were found in lung function. In spite of the heterogeneity of disease management studies in asthma and COPD care, this review showed promising improvements in quality of life and reductions in hospitalisations, especially for triple intervention programmes.

Group patient visits for Parkinson disease: a randomized feasibility trial.

PubMed

Dorsey, E R; Deuel, L M; Beck, C A; Gardiner, I F; Scoglio, N J; Scott, J C; Marshall, F J; Biglan, K M

2011-05-03

Group patient visits are medical appointments shared among patients with a common medical condition. This care delivery method has demonstrated benefits for individuals with chronic conditions but has not been evaluated for Parkinson disease (PD). We conducted a 12-month, randomized trial of group patient visits vs usual (one-on-one) care for patients with PD. Visits were led by one of 3 study physicians, included patients and caregivers, and lasted approximately 90 minutes. Those receiving group visits had 4 sessions over 12 months. The primary outcome measure was feasibility as measured by the ability to recruit participants and by the proportion of participants who completed the study. The primary efficacy outcome was quality of life as measured by the PD Questionnaire-39. Thirty patients and 27 caregivers enrolled in the study. Thirteen of the 15 patients randomized to group patient visits and 14 of the 15 randomized to usual care completed the study. Quality of life measured 12 months after baseline between the 2 groups was not different (25.9 points for group patient visits vs 26.0 points for usual care; p = 0.99). Group patient visits may be a feasible means of providing care to individuals with PD and may offer an alternative or complementary method of care delivery for some patients and physicians. This study provides Class II evidence that group patient visits did not improve quality of life for individuals with PD over a 1-year period.

Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults.

PubMed

van Dessel, Nikki; den Boeft, Madelon; van der Wouden, Johannes C; Kleinstäuber, Maria; Leone, Stephanie S; Terluin, Berend; Numans, Mattijs E; van der Horst, Henriëtte E; van Marwijk, Harm

2014-11-01

Medically unexplained physical symptoms (MUPS) are physical symptoms for which no adequate medical explanation can be found after proper examination. The presence of MUPS is the key feature of conditions known as 'somatoform disorders'. Various psychological and physical therapies have been developed to treat somatoform disorders and MUPS. Although there are several reviews on non-pharmacological interventions for somatoform disorders and MUPS, a complete overview of the whole spectrum is missing. To assess the effects of non-pharmacological interventions for somatoform disorders (specifically somatisation disorder, undifferentiated somatoform disorder, somatoform disorders unspecified, somatoform autonomic dysfunction, pain disorder, and alternative somatoform diagnoses proposed in the literature) and MUPS in adults, in comparison with treatment as usual, waiting list controls, attention placebo, psychological placebo, enhanced or structured care, and other psychological or physical therapies. We searched the Cochrane Depression, Anxiety and Neurosis Review Group's Specialised Register (CCDANCTR) to November 2013. This register includes relevant randomised controlled trials (RCTs) from The Cochrane Library, EMBASE, MEDLINE, and PsycINFO. We ran an additional search on the Cochrane Central Register of Controlled Trials and a cited reference search on the Web of Science. We also searched grey literature, conference proceedings, international trial registers, and relevant systematic reviews. We included RCTs and cluster randomised controlled trials which involved adults primarily diagnosed with a somatoform disorder or an alternative diagnostic concept of MUPS, who were assigned to a non-pharmacological intervention compared with usual care, waiting list controls, attention or psychological placebo, enhanced care, or another psychological or physical therapy intervention, alone or in combination. Four review authors, working in pairs, conducted data extraction and assessment of risk of bias. We resolved disagreements through discussion or consultation with another review author. We pooled data from studies addressing the same comparison using standardised mean differences (SMD) or risk ratios (RR) and a random-effects model. Primary outcomes were severity of somatic symptoms and acceptability of treatment. We included 21 studies with 2658 randomised participants. All studies assessed the effectiveness of some form of psychological therapy. We found no studies that included physical therapy.Fourteen studies evaluated forms of cognitive behavioural therapy (CBT); the remainder evaluated behaviour therapies, third-wave CBT (mindfulness), psychodynamic therapies, and integrative therapy. Fifteen included studies compared the studied psychological therapy with usual care or a waiting list. Five studies compared the intervention to enhanced or structured care. Only one study compared cognitive behavioural therapy with behaviour therapy.Across the 21 studies, the mean number of sessions ranged from one to 13, over a period of one day to nine months. Duration of follow-up varied between two weeks and 24 months. Participants were recruited from various healthcare settings and the open population. Duration of symptoms, reported by nine studies, was at least several years, suggesting most participants had chronic symptoms at baseline.Due to the nature of the intervention, lack of blinding of participants, therapists, and outcome assessors resulted in a high risk of bias on these items for most studies. Eleven studies (52% of studies) reported a loss to follow-up of more than 20%. For other items, most studies were at low risk of bias. Adverse events were seldom reported.For all studies comparing some form of psychological therapy with usual care or a waiting list that could be included in the meta-analysis, the psychological therapy resulted in less severe symptoms at end of treatment (SMD -0.34; 95% confidence interval (CI) -0.53 to -0.16; 10 studies, 1081 analysed participants). This effect was considered small to medium; heterogeneity was moderate and overall quality of the evidence was low. Compared with usual care, psychological therapies resulted in a 7% higher proportion of drop-outs during treatment (RR acceptability 0.93; 95% CI 0.88 to 0.99; 14 studies, 1644 participants; moderate-quality evidence). Removing one outlier study reduced the difference to 5%. Results for the subgroup of studies comparing CBT with usual care were similar to those in the whole group.Five studies (624 analysed participants) assessed symptom severity comparing some psychological therapy with enhanced care, and found no clear evidence of a difference at end of treatment (pooled SMD -0.19; 95% CI -0.43 to 0.04; considerable heterogeneity; low-quality evidence). Five studies (679 participants) showed that psychological therapies were somewhat less acceptable in terms of drop-outs than enhanced care (RR 0.93; 95% CI 0.87 to 1.00; moderate-quality evidence). When all psychological therapies included this review were combined they were superior to usual care or waiting list in terms of reduction of symptom severity, but effect sizes were small. As a single treatment, only CBT has been adequately studied to allow tentative conclusions for practice to be drawn. Compared with usual care or waiting list conditions, CBT reduced somatic symptoms, with a small effect and substantial differences in effects between CBT studies. The effects were durable within and after one year of follow-up. Compared with enhanced or structured care, psychological therapies generally were not more effective for most of the outcomes. Compared with enhanced care, CBT was not more effective. The overall quality of evidence contributing to this review was rated low to moderate.The intervention groups reported no major harms. However, as most studies did not describe adverse events as an explicit outcome measure, this result has to be interpreted with caution.An important issue was that all studies in this review included participants who were willing to receive psychological treatment. In daily practice, there is also a substantial proportion of participants not willing to accept psychological treatments for somatoform disorders or MUPS. It is unclear how large this group is and how this influences the relevance of CBT in clinical practice.The number of studies investigating various treatment modalities (other than CBT) needs to be increased; this is especially relevant for studies concerning physical therapies. Future studies should include participants from a variety of age groups; they should also make efforts to blind outcome assessors and to conduct follow-up assessments until at least one year after the end of treatment.

Cost-effectiveness of the PECARN rules in children with minor head trauma.

PubMed

Nishijima, Daniel K; Yang, Zhuo; Urbich, Michael; Holmes, James F; Zwienenberg-Lee, Marike; Melnikow, Joy; Kuppermann, Nathan

2015-01-01

To improve the efficiency and appropriateness of computed tomography (CT) use in children with minor head trauma, clinical prediction rules were derived and validated by the Pediatric Emergency Care Applied Research Network (PECARN). The objective of this study was to conduct a cost-effectiveness analysis comparing the PECARN traumatic brain injury prediction rules to usual care for selective CT use. We used decision analytic modeling to project the outcomes, costs, and cost-effectiveness of applying the PECARN rules compared with usual care in a hypothetical cohort of 1,000 children with minor blunt head trauma. Clinical management was directed by level of risk as specified by the presence or absence of variables in the PECARN traumatic brain injury prediction rules. Immediate costs of care (diagnostic testing, treatment [not including clinician time], and hospital stay) were derived on single-center data. Quality-adjusted life-year losses related to the sequelae of clinically important traumatic brain injuries and to radiation-induced cancers, number of CT scans, number of radiation-induced cancers, number of missed clinically important traumatic brain injury, and total costs were evaluated. Compared with the usual care strategy, the PECARN strategy was projected to miss slightly more children with clinically important traumatic brain injuries (0.26 versus 0.02 per 1,000 children) but used fewer cranial CT scans (274 versus 353), resulted in fewer radiation-induced cancers (0.34 versus 0.45), cost less ($904,940 versus $954,420), and had lower net quality-adjusted life-year loss (-4.64 versus -5.79). Because the PECARN strategy was more effective (less quality-adjusted life-year loss) and less costly, it dominated the usual care strategy. Results were robust under sensitivity analyses. Application of the PECARN traumatic brain injury prediction rules for children with minor head trauma would lead to beneficial outcomes and more cost-effective care. Copyright © 2014 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial.

PubMed

Munneke, Marten; Nijkrake, Maarten J; Keus, Samyra Hj; Kwakkel, Gert; Berendse, Henk W; Roos, Raymund Ac; Borm, George F; Adang, Eddy M; Overeem, Sebastiaan; Bloem, Bastiaan R

2010-01-01

Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured referrals to these trained physiotherapists to increase the numbers of patients they treat. We aimed to assess the efficacy of this approach for improving health-care outcomes. Between February, 2005, and August, 2007, we did a cluster-randomised trial with 16 clusters (defined as community hospitals and their catchment area). Clusters were randomly allocated by use of a variance minimisation algorithm to ParkinsonNet care (n=8) or usual care (n=8). Patients were assessed at baseline and at 8, 16, and 24 weeks of follow-up. The primary outcome was a patient preference disability score, the patient-specific index score, at 16 weeks. Health secondary outcomes were functional mobility, mobility-related quality of life, and total societal costs over 24 weeks. Analysis was by intention to treat. This trial is registered, number NCT00330694. We included 699 patients. Baseline characteristics of the patients were comparable between the ParkinsonNet clusters (n=358) and usual-care clusters (n=341). The primary endpoint was similar for patients within the ParkinsonNet clusters (mean 47.7, SD 21.9) and control clusters (48.3, 22.4). Health secondary endpoints were also similar for patients in both study groups. Total costs over 24 weeks were lower in ParkinsonNet clusters compared with usual-care clusters (difference euro727; 95% CI 56-1399). Implementation of ParkinsonNet networks did not change health outcomes for patients living in ParkinsonNet clusters. However, health-care costs were reduced in ParkinsonNet clusters compared with usual-care clusters. ZonMw; Netherlands Organisation for Scientific Research; Dutch Parkinson's Disease Society; National Parkinson Foundation; Stichting Robuust. Copyright 2010 Elsevier Ltd. All rights reserved.

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial.

PubMed

2015-07-04

Early mobilisation after stroke is thought to contribute to the effects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke. We did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteria were randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0-2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561. Between July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59-0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93-1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation. First mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refining present guidelines; however, clinical recommendations should be informed by future analyses of dose-response associations. National Health and Medical Research Council, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, UK Stroke Association, National Institute of Health Research. Copyright © 2015 Bernhardt et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd.. All rights reserved.

Effects of a continuum of care intervention on frail older persons' life satisfaction: a randomized controlled study.

PubMed

Berglund, Helene; Hasson, Henna; Kjellgren, Karin; Wilhelmson, Katarina

2015-04-01

The aim of this study was to analyse effects of a comprehensive continuum of care (intervention group) on frail older persons' life satisfaction, as compared to those receiving usual care (control group). The intervention included geriatric assessment, case management, interprofessional collaboration, support for relatives and organising of care-planning meetings in older persons' own homes. Improvements in older persons' subjective well-being have been shown in studies including care planning and coordination by a case manager. However, effects of more complex continuum of care interventions on frail older persons' life satisfaction are not well explored. Randomised controlled study. The validated LiSat-11 scale was used in face-to-face interviews to assess older persons' life satisfaction at baseline and at three, six and 12 months after the baseline. The odds ratio for improving or maintaining satisfaction was compared for intervention and control groups from baseline to three-month, three- to six-month as well as six- to 12-month follow-ups. Older persons who received the intervention were more likely to improve or maintain satisfaction than those who received usual care, between 6 and 12 month follow-ups, for satisfaction regarding functional capacity, psychological health and financial situation. A comprehensive continuum of care intervention comprising several components had a positive effect on frail older persons' satisfaction with functional capacity, psychological health and financial situation. Frail older persons represent a great proportion of the persons in need of support from the health care system. Health care professionals need to consider continuum of care interventions' impact on life satisfaction. As life satisfaction is an essential part of older persons' well-being, we propose that policy makers and managers promote comprehensive continuum of care solutions. © 2014 John Wiley & Sons Ltd.

Dissemination of Cognitive Therapy for Panic Disorder in Primary Care

PubMed Central

Grey, Nick; Salkovskis, Paul; Quigley, Alexandra; Clark, David M.; Ehlers, Anke

2011-01-01

This study investigated whether brief training in cognitive therapy for panic disorder (Clark et al., 1994) can improve the outcomes that primary care therapists obtain with their patients. Seven primary care therapists treated 36 patients meeting DSM-IV (APA, 1994) criteria for panic disorder with or without agoraphobia in general practice surgeries. Outcomes for the cohort of patients whom the therapists treated with their usual methods (treatment-as-usual) before the training (N = 12) were compared with those obtained with similar patients treated by the same therapists after brief training and ongoing supervision in cognitive therapy (CT) for panic disorder (N = 24). Treatment-as-usual led to significant improvements in panic severity, general anxiety, and depression. However, only a small proportion (17% of the intent-to-treat sample) became panic free and there was no improvement in agoraphobic avoidance. Patients treated with CT achieved significantly better outcomes on all measures of panic attacks, including panic-free rate (54%, intent-to-treat), and showed significantly greater improvements in agoraphobic avoidance and patient-rated general anxiety. In conclusion, cognitive therapy for panic disorder can be successfully disseminated in primary care with a brief therapist training and supervision programme that leads to significant improvements in patient outcomes. PMID:22661906

Effectiveness and cost effectiveness of counselling in primary care.

PubMed

Bower, P; Rowland, N

2006-07-19

The prevalence of mental health and psychosocial problems in primary care is high. This review examines the clinical and cost-effectiveness of psychological therapies provided in primary care by counsellors. To assess the effectiveness and cost effectiveness of counselling in primary care by reviewing cost and outcome data in randomised controlled trials for patients with psychological and psychosocial problems considered suitable for counselling. To update the review, the following electronic databases were searched on 25-10-2005: MEDLINE, EMBASE, PsycLIT, CINAHL, the Cochrane Controlled Trials register and the Cochrane Collaboration Depression, Anxiety and Neurosis (CCDAN) trials registers. All controlled trials comparing counselling in primary care with other treatments for patients with psychological and psychosocial problems considered suitable for counselling. Trials completed before the end of June 2005 were included in the review. Data were extracted using a standardised data extraction sheet. Trials were rated for quality using CCDAN criteria, to assess the extent to which their design and conduct were likely to have prevented systematic error. Continuous measures of outcome were combined using standardised mean differences. An overall effect size was calculated for each outcome with 95% confidence intervals (CI). Continuous data from different measuring instruments were transformed into a standard effect size by dividing mean values by standard deviations. Sensitivity analyses were undertaken to test the robustness of the results. Economic analyses were summarised in narrative form. Eight trials were included in the review. The analysis found significantly greater clinical effectiveness in the counselling group compared with usual care in the short-term (standardised mean difference -0.28, 95% CI -0.43 to -0.13, n = 772, 6 trials) but not the long-term (standardised mean difference -0.09, 95% CI -0.27 to 0.10, n = 475, 4 trials). Levels of satisfaction with counselling were high. There was some evidence that the overall costs of counselling and usual care were similar. Counselling is associated with modest improvement in short-term outcome compared to usual care, but provides no additional advantages in the long-term. Patients are satisfied with counselling. Although some types of health care utilisation may be reduced, counselling does not seem to reduce overall healthcare costs.

Pheochromocytoma and Paraganglioma Treatment (PDQ®)—Health Professional Version

Cancer.gov

Pheochromocytoma and paraganglioma treatment is usually surgery, however, preoperative medical preparation is critical. Palliative care for metastatic disease may include chemotherapy, radiation therapy, targeted therapy, and other modalities. Get detailed information in this clinician summary.

Cost analysis of the History, ECG, Age, Risk factors, and initial Troponin (HEART) Pathway randomized control trial.

PubMed

Riley, Robert F; Miller, Chadwick D; Russell, Gregory B; Harper, Erin N; Hiestand, Brian C; Hoekstra, James W; Lefebvre, Cedric W; Nicks, Bret A; Cline, David M; Askew, Kim L; Mahler, Simon A

2017-01-01

The HEART Pathway is a diagnostic protocol designed to identify low-risk patients presenting to the emergency department with chest pain that are safe for early discharge. This protocol has been shown to significantly decrease health care resource utilization compared with usual care. However, the impact of the HEART Pathway on the cost of care has yet to be reported. We performed a cost analysis of patients enrolled in the HEART Pathway trial, which randomized participants to either usual care or the HEART Pathway protocol. For low-risk patients, the HEART Pathway recommended early discharge from the emergency department without further testing. We compared index visit cost, cost at 30 days, and cardiac-related health care cost at 30 days between the 2 treatment arms. Costs for each patient included facility and professional costs. Cost at 30 days included total inpatient and outpatient costs, including the index encounter, regardless of etiology. Cardiac-related health care cost at 30 days included the index encounter and costs adjudicated to be cardiac-related within that period. Two hundred seventy of the 282 patients enrolled in the trial had cost data available for analysis. There was a significant reduction in cost for the HEART Pathway group at 30 days (median cost savings of $216 per individual), which was most evident in low-risk (Thrombolysis In Myocardial Infarction score of 0-1) patients (median savings of $253 per patient) and driven primarily by lower cardiac diagnostic costs in the HEART Pathway group. Using the HEART Pathway as a decision aid for patients with undifferentiated chest pain resulted in significant cost savings. Copyright © 2016 Elsevier Inc. All rights reserved.

Healthy Colon, Healthy Life

PubMed Central

Walsh, Judith M.E.; Salazar, Rene; Nguyen, Tung T.; Kaplan, Celia; Nguyen, Lamkieu; Hwang, Jimmy; McPhee, Stephen J.; Pasick, Rena J.

2014-01-01

Background Colorectal cancer (CRC) screening rates are increasing, but they are still low, particularly in ethnic minority groups. In many resource-poor settings, fecal occult blood test (FOBT) is the main screening option. Intervention Culturally tailored telephone counseling by community health advisors employed by a community-based organization, culturally tailored brochures, and customized FOBT kits. Design RCT. Participants were randomized to (1) basic intervention: culturally tailored brochure plus FOBT kit (n=765); (2) enhanced intervention: brochure, FOBT plus telephone counseling (n=768); or (3) usual care (n=256). Setting/participants Latino and Vietnamese primary care patients at a large public hospital. Main outcome measures Self-reported receipt of FOBT or any CRC screening at 1-year follow-up. Results 1358 individuals (718 Latinos and 640 Vietnamese) completed the follow-up survey. Self-reported FOBT screening rates increased by 7.8 % in the control group, by 15.1 % in the brochure group, and by 25.1 % in the brochure/telephone counseling group (p<0.01 for differences between each intervention and usual care and for the difference between brochure/telephone counseling and brochure alone). For any CRC screening, rates increased by 4.1 % in the usual care group, by 11.9 % in the FOBT/brochure group, and by 21.4 % in the brochure/telephone counseling group (p<0.01 for differences between each intervention and usual care and for the difference between the basic and the enhanced intervention). Conclusions An intervention that included culturally tailored brochures and tailored telephone counseling increased CRC screening in Latinos and the Vietnamese. Brochure and telephone counseling together had the greatest impact. Future research should address replication and dissemination of this model for Latinos and Vietnamese in other communities, and adaptation of the model for other groups. PMID:20547275

Hospice care delivered at home, in nursing homes and in dedicated hospice facilities: A systematic review of quantitative and qualitative evidence.

PubMed

Candy, B; Holman, A; Leurent, B; Davis, S; Jones, L

2011-01-01

Hospice care supports patients and their families physically and emotionally through the dying phase. In many countries a substantial portion of specialised end-of-life care is provided through hospices. Such care has developed outside of general healthcare and is commonly provided in a patient's home or in dedicated facilities. Hospice provision may need to increase in the future due to an ageing population with a greater need for access to end-of-life care. In this systematic review we sought to identify the current evidence on (1) the effectiveness, including cost-effectiveness, of hospices, and hospice care in a patient's home and in nursing homes and (2) the experiences of those who use and of those who provide such services. We included quantitative and qualitative studies on hospice care that was provided in a patient's home, nursing home or hospice. We did not include studies on end-of-life care that was provided as part of general healthcare provision, such as by general practitioners in primary care, community nurses or within general hospitals. For quantitative evaluations we included only those that compared hospice care with usual generalist healthcare. The databases CINAHL, MEDLINE, EMBASE, and The Cochrane Library were searched from 2003 to 2009. Evidence was assessed for quality and data extractions double-checked. For quantitative studies we present the outcome data comparing hospice versus usual care. For qualitative evaluations we organise findings thematically. Eighteen comparative evaluations and four thematic papers were identified. Quantitative evidence, mostly of limited quality in design, showed that hospice care at home reduced general health care use and increased family and patient satisfaction with care. Main themes in the qualitative literature revealed that home hospice services support families to sustain patient care at home and hospice day care services generate for the patient a renewed sense of meaning and purpose. Although studies had methodological limitations, in this review we found much evidence to support the benefits of hospice care. There were limited evaluations found on the impact of hospice care on psychological well-being, such as symptoms of depression, and on inpatient hospice care and non-hospital related costs. Copyright © 2010 Elsevier Ltd. All rights reserved.

Oncologists' perspectives on post-cancer treatment communication and care coordination with primary care physicians.

PubMed

Klabunde, C N; Haggstrom, D; Kahn, K L; Gray, S W; Kim, B; Liu, B; Eisenstein, J; Keating, N L

2017-07-01

Post-treatment cancer care is often fragmented and of suboptimal quality. We explored factors that may affect cancer survivors' post-treatment care coordination, including oncologists' use of electronic technologies such as e-mail and integrated electronic health records (EHRs) to communicate with primary care physicians (PCPs). We used data from a survey (357 respondents; participation rate 52.9%) conducted in 2012-2013 among medical oncologists caring for patients in a large US study of cancer care delivery and outcomes. Oncologists reported their frequency and mode of communication with PCPs, and role in providing post-treatment care. Seventy-five per cent said that they directly communicated with PCPs about post-treatment status and care recommendations for all/most patients. Among those directly communicating with PCPs, 70% always/usually used written correspondence, while 36% always/usually used integrated EHRs; telephone and e-mail were less used. Eighty per cent reported co-managing with PCPs at least one post-treatment general medical care need. In multivariate-adjusted analyses, neither communication mode nor intensity were associated with co-managing survivors' care. Oncologists' reliance on written correspondence to communicate with PCPs may be a barrier to care coordination. We discuss new research directions for enhancing communication and care coordination between oncologists and PCPs, and to better meet the needs of cancer survivors post-treatment. © 2017 John Wiley & Sons Ltd.

Study protocol of a randomized controlled trial to test the effect of a smartphone application on oral-health behavior and oral hygiene in adolescents with fixed orthodontic appliances.

PubMed

Scheerman, Janneke F M; van Meijel, Berno; van Empelen, Pepijn; Kramer, Gem J C; Verrips, Gijsbert H W; Pakpour, Amir H; Van den Braak, Matheus C T; van Loveren, Cor

2018-02-07

Adolescents with fixed orthodontic appliances are at high risk of developing dental caries. To date, new smartphone technologies have seldom been used to support them in the preventive behavior that can help prevent dental caries. After an intervention-mapping process, we developed a smartphone application (the WhiteTeeth app) for preventing dental caries through improved oral-health behavior and oral hygiene. The app, which is intended to be used at home, will help adolescents with fixed orthodontic appliances perform their oral self-care behavior. The app is based on the Health Action Process Approach (HAPA) theory, and incorporates several behavior-change techniques that target the psychosocial factors of oral-health behavior. This article describes the protocol of a randomized controlled trial (RCT) to evaluate the effects of the WhiteTeeth app on oral-health behavior and oral-hygiene outcomes (presence of dental plaque and gingival bleeding) compared with those of care as usual, in patients aged 12-16 with fixed orthodontic appliances. The RCT has two conditions: an experimental group that will receive the WhiteTeeth app in addition to care as usual, and a control group that will only receive care as usual. Care as usual will include routine oral-health education and instruction at orthodontic check-ups. In the western part of the Netherlands 146 participants will be recruited from four orthodontic clinics. Data will be collected during three orthodontic check-ups: baseline (T0), 6 weeks of follow-up (T1) and 12 weeks of follow-up (T2). The primary study outcomes are the presence of dental plaque (measured with a modified Silness and Loë Plaque Index); and gingival bleeding (measured with the Bleeding on Marginal Probing Index). Secondary outcomes include changes in self-reported oral-health behaviors and its psychosocial factors identified by the HAPA theory, such as outcome expectancies, intention, action self-efficacy, coping planning and action control. Since the intervention was designed to target psychosocial factors in the motivational and volitional components of the behavior-change process, we hypothesize that the app will cause greater improvements in oral-health behavior and oral hygiene more than traditional oral-health-promotion programs (i.e., care as usual). The trial has been registered with the Dutch Trial Register ( NTR6206 : 20 February 2017).

The effect of motivational interviewing on glycaemic control and perceived competence of diabetes self-management in patients with type 1 and type 2 diabetes mellitus after attending a group education programme: a randomised controlled trial.

PubMed

Rosenbek Minet, L K; Wagner, L; Lønvig, E M; Hjelmborg, J; Henriksen, J E

2011-07-01

The aim of this study was to measure the efficacy of motivational interviewing (MI) compared with usual care on changes in glycaemic control and competence of diabetes self-management in patients with diabetes mellitus. Patients were eligible if they had type 1 or 2 diabetes mellitus, were over 18 years of age and had participated in a 4 day group education programme offered at a diabetes clinic at a university hospital in Denmark. Exclusion criteria included pregnancy, severe debilitating disease and cognitive deficit. Out of 469 patients who attended the group education programme, 349 patients were randomised to either a usual care control group or an intervention group, which received up to five individual counselling sessions in 1 year based on MI, in addition to usual care. A randomised parallel design was used and open-label allocation was done by random permuted blocks, with allocation concealment by sequentially numbered, sealed, opaque envelopes. The primary outcome was glycated haemoglobin (HbA(1c)). Analysis regarding measurements of glycated haemoglobin (HbA(1c)) and competence of self-management (using the Problem Areas in Diabetes Scale [PAID] and Perceived Competence for Diabetes Scale [PCDS]) was based on 298 participants followed for a 24 month period. Data were collected at the Department of Endocrinology at Odense University Hospital. Our hypotheses were that MI could: (1) reduce HbA(1c) levels; (2) increase self-efficacy; and (3) increase diabetes self-care, compared with usual care. Out of the 176 included in the control group and 173 in the intervention group, 153 and 145 were analysed in the groups, respectively. When using the baseline value as covariate there were no significant differences in change score between the two study groups with regard to mean level of HbA(1c) (0.131, p = 0.221), PAID scores (-1.793, p = 0.191) or PCDS scores (0.017, p = 0.903) at the 24 month follow-up, using a mixed effects regression model. The patients in the intervention group showed significantly higher levels of perceived competence in dealing with diabetes compared with the control group (mean change score = -0.387, p = 0.002) following 1 year of intervention. We were unable to demonstrate any benefit, over or above usual care, of MI in patients with diabetes who have just completed a diabetes education programme, and who have well-regulated diabetes. Clinical Trials NCT00555854.

How is a specialist depression service effective for persistent moderate to severe depressive disorder?: a qualitative study of service user experience.

PubMed

Thomson, Louise; Barker, Marcus; Kaylor-Hughes, Catherine; Garland, Anne; Ramana, Rajini; Morriss, Richard; Hammond, Emily; Hopkins, Gail; Simpson, Sandra

2018-06-15

A specialist depression service (SDS) offering collaborative pharmacological and cognitive behaviour therapy treatment for persistent depressive disorder showed effectiveness against depression symptoms versus usual community based multidisciplinary care in a randomised controlled trial (RCT) in specialist mental health services in England. However, there is uncertainty concerning how specialist depression services effect such change. The current study aimed to evaluate the factors which may explain the greater effectiveness of SDS compared to Treatment as Usual (TAU) by exploring the experience of the RCT participants. Qualitative audiotaped and transcribed semi-structured interviews were conducted 12-18 months after baseline with 21 service users (12 SDS, 9 TAU arms) drawn from all three sites. Inductive thematic analysis using a grounded approach contrasted the experiences of SDS with TAU participants. Four themes emerged in relation to service user experience: 1. Specific treatment components of the SDS: which included sub-themes of the management of medication change, explaining and developing treatment strategies, setting realistic expectations, and person-centred and holistic approach; 2. Individual qualities of SDS clinicians; 3. Collaborative team context in SDS: which included sub-themes of communication between healthcare professionals, and continuity of team members; 4. Accessibility to SDS: which included sub-themes of flexibility of locations, frequent consultation as reinforcement, gradual pace of treatment, and challenges of returning to usual care. The study uncovered important mechanisms and contextual factors in the SDS that service users experience as different from TAU, and which may explain the greater effectiveness of the SDS: the technical expertise of the healthcare professionals, personal qualities of clinicians, teamwork, gradual pace of care, accessibility and managing service transitions. Usual care in other specialist mental health services may share many of the features from the SDS. "Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder" was registered in www.ClinicalTrials.gov ( NCT01047124 ) on 12-01-2010 and the ISRCTN registry was registered in www.isrctn.com ( ISRCTN10963342 ) on 25-11-2015 (retrospectively registered).

Adult community health-promoting interventions in primary health care: A systematic review.

PubMed

March, Sebastià; Torres, Elena; Ramos, María; Ripoll, Joana; García, Atanasio; Bulilete, Oana; Medina, David; Vidal, Clara; Cabeza, Elena; Llull, Micaela; Zabaleta-del-Olmo, Edurne; Aranda, José Manuel; Sastre, Silvia; Llobera, Joan

2015-07-01

To examine evidence on the effectiveness of health-promoting community interventions carried out in primary health care. Systematic review of originals and systematic reviews of health-promoting community interventions with the participation of primary health care. A working definition of community activities was used in the inclusion criteria. Databases searched up to 2013: PUBMED, EMBASE, CINHAL, Web of SCIENCE, IBECS, IME, and PSICODOC. No restrictions on year of publication or design. Articles were reviewed by separate researchers to identify risks of bias. Fifty-one articles published between 1966 and 2013 were included: 11 systematic reviews and 40 originals that described 39 community interventions. There is evidence on the effectiveness of community interventions in reducing cardiovascular risk factors, encouraging physical exercise, preventing falls and improving self-care among chronic patients compared with usual individual care. The effectiveness of some interventions increases when the community is involved in their development. Most assessments show positive results despite design limitations. The community approach may be more effective than the individual in usual preventive interventions in primary care. There is a lack of evidence on many community interventions in primary care and further research is needed. Copyright © 2015 Elsevier Inc. All rights reserved.

Effectiveness of Stepped Care for Chronic Fatigue Syndrome: A Randomized Noninferiority Trial

ERIC Educational Resources Information Center

Tummers, Marcia; Knoop, Hans; Bleijenberg, Gijs

2010-01-01

Objective: In this randomized noninferiority study, the effectiveness and efficiency of stepped care for chronic fatigue syndrome (CFS) was compared to care as usual. Stepped care was formed by guided self-instruction, followed by cognitive behavior therapy (CBT) if the patient desired it. Care as usual encompassed CBT after a waiting period.…

Comparisons of Interventions for Preventing Falls in Older Adults: A Systematic Review and Meta-analysis.

PubMed

Tricco, Andrea C; Thomas, Sonia M; Veroniki, Areti Angeliki; Hamid, Jemila S; Cogo, Elise; Strifler, Lisa; Khan, Paul A; Robson, Reid; Sibley, Kathryn M; MacDonald, Heather; Riva, John J; Thavorn, Kednapa; Wilson, Charlotte; Holroyd-Leduc, Jayna; Kerr, Gillian D; Feldman, Fabio; Majumdar, Sumit R; Jaglal, Susan B; Hui, Wing; Straus, Sharon E

2017-11-07

Falls result in substantial burden for patients and health care systems, and given the aging of the population worldwide, the incidence of falls continues to rise. To assess the potential effectiveness of interventions for preventing falls. MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Ageline databases from inception until April 2017. Reference lists of included studies were scanned. Randomized clinical trials (RCTs) of fall-prevention interventions for participants aged 65 years and older. Pairs of reviewers independently screened the studies, abstracted data, and appraised risk of bias. Pairwise meta-analysis and network meta-analysis were conducted. Injurious falls and fall-related hospitalizations. A total of 283 RCTs (159 910 participants; mean age, 78.1 years; 74% women) were included after screening of 10 650 titles and abstracts and 1210 full-text articles. Network meta-analysis (including 54 RCTs, 41 596 participants, 39 interventions plus usual care) suggested that the following interventions, when compared with usual care, were associated with reductions in injurious falls: exercise (odds ratio [OR], 0.51 [95% CI, 0.33 to 0.79]; absolute risk difference [ARD], -0.67 [95% CI, -1.10 to -0.24]); combined exercise and vision assessment and treatment (OR, 0.17 [95% CI, 0.07 to 0.38]; ARD, -1.79 [95% CI, -2.63 to -0.96]); combined exercise, vision assessment and treatment, and environmental assessment and modification (OR, 0.30 [95% CI, 0.13 to 0.70]; ARD, -1.19 [95% CI, -2.04 to -0.35]); and combined clinic-level quality improvement strategies (eg, case management), multifactorial assessment and treatment (eg, comprehensive geriatric assessment), calcium supplementation, and vitamin D supplementation (OR, 0.12 [95% CI, 0.03 to 0.55]; ARD, -2.08 [95% CI, -3.56 to -0.60]). Pairwise meta-analyses for fall-related hospitalizations (2 RCTs; 516 participants) showed no significant association between combined clinic- and patient-level quality improvement strategies and multifactorial assessment and treatment relative to usual care (OR, 0.78 [95% CI, 0.33 to 1.81]). Exercise alone and various combinations of interventions were associated with lower risk of injurious falls compared with usual care. Choice of fall-prevention intervention may depend on patient and caregiver values and preferences.

Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer: update to study protocol with follow-up extension.

PubMed

Sawka, Anna M; Straus, Sharon; Rodin, Gary; Thorpe, Kevin E; Ezzat, Shereen; Gafni, Amiram; Goldstein, David P

2015-07-14

Patient decision aids (P-DAs) are used to inform patients about healthcare choices, but there is limited knowledge about their longer term effects, beyond the time period of decision-making. We developed a computerized P-DA that explains the choice of radioactive iodine (RAI) adjuvant treatment or no RAI, for patients with low risk papillary thyroid cancer after total thyroidectomy. The original protocol for a randomized controlled trial, comparing the use of the P-DA (with usual care) to usual care alone, has been published in Trials http://www.trialsjournal.com/content/11/1/81. We found that P-DA (with usual care) significantly improved patients' medical knowledge at the time of decision-making (primary outcome) compared to usual care alone (control). In this update, we present the protocol for an extended follow-up study (15 to 23 months post-randomization), including qualitative and quantitative methods. The patient outcomes evaluated using quantitative questionnaires include: the degree to which patients feel well-informed about their RAI treatment choice, decision satisfaction, decision regret, cancer-related worry, mood, and trust in the treating physician. The qualitative component explores the experiences of RAI treatment decision-making, treatment satisfaction, and trial participation in a representative subgroup of patients. Extended follow-up study results will be described for the entire study population, and data will be compared between the P-DA and control groups. This mixed methods extended follow-up study will provide data on long term outcomes, relating to the use of a computerized P-DA in decision-making about adjuvant RAI treatment in early stage papillary thyroid cancer. Our results are intended to inform future research in this area, particularly relating to long term effects of the use of P-DAs in making healthcare choices. Clinicaltrials.gov identifier NCT01083550, registered 24 February 2010 and last updated 5 January 2015.

Ultrasound imaging to tailor the treatment of acute shoulder pain: a randomised controlled trial in general practice.

PubMed

Ottenheijm, Ramon P G; Cals, Jochen W L; Winkens, Bjorn; Weijers, René E; de Bie, Rob A; Dinant, Geert-Jan

2016-11-21

To determine the clinical effectiveness of ultrasound tailored treatment in patients with acute subacromial disorders. Pragmatic randomised controlled trial. Dutch general practice. Patients aged 18-65 years with acute (duration <3 months) unilateral shoulder pain and no previous treatment, in whom the general practitioner suspected a subacromial disorder was enrolled. All patients underwent ultrasound imaging of the affected shoulder. Patients who were still symptomatic after a qualification period of 2 weeks with standard treatment were randomised to treatment tailored to ultrasound diagnosis (disclosure of the ultrasound diagnosis) or usual care (non-disclosure of the ultrasound diagnosis). Patient-perceived recovery using the Global Perceived Effect questionnaire at 1 year. 129 patients were included. 18 patients recovered during the 2-week qualification period, resulting in 111 randomised patients; 56 were allocated to ultrasound tailored treatment and 55 to usual care. After 1 year, no statistically significant differences in recovery were found between the ultrasound tailored treatment group (72.5% (37/51)) and the usual care group (60% (30/50), OR 2.24 (95% CI 0.72 to 6.89; p=0.16)). Also, healthcare use was similar. This study has shown no clinically significant difference in the primary outcome measure between the ultrasound tailored treatment and usual care groups. Furthermore, there was no overall difference in healthcare resources used between groups. Although no formal cost data are included, one can only assume that the ultrasound examinations are additional costs for the intervention group, which cannot be justified in routine practice based on this trial. Based on this study, no change in current pragmatic guidelines to incorporate early ultrasound imaging can be recommended. NTR2403; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Effectiveness of a stepped-care intervention to prevent major depression in patients with type 2 diabetes mellitus and/or coronary heart disease and subthreshold depression: A pragmatic cluster randomized controlled trial.

PubMed

Pols, Alide D; van Dijk, Susan E; Bosmans, Judith E; Hoekstra, Trynke; van Marwijk, Harm W J; van Tulder, Maurits W; Adriaanse, Marcel C

2017-01-01

Given the public health significance of poorly treatable co-morbid major depressive disorders (MDD) among patients with type 2 diabetes mellitus (DM2) and coronary heart disease (CHD), we need to investigate whether strategies to prevent the development of major depression could reduce its burden of disease. We therefore evaluated the effectiveness of a stepped-care program for subthreshold depression in comparison with usual care in patients with DM2 and/or CHD. A cluster randomized controlled trial, with 27 primary care centers serving as clusters. A total of 236 DM2 and/or CHD patients with subthreshold depression (nine item Patient Health Questionnaire (PHQ-9) score ≥ 6, no current MDD according to DSM-IV criteria) were allocated to the intervention group (N = 96) or usual care group (n = 140). The stepped-care program was delivered by trained practice nurses during one year and consisted of four sequential treatment steps: watchful waiting, guided self-help, problem solving treatment and referral to the general practitioner. The primary outcome was the 12-month cumulative incidence of MDD as measured with the Mini International Neuropsychiatric Interview (MINI). Secondary outcomes included severity of depression (measured by PHQ-9) at 3, 6, 9 and 12 months. Of 236 patients (mean age, 67,5 (SD 10) years; 54.7% men), 210 (89%) completed the MINI at 12 months. The cumulative incidence of MDD was 9 of 89 (10.1%) participants in the intervention group and 12 of 121 (9.9%) participants in the usual care group. We found no statistically significant overall effect of the intervention (OR = 1.21; 95% confidence interval (0.12 to 12.41)) and there were no statistically significant differences in the course or severity of depressive symptoms between the two groups. This study suggest that Step-Dep was not more effective in preventing MDD than usual care in a primary care population with DM2 and/or CHD and subthreshold depression.

Cost-effectiveness of computerized cognitive-behavioural therapy for the treatment of depression in primary care: findings from the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial.

PubMed

Duarte, A; Walker, S; Littlewood, E; Brabyn, S; Hewitt, C; Gilbody, S; Palmer, S

2017-07-01

Computerized cognitive-behavioural therapy (cCBT) forms a core component of stepped psychological care for depression. Existing evidence for cCBT has been informed by developer-led trials. This is the first study based on a large independent pragmatic trial to assess the cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care compared with usual GP care alone and to establish the differential cost-effectiveness of a free-to-use cCBT programme (MoodGYM) in comparison with a commercial programme (Beating the Blues) in primary care. Costs were estimated from a healthcare perspective and outcomes measured using quality-adjusted life years (QALYs) over 2 years. The incremental cost-effectiveness of each cCBT programme was compared with usual GP care. Uncertainty was estimated using probabilistic sensitivity analysis and scenario analyses were performed to assess the robustness of results. Neither cCBT programme was found to be cost-effective compared with usual GP care alone. At a £20 000 per QALY threshold, usual GP care alone had the highest probability of being cost-effective (0.55) followed by MoodGYM (0.42) and Beating the Blues (0.04). Usual GP care alone was also the cost-effective intervention in the majority of scenario analyses. However, the magnitude of the differences in costs and QALYs between all groups appeared minor (and non-significant). Technically supported cCBT programmes do not appear any more cost-effective than usual GP care alone. No cost-effective advantage of the commercially developed cCBT programme was evident compared with the free-to-use cCBT programme. Current UK practice recommendations for cCBT may need to be reconsidered in the light of the results.

Collection of family health history for assessment of chronic disease risk in primary care.

PubMed

Powell, Karen P; Christianson, Carol A; Hahn, Susan E; Dave, Gaurav; Evans, Leslie R; Blanton, Susan H; Hauser, Elizabeth; Agbaje, Astrid; Orlando, Lori A; Ginsburg, Geoffrey S; Henrich, Vincent C

2013-01-01

Family health history can predict a patient's risk for common complex diseases. This project assessed the completeness of family health history data in medical charts and evaluated the utility of these data for performing risk assessments in primary care. Family health history data were collected and analyzed to determine the presence of quality indicators that are necessary for effective and accurate assessment of disease risk. More than 99% of the 390 paper charts analyzed contained information about family health history, which was usually scattered throughout the chart. Information on the health of the patient's parents was collected more often than information on the health of other relatives. Key information that was often not collected included age of disease onset, affected side of the family, and second-degree relatives affected. Less than 4% of patient charts included family health histories that were informative enough to accurately assess risk for common complex diseases. Limitations of this study include the small number of charts reviewed per provider, the fact that the sample consisted of primary care providers in a single geographic location, and the inability to assess ethnicity, consanguinity, and other indicators of the informativeness of family health history. The family health histories collected in primary care are usually not complete enough to assess the patient's risk for common complex diseases. This situation could be improved with use of tools that analyze the family health history information collected and provide risk-stratified decision support recommendations for primary care.

Feasibility of a multifaceted educational strategy for strengthening rural primary health care.

PubMed

Reyes-Morales, Hortensia; Gómez-Bernal, Enrique; Gutiérrez-Alba, Gaudencio; Aguilar-Ye, Arturo; Ruiz-Larios, José Arturo; Alonso-Núñez, Gabriel de Jesús

2017-01-01

To evaluate the feasibility and acceptability of a comprehensive educational strategy designed to improve care quality in rural areas of Mexico. A demonstration study was performed in 18 public rural health centers in Mexico, including an educational intervention that consists of the following steps: Development of the strategy; Selection and training of instructors (specialist physicians from the referral hospital and multidisciplinary field teams); Implementation of the strategy among health care teams for six priority causes of visit, through workshops, individual tutorials, and round-table case-review sessions. Feasibility and acceptability were evaluated using checklists, direct observation, questionnaires and in-depth interviews with key players. Despite some organizational barriers, the strategy was perceived as worthy by the participants because of the personalized tutorials and the improved integration of health teams within their usual professional practice. The educational strategy proved to be acceptable; its feasibility for usual care conditions will depend on the improvement of organizational processes at rural facilities.

Effect of an enhanced medical home on serious illness and cost of care among high-risk children with chronic illness: a randomized clinical trial.

PubMed

Mosquera, Ricardo A; Avritscher, Elenir B C; Samuels, Cheryl L; Harris, Tomika S; Pedroza, Claudia; Evans, Patricia; Navarro, Fernando; Wootton, Susan H; Pacheco, Susan; Clifton, Guy; Moody, Shade; Franzini, Luisa; Zupancic, John; Tyson, Jon E

Patient-centered medical homes have not been shown to reduce adverse outcomes or costs in adults or children with chronic illness. To assess whether an enhanced medical home providing comprehensive care prevents serious illness (death, intensive care unit [ICU] admission, or hospital stay >7 days) and/or reduces costs among children with chronic illness. Randomized clinical trial of high-risk children with chronic illness (≥3 emergency department visits, ≥2 hospitalizations, or ≥1 pediatric ICU admissions during previous year, and >50% estimated risk for hospitalization) treated at a high-risk clinic at the University of Texas, Houston, and randomized to comprehensive care (n = 105) or usual care (n = 96). Enrollment was between March 2011 and February 2013 (when predefined stopping rules for benefit were met) and outcome evaluations continued through August 31, 2013. Comprehensive care included treatment from primary care clinicians and specialists in the same clinic with multiple features to promote prompt effective care. Usual care was provided locally in private offices or faculty-supervised clinics without modification. Primary outcome: children with a serious illness (death, ICU admission, or hospital stay >7 days), costs (health system perspective). Secondary outcomes: individual serious illnesses, medical services, Medicaid payments, and medical school revenues and costs. In an intent-to-treat analysis, comprehensive care decreased both the rate of children with a serious illness (10 per 100 child-years vs 22 for usual care; rate ratio [RR], 0.45 [95% CI, 0.28-0.73]), and total hospital and clinic costs ($16,523 vs $26,781 per child-year, respectively; cost ratio, 0.58 [95% CI, 0.38-0.88]). In analyses of net monetary benefit, the probability that comprehensive care was cost neutral or cost saving was 97%. Comprehensive care reduced (per 100 child-years) serious illnesses (16 vs 44 for usual care; RR, 0.33 [95% CI, 0.17-0.66]), emergency department visits (90 vs 190; RR, 0.48 [95% CI, 0.34-0.67]), hospitalizations (69 vs 131; RR, 0.51 [95% CI, 0.33-0.77]), pediatric ICU admissions (9 vs 26; RR, 0.35 [95% CI, 0.18-0.70]), and number of days in a hospital (276 vs 635; RR, 0.36 [95% CI, 0.19-0.67]). Medicaid payments were reduced by $6243 (95% CI, $1302-$11,678) per child-year. Medical school losses (costs minus revenues) increased by $6018 (95% CI, $5506-$6629) per child-year. Among high-risk children with chronic illness, an enhanced medical home that provided comprehensive care to promote prompt effective care vs usual care reduced serious illnesses and costs. These findings from a single site of selected patients with a limited number of clinicians require study in larger, broader populations before conclusions about generalizability to other settings can be reached. clinicaltrials.gov Identifier: NCT02128776.

Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial.

PubMed

Sproson, Lise; Pownall, Sue; Enderby, Pam; Freeman, Jenny

2018-03-01

Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow-strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post-stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full-scale trial. Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration-Aspiration Scale (PAS) and patient-reported outcomes (Swallow Related Quality of Life-SWAL-QOL). Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual-care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. © 2017 Royal College of Speech and Language Therapists.

Improving Depression Treatment for Women: Integrating a Collaborative Care Depression Intervention into OB-GYN Care

PubMed Central

LaRocco-Cockburn, Anna; Reed, Susan D.; Melville, Jennifer; Croicu, Carmen; Russo, Joan; Inspektor, Michal; Edmondson, Eddie; Katon, Wayne

2013-01-01

Background Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been evaluated. Study design and methodology for a randomized, controlled trial of collaborative care depression management versus usual care in OB-GYN clinics and the details of the adapted collaborative care intervention and model implementation are described in this paper. Methods Women over age 18 years with clinically significant symptoms of depression, as measured by a Patient Health Questionnaire-9 (PHQ-9) score ≥10 and a clinical diagnosis of major depression or dysthymia, were randomized to the study intervention or to usual care and were followed for 18 months. The primary outcome assessed was change over time in the SCL-20 depression scale between baseline and 12 months. Baseline Results 205 women were randomized: 57% white, 20% African American, 9% Asian or Pacific Islander, 7% Hispanic, and 6% Native American. Mean age was 39 years. 4.6% were pregnant and 7.5% were within 12 months postpartum. The majority were single, (52%), and 95% had at least the equivalent of a high school diploma. Almost all patients met DSM IV criteria for major depression (99%) and approximately 33% met criteria for dysthymia. Conclusions An OB-GYN collaborative care team including a social worker, psychiatrist and OB-GYN physician who met weekly and used an electronic tracking system for patients were essential elements of the proposed depression care treatment model described here. Further study of models that improve quality of depression care that are adapted to the unique OB-GYN setting are needed. PMID:23939510

Initial Efficacy of a Cardiac Rehabilitation Transition Program: Cardiac TRUST

PubMed Central

Zullo, Melissa; Boxer, Rebecca; Moore, Shirley M.

2012-01-01

Patients recovering from cardiac events are increasingly using postacute care, such as home health care and skilled nursing facility services. The purpose of this pilot study was to test the initial efficacy, feasibility, and safety of a specially designed postacute care transitional rehabilitation intervention for cardiac patients. Cardiac Transitional Rehabilitation Using Self- Management Techniques (Cardiac TRUST) is a family-focused intervention that includes progressive low-intensity walking and education in self-management skills to facilitate recovery following a cardiac event. Using a randomized two-group design, exercise self-efficacy, steps walked, and participation in an outpatient cardiac rehabilitation program were compared in a sample of 38 older adults; 17 who received the Cardiac TRUST program and 21 who received usual care only. At discharge from postacute care, the intervention group had a trend for higher levels of self-efficacy for exercise outcomes (X=39.1, SD=7.4) than the usual care group (X=34.5; SD=7.0) (t-test 1.9, p=.06). During the 6 weeks following discharge, compared with the usual care group, the intervention group had more attendance in out-patient cardiac rehabilitation (33% compared to 11.8%, F=7.1, p=.03) and a trend toward more steps walked during the first week (X=1,307, SD=652 compared to X=782, SD=544, t-test 1.8, p=.07). The feasibility of the intervention was better for the home health participants than for those in the skilled nursing facility and there were no safety concerns. The provision of cardiac-focused rehabilitation during postacute care has the potential to bridge the gap in transitional services from hospitalization to outpatient cardiac rehabilitation for these patients at high risk for future cardiac events. Further evidence of the efficacy of Cardiac TRUST is warranted. PMID:22084960

Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial.

PubMed

Bleijenberg, Nienke; Drubbel, Irene; Schuurmans, Marieke J; Dam, Hester Ten; Zuithoff, Nicolaas P A; Numans, Mattijs E; de Wit, Niek J

2016-09-01

To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. Primary care setting, 39 general practices in the Netherlands. Community-dwelling people aged 60 and older (N = 3,092). A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results. © 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.

Does the addition of hip strengthening exercises improve outcomes following total knee arthroplasty? A study protocol for a randomized trial.

PubMed

Schache, Margaret B; McClelland, Jodie A; Webster, Kate E

2016-06-13

Total knee arthroplasty (TKA) is effective in reducing pain and improving function for end-stage knee osteoarthritis. However, muscle weakness and functional limitations persist despite assistance from post-operative rehabilitation programs that traditionally focus on quadriceps strengthening and range of movement exercises. Hip abductor muscle weakness is evident in knee osteoarthritis and hip muscle strengthening reduces knee pain in this group. Following TKA, people with weak hip abductor strength perform more poorly on measures of physical function. However, very little is known of the effectiveness of including hip abductor strengthening exercises in post-operative rehabilitation. The aim of this trial is to compare the effects of targeted hip abductor strengthening to those of traditional care in a TKA rehabilitation program on muscle strength, patient reported outcomes and functional performance measures. This protocol describes a single-blinded randomized controlled trial, where 104 participants referred for inpatient rehabilitation following TKA will be recruited. Participants will be randomized using computer-generated numbers to one of two groups: usual care or usual care with additional hip strengthening exercises. Participants will attend physiotherapy daily during their inpatient length of stay, and will then attend between six and eight physiotherapy sessions as an outpatient. Primary outcomes are isometric hip abductor strength and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes are stair climb test, 6 min walk test, timed up and go, 40 m fast-paced walk test, 30 second chair stand test, isometric quadriceps strength, Lower Extremity Functional Scale (LEFS) and SF-12. Outcome measures will be recorded at baseline (admission to inpatient rehabilitation), and then 3 weeks, 6 weeks and 6 months post admission to rehabilitation. The findings of this study will determine whether the addition of targeted hip strengthening to usual care rehabilitation improves physical performance and patient reported outcomes following TKA when compared to usual care rehabilitation. This will then determine whether targeted hip strengthening exercises should be included in traditional rehabilitation programs to improve the outcomes following total knee arthroplasty. The trial protocol was registered with the Australian Clinical Trial Registry ( ACTRN12615000863538 ) on 18 August 2015.

Impact of Protein Supplementation and Care and Support on Body Composition and CD4 Count among HIV-Infected Women Living in Rural India: Results from a Randomized Pilot Clinical Trial

PubMed Central

Nyamathi, Adeline; Sinha, Sanjeev; Ganguly, Kalyan K; Ramakrishna, Padma; Suresh, P.; Carpenter, Catherine L

2013-01-01

Body composition in HIV-infected individuals is subject to many influences. We conducted a pilot six-month randomized trial of 68 WLA (women living with AIDS) from rural India. High protein intervention combined with education and supportive care delivered by HIV-trained village women (Asha [Activated Social Health Activist] Life [AL]) was compared to standard protein with usual care delivered by village community assistants (Usual Care [UC]). Measurements included CD4 counts, ART adherence, socio-demographics, disease characteristics (questionnaires); and anthropometry (bioimpedance analyzer). Repeated measures analysis of variance modeled associations. AL significantly gained in BMI, muscle mass, fat mass, ART adherence, and CD4 counts compared to UC, with higher weight and muscle mass gains among ART adherent (≥ 66%) participants who had healthier immunity (CD4 ≥ 450). BMI of WLA improved through high protein supplementation combined with education and supportive care. Future research is needed to determine which intervention aspect was most responsible. PMID:23370835

Usual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.

PubMed

Freedland, Kenneth E; Mohr, David C; Davidson, Karina W; Schwartz, Joseph E

2011-05-01

To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. Selective qualitative review. Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment-as-usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. This review highlights the need for a scientific consensus statement on control groups in behavioral trials.

Non-pharmacological self-management for people living with migraine or tension-type headache: a systematic review including analysis of intervention components.

PubMed

Probyn, Katrin; Bowers, Hannah; Mistry, Dipesh; Caldwell, Fiona; Underwood, Martin; Patel, Shilpa; Sandhu, Harbinder Kaur; Matharu, Manjit; Pincus, Tamar

2017-08-11

To assess the effect of non-pharmacological self-management interventions against usual care, and to explore different components and delivery methods within those interventions PARTICIPANTS: People living with migraine and/or tension-type headache INTERVENTIONS: Non-pharmacological educational or psychological self-management interventions; excluding biofeedback and physical therapy.We assessed the overall effectiveness against usual care on headache frequency, pain intensity, mood, headache-related disability, quality of life and medication consumption in meta-analysis.We also provide preliminary evidence on the effectiveness of intervention components and delivery methods. We found a small overall effect for the superiority of self-management interventions over usual care, with a standardised mean difference (SMD) of -0.36 (-0.45 to -0.26) for pain intensity; -0.32 (-0.42 to -0.22) for headache-related disability, 0.32 (0.20 to 0.45) for quality of life and a moderate effect on mood (SMD=0.53 (-0.66 to -0.40)). We did not find an effect on headache frequency (SMD=-0.07 (-0.22 to 0.08)).Assessment of components and characteristics suggests a larger effect on pain intensity in interventions that included explicit educational components (-0.51 (-0.68 to -0.34) vs -0.28 (-0.40 to -0.16)); mindfulness components (-0.50 (-0.82 to -0.18) vs 0.34 (-0.44 to -0.24)) and in interventions delivered in groups vs one-to-one delivery (0.56 (-0.72 to -0.40) vs -0.39 (-0.52 to -0.27)) and larger effects on mood in interventions including a cognitive-behavioural therapy (CBT) component with an SMD of -0.72 (-0.93 to -0.51) compared with those without CBT -0.41 (-0.58 to -0.24). Overall we found that self-management interventions for migraine and tension-type headache are more effective than usual care in reducing pain intensity, mood and headache-related disability, but have no effect on headache frequency. Preliminary findings also suggest that including CBT, mindfulness and educational components in interventions, and delivery in groups may increase effectiveness. PROSPERO 2016:CRD42016041291. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Evaluating the association between the built environment and primary care access for new Medicaid enrollees in an urban environment using Walk and Transit Scores.

PubMed

Chaiyachati, Krisda H; Hom, Jeffrey K; Hubbard, Rebecca A; Wong, Charlene; Grande, David

2018-03-01

Worse health outcomes among those living in poverty are due in part to lower rates of health insurance and barriers to care. As the Affordable Care Act reduced financial barriers, identifying persistent barriers to accessible health care continues to be important. We examined whether the built environment as reflected by Walk Score™ (a measure of walkability to neighborhood resources) and Transit Score™ (a measure of transit access) is associated with having a usual source of care among low-income adults, newly enrolled in Medicaid. We received responses from 312 out of 1000 new Medicaid enrollees in Philadelphia, a large, densely populated urban area, who were surveyed between 2015 and 2016 to determine if they had identified a usual source of outpatient primary care. Respondents living at an address with a low Walk Scores (< 70) had 84% lower odds of having a usual source of care (OR 0.16, 95% CI 0.04-0.61). Transit scores were not associated with having a usual source of care. Walk Score may be a tool for policy makers and providers of care to identify populations at risk for worse primary care access.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

PubMed

Humphreys, Ioan; Drummond, Avril E R; Phillips, Ceri; Lincoln, Nadina B

2013-11-01

To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. Community. People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Orofacial manual therapy improves cervical movement impairment associated with headache and features of temporomandibular dysfunction: a randomized controlled trial.

PubMed

von Piekartz, Harry; Hall, Toby

2013-08-01

There is evidence that temporomandibular disorder (TMD) may be a contributing factor to cervicogenic headache (CGH), in part because of the influence of dysfunction of the temporomandibular joint on the cervical spine. The purpose of this randomized controlled trial was to determine whether orofacial treatment in addition to cervical manual therapy, was more effective than cervical manual therapy alone on measures of cervical movement impairment in patients with features of CGH and signs of TMD. In this study, 43 patients (27 women) with headache for more than 3-months and with some features of CGH and signs of TMD were randomly assigned to receive either cervical manual therapy (usual care) or orofacial manual therapy to address TMD in addition to usual care. Subjects were assessed at baseline, after 6 treatment sessions (3-months), and at 6-months follow-up. 38 subjects (25 female) completed all analysis at 6-months follow-up. The outcome criteria were: cervical range of movement (including the C1-2 flexion-rotation test) and manual examination of the upper 3 cervical vertebra. The group that received orofacial treatment in addition to usual care showed significant reduction in all aspects of cervical impairment after the treatment period. These improvements persisted to the 6-month follow-up, but were not observed in the usual care group at any point. These observations together with previous reports indicate that manual therapists should look for features of TMD when examining patients with headache, particularly if treatment fails when directed to the cervical spine. Copyright © 2013. Published by Elsevier Ltd.

The Fear Reduction Exercised Early (FREE) approach to low back pain: study protocol for a randomised controlled trial.

PubMed

Darlow, Ben; Stanley, James; Dean, Sarah; Abbott, J Haxby; Garrett, Sue; Mathieson, Fiona; Dowell, Anthony

2017-10-17

Low back pain (LBP) is a major health issue associated with considerable health loss and societal costs. General practitioners (GPs) play an important role in the management of LBP; however, GP care has not been shown to be the most cost-effective approach unless exercise and behavioural counselling are added to usual care. The Fear Reduction Exercised Early (FREE) approach to LBP has been developed to assist GPs to manage LBP by empowering exploration and management of psychosocial barriers to recovery and provision of evidence-based care and information. The aim of the Low Back Pain in General Practice (LBPinGP) trial is to explore whether patients with LBP who receive care from GPs trained in the FREE approach have better outcomes than those who receive usual care. This is a cluster randomised controlled superiority trial comparing the FREE approach with usual care for LBP management with investigator-blinded assessment of outcomes. GPs will be recruited and then cluster randomised (in practice groups) to the intervention or control arm. Intervention arm GPs will receive training in the FREE approach, and control arm GPs will continue to practice as usual. Patients presenting to their GP with a primary complaint of LBP will be allocated on the basis of allocation of the GP they consult. We aim to recruit 60 GPs and 275 patients (assuming patients are recruited from 75% of GPs and an average of 5 patients per GP complete the study, accounting for 20% patient participant dropout). Patient participants and the trial statistician will be blind to group allocation throughout the study. Analyses will be undertaken on an intention-to-treat basis. The primary outcome will be back-related functional impairment 6 months post-initial LBP consultation (interim data at 2 weeks, 6 weeks and 3 months), measured with the Roland-Morris Disability Questionnaire. Secondary patient outcomes include pain, satisfaction, quality of life, days off from work and costs of care. Secondary GP outcomes include beliefs about pain and impairment, GP confidence, and actual and reported clinical behaviour. Health economic and process evaluations will be conducted. In the LBPinGP trial, we will investigate providing an intervention during the first interaction a person with back pain has with their GP. Because the FREE approach is used within a normal GP consultation, if effective, it may be a cost-effective means of improving LBP care. Australian New Zealand Clinical Trials Registry, ACTRN12616000888460 . Registered on 6 July 2016.

Systematic review of integrated models of health care delivered at the primary-secondary interface: how effective is it and what determines effectiveness?

PubMed

Mitchell, Geoffrey K; Burridge, Letitia; Zhang, Jianzhen; Donald, Maria; Scott, Ian A; Dart, Jared; Jackson, Claire L

2015-01-01

Integrated multidisciplinary care is difficult to achieve between specialist clinical services and primary care practitioners, but should improve outcomes for patients with chronic and/or complex chronic physical diseases. This systematic review identifies outcomes of different models that integrate specialist and primary care practitioners, and characteristics of models that delivered favourable clinical outcomes. For quality appraisal, the Cochrane Risk of Bias tool was used. Data are presented as a narrative synthesis due to marked heterogeneity in study outcomes. Ten studies were included. Publication bias cannot be ruled out. Despite few improvements in clinical outcomes, significant improvements were reported in process outcomes regarding disease control and service delivery. No study reported negative effects compared with usual care. Economic outcomes showed modest increases in costs of integrated primary-secondary care. Six elements were identified that were common to these models of integrated primary-secondary care: (1) interdisciplinary teamwork; (2) communication/information exchange; (3) shared care guidelines or pathways; (4) training and education; (5) access and acceptability for patients; and (6) a viable funding model. Compared with usual care, integrated primary-secondary care can improve elements of disease control and service delivery at a modestly increased cost, although the impact on clinical outcomes is limited. Future trials of integrated care should incorporate design elements likely to maximise effectiveness.

The relationship of residential instability to medical care utilization among poor mothers in New York City.

PubMed

Duchon, L M; Weitzman, B C; Shinn, M

1999-12-01

This study examines the relationship between residential instability, including mobility and previous homelessness, and the use of medical care among previously sheltered and never-sheltered mothers in New York City. The study represents one of the first efforts to follow up on families after they are no longer homeless. Mothers from 543 welfare families in New York City were interviewed, once in 1988 (Time 1) and again beginning in 1992 (Time 2). The sample included 251 families who first entered shelters after their 1988 interview, and 292 families who spent no time in shelters before or after that point. Mothers were asked about the source and volume of medical care used in the year before follow-up. Bivariate and multivariate analyses showed that previously sheltered mothers had a greater reliance on emergency departments (EDs) and weaker ties to private physicians or health maintenance organizations (HMOs) than did mothers who never used shelters. Mobility before the Time 1 interview was associated with greater reliance on EDs and absence of a usual source of care. More recent mobility was not associated with a usual source of care. Current residential stability reduced the likelihood of using an emergency department or having no regular source of care. None of the measures of residential instability were related to the volume of outpatient care used by mothers. A history of residential instability, particularly previous shelter use, strongly predicts where poor mothers currently seek health care. Further research is needed to determine whether these patterns of health care use existed before mothers entered shelters. The study provides evidence that upon leaving shelters, mothers are not being well integrated into primary care services.

The CIPRUS study, a nurse-led psychological treatment for patients with undifferentiated somatoform disorder in primary care: study protocol for a randomised controlled trial.

PubMed

Sitnikova, Kate; Leone, Stephanie S; Zonneveld, Lyonne N L; van Marwijk, Harm W J; Bosmans, Judith E; van der Wouden, Johannes C; van der Horst, Henriëtte E

2017-05-03

Up to a third of patients presenting medically unexplained physical symptoms in primary care may have a somatoform disorder, of which undifferentiated somatoform disorder (USD) is the most common type. Psychological interventions can reduce symptoms associated with USD and improve functioning. Previous research has either been conducted in secondary care or interventions have been provided by general practitioners (GPs) or psychologists in primary care. As efficiency and cost-effectiveness are imperative in primary care, it is important to investigate whether nurse-led interventions are effective as well. The aim of this study is to examine the effectiveness and cost-effectiveness of a short cognitive behavioural therapy (CBT)-based treatment for patients with USD provided by mental health nurse practitioners (MHNPs), compared to usual care. In a cluster randomised controlled trial, 212 adult patients with USD will be assigned to the intervention or care as usual. The intervention group will be offered a short, individual CBT-based treatment by the MHNP in addition to usual GP care. The main goal of the intervention is that patients become less impaired by their physical symptoms and cope with symptoms in a more effective way. In six sessions patients will receive problem-solving treatment. The primary outcome is improvement in physical functioning, measured by the physical component summary score of the RAND-36. Secondary outcomes include health-related quality of life measured by the separate subscales of the RAND-36, somatization (PHQ-15) and symptoms of depression and anxiety (HADS). Problem-solving skills, health anxiety, illness perceptions, coping, mastery and working alliance will be assessed as potential mediators. Assessments will be done at 0, 2, 4, 8 and 12 months. An economic evaluation will be conducted from a societal perspective with quality of life as the primary outcome measure assessed by the EQ-5D-5L. Health care, patient and lost productivity costs will be assessed with the Tic-P. We expect that the intervention will improve physical functioning and is cost-effective compared to usual care. If so, more patients might successfully be treated in general practice, decreasing the number of referrals to specialist care. Dutch Trial Registry, identifier: NTR4686 , Registered on 14 July 2014.

The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

PubMed

van de Ven, Geertje; Draskovic, Irena; van Herpen, Elke; Koopmans, Raymond T C M; Donders, Rogier; Zuidema, Sytse U; Adang, Eddy M M; Vernooij-Dassen, Myrra J F J

2014-01-01

Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02). DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they adopt the DCM method. Dutch Trials Registry NTR2314.

Effectiveness and Cost of a Personalized Reminder Intervention to Improve Adherence to Glaucoma Care.

PubMed

Pizzi, Laura T; Tran, Judie; Shafa, Anousheh; Waisbourd, Michael; Hark, Lisa; Murchison, Ann P; Dai, Yang; Mayro, Eileen L; Haller, Julia A

2016-04-01

Glaucoma is the leadi ng cause of irreversible blindness in the USA. Glaucomatous vision loss is preventable with proper eye care, including appointment adherence. Therefore, interventions that improve appointment adherence can reduce the number of patients with more severe glaucoma. The primary study aim was to determine the efficacy and cost-effectiveness of a multifaceted personal reminder intervention, which included a customized letter and personal telephone outreach, in improving appointment adherence of patients with glaucoma. A secondary study aim was to identify patient characteristics that were associated with non-adherence. This prospective, randomized, controlled study included a cost-effectiveness analysis completed using a decision analytic model. The subjects included 256 patients with glaucoma. Study measures included appointment adherence and incremental cost effectiveness ratios. Patients in the intervention group were more likely to adhere to appointments (82.31 vs. 69.05 %; RR 1.23; 95 % CI 1.04-1.37, p < 0.012) than patients in the usual care group. Patients in the intervention group were 23 % more likely to adhere to appointments (RR 1.23; 95 % CI 1.08-1.41, p < 0.0021) than patients in the usual care group, when adjusting for age, secondary insurance, primary open angle glaucoma diagnosis, number of previous visits at Wills Eye Hospital, and follow-up recommendation using Poisson regression. Per-patient cost of the program was US$11.32, and cost per follow-up attended within the adherence window was US$73.56. A low cost reminder intervention consisting of a personalized letter and telephone outreach significantly improved appointment adherence of patients with glaucoma.

Telemonitoring and/or self-monitoring of blood pressure in hypertension (TASMINH4): protocol for a randomised controlled trial.

PubMed

Franssen, Marloes; Farmer, Andrew; Grant, Sabrina; Greenfield, Sheila; Heneghan, Carl; Hobbs, Richard; Hodgkinson, James; Jowett, Susan; Mant, Jonathan; Martin, Una; Milner, Siobhan; Monahan, Mark; Ogburn, Emma; Perera-Salazar, Rafael; Schwartz, Claire; Yu, Ly-Mee; McManus, Richard J

2017-02-13

Self-monitoring of hypertension is associated with lower systolic blood pressure (SBP). However, evidence for the use of self-monitoring to titrate antihypertensive medication by physicians is equivocal. Furthermore, there is some evidence for the efficacy of telemonitoring in the management of hypertension but it is not clear what this adds over and above self-monitoring. This trial aims to evaluate whether GP led antihypertensive titration using self-monitoring results in lower SBP compared to usual care and whether telemonitoring adds anything to self-monitoring alone. This will be a pragmatic primary care based, unblinded, randomised controlled trial of self-monitoring of BP with or without telemonitoring compared to usual care. Eligible patients will have poorly controlled hypertension (>140/90 mmHg) and will be recruited from primary care. Participants will be individually randomised to either usual care, self-monitoring alone, or self-monitoring with telemonitoring. The primary outcome of the trial will be difference in clinic SBP between intervention and control groups at 12 months adjusted for baseline SBP, gender, BP target and practice. At least 1110 patients will be sufficient to detect a difference in SBP between self-monitoring with or without telemonitoring and usual care of 5 mmHg with 90% power with an adjusted alpha of 0.017 (2-sided) to adjust for all three pairwise comparisons. Other outcomes will include adherence of anti-hypertensive medication, lifestyle behaviours, health-related quality of life, and adverse events. An economic analysis will consider both within trial costs and a model extrapolating the results thereafter. A qualitative sub study will gain insights into the views, experiences and decision making processes of patients and health care professionals focusing on the acceptability of self-monitoring and telemonitoring in the routine management of hypertension. The results of the trial will be directly applicable to primary care in the UK. If successful, self-monitoring of BP in people with hypertension would be applicable to hundreds of thousands of individuals in the UK. ISRCTN 83571366 . Registered 17 July 2014.

Cost-effectiveness analysis of acupuncture, counselling and usual care in treating patients with depression: the results of the ACUDep trial.

PubMed

Spackman, Eldon; Richmond, Stewart; Sculpher, Mark; Bland, Martin; Brealey, Stephen; Gabe, Rhian; Hopton, Ann; Keding, Ada; Lansdown, Harriet; Perren, Sara; Torgerson, David; Watt, Ian; MacPherson, Hugh

2014-01-01

New evidence on the clinical effectiveness of acupuncture plus usual care (acupuncture) and counselling plus usual care (counselling) for patients with depression suggests the need to investigate the health-related quality of life and costs of these treatments to understand whether they should be considered a good use of limited health resources. The cost-effectiveness analyses are based on the Acupuncture, Counselling or Usual care for Depression (ACUDep) trial results. Statistical analyses demonstrate a difference in mean quality adjusted life years (QALYs) and suggest differences in mean costs which are mainly due to the price of the interventions. Probabilistic sensitivity analysis is used to express decision uncertainty. Acupuncture and counselling are found to have higher mean QALYs and costs than usual care. In the base case analysis acupuncture has an incremental cost-effectiveness ratio (ICER) of £4,560 per additional QALY and is cost-effective with a probability of 0.62 at a cost-effectiveness threshold of £20,000 per QALY. Counselling compared with acupuncture is more effective and more costly with an ICER of £71,757 and a probability of being cost-effective of 0.36. A scenario analysis of counselling versus usual care, excluding acupuncture as a comparator, results in an ICER of £7,935 and a probability of 0.91. Acupuncture is cost-effective compared with counselling or usual care alone, although the ranking of counselling and acupuncture depends on the relative cost of delivering these interventions. For patients in whom acupuncture is unavailable or perhaps inappropriate, counselling has an ICER less than most cost-effectiveness thresholds. However, further research is needed to determine the most cost-effective treatment pathways for depressed patients when the full range of available interventions is considered.

Dancing for Parkinson Disease: A Randomized Trial of Irish Set Dancing Compared With Usual Care.

PubMed

Shanahan, Joanne; Morris, Meg E; Bhriain, Orfhlaith Ni; Volpe, Daniele; Lynch, Tim; Clifford, Amanda M

2017-09-01

To examine the feasibility of a randomized controlled study design and to explore the benefits of a set dancing intervention compared with usual care. Randomized controlled design, with participants randomized to Irish set dance classes or a usual care group. Community based. Individuals with idiopathic Parkinson disease (PD) (N=90). The dance group attended a 1.5-hour dancing class each week for 10 weeks and undertook a home dance program for 20 minutes, 3 times per week. The usual care group continued with their usual care and daily activities. The primary outcome was feasibility, determined by recruitment rates, success of randomization and allocation procedures, attrition, adherence, safety, willingness of participants to be randomized, resource availability, and cost. Secondary outcomes were motor function (motor section of the Unified Parkinson's Disease Rating Scale), quality of life (Parkinson's Disease Questionnaire-39), functional endurance (6-min walk test), and balance (mini-BESTest). Ninety participants were randomized (45 per group). There were no adverse effects or resource constraints. Although adherence to the dancing program was 93.5%, there was >40% attrition in each group. Postintervention, the dance group had greater nonsignificant gains in quality of life than the usual care group. There was a meaningful deterioration in endurance in the usual care group. There were no meaningful changes in other outcomes. The exit questionnaire showed participants enjoyed the classes and would like to continue participation. For people with mild to moderately severe PD, set dancing is feasible and enjoyable and may improve quality of life. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Interventions to enhance return-to-work for cancer patients.

PubMed

de Boer, Angela G E M; Taskila, Tyna K; Tamminga, Sietske J; Feuerstein, Michael; Frings-Dresen, Monique H W; Verbeek, Jos H

2015-09-25

Cancer patients are 1.4 times more likely to be unemployed than healthy people. Therefore it is important to provide cancer patients with programmes to support the return-to-work (RTW) process. This is an update of a Cochrane review first published in 2011. To evaluate the effectiveness of interventions aimed at enhancing RTW in cancer patients compared to alternative programmes including usual care or no intervention. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, in the Cochrane Library Issue 3, 2014), MEDLINE (January 1966 to March 2014), EMBASE (January 1947 to March 2014), CINAHL (January 1983 to March, 2014), OSH-ROM and OSH Update (January 1960 to March, 2014), PsycINFO (January 1806 to 25 March 2014), DARE (January 1995 to March, 2014), ClinicalTrials.gov, Trialregister.nl and Controlled-trials.com up to 25 March 2014. We also examined the reference lists of included studies and selected reviews, and contacted authors of relevant studies. We included randomised controlled trials (RCTs) of the effectiveness of psycho-educational, vocational, physical, medical or multidisciplinary interventions enhancing RTW in cancer patients. The primary outcome was RTW measured as either RTW rate or sick leave duration measured at 12 months' follow-up. The secondary outcome was quality of life. Two review authors independently assessed trials for inclusion, assessed the risk of bias and extracted data. We pooled study results we judged to be clinically homogeneous in different comparisons reporting risk ratios (RRs) with 95% confidence intervals (CIs). We assessed the overall quality of the evidence for each comparison using the GRADE approach. Fifteen RCTs including 1835 cancer patients met the inclusion criteria and because of multiple arms studies we included 19 evaluations. We judged six studies to have a high risk of bias and nine to have a low risk of bias. All included studies were conducted in high income countries and most studies were aimed at breast cancer patients (seven trials) or prostate cancer patients (two trials).Two studies involved psycho-educational interventions including patient education and teaching self-care behaviours. Results indicated low quality evidence of similar RTW rates for psycho-educational interventions compared to care as usual (RR 1.09, 95% CI 0.88 to 1.35, n = 260 patients) and low quality evidence that there is no difference in the effect of psycho-educational interventions compared to care as usual on quality of life (standardised mean difference (SMD) 0.05, 95% CI -0.2 to 0.3, n = 260 patients). We did not find any studies on vocational interventions. In one study breast cancer patients were offered a physical training programme. Low quality evidence suggested that physical training was not more effective than care as usual in improving RTW (RR 1.20, 95% CI 0.32 to 4.54, n = 28 patients) or quality of life (SMD -0.37, 95% CI -0.99 to 0.25, n = 41 patients).Seven RCTs assessed the effects of a medical intervention on RTW. In all studies a less radical or functioning conserving medical intervention was compared with a more radical treatment. We found low quality evidence that less radical, functioning conserving approaches had similar RTW rates as more radical treatments (RR 1.04, 95% CI 0.96 to 1.09, n = 1097 patients) and moderate quality evidence of no differences in quality of life outcomes (SMD 0.10, 95% CI -0.04 to 0.23, n = 1028 patients).Five RCTs involved multidisciplinary interventions in which vocational counselling was combined with patient education, patient counselling, and biofeedback-assisted behavioral training or physical exercises. Moderate quality evidence showed that multidisciplinary interventions involving physical, psycho-educational and vocational components led to higher RTW rates than care as usual (RR 1.11, 95% CI 1.03 to 1.16, n = 450 patients). We found no differences in the effect of multidisciplinary interventions compared to care as usual on quality of life outcomes (SMD 0.03, 95% CI -0.20 to 0.25, n = 316 patients). We found moderate quality evidence that multidisciplinary interventions enhance the RTW of patients with cancer.

Economic Evaluation of Community-Based Case Management of Patients Suffering From Chronic Obstructive Pulmonary Disease.

PubMed

Sørensen, Sabrina Storgaard; Pedersen, Kjeld Møller; Weinreich, Ulla Møller; Ehlers, Lars

2017-06-01

To analyse the cost effectiveness of community-based case management for patients suffering from chronic obstructive pulmonary disease (COPD). The study took place in the third largest municipality in Denmark and was conducted as a randomised controlled trial with 12 months of follow-up. A total of 150 patients with COPD were randomised into two groups receiving usual care and case management in addition to usual care. Case management included among other things self care proficiency, medicine compliance, and care coordination. Outcome measure for the analysis was the incremental cost-effectiveness ratio (ICER) as cost per quality-adjusted life year (QALY) from the perspective of the healthcare sector. Costs were valued in British Pounds (£) at price level 2016. Scenario analyses and probabilistic sensitivity analyses were conducted in order to assess uncertainty of the ICER estimate. The intervention resulted in a QALY improvement of 0.0146 (95% CI -0.0216; 0.0585), and a cost increase of £494 (95% CI -1778; 2766) per patient. No statistically significant difference was observed either in costs or effects. The ICER was £33,865 per QALY gained. Scenario analyses confirmed the robustness of the result and revealed slightly lower ICERs of £28,100-£31,340 per QALY. Analysis revealed that case management led to a positive incremental QALY, but were more costly than usual care. The highly uncertain ICER somewhat exceeds for instance the threshold value used by the National Institute of Health and Care Excellence (NICE). No formally established Danish threshold value exists. ClinicalTrials.gov Identifier: NCT01512836.

Evaluation of a "Just-in-Time" Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial.

PubMed

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p < 0.01), osteoporosis knowledge (p = 0.04), activation (p < 0.01), dietary self-efficacy (p = 0.06), and osteoporosis care satisfaction (p < 0.01). Compared with PAADRN intervention participants (n = 39), nurse consultation participants had improved dietary self-efficacy (p = 0.07) and osteoporosis care satisfaction (p = 0.05). No significant improvements in osteoporosis-related outcomes were achieved vs PAADRN controls (n = 70). "Just-in-time" nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care.

Psychoeducation as a Mediator of Treatment Approach on Parent Engagement in Child Psychotherapy for Disruptive Behavior.

PubMed

Martinez, Jonathan I; Lau, Anna S; Chorpita, Bruce F; Weisz, John R

2017-01-01

Parent engagement in treatment for child disruptive behavior has been associated with improved child outcomes in care. However, many families who enter care do not receive an adequate dose of treatment, and parents are often not involved. We examined therapists' use of psychoeducation, a therapeutic practice used to present factual information about target problems and treatments, and its association with parent engagement in child psychotherapy. Participants were drawn from the Child System and Treatment Enhancement Projects' multisite trial contrasting standard evidence-based treatments, modular treatment, or usual care. We included an ethnically diverse sample of 46 youth (ages 7-13) who received treatment for disruptive behavior in modular treatment or usual care. A reliable observational coding system was developed to assess therapists' in-session use of psychoeducation strategies (e.g., discussing causes of misbehavior, describing and providing rationale for treatment, etc.), as well as other engagement strategies (e.g., collaborative goal setting, managing expectations, etc.), in the early phase of treatment. Findings revealed that modular treatment therapists provided more psychoeducation and other engagement strategies compared with usual care therapists. Furthermore, psychoeducation strategies employed by therapists early on uniquely predicted subsequent parent involvement in treatment, over and above the use of other engagement strategies. Finally, therapists' use of the psychoeducation strategy of discussing causes of child's misbehavior mediated the effect of treatment condition on parent involvement in their child's therapy. These findings suggest that the implementation of psychoeducation strategies upon entry into care promotes parent involvement in child psychotherapy for disruptive behavior.

Clinical Effectiveness Research in Managed-care Systems: Lessons from the Pediatric Asthma Care PORT

PubMed Central

Finkelstein, Jonathan A; Lozano, Paula; Streiff, Kachen A; Arduino, Kelly E; Sisk, Cynthia A; Wagner, Edward H; Weiss, Kevin B; Inui, Thomas S

2002-01-01

Objective To highlight the unique challenges of evaluative research on practice behavior change in the “real world” settings of contemporary managed-care organizations, using the experience of the Pediatric Asthma Care PORT (Patient Outcomes Research Team). Study Setting The Pediatric Asthma Care PORT is a five-year initiative funded by the Agency for Healthcare Research and Quality to study strategies for asthma care improvement in three managed-care plans in Chicago, Seattle, and Boston. At its core is a randomized trial of two care improvement strategies compared with usual care: (1) a targeted physician education program using practice based Peer Leaders (PL) as change agents, (2) adding to the PL intervention a “Planned Asthma Care Intervention” incorporating joint “asthma check-ups” by nurse-physician teams. During the trial, each of the participating organizations viewed asthma care improvement as an immediate priority and had their own corporate improvement programs underway. Data Collection Investigators at each health plan described the organizational and implementation challenges in conducting the PAC PORT randomized trial. These experiences were reviewed for common themes and “lessons” that might be useful to investigators planning interventional research in similar care-delivery settings. Conclusions Randomized trials in “real world” settings represent the most robust design available to test care improvement strategies. In complex, rapidly changing managed-care organizations, blinding is not feasible, corporate initiatives may complicate implementation, and the assumption that a “usual care” arm will be static is highly likely to be mistaken. Investigators must be prepared to use innovative strategies to maintain the integrity of the study design, including: continuous improvement within the intervention arms, comanagement by researchers and health plan managers of condition-related quality improvement initiatives, procedures for avoiding respondent burden in health plan enrollees, and anticipation and minimization of risks from experimental arm contamination and major organizational change. With attention to these delivery system issues, as well as the usual design features of randomized trials, we believe managed-care organizations can serve as important laboratories to test care improvement strategies. PMID:12132605

[Comparing case management care models for people with dementia and their caregivers: the design of the COMPAS study].

PubMed

van Hout, H P J; Macneil Vroomen, J L; Van Mierlo, L D; Meiland, F J M; Moll van Charante, E P; Joling, K J; van den Dungen, P; Dröes, R M; van der Horst, H E; de Rooij, S E J A

2014-04-01

Dementia care in The Netherlands is shifting from fragmented, ad hoc care to more coordinated and personalized care. Case management contributes to this shift. The linkage model and a combination of intensive case management and joint agency care models were selected based on their emerging prominence in The Netherlands. It is unclear if these different forms of case management are more effective than usual care in improving or preserving the functioning and well-being at the patient and caregiver level and at the societal cost. The objective of this article is to describe the design of a study comparing these two case management care models against usual care. Clinical and cost outcomes are investigated while care processes and the facilitators and barriers for implementation of these models are considered. Mixed methods include a prospective, observational, controlled, cohort study among persons with dementia and their primary informal caregiver in regions of The Netherlands with and without case management including a qualitative process evaluation. Community-dwelling individuals with a dementia diagnosis with an informal caregiver are included. The primary outcome measure is the Neuropsychiatric Inventory for the people with dementia and the General Health Questionnaire for their caregivers. Costs are measured from a societal perspective. Semi-structured interviews with stakeholders based on the theoretical model of adaptive implementation are planned. 521 pairs of persons with dementia and their primary informal caregiver were included and are followed over two years. In the linked model substantially more impeding factors for implementation were identified compared with the model. This article describes the design of an evaluation study of two case management models along with clinical and economic data from persons with dementia and caregivers. The impeding and facilitating factors differed substantially between the two models. Further results on cost-effectiveness are expected by the beginning of 2015. This is a Dutch adaptation of MacNeil Vroomen et al., Comparing Dutch case management care models for people with dementia and their caregivers: The design of the COMPAS study.

Integrated, multidisciplinary care for hand eczema: design of a randomized controlled trial and cost-effectiveness study

PubMed Central

2009-01-01

Background The individual and societal burden of hand eczema is high. Literature indicates that moderate to severe hand eczema is a disease with a poor prognosis. Many patients are hampered in their daily activities, including work. High costs are related to high medical consumption, productivity loss and sick leave. Usual care is suboptimal, due to a lack of optimal instruction and coordination of care, and communication with the general practitioner/occupational physician and people involved at the workplace. Therefore, an integrated, multidisciplinary intervention involving a dermatologist, a care manager, a specialized nurse and a clinical occupational physician was developed. This paper describes the design of a study to investigate the effectiveness and cost-effectiveness of integrated care for hand eczema by a multidisciplinary team, coordinated by a care manager, consisting of instruction on avoiding relevant contact factors, both in the occupational and in the private environment, optimal skin care and treatment, compared to usual, dermatologist-led care. Methods The study is a multicentre, randomized, controlled trial with an economic evaluation alongside. The study population consists of patients with chronic, moderate to severe hand eczema, who visit an outpatient clinic of one of the participating 5 (three university and two general) hospitals. Integrated, multidisciplinary care, coordinated by a care manager, including allergo-dermatological evaluation by a dermatologist, occupational intervention by a clinical occupational physician, and counselling by a specialized nurse on optimizing topical treatment and skin care will be compared with usual care by a dermatologist. The primary outcome measure is the cumulative difference in reduction of the clinical severity score HECSI between the groups. Secondary outcome measures are the patient's global assessment, specific quality of life with regard to the hands, generic quality of life, sick leave and patient satisfaction. An economic evaluation will be conducted alongside the RCT. Direct and indirect costs will be measured. Outcome measures will be assessed at baseline and after 4, 12, 26 and 52 weeks. All statistical analyses will be performed on the intention-to-treat principle. In addition, per protocol analyses will be carried out. Discussion To improve societal participation of patients with moderate to severe hand eczema, an integrated care intervention was developed involving both person-related and environmental factors. Such integrated care is expected to improve the patients' clinical signs, quality of life and to reduce sick leave and medical costs. Results will become available in 2011. PMID:19951404

A randomized trial of exercise therapy in patients with acute low back pain. Efficacy on sickness absence.

PubMed

Faas, A; van Eijk, J T; Chavannes, A W; Gubbels, J W

1995-04-15

A randomized, placebo-controlled trial in which patients received either usual care by a general practitioner (information and analgesics), or placebo physiotherapy given by a physiotherapist, or exercise therapy given by a physiotherapist. To assess the efficacy of exercise therapy on sickness absence from work in patients with acute low back pain. Exercise therapy during the nonchronic phase of back pain is considered to reduce sickness absence, but this opinion is controversial. Patients with acute nonspecific low back pain and a paid job were included for analysis. Sickness absence (number of days) was checked monthly during the 1-year follow-up period and compliance was also assessed. From 40 general practices 363 patients who were gainfully employed were included. In the exercise therapy group the percentage of patients with sickness absence was higher and the duration of absence was longer than in the placebo and usual care groups, but these differences were not significant. Indications of more absence in the exercise therapy group appeared to be based largely on a greater number of patients with absences during the first 3 months. Patients in the exercise group who had not reported sick at entry had more sickness absences during the follow-up year than patients in the usual care and placebo group. Good compliance did not affect the results. Exercise therapy for patients with acute low back pain does not reduce sickness absence.

The AViKA (Adding Value in Knee Arthroplasty) postoperative care navigation trial: rationale and design features.

PubMed

Losina, Elena; Collins, Jamie E; Daigle, Meghan E; Donnell-Fink, Laurel A; Prokopetz, Julian J Z; Strnad, Doris; Lerner, Vladislav; Rome, Benjamin N; Ghazinouri, Roya; Skoniecki, Debra J; Katz, Jeffrey N; Wright, John

2013-10-12

Utilization of total knee arthroplasty is increasing rapidly. A substantial number of total knee arthroplasty recipients have persistent pain after surgery. Our objective was to design a randomized controlled trial to establish the efficacy of a motivational-interviewing-based telephone intervention aimed at improving patient outcomes and satisfaction following total knee arthroplasty. The study was conducted at Brigham and Women's Hospital in Boston, Massachusetts. The study focused on individuals 40 years or older with a primary diagnosis of osteoarthritis who were scheduled for total knee arthroplasty. The study compared two management strategies over the first six months postoperatively: 1) enhanced postoperative care with frequent follow-up by a care navigator; 2) usual postoperative care. Those who were randomized into the enhanced postoperative care arm received ten calls from a trained non-clinician care navigator over the first six postoperative months. The navigator used motivational interviewing techniques to engage patients in discussions related to their rehabilitation goals, including patient's plans for and confidence in achieving those goals. Patients in the usual care arm received standard postoperative management and received no navigator phone calls. Patients in both arms were assessed at baseline, three months, and six months postoperatively. The primary outcome of the study was improvement in function as measured by the difference in Western Ontario and McMaster Universities Osteoarthritis Index function score between preoperative (baseline) status and six months postoperatively. Data were collected to identify factors that may be related to total knee arthroplasty outcomes, including preoperative pain, pain catastrophizing, self-efficacy, and depression. A formal economic analysis is also planned to determine the cost-effectiveness of the care navigator as a component of total knee arthroplasty care. ClinicalTrials.gov NCT01540851.

Collaborative depression care among Latino patients in diabetes disease management, Los Angeles, 2011-2013.

PubMed

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen; Wu, Shinyi

2014-08-28

The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes-Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system.

Collaborative Depression Care Among Latino Patients in Diabetes Disease Management, Los Angeles, 2011–2013

PubMed Central

Wu, Brian; Jin, Haomiao; Vidyanti, Irene; Lee, Pey-Jiuan; Ell, Kathleen

2014-01-01

Introduction The prevalence of comorbid diabetes and depression is high, especially in low-income Hispanic or Latino patients. The complex mix of factors in safety-net care systems impedes the adoption of evidence-based collaborative depression care and results in persistent disparities in depression outcomes. The Diabetes–Depression Care-Management Adoption Trial examined whether the collaborative depression care model is an effective approach in safety-net clinics to improve clinical care outcomes of depression and diabetes. Methods A sample of 964 patients with diabetes from 5 safety-net clinics were enrolled in a quasi-experimental study that included 2 arms: usual care, in which primary medical providers and staff translated and adopted evidence-based depression care; and supportive care, in which providers of a disease management program delivered protocol-driven depression care. Because the study design established individual treatment centers as separate arms, we calculated propensity scores that interpreted the probability of treatment assignment conditional on observed baseline characteristics. Primary outcomes were 5 depression care outcomes and 7 diabetes care measures. Regression models with propensity score covariate adjustment were applied to analyze 6-month outcomes. Results Compared with usual care, supportive care significantly decreased Patient Health Questionnaire-9 scores, reduced the number of patients with moderate or severe depression, improved depression remission, increased satisfaction in care for patients with emotional problems, and significantly reduced functional impairment. Conclusion Implementing collaborative depression care in a diabetes disease management program is a scalable approach to improve depression outcomes and patient care satisfaction among patients with diabetes in a safety-net care system. PMID:25167093

The philanthropic string: medical aspects of military strategy.

PubMed

Dressler, D P; Hozid, J L

2001-04-01

Since antiquity, medical care has played an important role in both military strategy and conflict resolution. Although this is usually a negative and an unintended event, medical care can be a positive and a rational alternative to present-day weapons of mass destruction. Yet, military and civilian planners have not traditionally accepted, recognized, and used a "philanthropic string." Nevertheless, medical care can be an important factor in resolving international conflict, either in support of military operations or as a separate function. Therefore, it is timely, and pragmatic, to include humanitarian medical care in strategic military planning.

Cognitive behavioural therapy (CBT) for adults and adolescents with asthma.

PubMed

Kew, Kayleigh M; Nashed, Marina; Dulay, Valdeep; Yorke, Janelle

2016-09-21

People with asthma have a higher prevalence of anxiety and depression than the general population. This is associated with poorer asthma control, medication adherence, and health outcomes. Cognitive behavioural therapy (CBT) may be a way to improve the quality of life of people with asthma by addressing associated psychological issues, which may lead to a lower risk of exacerbations and better asthma control. To assess the efficacy of CBT for asthma compared with usual care. We searched the Cochrane Airways Group Specialised Register, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP). We also searched reference lists of all primary studies and review articles and contacted authors for unpublished data. The most recent searches were conducted in August 2016. We included parallel randomised controlled trials (RCTs) comparing any cognitive behavioural intervention to usual care or no intervention. We included studies of adults or adolescents with asthma, with or without comorbid anxiety or depression. We included studies reported as full text, those published as abstract only, and unpublished data. Two or more review authors independently screened the search results, extracted data, and assessed included studies for risk of bias. We analysed dichotomous data as odds ratios (ORs) and continuous data as mean differences (MDs) or standardised mean differences (SMD) where scales varied across studies, all using a random-effects model. The primary outcomes were asthma-related quality of life and exacerbations requiring at least a course of oral steroids. We rated all outcomes using GRADE and presented our confidence in the results in a 'Summary of findings' table. We included nine RCTs involving 407 adults with asthma in this review; no studies included adolescents under 18. Study size ranged from 10 to 94 (median 40), and mean age ranged from 39 to 53. Study populations generally had persistent asthma, but severity and diagnostic measures varied. Three studies recruited participants with psychological symptomatology, although with different criteria. Interventions ranged from 4 to 15 sessions, and primary measurements were taken at a mean of 3 months (range 1.2 to 12 months).Participants given CBT had improved scores on the Asthma Quality of Life Questionnaire (AQLQ) (MD 0.55, 95% confidence interval (CI) 0.17 to 0.93; participants = 214; studies = 6; I 2 = 53%) and on measures of asthma control (SMD -0.98, 95% CI -1.76 to -0.20; participants = 95; studies = 3; I 2 = 68%) compared to people getting usual care. The AQLQ effect appeared to be sustained up to a year after treatment, but due to its low quality this evidence must be interpreted with caution. As asthma exacerbations requiring at least a course of oral steroids were not consistently reported, we could not perform a meta-analysis.Anxiety scores were difficult to pool but showed a benefit of CBT compared with usual care (SMD -0.38, 95% CI -0.73 to -0.03), although this depended on the analysis used. The confidence intervals for the effect on depression scales included no difference between CBT and usual care when measured as change from baseline (SMD -0.33, 95% CI -0.70 to 0.05) or endpoint scores (SMD -0.41, 95% CI -0.87 to 0.05); the same was true for medication adherence (MD -1.40, 95% CI -2.94 to 0.14; participants = 23; studies = 1; I 2 = 0%).Subgroup analyses conducted on the AQLQ outcome did not suggest a clear difference between individual and group CBT, baseline psychological status, or CBT model. The small number of studies and the variation between their designs, populations, and other intervention characteristics limited the conclusions that could be drawn about these possibly moderating factors.The inability to blind participants and investigators to group allocation introduced significant potential bias, and overall we had low confidence in the evidence. For adults with persistent asthma, CBT may improve quality of life, asthma control, and anxiety levels compared with usual care. Risks of bias, imprecision of effects, and inconsistency between results reduced our confidence in the results to low, and evidence was lacking regarding the effect of CBT on asthma exacerbations, unscheduled contacts, depression, and medication adherence. There was much variation between studies in how CBT was delivered and what constituted usual care, meaning the most optimal method of CBT delivery, format, and target population requires further investigation. There is currently no evidence for the use of CBT in adolescents with asthma.

Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults.

PubMed

Gibson, William; Wand, Benedict M; O'Connell, Neil E

2017-09-14

Neuropathic pain, which is due to nerve disease or damage, represents a significant burden on people and society. It can be particularly unpleasant and achieving adequate symptom control can be difficult. Non-pharmacological methods of treatment are often employed by people with neuropathic pain and may include transcutaneous electrical nerve stimulation (TENS). This review supersedes one Cochrane Review 'Transcutaneous electrical nerve stimulation (TENS) for chronic pain' (Nnoaham 2014) and one withdrawn protocol 'Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults' (Claydon 2014). This review replaces the original protocol for neuropathic pain that was withdrawn. To determine the analgesic effectiveness of TENS versus placebo (sham) TENS, TENS versus usual care, TENS versus no treatment and TENS in addition to usual care versus usual care alone in the management of neuropathic pain in adults. We searched CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, Web of Science, PEDro, LILACS (up to September 2016) and various clinical trials registries. We also searched bibliographies of included studies for further relevant studies. We included randomised controlled trials where TENS was evaluated in the treatment of central or peripheral neuropathic pain. We included studies if they investigated the following: TENS versus placebo (sham) TENS, TENS versus usual care, TENS versus no treatment and TENS in addition to usual care versus usual care alone in the management of neuropathic pain in adults. Two review authors independently screened all database search results and identified papers requiring full-text assessment. Subsequently, two review authors independently applied inclusion/exclusion criteria to these studies. The same review authors then independently extracted data, assessed for risk of bias using the Cochrane standard tool and rated the quality of evidence using GRADE. We included 15 studies with 724 participants. We found a range of treatment protocols in terms of duration of care, TENS application times and intensity of application. Briefly, duration of care ranged from four days through to three months. Similarly, we found variation of TENS application times; from 15 minutes up to hourly sessions applied four times daily. We typically found intensity of TENS set to comfortable perceptible tingling with very few studies titrating the dose to maintain this perception. Of the comparisons, we had planned to explore, we were only able to undertake a quantitative synthesis for TENS versus sham TENS. Insufficient data and large diversity in the control conditions prevented us from undertaking a quantitative synthesis for the remaining comparisons.For TENS compared to sham TENS, five studies were suitable for pooled analysis. We described the remainder of the studies in narrative form. Overall, we judged 11 studies at high risk of bias, and four at unclear risk. Due to the small number of eligible studies, the high levels of risk of bias across the studies and small sample sizes, we rated the quality of the evidence as very low for the pooled analysis and very low individual GRADE rating of outcomes from single studies. For the individual studies discussed in narrative form, the methodological limitations, quality of reporting and heterogeneous nature of interventions compared did not allow for reliable overall estimates of the effect of TENS.Five studies (across various neuropathic conditions) were suitable for pooled analysis of TENS versus sham TENS investigating change in pain intensity using a visual analogue scale. We found a mean postintervention difference in effect size favouring TENS of -1.58 (95% confidence interval (CI) -2.08 to -1.09, P < 0.00001, n = 207, six comparisons from five studies) (very low quality evidence). There was no significant heterogeneity in this analysis. While this exceeded our prespecified minimally important difference for pain outcomes, we assessed the quality of evidence as very low meaning we have very little confidence in this effect estimate and the true effect is likely to be substantially different from that reported in this review. Only one study of these five investigated health related quality of life as an outcome meaning we were unable to report on this outcome in this comparison. Similarly, we were unable to report on global impression of change or changes in analgesic use in this pooled analysis.Ten small studies compared TENS to some form of usual care. However, there was great diversity in what constituted usual care, precluding pooling of data. Most of these studies found either no difference in pain outcomes between TENS versus other active treatments or favoured the comparator intervention (very low quality evidence). We were unable to report on other primary and secondary outcomes in these single trials (health-related quality of life, global impression of change and changes in analgesic use).Of the 15 included studies, three reported adverse events which were minor and limited to 'skin irritation' at or around the site of electrode placement (very low quality evidence). Three studies reported no adverse events while the remainder did not report any detail with regard adverse events. In this review, we reported on the comparison between TENS and sham TENS. The quality of the evidence was very low meaning we were unable to confidently state whether TENS is effective for pain control in people with neuropathic pain. The very low quality of evidence means we have very limited confidence in the effect estimate reported; the true effect is likely to be substantially different. We make recommendations with respect to future TENS study designs which may meaningfully reduce the uncertainty relating to the effectiveness of this treatment modality.

The cost-effectiveness of a family meetings intervention to prevent depression and anxiety in family caregivers of patients with dementia: a randomized trial.

PubMed

Joling, Karlijn J; Bosmans, Judith E; van Marwijk, Harm W J; van der Horst, Henriëtte E; Scheltens, Philip; MacNeil Vroomen, Janet L; van Hout, Hein P J

2013-09-22

Dementia imposes a heavy burden on health and social care systems as well as on family caregivers who provide a substantial portion of the care. Interventions that effectively support caregivers may prevent or delay patient institutionalization and hence be cost-effective. However, evidence about the cost-effectiveness of such interventions is scarce. The aim of this study was to evaluate the cost-effectiveness of a family meetings intervention for family caregivers of dementia patients in comparison with usual care over a period of 12 months. The economic evaluation was conducted from a societal perspective alongside a randomized trial of 192 primary caregivers with community-dwelling dementia patients. Outcome measures included the Quality Adjusted Life-Years (QALY) of caregivers and patients and the incidence of depression and anxiety disorders in caregivers. Missing cost and effect data were imputed using multiple imputations. Bootstrapping was used to estimate uncertainty around the cost-differences and the incremental cost-effectiveness ratio (ICER). The bootstrapped cost-effect pairs were plotted on a cost-effectiveness plane and used to estimate cost-effectiveness curves. No significant differences in costs and effects between the groups were found. At 12 months, total costs per patient and primary caregiver dyad were substantial: €77,832 for the intervention group and €75,201 for the usual care group (adjusted mean difference per dyad €4,149, 95% CI -13,371 to 21,956, ICER 157,534). The main cost driver was informal care (66% of total costs), followed by patients' day treatment and costs of hospital and long-term care facility admissions (23%). Based on the cost-effectiveness acceptability curves, the maximum probability that the intervention was considered cost-effective in comparison with usual care reached 0.4 for the outcome QALY per patient-caregiver dyad and 0.6 for the caregivers' incidence of depression and/or anxiety disorders regardless of the willingness to pay. The annual costs of caring for a person with dementia were substantial with informal care being by far the largest contributor to the total societal costs. Based on this study, family meetings cannot be considered a cost-effective intervention strategy in comparison with usual care. ISRCTN register, ISRCTN90163486.

Randomised controlled feasibility trial of a web-based weight management intervention with nurse support for obese patients in primary care

PubMed Central

2014-01-01

Background There is a need for cost-effective weight management interventions that primary care can deliver to reduce the morbidity caused by obesity. Automated web-based interventions might provide a solution, but evidence suggests that they may be ineffective without additional human support. The main aim of this study was to carry out a feasibility trial of a web-based weight management intervention in primary care, comparing different levels of nurse support, to determine the optimal combination of web-based and personal support to be tested in a full trial. Methods This was an individually randomised four arm parallel non-blinded trial, recruiting obese patients in primary care. Following online registration, patients were randomly allocated by the automated intervention to either usual care, the web-based intervention only, or the web-based intervention with either basic nurse support (3 sessions in 3 months) or regular nurse support (7 sessions in 6 months). The main outcome measure (intended as the primary outcome for the main trial) was weight loss in kg at 12 months. As this was a feasibility trial no statistical analyses were carried out, but we present means, confidence intervals and effect sizes for weight loss in each group, uptake and retention, and completion of intervention components and outcome measures. Results All randomised patients were included in the weight loss analyses (using Last Observation Carried Forward). At 12 months mean weight loss was: usual care group (n = 43) 2.44 kg; web-based only group (n = 45) 2.30 kg; basic nurse support group (n = 44) 4.31 kg; regular nurse support group (n = 47) 2.50 kg. Intervention effect sizes compared with usual care were: d = 0.01 web-based; d = 0.34 basic nurse support; d = 0.02 regular nurse support. Two practices deviated from protocol by providing considerable weight management support to their usual care patients. Conclusions This study demonstrated the feasibility of delivering a web-based weight management intervention supported by practice nurses in primary care, and suggests that the combination of the web-based intervention with basic nurse support could provide an effective solution to weight management support in a primary care context. Trial registration Current Controlled Trials ISRCTN31685626. PMID:24886516

Feasibility of an ED-to-Home Intervention to Engage Patients: A Mixed-Methods Investigation

PubMed Central

Schumacher, Jessica R.; Lutz, Barbara J.; Hall, Allyson G.; Pines, Jesse M.; Jones, Andrea L.; Hendry, Phyllis; Kalynych, Colleen; Carden, Donna L.

2017-01-01

Introduction Older, chronically ill patients with limited health literacy are often under-engaged in managing their health and turn to the emergency department (ED) for healthcare needs. We tested the impact of an ED-initiated coaching intervention on patient engagement and follow-up doctor visits in this high-risk population. We also explored patients’ care-seeking decisions. Methods We conducted a mixed-methods study including a randomized controlled trial and in-depth interviews in two EDs in northern Florida. Participants were chronically ill older ED patients with limited health literacy and Medicare as a payer source. Patients were assigned to an evidence-based coaching intervention (n= 35) or usual post-ED care (n= 34). Qualitative interviews (n=9) explored patients’ reasons for ED use. We assessed average between-group differences in patient engagement over time with the Patient Activation Measure (PAM) tool, using logistic regression and a difference-in-difference approach. Between-group differences in follow-up doctor visits were determined. We analyzed qualitative data using open coding and thematic analysis. Results PAM scores fell in both groups after the ED visit but fell significantly more in “usual care” (average decline −4.64) than “intervention” participants (average decline −2.77) (β=1.87, p=0.043). There were no between-group differences in doctor visits. Patients described well-informed reasons for ED visits including onset and severity of symptoms, lack of timely provider access, and immediate and comprehensive ED care. Conclusion The coaching intervention significantly reduced declines in patient engagement observed after usual post-ED care. Patients reported well-informed reasons for ED use and will likely continue to make ED visits unless strategies, such as ED-initiated coaching, are implemented to help vulnerable patients better manage their health and healthcare. PMID:28611897

A break-even analysis for dementia care collaboration: Partners in Dementia Care.

PubMed

Morgan, Robert O; Bass, David M; Judge, Katherine S; Liu, C F; Wilson, Nancy; Snow, A Lynn; Pirraglia, Paul; Garcia-Maldonado, Maurilio; Raia, Paul; Fouladi, N N; Kunik, Mark E

2015-06-01

Dementia is a costly disease. People with dementia, their families, and their friends are affected on personal, emotional, and financial levels. Prior work has shown that the "Partners in Dementia Care" (PDC) intervention addresses unmet needs and improves psychosocial outcomes and satisfaction with care. We examined whether PDC reduced direct Veterans Health Administration (VHA) health care costs compared with usual care. This study was a cost analysis of the PDC intervention in a 30-month trial involving five VHA medical centers. Study subjects were veterans (N = 434) 50 years of age and older with dementia and their caregivers at two intervention (N = 269) and three comparison sites (N = 165). PDC is a telephone-based care coordination and support service for veterans with dementia and their caregivers, delivered through partnerships between VHA medical centers and local Alzheimer's Association chapters. We tested for differences in total VHA health care costs, including hospital, emergency department, nursing home, outpatient, and pharmacy costs, as well as program costs for intervention participants. Covariates included caregiver reports of veterans' cognitive impairment, behavior problems, and personal care dependencies. We used linear mixed model regression to model change in log total cost post-baseline over a 1-year follow-up period. Intervention participants showed higher VHA costs than usual-care participants both before and after the intervention but did not differ significantly regarding change in log costs from pre- to post-baseline periods. Pre-baseline log cost (p ≤ 0.001), baseline cognitive impairment (p ≤ 0.05), number of personal care dependencies (p ≤ 0.01), and VA service priority (p ≤ 0.01) all predicted change in log total cost. These analyses show that PDC meets veterans' needs without significantly increasing VHA health care costs. PDC addresses the priority area of care coordination in the National Plan to Address Alzheimer's Disease, offering a low-cost, structured, protocol-driven, evidence-based method for effectively delivering care coordination.

Treatment-Based Classification versus Usual Care for Management of Low Back Pain

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-11-1-0657 TITLE: Treatment-Based Classification versus Usual Care for Management of Low Back Pain PRINCIPAL INVESTIGATOR...Treatment-Based Classification versus Usual Care for Management of Low Back Pain 5b. GRANT NUMBER W81XWH-11-1-0657 5c. PROGRAM ELEMENT NUMBER 6...AUTHOR(S) MAJ Daniel Rhon – daniel_rhon@baylor.edu 5d. PROJECT NUMBER 5e. TASK NUMBER 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S

Outcomes of patients discharged from pharmacy-managed cardiovascular disease management.

PubMed

Olson, Kari L; Delate, Thomas; Rasmussen, Jon; Humphries, Tammy L; Merenich, John A

2009-08-01

To evaluate whether patients with coronary artery disease (CAD) discharged from the Clinical Pharmacy Cardiac Risk Service (CPCRS) would maintain their lipid goals with use of an electronic laboratory reminder system. A 2-year, randomized study at Kaiser Permanente Colorado. Patients with prior CAD (acute myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention) who had been enrolled in the CPCRS for at least 1 year and who had 2 consecutive low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol, and blood pressure readings at goal within 6 months before enrollment were randomized to remain in the CPCRS (CPCRS care) or to receive usual care from primary care physicians plus laboratory reminder letters (usual care). The primary outcome was maintenance of LDL-C goal at study end. The t test and chi(2) test of association were used to assess differences in mean and categorical values, respectively. A total of 421 patients (214 CPCRS care, 207 usual care) were randomized. Their mean age was 72 years; 74% were male. After 1.7 years of follow-up, the proportions of patients maintaining their LDL-C goal of <100 mg/dL were 91% and 93.1% in the CPCRS care and usual care groups, respectively (P = .46). The proportions maintaining their LDL-C goal of <70 mg/dL were 68.6% and 56.8% in the CPCRS care and usual care groups, respectively (P = .23). This study demonstrated that LDL-C measures can remain controlled in most patients discharged from a cardiac disease management program.

Multi-faceted implementation strategy to increase use of a clinical guideline for the diagnosis of deep venous thrombosis in primary care.

PubMed

Kingma, Anna E C; van Stel, Henk F; Oudega, Ruud; Moons, Karel G M; Geersing, Geert-Jan

2017-08-01

A clinical decision rule (CDR), combined with a negative D-dimer test, can safely rule out deep venous thrombosis (DVT) in primary care. This strategy is recommended by guidelines, yet uptake by GPs is low. To evaluate a multi-faceted implementation strategy aimed at increased use of the guideline recommended CDR plus D-dimer test in primary care patients with suspected DVT. This multi-faceted implementation strategy consisted of educational outreach visits, financial reimbursements and periodical newsletters. 217 Dutch GPs (implementation group) received this strategy and included patients. Effectiveness was measured through the following patient-level outcomes: (i) proportion of non-referred patients, (ii) proportion of missed DVT cases within this group and (iii) the proportion of patients in whom the guideline was applied incorrectly. Implementation outcomes ('acceptability', 'feasibility', 'fidelity' and 'sustainability') were assessed with an online questionnaire. Patient-level outcomes were compared with those of patients included by 450 GPs, uninformed about the study's purposes providing information about usual care. 336 (54%) of 619 analyzable implementation group patients were not referred, missing 6 [1.8% (95% confidence interval 0.7% to 3.9%)] DVT cases. Incorrect guideline use was observed in 199 patients (32%). Self-reported acceptability, feasibility and expected sustainability were high. Guideline use increased from 42% to an expected continuation of use of 91%. Only 32 usual care GPs included 62 patients, making formal comparison unreliable. This multi-faceted implementation strategy safely reduced patient referral to secondary care, despite frequently incorrect application of the guideline and resulted in high acceptability, feasibility and expected sustainability. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The effect of a collaborative pharmacist-hospital care transition program on the likelihood of 30-day readmission.

PubMed

Kirkham, Heather S; Clark, Bobby L; Paynter, Jacquelyn; Lewis, Geraint H; Duncan, Ian

2014-05-01

The effect of a collaborative pharmacist-hospital care transition program on the likelihood of 30-day readmission was evaluated. This retrospective cohort study was conducted in two acute care hospitals within the same hospital system in the southeastern United States. One hospital initiated a care transition program in January 2011; the other hospital did not have such a program. All patients who were discharged from either hospital to home from January 1, 2010, through December 31, 2011, were included in the study. The two key program components included bedside delivery of postdischarge medications and follow-up telephone calls two to three days after discharge. The likelihood of readmission was assessed using multiple logistic regression. Over the 2-year study period, 19,659 unique patients had 26,781 qualifying index admissions, 2,523 of which resulted in a readmission within 30 days of discharge. After adjusting for various demographic and clinical characteristics, the usual care group (i.e., patients who did not participate in the program) had nearly twice the odds of readmission within 30 days (odds ratio [OR], 1.90; 95% confidence interval [CI], 1.35-2.67), compared with the intervention group (i.e., program participants). For patients age 65 years or older, those in the usual care group had a sixfold increase in the odds of a 30-day readmission (OR, 6.05; 95% CI, 1.92-19.00) relative to those in the intervention group. A care transition program was associated with a lower likelihood of readmission and had a greater effect on older patients.

COMET: a multicomponent home-based disease-management programme versus routine care in severe COPD.

PubMed

Kessler, Romain; Casan-Clara, Pere; Koehler, Dieter; Tognella, Silvia; Viejo, Jose Luis; Dal Negro, Roberto W; Díaz-Lobato, Salvador; Reissig, Karina; Rodríguez González-Moro, José Miguel; Devouassoux, Gilles; Chavaillon, Jean-Michel; Botrus, Pierre; Arnal, Jean-Michel; Ancochea, Julio; Bergeron-Lafaurie, Anne; De Abajo, Carlos; Randerath, Winfried J; Bastian, Andreas; Cornelissen, Christian G; Nilius, Georg; Texereau, Joëlle B; Bourbeau, Jean

2018-01-01

The COPD Patient Management European Trial (COMET) investigated the efficacy and safety of a home-based COPD disease management intervention for severe COPD patients.The study was an international open-design clinical trial in COPD patients (forced expiratory volume in 1 s <50% of predicted value) randomised 1:1 to the disease management intervention or to the usual management practices at the study centre. The disease management intervention included a self-management programme, home telemonitoring, care coordination and medical management. The primary end-point was the number of unplanned all-cause hospitalisation days in the intention-to-treat (ITT) population. Secondary end-points included acute care hospitalisation days, BODE (body mass index, airflow obstruction, dyspnoea and exercise) index and exacerbations. Safety end-points included adverse events and deaths.For the 157 (disease management) and 162 (usual management) patients eligible for ITT analyses, all-cause hospitalisation days per year (mean±sd) were 17.4±35.4 and 22.6±41.8, respectively (mean difference -5.3, 95% CI -13.7 to -3.1; p=0.16). The disease management group had fewer per-protocol acute care hospitalisation days per year (p=0.047), a lower BODE index (p=0.01) and a lower mortality rate (1.9% versus 14.2%; p<0.001), with no difference in exacerbation frequency. Patient profiles and hospitalisation practices varied substantially across countries.The COMET disease management intervention did not significantly reduce unplanned all-cause hospitalisation days, but reduced acute care hospitalisation days and mortality in severe COPD patients. Copyright ©ERS 2018.

The way in which a physiotherapy service is structured can improve patient outcome from a surgical intensive care: a controlled clinical trial

PubMed Central

2012-01-01

Introduction The physiological basis of physiotherapeutic interventions used in intensive care has been established. We must determine the optimal service approach that will result in improved patient outcome. The aim of this article is to report on the estimated effect of providing a physiotherapy service consisting of an exclusively allocated physiotherapist providing evidence-based/protocol care, compared with usual care on patient outcomes. Methods An exploratory, controlled, pragmatic, sequential-time-block clinical trial was conducted in the surgical unit of a tertiary hospital in South Africa. Protocol care (3 weeks) and usual care (3 weeks) was provided consecutively for two 6-week intervention periods. Each intervention period was followed by a washout period. The physiotherapy care provided was based on the unit admission date. Data were analyzed with Statistica in consultation with a statistician. Where indicated, relative risks with 95% confidence intervals (CIs) are reported. Significant differences between groups or across time are reported at the alpha level of 0.05. All reported P values are two-sided. Results Data of 193 admissions were analyzed. No difference was noted between the two patient groups at baseline. Patients admitted to the unit during protocol care were less likely to be intubated after unit admission (RR, 0.16; 95% CI, 0.07 to 0.71; RRR, 0.84; NNT, 5.02; P = 0.005) or to fail an extubation (RR, 0.23; 95% CI, 0.05 to 0.98; RRR, 0.77; NNT, 6.95; P = 0.04). The mean difference in the cumulative daily unit TISS-28 score during the two intervention periods was 1.99 (95% CI, 0.65 to 3.35) TISS-28 units (P = 0.04). Protocol-care patients were discharged from the hospital 4 days earlier than usual-care patients (P = 0.05). A tendency noted for more patients to reach independence in the transfers (P = 0.07) and mobility (P = 0.09) categories of the Barthel Index. Conclusions A physiotherapy service approach that includes an exclusively allocated physiotherapist providing evidence-based/protocol care that addresses pulmonary dysfunction and promotes early mobility improves patient outcome. This could be a more cost-effective service approach to care than is usual care. This information can now be considered by administrators in the management of scarce physiotherapy resources and by researchers in the planning of a multicenter randomized controlled trial. Trial registration PACTR201206000389290 PMID:23232109

Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial

PubMed Central

2014-01-01

Background Among the multiple conservative modalities, physiotherapy is a commonly utilized treatment modality in managing chronic non-specific spinal pain. Despite the scientific progresses with regard to pain and motor control neuroscience, treatment of chronic spinal pain (CSP) often tends to stick to a peripheral biomechanical model, without targeting brain mechanisms. With a view to enhance clinical efficacy of existing physiotherapeutic treatments for CSP, the development of clinical strategies targeted at ‘training the brain’ is to be pursued. Promising proof-of-principle results have been reported for the effectiveness of a modern neuroscience approach to CSP when compared to usual care, but confirmation is required in a larger, multi-center trial with appropriate evidence-based control intervention and long-term follow-up. The aim of this study is to assess the effectiveness of a modern neuroscience approach, compared to usual care evidence-based physiotherapy, for reducing pain and improving functioning in patients with CSP. A secondary objective entails examining the effectiveness of the modern neuroscience approach versus usual care physiotherapy for normalizing brain gray matter in patients with CSP. Methods/Design The study is a multi-center, triple-blind, two-arm (1:1) randomized clinical trial with 1-year follow-up. 120 CSP patients will be randomly allocated to either the experimental (receiving pain neuroscience education followed by cognition-targeted motor control training) or the control group (receiving usual care physiotherapy), each comprising of 3 months treatment. The main outcome measures are pain (including symptoms and indices of central sensitization) and self-reported disability. Secondary outcome measures include brain gray matter structure, motor control, muscle properties, and psychosocial correlates. Clinical assessment and brain imaging will be performed at baseline, post-treatment and at 1-year follow-up. Web-based questionnaires will be completed at baseline, after the first 3 treatment sessions, post-treatment, and at 6 and 12-months follow-up. Discussion Findings may provide empirical evidence on: (1) the effectiveness of a modern neuroscience approach to CSP for reducing pain and improving functioning, (2) the effectiveness of a modern neuroscience approach for normalizing brain gray matter in CSP patients, and (3) factors associated with therapy success. Hence, this trial might contribute towards refining guidelines for good clinical practice and might be used as a basis for health authorities’ recommendations. Trial registration ClinicalTrials.gov Identifier: NCT02098005. PMID:24885889

Chemotherapy-related neuropathic symptom management: a randomized trial of an automated symptom-monitoring system paired with nurse practitioner follow-up.

PubMed

Kolb, Noah Allan; Smith, Albert Gordon; Singleton, John Robinson; Beck, Susan L; Howard, Diantha; Dittus, Kim; Karafiath, Summer; Mooney, Kathi

2018-05-01

The purpose of this study was to evaluate a new care model to reduce chemotherapy-induced neuropathic symptoms. Neuropathic symptom usual care was prospectively compared to an automated symptom-monitoring and coaching system, SymptomCare@Home (SCH), which included nurse practitioner follow-up triggered by moderate to severe symptoms. Patients beginning chemotherapy were randomized to usual care (UC) or to the SCH intervention. This sub-analysis included only taxane/platin therapies. Participants called the automated telephone symptom-monitoring system daily to report numbness and tingling. The monitoring system recorded patient-reported neuropathic symptom severity, distress, and activity interference on a 0-10 scale. UC participants were instructed to call their oncologist for symptom management. SCH participants with symptom severity of ≥ 4 received automated self-care strategies, and a nurse practitioner (NP) provided guideline-based care. There were 252 participants, 78.6% of which were female. Mean age was 55.1 years. Mean follow-up was 90.2 ± 39.9 days (81.1 ± 40.3 calls). SCH participants had fewer days of moderate (1.8 ± 4.0 vs. 8.6 ± 17.3, p < 0.001) and severe chemotherapy-induced peripheral neuropathy symptoms (0.3 ± 1.0 vs. 1.1 ± 5.2, p = 0.006). SCH participants had fewer days with moderate and severe symptom-related distress (1.4 ± 3.7 vs. 6.9 ± 15.0, p < 0.001; 0.2 ± 0.9 vs. 1.5 ± 6.1, p = 0.001) and trended towards less activity interference (3.3 ± 1.9 vs. 3.8 ± 2.1, p = 0.08). Other neuropathic symptoms were addressed in 5.8-15.4% of SCH follow-up calls. The SCH system effectively identified neuropathic symptoms and their severity and, paired with NP follow-up, reduced symptom prevalence, severity, and distress compared to usual care.

Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

PubMed

Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger

2015-12-02

Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results from the present study will add to the current knowledge on tailored strategies, which aims to improve the uptake of evidence-based OA care recommendations and improve the quality of OA care in primary health care. The new knowledge can be used in national and international initiatives designed to improve the quality of OA care. ClinicalTrials.gov NCT02333656.

Effects of Self-Management Support on Structure, Process, and Outcomes Among Vulnerable Patients With Diabetes

PubMed Central

Schillinger, Dean; Handley, Margaret; Wang, Frances; Hammer, Hali

2009-01-01

OBJECTIVE Despite the importance of self-management support (SMS), few studies have compared SMS interventions, involved diverse populations, or entailed implementation in safety net settings. We examined the effects of two SMS strategies across outcomes corresponding to the Chronic Care Model. RESEARCH DESIGN AND METHODS A total of 339 outpatients with poorly controlled diabetes from county-run clinics were enrolled in a three-arm trial. Participants, more than half of whom spoke limited English, were uninsured, and/or had less than a high school education, were randomly assigned to usual care, interactive weekly automated telephone self-management support with nurse follow-up (ATSM), or monthly group medical visits with physician and health educator facilitation (GMV). We measured 1-year changes in structure (Patient Assessment of Chronic Illness Care [PACIC]), communication processes (Interpersonal Processes of Care [IPC]), and outcomes (behavioral, functional, and metabolic). RESULTS Compared with the usual care group, the ATSM and GMV groups showed improvements in PACIC, with effect sizes of 0.48 and 0.50, respectively (P < 0.01). Only the ATSM group showed improvements in IPC (effect sizes 0.40 vs. usual care and 0.25 vs. GMV, P < 0.05). Both SMS arms showed improvements in self-management behavior versus the usual care arm (P < 0.05), with gains being greater for the ATSM group than for the GMV group (effect size 0.27, P = 0.02). The ATSM group had fewer bed days per month than the usual care group (−1.7 days, P = 0.05) and the GMV group (−2.3 days, P < 0.01) and less interference with daily activities than the usual care group (odds ratio 0.37, P = 0.02). We observed no differences in A1C change. CONCLUSIONS Patient-centered SMS improves certain aspects of diabetes care and positively influences self-management behavior. ATSM seems to be a more effective communication vehicle than GMV in improving behavior and quality of life. PMID:19131469

Hospital-Level Care at Home for Acutely Ill Adults: a Pilot Randomized Controlled Trial.

PubMed

Levine, David M; Ouchi, Kei; Blanchfield, Bonnie; Diamond, Keren; Licurse, Adam; Pu, Charles T; Schnipper, Jeffrey L

2018-05-01

Hospitals are standard of care for acute illness, but hospitals can be unsafe, uncomfortable, and expensive. Providing substitutive hospital-level care in a patient's home potentially reduces cost while maintaining or improving quality, safety, and patient experience, although evidence from randomized controlled trials in the US is lacking. Determine if home hospital care reduces cost while maintaining quality, safety, and patient experience. Randomized controlled trial. Adults admitted via the emergency department with any infection or exacerbation of heart failure, chronic obstructive pulmonary disease, or asthma. Home hospital care, including nurse and physician home visits, intravenous medications, continuous monitoring, video communication, and point-of-care testing. Primary outcome was direct cost of the acute care episode. Secondary outcomes included utilization, 30-day cost, physical activity, and patient experience. Nine patients were randomized to home, 11 to usual care. Median direct cost of the acute care episode for home patients was 52% (IQR, 28%; p = 0.05) lower than for control patients. During the care episode, home patients had fewer laboratory orders (median per admission: 6 vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04). Home patients were more physically active (median minutes, 209 vs. 78; p < 0.01), with a trend toward more sleep. No adverse events occurred in home patients, one occurred in control patients. Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower, with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups. The use of substitutive home-hospitalization compared to in-hospital usual care reduced cost and utilization and improved physical activity. No significant differences in quality, safety, and patient experience were noted, with more definitive results awaiting a larger trial. Trial Registration NCT02864420.

MEDication reminder APPs to improve medication adherence in Coronary Heart Disease (MedApp-CHD) Study: a randomised controlled trial protocol.

PubMed

Santo, Karla; Chow, Clara K; Thiagalingam, Aravinda; Rogers, Kris; Chalmers, John; Redfern, Julie

2017-10-08

The growing number of smartphone health applications available in the app stores makes these apps a promising tool to help reduce the global problem of non-adherence to long-term medications. However, to date, there is limited evidence that available medication reminder apps are effective. This study aims to determine the impact of medication reminder apps on adherence to cardiovascular medication when compared with usual care for people with coronary heart disease (CHD) and to determine whether an advanced app compared with a basic app is associated with higher adherence. Randomised controlled trial with follow-up at 3 months to evaluate the feasibility and effectiveness of medication reminder apps on medication adherence compared with usual care. An estimated sample size of 156 patients with CHD will be randomised to one of three groups (usual care group, basic medication reminder app group and advanced medication reminder app group). The usual care group will receive standard care for CHD with no access to a medication reminder app. The basic medication reminder app group will have access to a medication reminder app with a basic feature of providing simple daily reminders with no interactivity. The advanced medication reminder app group will have access to a medication reminder app with additional interactive and customisable features. The primary outcome is medication adherence measured by the eight-item Morisky Medication Adherence Scale at 3 months. Secondary outcomes include clinical measurements of blood pressure and cholesterol levels, and medication knowledge. A process evaluation will also be performed to assess the feasibility of the intervention by evaluating the acceptability, utility and engagement with the apps. Ethical approval has been obtained from the Western Sydney Local Health Network Human Research Ethics Committee (AU/RED/HREC/1/WMEAD/3). Study findings will be disseminated via usual scientific forums. ACTRN12616000661471; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Advanced practice physiotherapy in patients with musculoskeletal disorders: a systematic review

PubMed Central

2012-01-01

Background The convergence of rising health care costs and physician shortages have made health care transformation a priority in many countries resulting in the emergence of new models of care that often involve the extension of the scope of practice for allied health professionals. Physiotherapists in advanced practice/extended scope roles have emerged as key providers in such new models, especially in settings providing services to patients with musculoskeletal disorders. However, evidence of the systematic evaluation of advance physiotherapy practice (APP) models of care is scarce. A systematic review was done to update the evaluation of physiotherapists in APP roles in the management of patients with musculoskeletal disorders. Methods Structured literature search was conducted in 3 databases (Medline, Cinahl and Embase) for articles published between 1980 and 2011. Included studies needed to present original quantitative data that addressed the impact or the effect of APP care. A total of 16 studies met all inclusion criteria and were included. Pairs of raters used four structured quality appraisal methodological tools depending on design of studies to analyse included studies. Results Included studies varied in designs and objectives and could be categorized in four areas: diagnostic agreement or accuracy compared to medical providers, treatment effectiveness, economic efficiency or patient satisfaction. There was a wide range in the quality of studies (from 25% to 93%), with only 43% of papers reaching or exceeding a score of 70% on the methodological quality rating scales. Their findings are however consistent and suggest that APP care may be as (or more) beneficial than usual care by physicians for patients with musculoskeletal disorders, in terms of diagnostic accuracy, treatment effectiveness, use of healthcare resources, economic costs and patient satisfaction. Conclusions The emerging evidence suggests that physiotherapists in APP roles provide equal or better usual care in comparison to physicians in terms of diagnostic accuracy, treatment effectiveness, use of healthcare resources, economic costs and patient satisfaction. There is a need for more methodologically sound studies to evaluate the effectiveness APP care. PMID:22716771

An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke.

PubMed

Wagner, Todd H; Lo, Albert C; Peduzzi, Peter; Bravata, Dawn M; Huang, Grant D; Krebs, Hermano I; Ringer, Robert J; Federman, Daniel G; Richards, Lorie G; Haselkorn, Jodie K; Wittenberg, George F; Volpe, Bruce T; Bever, Christopher T; Duncan, Pamela W; Siroka, Andrew; Guarino, Peter D

2011-09-01

Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness. We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization. A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different. The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration- URL: http://clinicaltrials.gov. Unique identifier: NCT00372411.

Economic Evaluation of a Problem Solving Intervention to Prevent Recurrent Sickness Absence in Workers with Common Mental Disorders

PubMed Central

Arends, Iris; Bültmann, Ute; van Rhenen, Willem; Groen, Henk; van der Klink, Jac J. L.

2013-01-01

Objectives Workers with common mental disorders (CMDs) frequently experience recurrent sickness absence but scientifically evaluated interventions to prevent recurrences are lacking. The objectives of this study are to evaluate the cost-effectiveness and cost-benefit of a problem solving intervention aimed at preventing recurrent sickness absence in workers with CMDs compared to care as usual. Methods An economic evaluation was conducted alongside a cluster-randomised controlled trial with 12 months follow-up. Treatment providers were randomised to either a 2-day training in the SHARP-at work intervention, i.e. a problem solving intervention, or care as usual. Effect outcomes were the incidence of recurrent sickness absence and time to recurrent sickness absence. Self-reported health care utilisation was measured by questionnaires. A cost-effectiveness analysis (CEA) from the societal perspective and a cost-benefit analysis (CBA) from the employer’s perspective were conducted. Results The CEA showed that the SHARP-at work intervention was more effective but also more expensive than care as usual. The CBA revealed that employer’s occupational health care costs were significantly higher in the intervention group compared to care as usual. Overall, the SHARP-at work intervention showed no economic benefit compared to care as usual. Conclusions As implementation of the SHARP-at work intervention might require additional investments, health care policy makers need to decide if these investments are worthwhile considering the results that can be accomplished in reducing recurrent sickness absence. PMID:23951270

Organ donation video messaging in motor vehicle offices: results of a randomized trial.

PubMed

Rodrigue, James R; Fleishman, Aaron; Fitzpatrick, Sean; Boger, Matthew

2015-12-01

Since nearly all registered organ donors in the United States signed up via a driver's license transaction, motor vehicle (MV) offices represent an important venue for organ donation education. To evaluate the impact of organ donation video messaging in MV offices. A 2-group (usual care vs usual care+video messaging) randomized trial with baseline, intervention, and follow-up assessment phases. Twenty-eight MV offices in Massachusetts. Usual care comprised education of MV clerks, display of organ donation print materials (ie, posters, brochures, signing mats), and a volunteer ambassador program. The intervention included video messaging with silent (subtitled) segments highlighting individuals affected by donation, playing on a recursive loop on monitors in MV waiting rooms. Aggregate monthly donor designation rates at MV offices (primary) and percentage of MV customers who registered as donors after viewing the video (secondary). Controlling for baseline donor designation rate, analysis of covariance showed a significant group effect for intervention phase (F=7.3, P=.01). The usual-care group had a significantly higher aggregate monthly donor designation rate than the intervention group had. In the logistic regression model of customer surveys (n=912), prior donor designation (β=-1.29, odds ratio [OR]=0.27 [95% CI=0.20-0.37], P<.001), white race (β=0.57 OR=1.77 [95% CI=1.23-2.54], P=.002), and viewing the intervention video (β=0.73, OR=1.54 [95% CI=1.24-2.60], P=.01) were statistically significant predictors of donor registration on the day of the survey. The relatively low uptake of the video intervention by customers most likely contributed to the negative trial finding.

Early initiation of post-sternotomy cardiac rehabilitation exercise training (SCAR): study protocol for a randomised controlled trial and economic evaluation

PubMed Central

Lobley, Grace; Worrall, Sandra; Powell, Richard; Kimani, Peter K; Banerjee, Prithwish; Barker, Thomas

2018-01-01

Introduction Current guidelines recommend abstinence from supervised cardiac rehabilitation (CR) exercise training for 6 weeks post-sternotomy. This practice is not based on empirical evidence, thus imposing potentially unnecessary activity restrictions. Delayed participation in CR exercise training promotes muscle atrophy, reduces cardiovascular fitness and prolongs recovery. Limited data suggest no detrimental effect of beginning CR exercise training as early as 2 weeks post-surgery, but randomised controlled trials are yet to confirm this. The purpose of this trial is to compare CR exercise training commenced early (2 weeks post-surgery) with current usual care (6 weeks post-surgery) with a view to informing future CR guidelines for patients recovering from sternotomy. Methods and analysis In this assessor-blind randomised controlled trial, 140 cardiac surgery patients, recovering from sternotomy, will be assigned to 8 weeks of twice-weekly supervised CR exercise training commencing at either 2 weeks (early CR) or 6 weeks (usual care CR) post-surgery. Usual care exercise training will adhere to current UK recommendations. Participants in the early CR group will undertake a highly individualised 2–3 week programme of functional mobility, strength and cardiovascular exercise before progressing to a usual care CR programme. Outcomes will be assessed at baseline (inpatient), pre-CR (2 or 6 weeks post-surgery), post-CR (10 or 14 weeks post-surgery) and 12 months. The primary outcome will be change in 6 min walk distance. Secondary outcomes will include measures of functional fitness, quality of life and cost-effectiveness. Ethics and dissemination Recruitment commenced on July 2017 and will complete by December 2019. Results will be disseminated via national governing bodies, scientific meetings and peer-reviewed journals. Trial registration number NCT03223558; Pre-results. PMID:29574443

Effects of resistance training, endurance training and whole-body vibration on lean body mass, muscle strength and physical performance in older people: a systematic review and network meta-analysis.

PubMed

Lai, Chih-Chin; Tu, Yu-Kang; Wang, Tyng-Guey; Huang, Yi-Ting; Chien, Kuo-Liong

2018-05-01

A variety of different types of exercise are promoted to improve muscle strength and physical performance in older people. We aimed to determine the relative effects of resistance training, endurance training and whole-body vibration on lean body mass, muscle strength and physical performance in older people. A systematic review and network meta-analysis. Adults aged 60 and over. Evidence from randomised controlled trials of resistance training, endurance training and whole-body vibration were combined. The effects of exercise interventions on lean body mass, muscle strength and physical performance were evaluated by conducting a network meta-analysis to compare multiple interventions and usual care. Risk of bias of included studies was assessed using the Cochrane Collaboration's tool. A meta-regression was performed to assess potential effect modifiers. Data were obtained from 30 trials involving 1,405 participants (age range: 60-92 years). No significant differences were found between the effects of exercise or usual care on lean body mass. Resistance training (minimum 6 weeks duration) achieved greater muscle strength improvement than did usual care (12.8 kg; 95% confidence interval [CI]: 8.5-17.0 kg). Resistance training and whole-body vibration were associated with greater physical performance improvement compared with usual care (2.6 times greater [95% CI: 1.3-3.9] and 2.1 times greater [95% CI: 0.5-3.7], respectively). Resistance training is the most effect intervention to improve muscle strength and physical performance in older people. Our findings also suggest that whole-body vibration is beneficial for physical performance. However, none of the three exercise interventions examined had a significant effect on lean body mass.

The effects of inpatient exercise therapy on the length of hospital stay in stages I-III colon cancer patients: randomized controlled trial.

PubMed

Ahn, Ki-Yong; Hur, Hyuk; Kim, Dong-Hyun; Min, Jihee; Jeong, Duck Hyoun; Chu, Sang Hui; Lee, Ji Won; Ligibel, Jennifer A; Meyerhardt, Jeffrey A; Jones, Lee W; Jeon, Justin Y; Kim, Nam Kyu

2013-05-01

This study aimed to examine the effects of a postsurgical, inpatient exercise program on postoperative recovery in operable colon cancer patients We conducted the randomized controlled trial with two arms: postoperative exercise vs. usual care. Patients with stages I-III colon cancer who underwent colectomy between January and December 2011 from the Colorectal Cancer Clinic, were recruited for the study. Subjects in the intervention group participated in the postoperative inpatient exercise program consisted of twice daily exercise, including stretching, core, balance, and low-intensity resistance exercises. The usual care group was not prescribed a structured exercise program. The primary endpoint was the length of hospital stay. Secondary endpoints were time to flatus, time to first liquid diet, anthropometric measurements, and physical function measurements. A total of 31 (86.1 %) patients completed the trial, with adherence to exercise interventions at 84.5 %. The mean length of hospital stay was 7.82 ± 1.07 days in the exercise group compared with 9.86 ± 2.66 days in usual care (mean difference, 2.03 days; 95 % confidence interval (CI), -3.47 to -0.60 days; p = 0.005) in per-protocol analysis. The mean time to flatus was 52.18 ± 21.55 h in the exercise group compared with 71.86 ± 29.2 h in the usual care group (mean difference, 19.69 h; 95 % CI, -38.33 to -1.04 h; p = 0.036). Low-to-moderate-intensity postsurgical exercise reduces length of hospital stay and improves bowel motility after colectomy procedure in patients with stages I-III colon cancer.

Cost-benefit evaluation of liposomal bupivacaine in the management of patients undergoing total knee arthroplasty.

PubMed

Kirkness, Carmen S; Asche, Carl V; Ren, Jinma; Kim, Minchul; Rainville, Edward C

2016-05-01

Results of a cost-benefit analysis of intraoperative use of liposomal bupivacaine for postsurgical pain management in patients undergoing total knee arthroplasty (TKA) are presented. In a retrospective single-site study, clinical and cost outcomes were compared in a group of 134 consecutive patients who received liposomal bupivacaine (by local infiltration) during TKA and a propensity score-matched historical cohort of 134 patients undergoing TKA who received usual care (continuous femoral nerve blockade with conventional bupivacaine delivered via elastomeric pump). Postsurgical pain scores and opioid use were similar in the two study groups; the mean total amount of nonsteroidal antiinflammatory drugs administered was lower in the liposomal bupivacaine group. Patients who received liposomal bupivacaine typically ambulated earlier than those who received usual care (22% and 3%, respectively, walked on the day of surgery; p < 0.05) and were more likely to be discharged within two days (50% versus 19%, p < 0.001); on average, liposomal bupivacaine- treated patients walked farther on the day of surgery (6.0 m versus 3.1 m, p < 0.001) and the day after surgery (63.7 m versus 25.5 m, p < 0.001) and had a shorter length of stay (LOS) (3.1 days versus 3.6 days, p < 0.03). The mean adjusted total direct hospital cost per patient was significantly lower with liposomal bupivacaine use versus usual care ($8758 versus $9213, p = 0.033). In patients undergoing TKA, intraoperative administration of liposomal bupivacaine for management of postsurgical pain was found to offer advantages over usual care, including decreased time to ambulation and reduced hospital LOS. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Intensive walking exercise for lower extremity peripheral arterial disease: A systematic review and meta-analysis.

PubMed

Lyu, Xiafei; Li, Sheyu; Peng, Shifeng; Cai, Huimin; Liu, Guanjian; Ran, Xingwu

2016-05-01

Supervised treadmill exercise is the recommended therapy for peripheral arterial disease (PAD) patients with intermittent claudication (IC). However, most PAD patients do not exhibit typical symptoms of IC. The aim of the present study was to explore the efficacy and safety of intensive walking exercise in PAD patients with and without IC. The PubMed, Embase and Cochrane Library databases were systematically searched. Randomized controlled trials comparing the effects of intensive walking exercise with usual care in patients with PAD were included for systematic review and meta-analysis. Eighteen trials with 1200 patients were eligible for the present analysis. Compared with usual care, intensive walking exercise significantly improved the maximal walking distance (MWD), pain-free walking distance, and the 6-min walking distance in patients with PAD (P < 0.00001 for all). Subgroup analyses indicated that a lesser improvement in MWD was observed in the subgroup with more diabetes patients, and that the subgroup with better baseline walking ability exhibited greater improvement in walking performance. In addition, similar improvements in walking performance were observed for exercise programs of different durations and modalities. No significant difference was found in adverse events between the intensive walking and usual care groups (relative risk 0.84; 95% confidence interval 0.51, 1.39; P = 0.50). Regardless of exercise length and modality, regularly intensive walking exercise improves walking ability in PAD patients more than usual care. The presence of diabetes may attenuate the improvements in walking performance in patients with PAD following exercise. © 2015 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Wiley Publishing Asia Pty Ltd.

Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee. 2: economic evaluation alongside a randomized controlled trial.

PubMed

Pinto, D; Robertson, M C; Abbott, J H; Hansen, P; Campbell, A J

2013-10-01

To evaluate the cost effectiveness of manual physiotherapy, exercise physiotherapy, and a combination of these therapies for patients with osteoarthritis of the hip or knee. 206 Adults who met the American College of Rheumatology criteria for hip or knee osteoarthritis were included in an economic evaluation from the perspectives of the New Zealand health system and society alongside a randomized controlled trial. Resource use was collected using the Osteoarthritis Costs and Consequences Questionnaire. Quality-adjusted life years (QALYs) were calculated using the Short Form 6D. Willingness-to-pay threshold values were based on one to three times New Zealand's gross domestic product (GDP) per capita of NZ$ 29,149 (in 2009). All three treatment programmes resulted in incremental QALY gains relative to usual care. From the perspective of the New Zealand health system, exercise therapy was the only treatment to result in an incremental cost utility ratio under one time GDP per capita at NZ$ 26,400 (-$34,081 to $103,899). From the societal perspective manual therapy was cost saving relative to usual care for most scenarios studied. Exercise therapy resulted in incremental cost utility ratios regarded as cost effective but was not cost saving. For most scenarios combined therapy was not as cost effective as the two therapies alone. In this study, exercise therapy and manual therapy were more cost effective than usual care at policy relevant values of willingness-to-pay from both the perspective of the health system and society. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12608000130369. Copyright © 2013 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Online diabetes self-management program: a randomized study.

PubMed

Lorig, Kate; Ritter, Philip L; Laurent, Diana D; Plant, Kathryn; Green, Maurice; Jernigan, Valarie Blue Bird; Case, Siobhan

2010-06-01

We hypothesized that people with type 2 diabetes in an online diabetes self-management program, compared with usual-care control subjects, would 1) demonstrate reduced A1C at 6 and 18 months, 2) have fewer symptoms, 3) demonstrate increased exercise, and 4) have improved self-efficacy and patient activation. In addition, participants randomized to listserve reinforcement would have better 18-month outcomes than participants receiving no reinforcement. A total of 761 participants were randomized to 1) the program, 2) the program with e-mail reinforcement, or 3) were usual-care control subjects (no treatment). This sample included 110 American Indians/Alaska Natives (AI/ANs). Analyses of covariance models were used at the 6- and 18-month follow-up to compare groups. At 6 months, A1C, patient activation, and self-efficacy were improved for program participants compared with usual care control subjects (P < 0.05). There were no changes in other health or behavioral indicators. The AI/AN program participants demonstrated improvements in health distress and activity limitation compared with usual-care control subjects. The subgroup with initial A1C >7% demonstrated stronger improvement in A1C (P = 0.01). At 18 months, self-efficacy and patient activation were improved for program participants. A1C was not measured. Reinforcement showed no improvement. An online diabetes self-management program is acceptable for people with type 2 diabetes. Although the results were mixed they suggest 1) that the program may have beneficial effects in reducing A1C, 2) AI/AN populations can be engaged in and benefit from online interventions, and 3) our follow-up reinforcement appeared to have no value.

Effect of a Collaborative Care Intervention vs Usual Care on Health Status of Patients With Chronic Heart Failure: The CASA Randomized Clinical Trial.

PubMed

Bekelman, David B; Allen, Larry A; McBryde, Connor F; Hattler, Brack; Fairclough, Diane L; Havranek, Edward P; Turvey, Carolyn; Meek, Paula M

2018-04-01

Many patients with chronic heart failure experience reduced health status despite receiving conventional therapy. To determine whether a symptom and psychosocial collaborative care intervention improves heart failure-specific health status, depression, and symptom burden in patients with heart failure. A single-blind, 2-arm, multisite randomized clinical trial was conducted at Veterans Affairs, academic, and safety-net health systems in Colorado among outpatients with symptomatic heart failure and reduced health status recruited between August 2012 and April 2015. Data from all participants were included regardless of level of participation, using an intent-to-treat approach. Patients were randomized 1:1 to receive the Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) intervention or usual care. The CASA intervention included collaborative symptom care provided by a nurse and psychosocial care provided by a social worker, both of whom worked with the patients' primary care clinicians and were supervised by a study primary care clinician, cardiologist, and palliative care physician. The primary outcome was patient-reported heart failure-specific health status, measured by difference in change scores on the Kansas City Cardiomyopathy Questionnaire (range, 0-100) at 6 months. Secondary outcomes included depression (measured by the 9-item Patient Health Questionnaire), anxiety (measured by the 7-item Generalized Anxiety Disorder Questionnaire), overall symptom distress (measured by the General Symptom Distress Scale), specific symptoms (pain, fatigue, and shortness of breath), number of hospitalizations, and mortality. Of 314 patients randomized (157 to intervention arm and 157 to control arm), there were 67 women and 247 men, mean (SD) age was 65.5 (11.4) years, and 178 (56.7%) had reduced ejection fraction. At 6 months, the mean Kansas City Cardiomyopathy Questionnaire score improved 5.5 points in the intervention arm and 2.9 points in the control arm (difference, 2.6; 95% CI, -1.3 to 6.6; P = .19). Among secondary outcomes, depressive symptoms and fatigue improved at 6 months with CASA (effect size of -0.29 [95% CI, -0.53 to -0.04] for depressive symptoms and -0.30 [95% CI, -0.55 to -0.06] for fatigue; P = .02 for both). There were no significant changes in overall symptom distress, pain, shortness of breath, or number of hospitalizations. Mortality at 12 months was similar in both arms (10 patients died receiving CASA, and 13 patients died receiving usual care; P = .52). This multisite randomized clinical trial of the CASA intervention did not demonstrate improved heart failure-specific health status. Secondary outcomes of depression and fatigue, both difficult symptoms to treat in heart failure, improved. clinicaltrials.gov Identifier: NCT01739686.

A randomised controlled trial of a consumer-focused e-health strategy for cardiovascular risk management in primary care: the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) study protocol.

PubMed

Redfern, Julie; Usherwood, T; Harris, M F; Rodgers, A; Hayman, N; Panaretto, K; Chow, C; Lau, A Y S; Neubeck, L; Coorey, G; Hersch, F; Heeley, E; Patel, A; Jan, S; Zwar, N; Peiris, D

2014-01-31

Fewer than half of all people at highest risk of a cardiovascular event are receiving and adhering to best practice recommendations to lower their risk. In this project, we examine the role of an e-health-assisted consumer-focused strategy as a means of overcoming these gaps between evidence and practice. Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) aims to test whether a consumer-focused e-health strategy provided to Aboriginal and Torres Strait Islander and non-indigenous adults, recruited through primary care, at moderate-to-high risk of a cardiovascular disease event will improve risk factor control when compared with usual care. Randomised controlled trial of 2000 participants with an average of 18 months of follow-up to evaluate the effectiveness of an integrated consumer-directed e-health portal on cardiovascular risk compared with usual care in patients with cardiovascular disease or who are at moderate-to-high cardiovascular disease risk. The trial will be augmented by formal economic and process evaluations to assess acceptability, equity and cost-effectiveness of the intervention. The intervention group will participate in a consumer-directed e-health strategy for cardiovascular risk management. The programme is electronically integrated with the primary care provider's software and will include interactive smart phone and Internet platforms. The primary outcome is a composite endpoint of the proportion of people meeting the Australian guideline-recommended blood pressure (BP) and cholesterol targets. Secondary outcomes include change in mean BP and fasting cholesterol levels, proportion meeting BP and cholesterol targets separately, self-efficacy, health literacy, self-reported point prevalence abstinence in smoking, body mass index and waist circumference, self-reported physical activity and self-reported medication adherence. Primary ethics approval was received from the University of Sydney Human Research Ethics Committee and the Aboriginal Health and Medical Research Council. Results will be disseminated via the usual scientific forums including peer-reviewed publications and presentations at international conferences ACTRN12613000715774.

Asynchronous and Synchronous Teleconsultation for Diabetes Care: A Systematic Literature Review

PubMed Central

Verhoeven, Fenne; Tanja-Dijkstra, Karin; Nijland, Nicol; Eysenbach, Gunther; van Gemert-Pijnen, Lisette

2010-01-01

Aim A systematic literature review, covering publications from 1994 to 2009, was carried out to determine the effects of teleconsultation regarding clinical, behavioral, and care coordination outcomes of diabetes care compared to usual care. Two types of teleconsultation were distinguished: (1) asynchronous teleconsultation for monitoring and delivering feedback via email and cell phone, automated messaging systems, or other equipment without face-to-face contact; and (2) synchronous teleconsultation that involves real-time, face-to-face contact (image and voice) via videoconferencing equipment (television, digital camera, webcam, videophone, etc.) to connect caregivers and one or more patients simultaneously, e.g., for the purpose of education. Methods Electronic databases were searched for relevant publications about asynchronous and synchronous tele-consultation [Medline, Picarta, Psychinfo, ScienceDirect, Telemedicine Information Exchange, Institute for Scientific Information Web of Science, Google Scholar]. Reference lists of identified publications were hand searched. The contribution to diabetes care was examined for clinical outcomes [e.g., hemoglobin A1c (HbA1c), dietary values, blood pressure, quality of life], for behavioral outcomes (patient-caregiver interaction, self-care), and for care coordination outcomes (usability of technology, cost-effectiveness, transparency of guidelines, equity of access to care). Randomized controlled trials with HbA1c as an outcome were pooled using standard meta-analytical methods. Results Of 2060 publications identified, 90 met inclusion criteria for electronic communication between (groups of) caregivers and patients with type 1 and 2 or gestational diabetes. Studies that evaluated teleconsultation not particularly aimed at diabetes were excluded, as were those that described interventions aimed solely at clinical improvements (e.g., HbA1c or lipid profiles). In 63 of 90 interventions, the interaction had an asynchronous teleconsultation character, in 18 cases interaction was synchronously (videoconferencing), and 9 involved a combination of synchronous with asynchronous interaction. Most of the reported improvements concerned clinical values (n = 49), self-care (n = 46), and satisfaction with technology (n = 43). A minority of studies demonstrated improvements in patient-caregiver interactions (n = 28) and cost reductions (n = 27). Only a few studies reported enhanced quality of life (n = 12), transparency of health care (n = 7), and improved equity in care delivery (n = 4). Asynchronous and synchronous applications appeared to differ in the type of contribution they made to diabetes care compared to usual care: asynchronous applications were more successful in improving clinical values and self-care, whereas synchronous applications led to relatively high usability of technology and cost reduction in terms of lower travel costs for both patients and care providers and reduced unscheduled visits compared to usual care. The combined applications (n = 9) scored best according to quality of life (22.2%). No differences between synchronous and asynchronous teleconsultation could be observed regarding the positive effect of technology on the quality of patient-provider interaction. Both types of applications resulted in intensified contact and increased frequency of transmission of clinical values with respect to usual care. Fifteen of the studies contained HbA1c data that permitted pooling. There was significant statistical heterogeneity among the pooled randomized controlled trials (χ2 = 96.46, P < 0.001). The pooled reduction in HbA1c was not statically significant (weighted mean difference -0.10; 95% confidence interval -0.39 to 0.18). Conclusion The included studies suggest that both synchronous and asynchronous teleconsultations for diabetes care are feasible, cost-effective, and reliable. However, it should be noted that many of the included studies showed no significant differences between control (usual care) and intervention groups. This might be due to the diversity and lack of quality in study designs (e.g., inaccurate or incompletely reported sample size calculations). Future research needs quasi-experimental study designs and a holistic approach that focuses on multilevel determinants (clinical, behavioral, and care coordination) to promote self-care and proactive collaborations between health care professionals and patients to manage diabetes care. Also, a participatory design approach is needed in which target users are involved in the development of cost-effective and personalized interventions. Currently, too often technology is developed within the scope of the existing structures of the health care system. Including patients as part of the design team stimulates and enables designers to think differently, unconventionally, or from a new perspective, leading to applications that are better tailored to patients' needs. PMID:20513335

History of foster care among homeless adults with mental illness in Vancouver, British Columbia: a precursor to trajectories of risk.

PubMed

Patterson, Michelle L; Moniruzzaman, Akm; Somers, Julian M

2015-02-26

It is well documented that a disproportionate number of homeless adults have childhood histories of foster care placement(s). This study examines the relationship between foster care placement as a predictor of adult substance use disorders (including frequency, severity and type), mental illness, vocational functioning, service use and duration of homelessness among a sample of homeless adults with mental illness. We hypothesize that a history of foster care predicts earlier, more severe and more frequent substance use, multiple mental disorder diagnoses, discontinuous work history, and longer durations of homelessness. This study was conducted using baseline data from two randomized controlled trials in Vancouver, British Columbia for participants who responded to a series of questions pertaining to out-of-home care at 12 months follow-up (n = 442). Primary outcomes included current mental disorders; substance use including type, frequency and severity; physical health; duration of homelessness; vocational functioning; and service use. In multivariable regression models, a history of foster care placement independently predicted incomplete high school, duration of homelessness, discontinuous work history, less severe types of mental illness, multiple mental disorders, early initiation of drug and/or alcohol use, and daily drug use. This is the first Canadian study to investigate the relationship between a history of foster care and current substance use among homeless adults with mental illness, controlling for several other potential confounding factors. It is important to screen homeless youth who exit foster care for substance use, and to provide integrated treatment for concurrent disorders to homeless youth and adults who have both psychiatric and substance use problems. Both trials are registered with the International Standard Randomized Control Trial Number Register and were assigned ISRCTN57595077 (Vancouver At Home Study: Housing First plus assertive community treatment versus congregate housing plus supports versus treatment as usual) and ISRCTN66721740 (Vancouver At Home Study: Housing First plus intensive case management versus treatment as usual) on September 9, 2012.

Cost-effectiveness of integrated COPD care: the RECODE cluster randomised trial.

PubMed

Boland, Melinde R S; Kruis, Annemarije L; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

2015-11-01

To investigate the cost-effectiveness of a chronic obstructive pulmonary disease (COPD) disease management (COPD-DM) programme in primary care, called RECODE, compared to usual care. A 2-year cluster-randomised controlled trial. 40 general practices in the western part of the Netherlands. 1086 patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. A multidisciplinary team of caregivers was trained in motivational interviewing, setting up individual care plans, exacerbation management, implementing clinical guidelines and redesigning the care process. In addition, clinical decision-making was supported by feedback reports provided by an ICT programme. We investigated the impact on health outcomes (quality-adjusted life years (QALYs), Clinical COPD Questionnaire, St. George's Respiratory Questionnaire and exacerbations) and costs (healthcare and societal perspective). The intervention costs were €324 per patient. Excluding these costs, the intervention group had €584 (95% CI €86 to €1046) higher healthcare costs than did the usual care group and €645 (95% CI €28 to €1190) higher costs from the societal perspective. Health outcomes were similar in both groups, except for 0.04 (95% CI -0.07 to -0.01) less QALYs in the intervention group. This integrated care programme for patients with COPD that mainly included professionally directed interventions was not cost-effective in primary care. Netherlands Trial Register NTR2268. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Cost-effectiveness of integrated COPD care: the RECODE cluster randomised trial

PubMed Central

Boland, Melinde R S; Kruis, Annemarije L; Tsiachristas, Apostolos; Assendelft, Willem J J; Gussekloo, Jacobijn; Blom, Coert M G; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H

2015-01-01

Objectives To investigate the cost-effectiveness of a chronic obstructive pulmonary disease (COPD) disease management (COPD-DM) programme in primary care, called RECODE, compared to usual care. Design A 2-year cluster-randomised controlled trial. Setting 40 general practices in the western part of the Netherlands. Participants 1086 patients with COPD according to GOLD (Global Initiative for COPD) criteria. Exclusion criteria were terminal illness, cognitive impairment, alcohol or drug misuse and inability to fill in Dutch questionnaires. Practices were included if they were willing to create a multidisciplinary COPD team. Interventions A multidisciplinary team of caregivers was trained in motivational interviewing, setting up individual care plans, exacerbation management, implementing clinical guidelines and redesigning the care process. In addition, clinical decision-making was supported by feedback reports provided by an ICT programme. Main outcome measures We investigated the impact on health outcomes (quality-adjusted life years (QALYs), Clinical COPD Questionnaire, St. George's Respiratory Questionnaire and exacerbations) and costs (healthcare and societal perspective). Results The intervention costs were €324 per patient. Excluding these costs, the intervention group had €584 (95% CI €86 to €1046) higher healthcare costs than did the usual care group and €645 (95% CI €28 to €1190) higher costs from the societal perspective. Health outcomes were similar in both groups, except for 0.04 (95% CI −0.07 to −0.01) less QALYs in the intervention group. Conclusions This integrated care programme for patients with COPD that mainly included professionally directed interventions was not cost-effective in primary care. Trial registration number Netherlands Trial Register NTR2268. PMID:26525419

Home blood pressure monitoring, secure electronic messaging and medication intensification for improving hypertension control: a mediation analysis.

PubMed

Ralston, J D; Cook, A J; Anderson, M L; Catz, S L; Fishman, P A; Carlson, J; Johnson, R; Green, B B

2014-01-01

We evaluated the role of home monitoring, communication with pharmacists, medication intensification, medication adherence and lifestyle factors in contributing to the effectiveness of an intervention to improve blood pressure control in patients with uncontrolled essential hypertension. We performed a mediation analysis of a published randomized trial based on the Chronic Care Model delivered over a secure patient website from June 2005 to December 2007. Study arms analyzed included usual care with a home blood pressure monitor and usual care with home blood pressure monitor and web-based pharmacist care. Mediator measures included secure messaging and telephone encounters; home blood pressure monitoring; medications intensification and adherence and lifestyle factors. Overall fidelity to the Chronic Care Model was assessed with the Patient Assessment of Chronic Care (PACIC) instrument. The primary outcome was percent of participants with blood pressure (BP) <140/90 mm Hg. At 12 months follow-up, patients in the web-based pharmacist care group were more likely to have BP <140/90 mm Hg (55%) compared to patients in the group with home blood pressure monitors only (37%) (p = 0.001). Home blood pressure monitoring accounted for 30.3% of the intervention effect, secure electronic messaging accounted for 96%, and medication intensification for 29.3%. Medication adherence and self-report of fruit and vegetable intake and weight change were not different between the two study groups. The PACIC score accounted for 22.0 % of the main intervention effect. The effect of web-based pharmacist care on improved blood pressure control was explained in part through a combination of home blood pressure monitoring, secure messaging, and antihypertensive medication intensification.

Institutional review board training for community practices: advice from the Agency for Health Care Research and Quality Practice-Based Research Network listserv.

PubMed

Dolor, Rowena J; Smith, Peter C; Neale, Anne Victoria

2008-01-01

Human subject protection training is required for all research personnel regardless of funding source. This article summarizes recommendations from a discussion about ethics training for community personnel from the practice-based research network (PBRN) listserv sponsored by the Agency for Health Care Research and Quality PBRN Resource Center. PBRN projects can involve community providers and their staff as subjects of the research project or as collaborators with recruitment and data collection. Distinguishing between usual care and research procedures is important for determining if training is required of community-based personnel. The use of research assistants or practice facilitators to collect research-related information is one way of limiting practice involvement to usual care procedures, thereby allowing PBRNs to limit training to dedicated research staff. Key methodologies for human subject protection training of community practice staff include on-site lectures, online modules, videotapes, and paper-based training. Ultimately, a discussion by the PBRN researcher with his or her governing Institutional Review Board is recommended for finding acceptable strategies within a PBRN.

Systematic review of the effectiveness of primary care nursing.

PubMed

Keleher, Helen; Parker, Rhian; Abdulwadud, Omar; Francis, Karen

2009-02-01

This paper reports on a systematic review that sought to answer the research question: What is the impact of the primary and community care nurse on patient health outcomes compared with usual doctor-led care in primary care settings? A range of pertinent text-words with medical subject headings were combined and electronic databases were searched. Because of the volume of published articles, the search was restricted to studies with high-level evidence. Overall, 31 relevant studies were identified and included in the review. We found modest international evidence that nurses in primary care settings can provide effective care and achieve positive health outcomes for patients similar to that provided by doctors. Nurses are effective in care management and achieve good patient compliance. Nurses are also effective in a more diverse range of roles including chronic disease management, illness prevention and health promotion. Nevertheless, there is insufficient evidence about primary care nurses' roles and impact on patient health outcomes.

Personalised care planning for adults with chronic or long-term health conditions.

PubMed

Coulter, Angela; Entwistle, Vikki A; Eccles, Abi; Ryan, Sara; Shepperd, Sasha; Perera, Rafael

2015-03-03

Personalised care planning is a collaborative process used in chronic condition management in which patients and clinicians identify and discuss problems caused by or related to the patient's condition, and develop a plan for tackling these. In essence it is a conversation, or series of conversations, in which they jointly agree goals and actions for managing the patient's condition. To assess the effects of personalised care planning for adults with long-term health conditions compared to usual care (i.e. forms of care in which active involvement of patients in treatment and management decisions is not explicitly attempted or achieved). We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, ProQuest, clinicaltrials.gov and WHO International Clinical Trials Registry Platform to July 2013. We included randomised controlled trials and cluster-randomised trials involving adults with long-term conditions where the intervention included collaborative (between individual patients and clinicians) goal setting and action planning. We excluded studies where there was little or no opportunity for the patient to have meaningful influence on goal selection, choice of treatment or support package, or both. Two of three review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. The primary outcomes were effects on physical health, psychological health, subjective health status, and capabilities for self management. Secondary outcomes included effects on health-related behaviours, resource use and costs, and type of intervention. A patient advisory group of people with experience of living with long-term conditions advised on various aspects of the review, including the protocol, selection of outcome measures and emerging findings. We included 19 studies involving a total of 10,856 participants. Twelve of these studies focused on diabetes, three on mental health, one on heart failure, one on end-stage renal disease, one on asthma, and one on various chronic conditions. All 19 studies included components that were intended to support behaviour change among patients, involving either face-to-face or telephone support. All but three of the personalised care planning interventions took place in primary care or community settings; the remaining three were located in hospital clinics. There was some concern about risk of bias for each of the included studies in respect of one or more criteria, usually due to inadequate or unclear descriptions of research methods. Physical healthNine studies measured glycated haemoglobin (HbA1c), giving a combined mean difference (MD) between intervention and control of -0.24% (95% confidence interval (CI) -0.35 to -0.14), a small positive effect in favour of personalised care planning compared to usual care (moderate quality evidence).Six studies measured systolic blood pressure, a combined mean difference of -2.64 mm/Hg (95% CI -4.47 to -0.82) favouring personalised care (moderate quality evidence). The pooled results from four studies showed no significant effect on diastolic blood pressure, MD -0.71 mm/Hg (95% CI -2.26 to 0.84).We found no evidence of an effect on cholesterol (LDL-C), standardised mean difference (SMD) 0.01 (95% CI -0.09 to 0.11) (five studies) or body mass index, MD -0.11 (95% CI -0.35 to 0.13) (four studies).A single study of people with asthma reported that personalised care planning led to improvements in lung function and asthma control. Psychological healthSix studies measured depression. We were able to pool results from five of these, giving an SMD of -0.36 (95% CI -0.52 to -0.20), a small effect in favour of personalised care (moderate quality evidence). The remaining study found greater improvement in the control group than the intervention group.Four other studies used a variety of psychological measures that were conceptually different so could not be pooled. Of these, three found greater improvement for the personalised care group than the usual care group and one was too small to detect differences in outcomes. Subjective health statusTen studies used various patient-reported measures of health status (or health-related quality of life), including both generic health status measures and condition-specific ones. We were able to pool data from three studies that used the SF-36 or SF-12, but found no effect on the physical component summary score SMD 0.16 (95% CI -0.05 to 0.38) or the mental component summary score SMD 0.07 (95% CI -0.15 to 0.28) (moderate quality evidence). Of the three other studies that measured generic health status, two found improvements related to personalised care and one did not.Four studies measured condition-specific health status. The combined results showed no difference between the intervention and control groups, SMD -0.01 (95% CI -0.11 to 0.10) (moderate quality evidence). Self-management capabilitiesNine studies looked at the effect of personalised care on self-management capabilities using a variety of outcome measures, but they focused primarily on self efficacy. We were able to pool results from five studies that measured self efficacy, giving a small positive result in favour of personalised care planning: SMD 0.25 (95% CI 0.07 to 0.43) (moderate quality evidence).A further five studies measured other attributes that contribute to self-management capabilities. The results from these were mixed: two studies found evidence of an effect on patient activation, one found an effect on empowerment, and one found improvements in perceived interpersonal support. Other outcomesPooled data from five studies on exercise levels showed no effect due to personalised care planning, but there was a positive effect on people's self-reported ability to carry out self-care activities: SMD 0.35 (95% CI 0.17 to 0.52).We found no evidence of adverse effects due to personalised care planning.The effects of personalised care planning were greater when more stages of the care planning cycle were completed, when contacts between patients and health professionals were more frequent, and when the patient's usual clinician was involved in the process. Personalised care planning leads to improvements in certain indicators of physical and psychological health status, and people's capability to self-manage their condition when compared to usual care. The effects are not large, but they appear greater when the intervention is more comprehensive, more intensive, and better integrated into routine care.

Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial.

PubMed

van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje P D; Hoogendijk, Emiel O; Muntinga, Maaike E; van Hout, Hein P J; Nijpels, Giel; van der Horst, Henriette E; van Tulder, Maurits W

2015-12-01

To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. Primary care (35 practices) in two regions in the Netherlands. Community-dwelling older adults who were frail according to their primary care physicians and the Program on Research for Integrating Services for the Maintenance of Autonomy case-finding tool questionnaire (N = 1,147). The GCM consisted of the following components: a regularly scheduled in-home comprehensive geriatric assessment by a practice nurse followed by a customized care plan, management and training of practice nurses by a geriatric expert team, and coordination of care through community network meetings and multidisciplinary team consultations of individuals with complex care needs. Outcomes were measured every 6 months and included costs from a societal perspective, health-related quality of life (Medical Outcomes Study 12-item Short-Form Survey (SF-12) physical (PCS) and mental component summary (MCS) scales), functional limitations (Katz activities of daily living and instrumental activities of daily living), and quality-adjusted life years based on the EQ-5D. Multilevel regression models adjusted for time and baseline confounders showed no significant differences in costs ($356, 95% confidence interval = -$488-1,134) and outcomes between intervention and usual care phases. Cost-effectiveness acceptability curves showed that, for the SF-12 PCS and MCS, the probability of the intervention being cost-effective was 0.76 if decision-makers are willing to pay $30,000 per point improvement on the SF-12 scales (range 0-100). For all other outcomes the probability of the intervention being cost-effective was low. Because the GCM was not cost-effective compared to usual care after 24 months of follow-up, widespread implementation in its current form is not recommended. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

The Astronomy of Aboriginal Australia

NASA Astrophysics Data System (ADS)

Norris, Ray P.; Hamacher, Duane W.

2011-06-01

The traditional cultures of Aboriginal Australians include a significant astronomical component, which is usually reported in terms of songs or stories associated with stars and constellations. Here we argue that the astronomical components extend further, and include a search for meaning in the sky, beyond simply mirroring the earth-bound understanding. In particular, we have found that traditional Aboriginal cultures include a deep understanding of the motion of objects in the sky, and that this knowledge was used for practical purposes such as constructing calendars. We also present evidence that traditional Aboriginal Australians made careful records and measurements of cyclical phenomena, and paid careful attention to unexpected phenomena such as eclipses and meteorite impacts.

Health care expenditures and therapeutic outcomes of a pharmacist-managed anticoagulation service versus usual medical care.

PubMed

Hall, Deanne; Buchanan, Julianne; Helms, Bethany; Eberts, Matthew; Mark, Scott; Manolis, Chronis; Peele, Pamela; Docimo, Anne

2011-07-01

To evaluate the differences in health care expenditures and therapeutic outcomes of patients receiving warfarin therapy management by a pharmacist-managed anticoagulation service compared with those receiving warfarin management by usual medical care. Retrospective, matched-cohort study. University of Pittsburgh Medical Center (UPMC) and UPMC Health Plan. Three hundred fifty adults who received warfarin therapy; 175 were managed by the pharmacist-managed anticoagulation service for at least 2 months between October 1, 2007, and September 30, 2008, (case patients) and 175 received usual care (matched comparison group). Medical claims data compared were direct anticoagulation cost and overall medical care costs, anticoagulation-related adverse events, hospitalizations and emergency department visits, frequency of international normalized ratio (INR) testing, and quantity of warfarin refills. Operational costs of the anticoagulation service were also calculated. The INR values and time within therapeutic range were assessed through anticoagulation service reports and laboratory results. The direct anticoagulation care cost was $35,465 versus $111,586 and the overall medical care cost was $754,191 versus $1,480,661 for the anticoagulation service group versus the usual care group. Accounting for operational and drug expenditure costs, the cost savings was $647,024 for the anticoagulation service group. The anticoagulation service group had significantly fewer anticoagulation-related adverse events (14 vs 41, p<0.0001), hospital admissions (3 vs 14, p<0.00001), and emergency department visits (58 vs 134, p<0.00001). The percentage of INR values in range and the percentage of time the INR values were in range were significantly higher in the anticoagulation service group (67.2% vs 54.6%, p<0.0001, and 73.7% vs 61.3%, p<0.0001, respectively). Compared with the usual care group, the anticoagulation service group had significantly more INR tests performed but demonstrated no significant difference in the quantity of drug refills. After accounting for operational costs, pharmacist-managed anticoagulation leads to reduced health care expenditure while improving therapeutic outcomes compared with usual medical care.

Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish 'TeleCare North' cluster-randomised trial.

PubMed

Witt Udsen, Flemming; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars

2017-05-17

To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. Community-based setting in the geographical area of North Denmark Region in Denmark. 26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI -754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI -0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. Clinicaltrials.gov, NCT01984840, 14 November 2013. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cost-effectiveness of telehealthcare to patients with chronic obstructive pulmonary disease: results from the Danish ‘TeleCare North’ cluster-randomised trial

PubMed Central

Witt Udsen, Flemming; Lilholt, Pernille Heyckendorff; Hejlesen, Ole; Ehlers, Lars

2017-01-01

Objectives To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. Design A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. Setting Community-based setting in the geographical area of North Denmark Region in Denmark. Participants 26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. Interventions In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. Main outcome measure Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. Results From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI −754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI −0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). Conclusions Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. Trial registration Clinicaltrials.gov, NCT01984840, 14 November 2013. PMID:28515193

Effect of adding postoperative noninvasive ventilation to usual care to prevent pulmonary complications in patients undergoing coronary artery bypass grafting: a randomized controlled trial.

PubMed

Al Jaaly, Emad; Fiorentino, Francesca; Reeves, Barnaby C; Ind, Philip W; Angelini, Gianni D; Kemp, Scott; Shiner, Robert J

2013-10-01

We compared the efficacy of noninvasive ventilation with bilevel positive airway pressure added to usual care versus usual care alone in patients undergoing coronary artery bypass grafting. We performed a 2-group, parallel, randomized controlled trial. The primary outcome was time until fit for discharge. Secondary outcomes were partial pressure of carbon dioxide, forced expiratory volume in 1 second, atelectasis, adverse events, duration of intensive care stay, and actual postoperative stay. A total of 129 patients were randomly allocated to bilevel positive airway pressure (66) or usual care (63). Three patients allocated to bilevel positive airway pressure withdrew. The median duration of bilevel positive airway pressure was 16 hours (interquartile range, 11-19). The median duration of hospital stay until fit for discharge was 5 days for the bilevel positive airway pressure group (interquartile range, 4-6) and 6 days for the usual care group (interquartile range, 5-7; hazard ratio, 1.68; 95% confidence interval, 1.08-2.31; P = .019). There was no significant difference in duration of intensive care, actual postoperative stay, and mean percentage of predicted forced expiratory volume in 1 second on day 3. Mean partial pressure of carbon dioxide was significantly reduced 1 hour after bilevel positive airway pressure application, but there was no overall difference between the groups up to 24 hours. Basal atelectasis occurred in 15 patients (24%) in the usual care group and 2 patients (3%) in the bilevel positive airway pressure group. Overall, 30% of patients in the bilevel positive airway pressure group experienced an adverse event compared with 59% in the usual care group. Among patients undergoing elective coronary artery bypass grafting, the use of bilevel positive airway pressure at extubation reduced the recovery time. Supported by trained staff, more than 75% of all patients allocated to bilevel positive airway pressure tolerated it for more than 10 hours. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Comparisons of Interventions for Preventing Falls in Older Adults

PubMed Central

Tricco, Andrea C.; Thomas, Sonia M.; Veroniki, Areti Angeliki; Hamid, Jemila S.; Cogo, Elise; Strifler, Lisa; Khan, Paul A.; Robson, Reid; Sibley, Kathryn M.; MacDonald, Heather; Riva, John J.; Thavorn, Kednapa; Wilson, Charlotte; Holroyd-Leduc, Jayna; Kerr, Gillian D.; Feldman, Fabio; Majumdar, Sumit R.; Jaglal, Susan B.; Hui, Wing

2017-01-01

Importance Falls result in substantial burden for patients and health care systems, and given the aging of the population worldwide, the incidence of falls continues to rise. Objective To assess the potential effectiveness of interventions for preventing falls. Data Sources MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Ageline databases from inception until April 2017. Reference lists of included studies were scanned. Study Selection Randomized clinical trials (RCTs) of fall-prevention interventions for participants aged 65 years and older. Data Extraction and Synthesis Pairs of reviewers independently screened the studies, abstracted data, and appraised risk of bias. Pairwise meta-analysis and network meta-analysis were conducted. Main Outcomes and Measures Injurious falls and fall-related hospitalizations. Results A total of 283 RCTs (159 910 participants; mean age, 78.1 years; 74% women) were included after screening of 10 650 titles and abstracts and 1210 full-text articles. Network meta-analysis (including 54 RCTs, 41 596 participants, 39 interventions plus usual care) suggested that the following interventions, when compared with usual care, were associated with reductions in injurious falls: exercise (odds ratio [OR], 0.51 [95% CI, 0.33 to 0.79]; absolute risk difference [ARD], −0.67 [95% CI, −1.10 to −0.24]); combined exercise and vision assessment and treatment (OR, 0.17 [95% CI, 0.07 to 0.38]; ARD, −1.79 [95% CI, −2.63 to −0.96]); combined exercise, vision assessment and treatment, and environmental assessment and modification (OR, 0.30 [95% CI, 0.13 to 0.70]; ARD, −1.19 [95% CI, −2.04 to −0.35]); and combined clinic-level quality improvement strategies (eg, case management), multifactorial assessment and treatment (eg, comprehensive geriatric assessment), calcium supplementation, and vitamin D supplementation (OR, 0.12 [95% CI, 0.03 to 0.55]; ARD, −2.08 [95% CI, −3.56 to −0.60]). Pairwise meta-analyses for fall-related hospitalizations (2 RCTs; 516 participants) showed no significant association between combined clinic- and patient-level quality improvement strategies and multifactorial assessment and treatment relative to usual care (OR, 0.78 [95% CI, 0.33 to 1.81]). Conclusions and Relevance Exercise alone and various combinations of interventions were associated with lower risk of injurious falls compared with usual care. Choice of fall-prevention intervention may depend on patient and caregiver values and preferences. PMID:29114830

Predicting Outcome in Computerized Cognitive Behavioral Therapy for Depression in Primary Care: A Randomized Trial

ERIC Educational Resources Information Center

de Graaf, L. Esther; Hollon, Steven D.; Huibers, Marcus J. H.

2010-01-01

Objective: To explore pretreatment and short-term improvement variables as potential moderators and predictors of 12-month follow-up outcome of unsupported online computerized cognitive behavioral therapy (CCBT), usual care, and CCBT combined with usual care for depression. Method: Three hundred and three depressed patients were randomly allocated…

Design and rationale of the ODYSSEY DM-DYSLIPIDEMIA trial: lipid-lowering efficacy and safety of alirocumab in individuals with type 2 diabetes and mixed dyslipidaemia at high cardiovascular risk.

PubMed

Müller-Wieland, Dirk; Leiter, Lawrence A; Cariou, Bertrand; Letierce, Alexia; Colhoun, Helen M; Del Prato, Stefano; Henry, Robert R; Tinahones, Francisco J; Aurand, Lisa; Maroni, Jaman; Ray, Kausik K; Bujas-Bobanovic, Maja

2017-05-25

Type 2 diabetes mellitus (T2DM) is often associated with mixed dyslipidaemia, where non-high-density lipoprotein cholesterol (non-HDL-C) levels may more closely align with cardiovascular risk than low-density lipoprotein cholesterol (LDL-C). We describe the design and rationale of the ODYSSEY DM-DYSLIPIDEMIA study that assesses the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk with non-HDL-C inadequately controlled despite maximally tolerated statin therapy. For the first time, atherogenic cholesterol-lowering with a PCSK9 inhibitor will be assessed with non-HDL-C as the primary endpoint with usual care as the comparator. DM-DYSLIPIDEMIA is a Phase 3b/4, randomised, open-label, parallel group, multinational study that planned to enrol 420 individuals. Main inclusion criteria were T2DM and mixed dyslipidaemia (non-HDL-C ≥100 mg/dl [≥2.59 mmol/l], and triglycerides ≥150 and <500 mg/dl [≥1.70 and <5.65 mmol/l]) with documented atherosclerotic cardiovascular disease or ≥1 additional cardiovascular risk factor. Participants were randomised (2:1) to alirocumab 75 mg every 2 weeks (Q2W) or lipid-lowering usual care on top of maximally tolerated statin (or no statin if intolerant). If randomised to usual care, investigators were able to add their pre-specified choice of one of the following to the patient's current statin regimen: ezetimibe, fenofibrate, omega-3 fatty acids or nicotinic acid, in accordance with local standard-of-care. Alirocumab-treated individuals with non-HDL-C ≥100 mg/dl at week 8 will undergo a blinded dose increase to 150 mg Q2W at week 12. The primary efficacy endpoint is non-HDL-C change from baseline to week 24 with alirocumab versus usual care; other lipid levels (including LDL-C), glycaemia-related measures, safety and tolerability will also be assessed. Alirocumab will be compared to fenofibrate in a secondary analysis. Recruitment completed with 413 individuals randomised in 14 countries worldwide. Results of this trial are expected in the second quarter of 2017. ODYSSEY DM-DYSLIPIDEMIA will provide information on the efficacy and safety of alirocumab versus lipid-lowering usual care in individuals with T2DM and mixed dyslipidaemia at high cardiovascular risk using non-HDL-C as the primary efficacy endpoint. Trial registration NCT02642159 (registered December 24, 2015).

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, Emily J; Cates, Christopher J; Kruske, Sue G; Morris, Peter S; Chang, Anne B; Brown, Ngiare

2009-01-21

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in May 2008. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Four studies were eligible for inclusion in the review. A total of 617 patients, aged from 5 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41), asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53), and in a single study, reducing asthma exacerbation in children (risk ratio for hospitalisations 0.32, 95%CI 0.15, 0.70). Current limited data show that culture-specific programmes for adults and children from minority groups with asthma, are more effective than generic programmes in improving most (quality of life, asthma knowledge, asthma exacerbations, asthma control) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, Emily J; Cates, Christopher J; Kruske, Sue G; Morris, Peter S; Brown, Ngiare; Chang, Anne B

2009-04-15

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in May 2008. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Four studies were eligible for inclusion in the review. A total of 617 patients, aged from 5 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41), asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53), and in a single study, reducing asthma exacerbation in children (risk ratio for hospitalisations 0.32, 95%CI 0.15, 0.70). Current limited data show that culture-specific programmes for adults and children from minority groups with asthma, are more effective than generic programmes in improving most (quality of life, asthma knowledge, asthma exacerbations, asthma control) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

Evaluation of a community-based inner-city disease management program for postmyocardial infarction patients: a randomized controlled trial

PubMed Central

Young, Wendy; Rewa, George; Goodman, Shaun G.; Jaglal, Susan Brenda; Cash, Linda; Lefkowitz, Charles; Coyte, Peter C.

2003-01-01

Background Disease management programs (DMPs) that use multidisciplinary teams and specialized clinics reduce hospital admissions and improve quality of life and functional status. Evaluations of cardiac DMPs delivered by home health nurses are required. Methods Between August 1999 and August 2000 we identified consecutive patients admitted to hospital with elevated cardiac enzymes. Patients who agreed were randomly assigned to participate in a DMP or to receive usual care. The DMP included 6 home visits by a cardiac-trained nurse, a standardized nurses' checklist, referral criteria for specialty care, communication with the family physician and patient education. We measured readmission days per 1000 follow-up days for angina, congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD); all-cause readmission days; and provincial claims for emergency department visits, physician visits, diagnostic or therapeutic services and laboratory services. Results We screened 715 consecutive patients admitted with elevated cardiac markers between August 1999 and August 2000. Of those screened 71 DMP and 75 usual care patients met the diagnostic criteria for myocardial infarction, were eligible for visits from a home health nurse and consented to participate in the study. Readmission days for angina, CHF and COPD per 1000 follow-up days were significantly higher for usual care patients than for DMP patients (incidence density ratio [IDR] = 1.59, 95% confidence interval [CI] 1.27–2.00, p < 0.001). All-cause readmission days per 1000 follow-up days were significantly higher for usual care patients than for DMP patients (IDR = 1.53, 95% CI 1.37–1.71, p < 0.001). The difference in emergency department encounters per 1000 follow-up days was significant (IDR = 2.08, 95% CI 1.56–2.77, p < 0.001). During the first 25 days after discharge, there were significantly fewer provincial claims submitted for DMP patients than for usual care patients for emergency department visits (p = 0.007), diagnostic or therapeutic services (p = 0.012) and laboratory services (p = 0.007). Interpretation The results provide evidence that an appropriately developed and implemented community-based inner-city DMP delivered by home health nurses has a positive impact on patient outcomes. PMID:14581307

Cost-Effectiveness of Collaborative Care for Depression in UK Primary Care: Economic Evaluation of a Randomised Controlled Trial (CADET)

PubMed Central

Green, Colin; Richards, David A.; Hill, Jacqueline J.; Gask, Linda; Lovell, Karina; Chew-Graham, Carolyn; Bower, Peter; Cape, John; Pilling, Stephen; Araya, Ricardo; Kessler, David; Bland, J. Martin; Gilbody, Simon; Lewis, Glyn; Manning, Chris; Hughes-Morley, Adwoa; Barkham, Michael

2014-01-01

Background Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking. Aims To assess the cost-effectiveness of collaborative care in a UK primary care setting. Methods An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression (n = 581). Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER) were calculated over a 12-month follow-up, from the perspective of the UK National Health Service and Personal Social Services (i.e. Third Party Payer). Sensitivity analyses are reported, and uncertainty is presented using the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness plane. Results The collaborative care intervention had a mean cost of £272.50 per participant. Health and social care service use, excluding collaborative care, indicated a similar profile of resource use between collaborative care and usual care participants. Collaborative care offered a mean incremental gain of 0.02 (95% CI: –0.02, 0.06) quality-adjusted life-years over 12 months, at a mean incremental cost of £270.72 (95% CI: –202.98, 886.04), and resulted in an estimated mean cost per QALY of £14,248. Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective, thereby dominating treatment as usual. Conclusion Collaborative care offers health gains at a relatively low cost, and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of £20,000 per QALY gained. Results here support the commissioning of collaborative care in a UK primary care setting. PMID:25121991

Results of the Medicare Health Support disease-management pilot program.

PubMed

McCall, Nancy; Cromwell, Jerry

2011-11-03

In the Medicare Modernization Act of 2003, Congress required the Centers for Medicare and Medicaid Services to test the commercial disease-management model in the Medicare fee-for-service program. The Medicare Health Support Pilot Program was a large, randomized study of eight commercial programs for disease management that used nurse-based call centers. We randomly assigned patients with heart failure, diabetes, or both to the intervention or to usual care (control) and compared them with the use of a difference-in-differences method to evaluate the effects of the commercial programs on the quality of clinical care, acute care utilization, and Medicare expenditures for Medicare fee-for-service beneficiaries. The study included 242,417 patients (163,107 in the intervention group and 79,310 in the control group). The eight commercial disease-management programs did not reduce hospital admissions or emergency room visits, as compared with usual care. We observed only 14 significant improvements in process-of-care measures out of 40 comparisons. These modest improvements came at substantial cost to the Medicare program in fees paid to the disease-management companies ($400 million), with no demonstrable savings in Medicare expenditures. In this large study, commercial disease-management programs using nurse-based call centers achieved only modest improvements in quality-of-care measures, with no demonstrable reduction in the utilization of acute care or the costs of care.

Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial.

PubMed

Bogner, Hillary R; Morales, Knashawn H; de Vries, Heather F; Cappola, Anne R

2012-01-01

Depression commonly accompanies diabetes, resulting in reduced adherence to medications and increased risk for morbidity and mortality. The objective of this study was to examine whether a simple, brief integrated approach to depression and type 2 diabetes mellitus (type 2 diabetes) treatment improved adherence to oral hypoglycemic agents and antidepressant medications, glycemic control, and depression among primary care patients. We undertook a randomized controlled trial conducted from April 2010 through April 2011 of 180 patients prescribed pharmacotherapy for type 2 diabetes and depression in primary care. Patients were randomly assigned to an integrated care intervention or usual care. Integrated care managers collaborated with physicians to offer education and guideline-based treatment recommendations and to monitor adherence and clinical status. Adherence was assessed using the Medication Event Monitoring System (MEMS). We used glycated hemoglobin (HbA(1c)) assays to measure glycemic control and the 9-item Patient Health Questionnaire (PHQ-9) to assess depression. Intervention and usual care groups did not differ statistically on baseline measures. Patients who received the intervention were more likely to achieve HbA(1c) levels of less than 7% (intervention 60.9% vs. usual care 35.7%; P < .001) and remission of depression (PHQ-9 score of less than 5: intervention 58.7% vs. usual care 30.7%; P < .001) in comparison with patients in the usual care group at 12 weeks. A randomized controlled trial of a simple, brief intervention integrating treatment of type 2 diabetes and depression was successful in improving outcomes in primary care. An integrated approach to depression and type 2 diabetes treatment may facilitate its deployment in real-world practices with competing demands for limited resources.

A Computerized Decision Support System for Depression in Primary Care

PubMed Central

Kurian, Benji T.; Trivedi, Madhukar H.; Grannemann, Bruce D.; Claassen, Cynthia A.; Daly, Ella J.; Sunderajan, Prabha

2009-01-01

Objective: In 2004, results from The Texas Medication Algorithm Project (TMAP) showed better clinical outcomes for patients whose physicians adhered to a paper-and-pencil algorithm compared to patients who received standard clinical treatment for major depressive disorder (MDD). However, implementation of and fidelity to the treatment algorithm among various providers was observed to be inadequate. A computerized decision support system (CDSS) for the implementation of the TMAP algorithm for depression has since been developed to improve fidelity and adherence to the algorithm. Method: This was a 2-group, parallel design, clinical trial (one patient group receiving MDD treatment from physicians using the CDSS and the other patient group receiving usual care) conducted at 2 separate primary care clinics in Texas from March 2005 through June 2006. Fifty-five patients with MDD (DSM-IV criteria) with no significant difference in disease characteristics were enrolled, 32 of whom were treated by physicians using CDSS and 23 were treated by physicians using usual care. The study's objective was to evaluate the feasibility and efficacy of implementing a CDSS to assist physicians acutely treating patients with MDD compared to usual care in primary care. Primary efficacy outcomes for depression symptom severity were based on the 17-item Hamilton Depression Rating Scale (HDRS17) evaluated by an independent rater. Results: Patients treated by physicians employing CDSS had significantly greater symptom reduction, based on the HDRS17, than patients treated with usual care (P < .001). Conclusions: The CDSS algorithm, utilizing measurement-based care, was superior to usual care for patients with MDD in primary care settings. Larger randomized controlled trials are needed to confirm these findings. Trial Registration: clinicaltrials.gov Identifier: NCT00551083 PMID:19750065

A computerized decision support system for depression in primary care.

PubMed

Kurian, Benji T; Trivedi, Madhukar H; Grannemann, Bruce D; Claassen, Cynthia A; Daly, Ella J; Sunderajan, Prabha

2009-01-01

In 2004, results from The Texas Medication Algorithm Project (TMAP) showed better clinical outcomes for patients whose physicians adhered to a paper-and-pencil algorithm compared to patients who received standard clinical treatment for major depressive disorder (MDD). However, implementation of and fidelity to the treatment algorithm among various providers was observed to be inadequate. A computerized decision support system (CDSS) for the implementation of the TMAP algorithm for depression has since been developed to improve fidelity and adherence to the algorithm. This was a 2-group, parallel design, clinical trial (one patient group receiving MDD treatment from physicians using the CDSS and the other patient group receiving usual care) conducted at 2 separate primary care clinics in Texas from March 2005 through June 2006. Fifty-five patients with MDD (DSM-IV criteria) with no significant difference in disease characteristics were enrolled, 32 of whom were treated by physicians using CDSS and 23 were treated by physicians using usual care. The study's objective was to evaluate the feasibility and efficacy of implementing a CDSS to assist physicians acutely treating patients with MDD compared to usual care in primary care. Primary efficacy outcomes for depression symptom severity were based on the 17-item Hamilton Depression Rating Scale (HDRS(17)) evaluated by an independent rater. Patients treated by physicians employing CDSS had significantly greater symptom reduction, based on the HDRS(17), than patients treated with usual care (P < .001). The CDSS algorithm, utilizing measurement-based care, was superior to usual care for patients with MDD in primary care settings. Larger randomized controlled trials are needed to confirm these findings. clinicaltrials.gov Identifier: NCT00551083.

Decision aids for people facing health treatment or screening decisions.

PubMed

Stacey, Dawn; Légaré, France; Lewis, Krystina; Barry, Michael J; Bennett, Carol L; Eden, Karen B; Holmes-Rovner, Margaret; Llewellyn-Thomas, Hilary; Lyddiatt, Anne; Thomson, Richard; Trevena, Lyndal

2017-04-12

Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values. To assess the effects of decision aids in people facing treatment or screening decisions. Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008. We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids. Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence. We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup. Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.

Update of Inpatient Treatment for Refractory Chronic Daily Headache.

PubMed

Lai, Tzu-Hsien; Wang, Shuu-Jiun

2016-01-01

Chronic daily headache (CDH) is a group of headache disorders, in which headaches occur daily or near-daily (>15 days per month) and last for more than 3 months. Important CDH subtypes include chronic migraine, chronic tension-type headache, hemicrania continua, and new daily persistent headache. Other headaches with shorter durations (<4 h/day) are usually not included in CDH. Common comorbidities of CDH are medication overuse headache and various psychiatric disorders, such as depression and anxiety. Indications of inpatient treatment for CDH patients include poor responses to outpatient management, need for detoxification for overuse of specific medications (particularly opioids and barbiturates), and severe psychiatric comorbidities. Inpatient treatment usually involves stopping acute pain, preventing future attacks, and detoxifying medication overuse if present. Multidisciplinary integrated care that includes medical staff from different disciplines (e.g., psychiatry, clinical psychology, and physical therapy) has been recommended. The outcomes of inpatient treatment are satisfactory in terms of decreasing headache intensity or frequency, withdrawal from medication overuse, reducing disability, and improving life quality, although long-term relapse is not uncommon. In conclusion, inpatient treatment may be useful for select patients with refractory CDH and should be incorporated in a holistic headache care program.

Fall Prevention in a Primary Care Setting.

PubMed

Siegrist, Monika; Freiberger, Ellen; Geilhof, Barbara; Salb, Johannes; Hentschke, Christian; Landendoerfer, Peter; Linde, Klause; Halle, Martin; Blank, Wolfgang A

2016-05-27

Falls and fall-related injuries are common in community-dwelling elderly people. Effective multifactorial fall prevention programs in the primary care setting may be a promising approach to reduce the incidence rate of falls. In a cluster randomized trial in 33 general practices 378 people living independently and at high risk of falling (65 to 94 years old; 285 women) were allocated to either a 16 week exercise-based fall prevention program including muscle strengthening and challenging balance training exercises, combined with a 12 week home-based exercise program (222 participants), or to usual care (156 participants). The main outcome was number of falls over a period of 12 months. Secondary outcomes were the number of fall-related injuries, physical function (Timed-Up-and-Go-Test, TUG, Chair-Stand-Test, CST, modified Romberg Test), and fear of falling. In the intervention group (n=222 patients in 17 general practices) 291 falls occurred, compared to 367 falls in the usual care group (n=156 patients in 16 general practices). We observed a lower incidence rate for falls in the intervention group (incidence rate ratio/IRR: 0.54; 95% confidence interval (CI): [0.35; 0.84], p=0.007) and for fall-related injuries (IRR: 0.66; [0.42; 0.94], p=0.033). Additionally, patients in the intervention group showed significant improvements in secondary endpoints (TUG: -2.39 s, [-3.91; -0.87], p=0.014; mRomberg: 1.70 s, [0.35; 3.04], p=0.037; fear of falling: -2.28 points, [-3.87; -0.69], p=0.022) compared to usual care. A complex falls prevention program in a primary care setting was effective in reducing falls and fall-related injuries in community dwelling older adults at risk.

Evaluation of a “Just-in-Time” Nurse Consultation on Bone Health: A Pilot Randomized Controlled Trial

PubMed Central

Roblin, Douglas W; Zelman, David; Plummer, Sally; Robinson, Brandi E; Lou, Yiyue; Edmonds, Stephanie W; Wolinsky, Fredric D; Saag, Kenneth G; Cram, Peter

2017-01-01

Context Evidence is inconclusive whether a nurse consultation can improve osteoporosis-related patient outcomes. Objective To evaluate whether a nurse consultation immediately after dual-energy x-ray absorptiometry (DXA) produced better osteoporosis-related outcomes than a simple intervention to activate adults in good bone health practices or usual care. Design Pilot randomized controlled trial, conducted within the larger Patient Activation After DXA Result Notification (PAADRN) trial (NCT01507662). After DXA, consenting adults age 50 years or older were randomly assigned to 3 groups: nurse consultation, PAADRN intervention (mailed letter with individualized fracture risk and an educational brochure), or usual care (control). Nurse consultation included reviewing DXA results, counseling on bone health, and ordering needed follow-up tests or physician referrals. Main Outcome Measures Change from baseline to 52 weeks in participant-reported osteoporosis-related pharmacotherapy, lifestyle, activation and self-efficacy, and osteoporosis care satisfaction. Results Nurse consultation participants (n = 104) reported 52-week improvements in strengthening and weight-bearing exercise (p = 0.09), calcium intake (p < 0.01), osteoporosis knowledge (p = 0.04), activation (p < 0.01), dietary self-efficacy (p = 0.06), and osteoporosis care satisfaction (p < 0.01). Compared with PAADRN intervention participants (n = 39), nurse consultation participants had improved dietary self-efficacy (p = 0.07) and osteoporosis care satisfaction (p = 0.05). No significant improvements in osteoporosis-related outcomes were achieved vs PAADRN controls (n = 70). Conclusion “Just-in-time” nurse consultation yielded a few improvements over 52 weeks in osteoporosis-related outcomes; however, most changes were not different from those obtained through the lower-cost PAADRN intervention or usual care. PMID:28746019

Do polypills lead to neglect of lifestyle risk factors? Findings from an individual participant data meta-analysis among 3140 patients at high risk of cardiovascular disease.

PubMed

Selak, Vanessa; Bullen, Chris; Stepien, Sandrine; Arroll, Bruce; Bots, Michiel; Bramley, Dale; Cass, Alan; Grobbee, Diederick; Hillis, Graham S; Molanus, Barbara; Neal, Bruce; Patel, Anushka; Rafter, Natasha; Rodgers, Anthony; Thom, Simon; Tonkin, Andrew; Usherwood, Tim; Wadham, Angela; Webster, Ruth

2016-09-01

The aim of this study was to investigate whether polypill-based care for the prevention of cardiovascular disease (CVD) is associated with a change in lifestyle risk factors when compared with usual care, among patients with CVD or high calculated cardiovascular risk. We conducted an individual participant data meta-analysis of three trials including patients from Australia, England, India, Ireland, the Netherlands and New Zealand that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior CVD event or who were at high risk of their first event. Analyses investigated any differential effect on anthropometric measures and self-reported lifestyle behaviours. Among 3140 patients (75% male, mean age 62 years and 76% with a prior CVD event) there was no difference in lifestyle risk factors in those randomised to polypill-based care compared with usual care over a median of 15 months, either across all participants combined, or in a range of subgroups. Furthermore, narrow confidence intervals (CIs) excluded any major effect; for example differences between the groups in body mass index was -0.1 (95% CI -0.2 to 0.1) kg/m(2), in weekly duration of moderate intensity physical activity was -2 (-26 to 23) minutes and the proportion of smokers was 16% vs 17% (RR 0.98, 0.84 to 1.15) at the end of trial. This analysis allays concern that polypill-based care may lead to neglect of lifestyle risk factors, at least among high-risk patients. Maximally effective preventive approaches should address lifestyle factors alongside pharmaceutical interventions, as recommended by major international guidelines. © The European Society of Cardiology 2016.

Psychological therapies for treatment-resistant depression in adults.

PubMed

Ijaz, Sharea; Davies, Philippa; Williams, Catherine J; Kessler, David; Lewis, Glyn; Wiles, Nicola

2018-05-14

Antidepressants are a first-line treatment for adults with moderate to severe major depression. However, many people prescribed antidepressants for depression don't respond fully to such medication, and little evidence is available to inform the most appropriate 'next step' treatment for such patients, who may be referred to as having treatment-resistant depression (TRD). National Institute for Health and Care Excellence (NICE) guidance suggests that the 'next step' for those who do not respond to antidepressants may include a change in the dose or type of antidepressant medication, the addition of another medication, or the start of psychotherapy. Different types of psychotherapies may be used for TRD; evidence on these treatments is available but has not been collated to date.Along with the sister review of pharmacological therapies for TRD, this review summarises available evidence for the effectiveness of psychotherapies for adults (18 to 74 years) with TRD with the goal of establishing the best 'next step' for this group. To assess the effectiveness of psychotherapies for adults with TRD. We searched the Cochrane Common Mental Disorders Controlled Trials Register (until May 2016), along with CENTRAL, MEDLINE, Embase, and PsycINFO via OVID (until 16 May 2017). We also searched the World Health Organization (WHO) trials portal (ICTRP) and ClinicalTrials.gov to identify unpublished and ongoing studies. There were no date or language restrictions. We included randomised controlled trials (RCTs) with participants aged 18 to 74 years diagnosed with unipolar depression that had not responded to minimum four weeks of antidepressant treatment at a recommended dose. We excluded studies of drug intolerance. Acceptable diagnoses of unipolar depression were based onthe Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) or earlier versions, International Classification of Diseases (ICD)-10, Feighner criteria, or Research Diagnostic Criteria. We included the following comparisons.1. Any psychological therapy versus antidepressant treatment alone, or another psychological therapy.2. Any psychological therapy given in addition to antidepressant medication versus antidepressant treatment alone, or a psychological therapy alone.Primary outcomes required were change in depressive symptoms and number of dropouts from study or treatment (as a measure of acceptability). We extracted data, assessed risk of bias in duplicate, and resolved disagreements through discussion or consultation with a third person. We conducted random-effects meta-analyses when appropriate. We summarised continuous outcomes using mean differences (MDs) or standardised mean differences (SMDs), and dichotomous outcomes using risk ratios (RRs). We included six trials (n = 698; most participants were women approximately 40 years of age). All studies evaluated psychotherapy plus usual care (with antidepressants) versus usual care (with antidepressants). Three studies addressed the addition of cognitive-behavioural therapy (CBT) to usual care (n = 522), and one each evaluated intensive short-term dynamic psychotherapy (ISTDP) (n = 60), interpersonal therapy (IPT) (n = 34), or group dialectical behavioural therapy (DBT) (n = 19) as the intervention. Most studies were small (except one trial of CBT was large), and all studies were at high risk of detection bias for the main outcome of self-reported depressive symptoms.A random-effects meta-analysis of five trials (n = 575) showed that psychotherapy given in addition to usual care (vs usual care alone) produced improvement in self-reported depressive symptoms (MD -4.07 points, 95% confidence interval (CI) -7.07 to -1.07 on the Beck Depression Inventory (BDI) scale) over the short term (up to six months). Effects were similar when data from all six studies were combined for self-reported depressive symptoms (SMD -0.40, 95% CI -0.65 to -0.14; n = 635). The quality of this evidence was moderate. Similar moderate-quality evidence of benefit was seen on the Patient Health Questionnaire-9 Scale (PHQ-9) from two studies (MD -4.66, 95% CI 8.72 to -0.59; n = 482) and on the Hamilton Depression Rating Scale (HAMD) from four studies (MD -3.28, 95% CI -5.71 to -0.85; n = 193).High-quality evidence shows no differential dropout (a measure of acceptability) between intervention and comparator groups over the short term (RR 0.85, 95% CI 0.58 to 1.24; six studies; n = 698).Moderate-quality evidence for remission from six studies (RR 1.92, 95% CI 1.46 to 2.52; n = 635) and low-quality evidence for response from four studies (RR 1.80, 95% CI 1.2 to 2.7; n = 556) indicate that psychotherapy was beneficial as an adjunct to usual care over the short term.With the addition of CBT, low-quality evidence suggests lower depression scores on the BDI scale over the medium term (12 months) (RR -3.40, 95% CI -7.21 to 0.40; two studies; n = 475) and over the long term (46 months) (RR -1.90, 95% CI -3.22 to -0.58; one study; n = 248). Moderate-quality evidence for adjunctive CBT suggests no difference in acceptability (dropout) over the medium term (RR 0.98, 95% CI 0.66 to 1.47; two studies; n = 549) and lower dropout over long term (RR 0.80, 95% CI 0.66 to 0.97; one study; n = 248).Two studies reported serious adverse events (one suicide, two hospitalisations, and two exacerbations of depression) in 4.2% of the total sample, which occurred only in the usual care group (no events in the intervention group).An economic analysis (conducted as part of an included study) from the UK healthcare perspective (National Health Service (NHS)) revealed that adjunctive CBT was cost-effective over nearly four years. Moderate-quality evidence shows that psychotherapy added to usual care (with antidepressants) is beneficial for depressive symptoms and for response and remission rates over the short term for patients with TRD. Medium- and long-term effects seem similarly beneficial, although most evidence was derived from a single large trial. Psychotherapy added to usual care seems as acceptable as usual care alone.Further evidence is needed on the effectiveness of different types of psychotherapies for patients with TRD. No evidence currently shows whether switching to a psychotherapy is more beneficial for this patient group than continuing an antidepressant medication regimen. Addressing this evidence gap is an important goal for researchers.

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN)

PubMed Central

Thompson, Tom P; Callaghan, Lynne; Hazeldine, Emma; Quinn, Cath; Walker, Samantha; Byng, Richard; Wallace, Gary; Creanor, Siobhan; Green, Colin; Hawton, Annie; Annison, Jill; Sinclair, Julia; Senior, Jane; Taylor, Adrian H

2018-01-01

Introduction People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. Methods and analysis A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. Ethics and dissemination The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. Trial registration numbers ISRCTN80475744; Pre-results. PMID:29866736

Large multi-centre pilot randomized controlled trial testing a low-cost, tailored, self-help smoking cessation text message intervention for pregnant smokers (MiQuit).

PubMed

Naughton, Felix; Cooper, Sue; Foster, Katharine; Emery, Joanne; Leonardi-Bee, Jo; Sutton, Stephen; Jones, Matthew; Ussher, Michael; Whitemore, Rachel; Leighton, Matthew; Montgomery, Alan; Parrott, Steve; Coleman, Tim

2017-07-01

To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Sixteen antenatal clinics in England. Four hundred and seven participants were randomized to the intervention (n = 203) or usual care (n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. © 2017 The Authors. Addiction published by John Wiley & Sons Ltd on behalf of Society for the Study of Addiction.

Cost-Effectiveness Analysis of Acupuncture, Counselling and Usual Care in Treating Patients with Depression: The Results of the ACUDep Trial

PubMed Central

Spackman, Eldon; Richmond, Stewart; Sculpher, Mark; Bland, Martin; Brealey, Stephen; Gabe, Rhian; Hopton, Ann; Keding, Ada; Lansdown, Harriet; Perren, Sara; Torgerson, David; Watt, Ian; MacPherson, Hugh

2014-01-01

Background New evidence on the clinical effectiveness of acupuncture plus usual care (acupuncture) and counselling plus usual care (counselling) for patients with depression suggests the need to investigate the health-related quality of life and costs of these treatments to understand whether they should be considered a good use of limited health resources. Methods and Findings The cost-effectiveness analyses are based on the Acupuncture, Counselling or Usual care for Depression (ACUDep) trial results. Statistical analyses demonstrate a difference in mean quality adjusted life years (QALYs) and suggest differences in mean costs which are mainly due to the price of the interventions. Probabilistic sensitivity analysis is used to express decision uncertainty. Acupuncture and counselling are found to have higher mean QALYs and costs than usual care. In the base case analysis acupuncture has an incremental cost-effectiveness ratio (ICER) of £4,560 per additional QALY and is cost-effective with a probability of 0.62 at a cost-effectiveness threshold of £20,000 per QALY. Counselling compared with acupuncture is more effective and more costly with an ICER of £71,757 and a probability of being cost-effective of 0.36. A scenario analysis of counselling versus usual care, excluding acupuncture as a comparator, results in an ICER of £7,935 and a probability of 0.91. Conclusions Acupuncture is cost-effective compared with counselling or usual care alone, although the ranking of counselling and acupuncture depends on the relative cost of delivering these interventions. For patients in whom acupuncture is unavailable or perhaps inappropriate, counselling has an ICER less than most cost-effectiveness thresholds. However, further research is needed to determine the most cost-effective treatment pathways for depressed patients when the full range of available interventions is considered. PMID:25426637

Electronic Health Record for Intensive Care based on Usual Windows Based Software.

PubMed

Reper, Arnaud; Reper, Pascal

2015-08-01

In Intensive Care Units, the amount of data to be processed for patients care, the turn over of the patients, the necessity for reliability and for review processes indicate the use of Patient Data Management Systems (PDMS) and electronic health records (EHR). To respond to the needs of an Intensive Care Unit and not to be locked with proprietary software, we developed an EHR based on usual software and components. The software was designed as a client-server architecture running on the Windows operating system and powered by the access data base system. The client software was developed using Visual Basic interface library. The application offers to the users the following functions: medical notes captures, observations and treatments, nursing charts with administration of medications, scoring systems for classification, and possibilities to encode medical activities for billing processes. Since his deployment in September 2004, the EHR was used to care more than five thousands patients with the expected software reliability and facilitated data management and review processes. Communications with other medical software were not developed from the start, and are realized by the use of basic functionalities communication engine. Further upgrade of the system will include multi-platform support, use of typed language with static analysis, and configurable interface. The developed system based on usual software components was able to respond to the medical needs of the local ICU environment. The use of Windows for development allowed us to customize the software to the preexisting organization and contributed to the acceptability of the whole system.

Evaluating and Managing Acute Low Back Pain in the Primary Care Setting

PubMed Central

Atlas, Steven J; Deyo, Richard A

2001-01-01

Acute low back pain is a common reason for patient calls or visits to a primary care clinician. Despite a large differential diagnosis, the precise etiology is rarely identified, although musculoligamentous processes are usually suspected. For most patients, back symptoms are nonspecific, meaning that there is no evidence for radicular symptoms or underlying systemic disease. Because episodes of acute, nonspecific low back pain are usually self-limited, many patients treat themselves without contacting their primary care clinician. When patients do call or schedule a visit, evaluation and management by primary care clinicians is appropriate. The history and physical examination usually provide clues to the rare but potentially serious causes of low back pain, as well as to identify patients at risk for prolonged recovery. Diagnostic testing, including plain x-rays, is often unnecessary during the initial evaluation. For patients with acute, nonspecific low back pain, the primary emphasis of treatment should be conservative care, time, reassurance, and education. Current recommendations focus on activity as tolerated (though not active exercise while pain is severe) and minimal if any bed rest. Referral for physical treatments is most appropriate for patients whose symptoms are not improving over 2 to 4 weeks. Specialty referral should be considered for patients with a progressive neurologic deficit, failure of conservative therapy, or an uncertain or serious diagnosis. The prognosis for most patients is good, although recurrence is common. Thus, educating patients about the natural history of acute low back pain and how to prevent future episodes can help ensure reasonable expectations. PMID:11251764

Motivational Interviewing or Reminders for Glaucoma Medication Adherence? Results of a Multi-Site Randomized Controlled Trial

PubMed Central

Schmiege, Sarah J.; Mansberger, Steven L.; Sheppler, Christina; Kammer, Jeffrey; Fitzgerald, Timothy; Kahook, Malik Y.

2017-01-01

Objective Nonadherence reduces glaucoma treatment efficacy. Motivational interviewing (MI) is a well-studied adherence intervention, but has not been tested in glaucoma. Reminder interventions also may improve adherence. Design 201 patients with glaucoma or ocular hypertension were urn-randomized to receive MI delivered by an ophthalmic technician (OT), usual care, or a minimal behavioral intervention (reminder calls). Main Outcome Measures Outcomes included electronic monitoring with Medication Event Monitoring System (MEMS) bottles, two self-report adherence measures, patient satisfaction, and clinical outcomes. Multilevel modeling was used to test differences in MEMS results by group over time; ANCOVA was used to compare groups on other measures. Results Reminder calls increased adherence compared to usual care based on MEMS, p = .005, and self-report, p = .04. MI had a nonsignificant effect but produced higher satisfaction than reminder calls, p = .007. Treatment fidelity was high on most measures, with observable differences in behavior between groups. All groups had high baseline adherence that limited opportunities for change. Conclusion Reminder calls, but not MI, led to better adherence than usual care. Although a large literature supports MI, reminder calls might be a cost-effective intervention for patients with high baseline adherence. Replication is needed with less adherent participants. PMID:27701902

Impact of Tranexamic Acid in Total Knee and Total Hip Replacement.

PubMed

Boyle, Jaclyn A; Soric, Mate M

2017-02-01

To evaluate the net clinical benefit of tranexamic acid use in patients undergoing total knee or total hip replacement. This is a retrospective study of patients undergoing total knee or total hip replacement. The primary outcome was the net clinical benefit of tranexamic acid use. Secondary outcomes included length of stay, incidence of venous thromboembolism, change in hemoglobin, and number of units of blood transfused. Four hundred and six patients were screened for inclusion and 327 patients met inclusion criteria; 174 patients received tranexamic acid versus 153 patients who received usual care. Tranexamic acid demonstrated a positive net clinical benefit versus usual care (40.8% vs 13.7%, P < .01) but did not affect length of stay (3.39 vs 3.37 days, respectively, P = .76). Venous thromboembolism was comparable between groups (2.3% vs 0.7%, P = .38). Average change in hemoglobin and need for transfusion were lower in the treatment group versus the usual care group, respectively (3.46 vs 4.26 mg/dL, P < .01). Tranexamic acid demonstrated a significant benefit in decreasing change in hemoglobin as well as the need for blood transfusion with no increase in the risk of venous thromboembolism in patients undergoing total knee or total hip replacement.

Andrographis paniculata (Chuān Xīn Lián) for symptomatic relief of acute respiratory tract infections in adults and children: A systematic review and meta-analysis.

PubMed

Hu, Xiao-Yang; Wu, Ruo-Han; Logue, Martin; Blondel, Clara; Lai, Lily Yuen Wan; Stuart, Beth; Flower, Andrew; Fei, Yu-Tong; Moore, Michael; Shepherd, Jonathan; Liu, Jian-Ping; Lewith, George

2017-01-01

Antimicrobial resistance (AMR) is a substantial threat to public health. Safe and effective alternatives are required to reduce unnecessary antibiotic prescribing. Andrographis Paniculata (A. Paniculata, Chuān Xīn Lián) has traditionally been used in Indian and Chinese herbal medicine for cough, cold and influenza, suggesting a role in respiratory tract infections (RTIs). This systematic review aimed to evaluate the clinical effectiveness and safety of A. Paniculata for symptoms of acute RTIs (ARTIs). English and Chinese databases were searched from their inception to March 2016 for randomised controlled trials (RCTs) evaluating oral A. Paniculata without language barriers (Protocol ID: CRD42016035679). The primary outcomes were improvement in ARTI symptoms and adverse events (AEs). A random effects model was used to pool the mean differences and risk ratio with 95% CI reported. Methodological quality was evaluated using the Cochrane risk of bias tool; two reviewers independently screened eligibility and extracted data. Thirty-three RCTs (7175 patients) were included. Most trials evaluated A. Paniculata (as a monotherapy and as a herbal mixture) provided commercially but seldom reported manufacturing or quality control details. A. Paniculata improved cough (n = 596, standardised mean difference SMD: -0.39, 95% confidence interval CI [-0.67, -0.10]) and sore throat (n = 314, SMD: -1.13, 95% CI [-1.37, -0.89]) when compared with placebo. A. Paniculata (alone or plus usual care) has a statistically significant effect in improving overall symptoms of ARTIs when compared to placebo, usual care, and other herbal therapies. Evidence also suggested that A. Paniculata (alone or plus usual care) shortened the duration of cough, sore throat and sick leave/time to resolution when compared versus usual care. No major AEs were reported and minor AEs were mainly gastrointestinal. The methodological quality of included trials was overall poor. A. Paniculata appears beneficial and safe for relieving ARTI symptoms and shortening time to symptom resolution. However, these findings should be interpreted cautiously owing to poor study quality and heterogeneity. Well-designed trials evaluating the effectiveness and potential to reduce antibiotic use of A. Paniculata are warranted.

Data feedback and behavioural change intervention to improve primary care prescribing safety (EFIPPS): multicentre, three arm, cluster randomised controlled trial.

PubMed

Guthrie, Bruce; Kavanagh, Kimberley; Robertson, Chris; Barnett, Karen; Treweek, Shaun; Petrie, Dennis; Ritchie, Lewis; Bennie, Marion

2016-08-18

 To evaluate the effectiveness of feedback on safety of prescribing compared with moderately enhanced usual care.  Three arm, highly pragmatic cluster randomised trial.  262/278 (94%) primary care practices in three Scottish health boards.  Practices were randomised to: "usual care," consisting of emailed educational material with support for searching to identify patients (88 practices at baseline, 86 analysed); usual care plus feedback on practice's high risk prescribing sent quarterly on five occasions (87 practices, 86 analysed); or usual care plus the same feedback incorporating a behavioural change component (87 practices, 86 analysed).  The primary outcome was a patient level composite of six prescribing measures relating to high risk use of antipsychotics, non-steroidal anti-inflammatories, and antiplatelets. Secondary outcomes were the six individual measures. The primary analysis compared high risk prescribing in the two feedback arms against usual care at 15 months. Secondary analyses examined immediate change and change in trend of high risk prescribing associated with implementation of the intervention within each arm.  In the primary analysis, high risk prescribing as measured by the primary outcome fell from 6.0% (3332/55 896) to 5.1% (2845/55 872) in the usual care arm, compared with 5.9% (3341/56 194) to 4.6% (2587/56 478) in the feedback only arm (odds ratio 0.88 (95% confidence interval 0.80 to 0.96) compared with usual care; P=0.007) and 6.2% (3634/58 569) to 4.6% (2686/58 582) in the feedback plus behavioural change component arm (0.86 (0.78 to 0.95); P=0.002). In the pre-specified secondary analysis of change in trend within each arm, the usual care educational intervention had no effect on the existing declining trend in high risk prescribing. Both types of feedback were associated with significantly more rapid decline in high risk prescribing after the intervention compared with before.  Feedback of prescribing safety data was effective at reducing high risk prescribing. The intervention would be feasible to implement at scale in contexts where electronic health records are in general use.Trial registration Clinical trials NCT01602705. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Improving diabetes care among patients overdue for recommended testing: a randomized controlled trial of automated telephone outreach.

PubMed

Simon, Steven R; Trinacty, Connie Mah; Soumerai, Stephen B; Piette, John D; Meigs, James B; Shi, Ping; Ensroth, Arthur; Ross-Degnan, Dennis

2010-07-01

The study's objective was to assess the effects of automated telephone outreach with speech recognition (ATO-SR) on diabetes-related testing. We identified 1,200 health plan members who were overdue for diabetes-related testing and randomly allocated 600 to ATO-SR and 600 to usual care (no intervention). The intervention included three interactive calls encouraging recommended testing. The primary outcome was retinopathy testing, since this was the health plan's principal goal. Tests for glycemia, hyperlipidemia, and nephropathy were secondary outcomes. In total, 232 participants (39%) verbally responded to the calls. There was no difference between the intervention and the usual care groups in the primary outcome (adjusted hazard ratio 0.93 [95% CI 0.71-1.22]) and no effect of the intervention on any of the secondary outcomes. Fewer than 40% of the patients randomized to ATO-SR interacted verbally with the system. The intervention had no effect on the study's outcomes.

Characterizing Time to Diagnostic Resolution After an Abnormal Cancer Screening Exam in Older Adult Participants in the Ohio Patient Navigation Research Program.

PubMed

DeSalvo, Jennifer M; Young, Gregory S; Krok-Schoen, Jessica L; Paskett, Electra D

2017-06-01

This study aims to test the effectiveness of a patient navigation (PN) intervention to reduce time to diagnostic resolution among older adults age ≥65 years versus those <65 years with abnormal breast, cervical, or colorectal cancer screening exams participating in the Ohio Patient Navigation Research Program (OPNRP). The OPNRP utilized a nested cohort group-randomized trial design to randomize 862 participants ( n = 67 for ≥65 years; n = 795 for <65 years) to PN or usual care conditions. A shared frailty Cox model tested the effect of PN on time to resolution. Older adult participants randomized to PN achieved a 6-month resolution rate that was 127% higher than those randomized to usual care ( p = .001). This effect was not significantly different from participants <65 years. PN significantly reduced time to diagnostic resolution among older adults beginning 6 months after an abnormal cancer screening exam. Health care systems should include this population in PN programs to reduce cancer disparities.

Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review.

PubMed

Pearse, Rupert M; Harrison, David A; MacDonald, Neil; Gillies, Michael A; Blunt, Mark; Ackland, Gareth; Grocott, Michael P W; Ahern, Aoife; Griggs, Kathryn; Scott, Rachael; Hinds, Charles; Rowan, Kathryn

2014-06-04

Small trials suggest that postoperative outcomes may be improved by the use of cardiac output monitoring to guide administration of intravenous fluid and inotropic drugs as part of a hemodynamic therapy algorithm. To evaluate the clinical effectiveness of a perioperative, cardiac output-guided hemodynamic therapy algorithm. OPTIMISE was a pragmatic, multicenter, randomized, observer-blinded trial of 734 high-risk patients aged 50 years or older undergoing major gastrointestinal surgery at 17 acute care hospitals in the United Kingdom. An updated systematic review and meta-analysis were also conducted including randomized trials published from 1966 to February 2014. Patients were randomly assigned to a cardiac output-guided hemodynamic therapy algorithm for intravenous fluid and inotrope (dopexamine) infusion during and 6 hours following surgery (n=368) or to usual care (n=366). The primary outcome was a composite of predefined 30-day moderate or major complications and mortality. Secondary outcomes were morbidity on day 7; infection, critical care-free days, and all-cause mortality at 30 days; all-cause mortality at 180 days; and length of hospital stay. Baseline patient characteristics, clinical care, and volumes of intravenous fluid were similar between groups. Care was nonadherent to the allocated treatment for less than 10% of patients in each group. The primary outcome occurred in 36.6% of intervention and 43.4% of usual care participants (relative risk [RR], 0.84 [95% CI, 0.71-1.01]; absolute risk reduction, 6.8% [95% CI, -0.3% to 13.9%]; P = .07). There was no significant difference between groups for any secondary outcomes. Five intervention patients (1.4%) experienced cardiovascular serious adverse events within 24 hours compared with none in the usual care group. Findings of the meta-analysis of 38 trials, including data from this study, suggest that the intervention is associated with fewer complications (intervention, 488/1548 [31.5%] vs control, 614/1476 [41.6%]; RR, 0.77 [95% CI, 0.71-0.83]) and a nonsignificant reduction in hospital, 28-day, or 30-day mortality (intervention, 159/3215 deaths [4.9%] vs control, 206/3160 deaths [6.5%]; RR, 0.82 [95% CI, 0.67-1.01]) and mortality at longest follow-up (intervention, 267/3215 deaths [8.3%] vs control, 327/3160 deaths [10.3%]; RR, 0.86 [95% CI, 0.74-1.00]). In a randomized trial of high-risk patients undergoing major gastrointestinal surgery, use of a cardiac output-guided hemodynamic therapy algorithm compared with usual care did not reduce a composite outcome of complications and 30-day mortality. However, inclusion of these data in an updated meta-analysis indicates that the intervention was associated with a reduction in complication rates. isrctn.org Identifier: ISRCTN04386758.

Web-based self-management for patients with multiple sclerosis: a practical, randomized trial.

PubMed

Miller, Deborah M; Moore, Shirley M; Fox, Robert J; Atreja, Ashish; Fu, Alex Z; Lee, Jar-Chi; Saupe, Welf; Stadtler, Maria; Chakraborty, Swati; Harris, C M; Rudick, Richard A

2011-01-01

No studies have addressed the use of electronic personal health records (e-PHRs) for self-management in complex neurological disorders. We assessed and tested an Internet-based self-management system that utilized the e-PHR and determined its impact on self-assessed well-being, clinician-assessed well-being, and healthcare utilization in patients with multiple sclerosis (MS). Subjects were randomized to usual care (a secure Web-based messaging system) or active intervention, which included secure messaging, self-monitoring, self-management of MS symptoms, and communication about upcoming clinic visits. Computers and Internet access were provided. Subjects were included if they had MS, lived within the county or region surrounding our MS center, had at least two appointments at our center in the previous 12 months, and demonstrated basic typing and computer skills. Study duration was 12 months. Of 220 subjects completing informed consent, 206 met the inclusion criteria. At the study's end, 83 subjects remained in the usual care group and 84 in the enhanced care group. Both groups used the available system components. The groups did not significantly differ on the primary endpoints or healthcare utilization. Self-management support is an emerging aspect of chronic care management. We established the feasibility of conducting a randomized, controlled trial using e-PHRs for patient self-management. We did not find that e-PHR-enabled self-management augmented multidisciplinary MS center-based care, possibly because the differences between interventions were not great enough.

A randomized trial of a lay person-led self-management group intervention for back pain patients in primary care.

PubMed

Von Korff, M; Moore, J E; Lorig, K; Cherkin, D C; Saunders, K; González, V M; Laurent, D; Rutter, C; Comite, F

1998-12-01

Randomized, controlled trial. To evaluate a four-session self-management group intervention for patients with pain in primary care, led by trained lay persons with back pain. The intervention was designed to reduce patient worries, encourage self-care, and reduce activity limitations. Randomized trials of educational interventions suggest that activating interventions may improve back pain outcomes. Expert opinion increasingly regards effective self-management of back pain as important in achieving good outcomes. In this study, an educational intervention designed to activate patients and support effective self-management was evaluated. Six to 8 weeks after a primary care visit for back pain, patients were invited to participate in an educational program to improve back pain self-management. Those showing interest by returning a brief questionnaire became eligible for the study. Participants (n = 255) randomly were assigned to either a self-management group intervention or to a usual care control group. The effect of the intervention, relative to usual care, was assessed 3, 6, and 12 months after randomization, controlling for baseline values. The intervention consisted of a four-session group applying problem-solving techniques to back pain self-management, supplemented by educational materials (book and videos) supporting active management of back pain. The groups were led by lay persons trained to implement a fully structured group protocol. The control group received usual care, supplemented by a book on back pain care. Participants randomly assigned to the self-management groups reported significantly less worry about back pain and expressed more confidence in self-care. Roland Disability Questionnaire Scores were significantly lower among participants in the self-management groups relative to the usual care controls at 6 months (P = 0.007), and this difference was sustained at 12 months at borderline significance levels (P = 0.09). Among self-management group participants, 48% showed a 50% or greater reduction in Roland Disability Questionnaire Score at 6 months, compared with 33% among the usual care controls. Self-management groups led by trained lay persons following a structured protocol were more effective than usual care in reducing worries, producing positive attitudes toward self-care, and reducing activity limitations among patients with back pain in primary care.

Do palliative care interventions reduce emergency department visits among patients with cancer at the end of life? A systematic review.

PubMed

DiMartino, Lisa D; Weiner, Bryan J; Mayer, Deborah K; Jackson, George L; Biddle, Andrea K

2014-12-01

Frequent emergency department (ED) visits are an indicator of poor quality of cancer care. Coordination of care through the use of palliative care teams may limit aggressive care and improve outcomes for patients with cancer at the end of life. To systematically review the literature to determine whether palliative care interventions implemented in the hospital, home, or outpatient clinic are more effective than usual care in reducing ED visits among patients with cancer at the end of life. PubMed, EMBASE, and CINAHL databases were searched from database inception to May 7, 2014. Only randomized/non-randomized controlled trials (RCTs) and observational studies examining the effect of palliative care interventions on ED visits among adult patients with cancer with advanced disease were considered. Data were abstracted from the articles that met all the inclusion criteria. A second reviewer independently abstracted data from 2 articles and discrepancies were resolved. From 464 abstracts, 2 RCTs, 10 observational studies, and 1 non-RCT/quasi-experimental study were included. Overall there is limited evidence to support the use of palliative care interventions to reduce ED visits, although studies examining effect of hospice care and those conducted outside of the United States reported a statistically significant reduction in ED visits. Evidence regarding whether palliative care interventions implemented in the hospital, home or outpatient clinic are more effective than usual care at reducing ED visits is not strongly substantiated based on the literature reviewed. Improvements in the quality of reporting for studies examining the effect of palliative care interventions on ED use are needed.

Effect of Primary Care Intervention on Breastfeeding Duration and Intensity

PubMed Central

Stuebe, Alison; Barnett, Josephine; Labbok, Miriam H.; Fletcher, Jason; Bernstein, Peter S.

2014-01-01

Objectives. We determined the effectiveness of primary care–based, and pre- and postnatal interventions to increase breastfeeding. Methods. We conducted 2 trials at obstetrics and gynecology practices in the Bronx, New York, from 2008 to 2011. The Provider Approaches to Improved Rates of Infant Nutrition & Growth Study (PAIRINGS) had 2 arms: usual care versus pre- and postnatal visits with a lactation consultant (LC) and electronically prompted guidance from prenatal care providers (EP). The Best Infant Nutrition for Good Outcomes (BINGO) study had 4 arms: usual care, LC alone, EP alone, or LC+EP. Results. In BINGO at 3 months, high intensity was greater for the LC+EP (odds ratio [OR] = 2.72; 95% confidence interval [CI] = 1.08, 6.84) and LC (OR = 3.22; 95% CI = 1.14, 9.09) groups versus usual care, but not for the EP group alone. In PAIRINGS at 3 months, intervention rates exceeded usual care (OR = 2.86; 95% CI = 1.21, 6.76); the number needed to treat to prevent 1 dyad from nonexclusive breastfeeding at 3 months was 10.3 (95% CI = 5.6, 50.7). Conclusions. LCs integrated into routine care alone and combined with EP guidance from prenatal care providers increased breastfeeding intensity at 3 months postpartum. PMID:24354834

Cost-Effectiveness of Collaborative Care for the Treatment of Depressive Disorders in Primary Care: A Systematic Review

PubMed Central

Grochtdreis, Thomas; Brettschneider, Christian; Wegener, Annemarie; Watzke, Birgit; Riedel-Heller, Steffi; Härter, Martin; König, Hans-Helmut

2015-01-01

Background For the treatment of depressive disorders, the framework of collaborative care has been recommended, which showed improved outcomes in the primary care sector. Yet, an earlier literature review did not find sufficient evidence to draw robust conclusions on the cost-effectiveness of collaborative care. Purpose To systematically review studies on the cost-effectiveness of collaborative care, compared with usual care for the treatment of patients with depressive disorders in primary care. Methods A systematic literature search in major databases was conducted. Risk of bias was assessed using the Cochrane Collaboration’s tool. Methodological quality of the articles was assessed using the Consensus on Health Economic Criteria (CHEC) list. To ensure comparability across studies, cost data were inflated to the year 2012 using country-specific gross domestic product inflation rates, and were adjusted to international dollars using purchasing power parities (PPP). Results In total, 19 cost-effectiveness analyses were reviewed. The included studies had sample sizes between n = 65 to n = 1,801, and time horizons between six to 24 months. Between 42% and 89% of the CHEC quality criteria were fulfilled, and in only one study no risk of bias was identified. A societal perspective was used by five studies. Incremental costs per depression-free day ranged from dominance to US$PPP 64.89, and incremental costs per QALY from dominance to US$PPP 874,562. Conclusion Despite our review improved the comparability of study results, cost-effectiveness of collaborative care compared with usual care for the treatment of patients with depressive disorders in primary care is ambiguous depending on willingness to pay. A still considerable uncertainty, due to inconsistent methodological quality and results among included studies, suggests further cost-effectiveness analyses using QALYs as effect measures and a time horizon of at least 1 year. PMID:25993034

Non-pharmacological self-management for people living with migraine or tension-type headache: a systematic review including analysis of intervention components

PubMed Central

Bowers, Hannah; Mistry, Dipesh; Caldwell, Fiona; Underwood, Martin; Patel, Shilpa; Sandhu, Harbinder Kaur; Matharu, Manjit; Pincus, Tamar

2017-01-01

Objectives To assess the effect of non-pharmacological self-management interventions against usual care, and to explore different components and delivery methods within those interventions Participants People living with migraine and/or tension-type headache Interventions Non-pharmacological educational or psychological self-management interventions; excluding biofeedback and physical therapy. We assessed the overall effectiveness against usual care on headache frequency, pain intensity, mood, headache-related disability, quality of life and medication consumption in meta-analysis. We also provide preliminary evidence on the effectiveness of intervention components and delivery methods. Results We found a small overall effect for the superiority of self-management interventions over usual care, with a standardised mean difference (SMD) of −0.36 (−0.45 to −0.26) for pain intensity; −0.32 (−0.42 to −0.22) for headache-related disability, 0.32 (0.20 to 0.45) for quality of life and a moderate effect on mood (SMD=0.53 (−0.66 to −0.40)). We did not find an effect on headache frequency (SMD=−0.07 (−0.22 to 0.08)). Assessment of components and characteristics suggests a larger effect on pain intensity in interventions that included explicit educational components (−0.51 (−0.68 to −0.34) vs −0.28 (−0.40 to −0.16)); mindfulness components (−0.50 (−0.82 to −0.18) vs 0.34 (−0.44 to −0.24)) and in interventions delivered in groups vs one-to-one delivery (0.56 (−0.72 to −0.40) vs −0.39 (−0.52 to −0.27)) and larger effects on mood in interventions including a cognitive–behavioural therapy (CBT) component with an SMD of −0.72 (−0.93 to −0.51) compared with those without CBT −0.41 (−0.58 to −0.24). Conclusion Overall we found that self-management interventions for migraine and tension-type headache are more effective than usual care in reducing pain intensity, mood and headache-related disability, but have no effect on headache frequency. Preliminary findings also suggest that including CBT, mindfulness and educational components in interventions, and delivery in groups may increase effectiveness. Trial registration number PROSPERO 2016:CRD42016041291 PMID:28801425

Comprehensive process model of clinical information interaction in primary care: results of a "best-fit" framework synthesis.

PubMed

Veinot, Tiffany C; Senteio, Charles R; Hanauer, David; Lowery, Julie C

2018-06-01

To describe a new, comprehensive process model of clinical information interaction in primary care (Clinical Information Interaction Model, or CIIM) based on a systematic synthesis of published research. We used the "best fit" framework synthesis approach. Searches were performed in PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Library and Information Science Abstracts, Library, Information Science and Technology Abstracts, and Engineering Village. Two authors reviewed articles according to inclusion and exclusion criteria. Data abstraction and content analysis of 443 published papers were used to create a model in which every element was supported by empirical research. The CIIM documents how primary care clinicians interact with information as they make point-of-care clinical decisions. The model highlights 3 major process components: (1) context, (2) activity (usual and contingent), and (3) influence. Usual activities include information processing, source-user interaction, information evaluation, selection of information, information use, clinical reasoning, and clinical decisions. Clinician characteristics, patient behaviors, and other professionals influence the process. The CIIM depicts the complete process of information interaction, enabling a grasp of relationships previously difficult to discern. The CIIM suggests potentially helpful functionality for clinical decision support systems (CDSSs) to support primary care, including a greater focus on information processing and use. The CIIM also documents the role of influence in clinical information interaction; influencers may affect the success of CDSS implementations. The CIIM offers a new framework for achieving CDSS workflow integration and new directions for CDSS design that can support the work of diverse primary care clinicians.

Post-Hospital Discharge Care: A Retrospective Cohort Study Exploring the Value of Pharmacist-Enhanced Care and Describing Medication-Related Problems.

PubMed

Hawes, Emily M; Pinelli, Nicole R; Sanders, Kimberly A; Lipshutz, Andrew M; Tong, Gretchen; Sievers, Lauren S; Chao, Sarah; Gwynne, Mark

2018-01-01

BACKGROUND Medication-related problems occur at high rates during care transitions. Evidence suggests that pharmacists are well-suited to identify and resolve medication-related problems during hospital admission and at discharge. Additional evidence is needed to understand the impact of face-to-face pharmacist visits in primary care after discharge. The purpose of the study was to describe medication-related problems found during face-to-face pharmacist visits in a medical home after hospital discharge. METHODS A retrospective cohort study was conducted within an academic primary care center staffed by family medicine trained physicians that evaluated patients who attended a hospital follow-up visit with pharmacist-enhanced care (N = 86) versus usual care (N = 86). The primary objective was to describe medication-related problems identified by pharmacists using a modified individualized Medication Assessment and Planning tool for patients receiving pharmacist-enhanced care. Secondary analyses were also conducted to compare 30-day and 60-day hospital readmission and emergency department visit rates in those exposed to pharmacist-enhanced care versus those who were not. RESULTS At baseline, the mean hospitalizations in the prior year were 1.1 ± 1.7 (pharmacist-enhanced care) and 0.76 ± 1.2 (usual care), indicating a low initial readmission risk. Of patients receiving pharmacist-enhanced care, 97.7% were found to have at least 1 medication-related problem, with an average of 4.36 medication-related problems per patient. The 30-day readmission rate was lower, but not significantly different between groups (8.1% for pharmacist-enhanced care versus 12.8% for usual care; adjusted odds ratio (OR), 0.47; 95% confidence interval (CI), 0.16-1.36). LIMITATIONS Limitations include the retrospective cohort study design and small sample size. Medication-related problems were identified and collected prospectively during pharmacist visits. CONCLUSION Medication-related problems are ubiquitous after hospital discharge. Larger prospective studies will be needed to understand the potential value of pharmacist-enhanced care during hospital follow-up visits on readmission rates in low-risk patient populations receiving care within a primary care medical home. ©2018 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.

Usual and Unusual Care: Existing Practice Control Groups In Randomized Controlled Trials of Behavioral Interventions

PubMed Central

Freedland, Kenneth E.; Mohr, David C.; Davidson, Karina W.; Schwartz, Joseph E.

2011-01-01

Objective To examine the use of existing practice control groups in randomized controlled trials of behavioral interventions, and the role of extrinsic healthcare services in the design and conduct of behavioral trials. Method Selective qualitative review. Results Extrinsic healthcare services, also known as nonstudy care, have important but under-recognized effects on the design and conduct of behavioral trials. Usual care, treatment as usual, standard of care, and other existing practice control groups pose a variety of methodological and ethical challenges, but they play a vital role in behavioral intervention research. Conclusion This review highlights the need for a scientific consensus statement on control groups in behavioral trials. PMID:21536837

An Economic Analysis of Robot-Assisted Therapy for Long-Term Upper-Limb Impairment After Stroke

PubMed Central

Wagner, Todd H.; Lo, Albert C.; Peduzzi, Peter; Bravata, Dawn M.; Huang, Grant D.; Krebs, Hermano I.; Ringer, Robert J.; Federman, Daniel G.; Richards, Lorie G.; Haselkorn, Jodie K.; Wittenberg, George F.; Volpe, Bruce T.; Bever, Christopher T.; Duncan, Pamela W.; Siroka, Andrew; Guarino, Peter D.

2015-01-01

Background and Purpose Stroke is a leading cause of disability. Rehabilitation robotics have been developed to aid in recovery after a stroke. This study determined the additional cost of robot-assisted therapy and tested its cost-effectiveness. Methods We estimated the intervention costs and tracked participants' healthcare costs. We collected quality of life using the Stroke Impact Scale and the Health Utilities Index. We analyzed the cost data at 36 weeks postrandomization using multivariate regression models controlling for site, presence of a prior stroke, and Veterans Affairs costs in the year before randomization. Results A total of 127 participants were randomized to usual care plus robot therapy (n=49), usual care plus intensive comparison therapy (n=50), or usual care alone (n=28). The average cost of delivering robot therapy and intensive comparison therapy was $5152 and $7382, respectively (P<0.001), and both were significantly more expensive than usual care alone (no additional intervention costs). At 36 weeks postrandomization, the total costs were comparable for the 3 groups ($17 831 for robot therapy, $19 746 for intensive comparison therapy, and $19 098 for usual care). Changes in quality of life were modest and not statistically different. Conclusions The added cost of delivering robot or intensive comparison therapy was recuperated by lower healthcare use costs compared with those in the usual care group. However, uncertainty remains about the cost-effectiveness of robotic-assisted rehabilitation compared with traditional rehabilitation. Clinical Trial Registration URL: http://clinicaltrials.gov. Unique identifier: NCT00372411. PMID:21757677

Pharmacist-led Chronic Disease Management: A Systematic Review of Effectiveness and Harms Compared With Usual Care.

PubMed

Greer, Nancy; Bolduc, Jennifer; Geurkink, Eric; Rector, Thomas; Olson, Kimberly; Koeller, Eva; MacDonald, Roderick; Wilt, Timothy J

2016-04-26

Increased involvement of pharmacists in patient care may increase access to health care and improve patient outcomes. To determine the effectiveness and harms of pharmacist-led chronic disease management for community-dwelling adults. MEDLINE, Cochrane Library, CINAHL, and International Pharmaceutical Abstracts from 1995 through February 2016, and reference lists of systematic reviews and included studies. 65 patient populations in 63 studies conducted in the United States and of any design reported outcomes of pharmacist-led chronic disease management versus a comparator for community-dwelling adults in the United States. Studies set in retail pharmacies were excluded. Data extraction done by a single investigator was confirmed by a second investigator; risk of bias was assessed by 2 investigators; and strength of evidence was determined by consensus. Pharmacist-led care was associated with similar numbers of office visits, urgent care or emergency department visits, and hospitalizations (moderate-strength evidence) and medication adherence (low-strength evidence) compared with usual care (typically continuing a prestudy visit schedule). Pharmacist-led care increased the number or dose of medications received and improved study-selected glycemic, blood pressure, and lipid goal attainment (moderate-strength evidence). Mortality and clinical events were similar (low-strength evidence). Evidence on patient satisfaction was mixed and insufficient. The reporting of harms was limited. Interventions were heterogeneous. Studies were typically short-term and designed to assess physiologic intermediate outcomes rather than clinical events. Reporting of many clinical outcomes of interest was limited, and often they were not the study-defined primary end points. Pharmacist-led chronic disease management was associated with effects similar to those of usual care for resource utilization and may improve physiologic goal attainment. Further research is needed to determine whether increased medication utilization and goal attainment improve clinical outcomes. Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Quality Enhancement Research Initiative.

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial.

PubMed

Kim, Sung-Phil; Kim, Joo-Hee; Kim, Bo-Kyung; Kim, Hyeong-Jun; Jung, In Chul; Cho, Jung Hyo; Kim, Jung-Eun; Kim, Mi-Kyung; Kwon, O-Jin; Kim, Ae-Ran; Park, Hyo-Ju; Seo, Bok-Nam

2017-04-13

Insomnia is a common sleep disorder that affects many adults either transiently or chronically. The societal cost of insomnia is on the rise, while long-term use of current drug treatments can involve adverse effects. Recently, electroacupuncture (EA) has been used to treat various conditions including insomnia. The objective of this study is to provide scientific evidence for the effect and safety of using EA to treat insomnia. In this multicentre, assessor-blind, three-arm, parallel-design, randomised controlled trial, 150 participants will be assigned to the EA group, the sham EA (SEA) group, or the usual care group. The EA and SEA groups will receive the specific treatments 2-3 times a week for 4 weeks, for a total of 10 sessions, whereas the usual care group will not receive EA and will continue with usual care during the same time period. The primary outcome measure will be changes in the Insomnia Severity Index 5 weeks after randomisation. The secondary outcomes will include the Pittsburgh Sleep Quality Index, the Hospital Anxiety and Depression Scale, a sleep diary, the EuroQoL-5 dimension questionnaire, the levels of melatonin and cortisol, and the Patient Global Impression of Change. Safety will be assessed at each visit. The results of this multicentre randomised controlled trial will contribute to provide rigorous clinical evidence for the effects and safety of EA for insomnia disorder. Korean Clinical Trial Registry, CRIS, KCT0001685 . Registered on 2 November 2015 (retrospectively registered). Date of enrolment of the first participant to the trial 13 October 2015.

Effectiveness of very early workplace interventions to reduce sickness absence: A systematic review of the literature and meta-analysis

PubMed Central

Vargas-Prada, Sergio; Demou, Evangelia; Lalloo, Drushca; Avila-Palencia, Ione; Sanati, Kaveh A.; Sampere, Maite; Freer, Kerry; Serra, Consol; Macdonald, Ewan B.

2017-01-01

Objective “To investigate the effectiveness of workplace interventions for return to work (RTW) delivered at very early stages (<15 days) of sickness absence. Methods A systematic literature search was conducted in Pubmed, HMIC, Cochrane library database, CINAHL, PsychInfo and Embase. Study selection, quality appraisal and data extraction were carried out by independent pairs of researchers using pre-established criteria. Workplace interventions before day 15 of SA, were included. Primary outcome measures included rates of and time until RTW, productivity loss, and recurrences of SA. Results We found limited available evidence on the benefits of ‘very early’ workplace interventions in terms of RTW after a SA episode compared to usual care. Only three randomised controlled trials classed as high or intermediate quality were identified. Early part-time sick leave together with appropriate job modifications led to a reduction on the duration and recurrence of SA. There is evidence of benefit of intervening during the first two weeks of SA for musculoskeletal disorders. Conclusion Our review has identified a lack of evidence from the literature at this time point to support ‘very early’ intervention compared to usual care. The methodological design of the studies, notably the extent and timing of usual care provided and variable compliance/crossover between groups could however explain the lack of demonstrated benefit. Consensus is required on the definition of ‘early’ and ‘very early’ interventions and further research is recommended to improve understanding of the factors influencing when and how best to intervene for maximum gain. PMID:27271024

Effectiveness of home blood pressure monitoring, Web communication, and pharmacist care on hypertension control: a randomized controlled trial.

PubMed

Green, Beverly B; Cook, Andrea J; Ralston, James D; Fishman, Paul A; Catz, Sheryl L; Carlson, James; Carrell, David; Tyll, Lynda; Larson, Eric B; Thompson, Robert S

2008-06-25

Treating hypertension decreases mortality and disability from cardiovascular disease, but most hypertension remains inadequately controlled. To determine if a new model of care that uses patient Web services, home blood pressure (BP) monitoring, and pharmacist-assisted care improves BP control. A 3-group randomized controlled trial, the Electronic Communications and Home Blood Pressure Monitoring study was based on the Chronic Care Model. The trial was conducted at an integrated group practice in Washington state, enrolling 778 participants aged 25 to 75 years with uncontrolled essential hypertension and Internet access. Care was delivered over a secure patient Web site from June 2005 to December 2007. Participants were randomly assigned to usual care, home BP monitoring and secure patient Web site training only, or home BP monitoring and secure patient Web site training plus pharmacist care management delivered through Web communications. Percentage of patients with controlled BP (<140/90 mm Hg) and changes in systolic and diastolic BP at 12 months. Of 778 patients, 730 (94%) completed the 1-year follow-up visit. Patients assigned to the home BP monitoring and Web training only group had a nonsignificant increase in the percentage of patients with controlled BP (<140/90 mm Hg) compared with usual care (36% [95% confidence interval {CI}, 30%-42%] vs 31% [95% CI, 25%-37%]; P = .21). Adding Web-based pharmacist care to home BP monitoring and Web training significantly increased the percentage of patients with controlled BP (56%; 95% CI, 49%-62%) compared with usual care (P < .001) and home BP monitoring and Web training only (P < .001). Systolic BP was decreased stepwise from usual care to home BP monitoring and Web training only to home BP monitoring and Web training plus pharmacist care. Diastolic BP was decreased only in the pharmacist care group compared with both the usual care and home BP monitoring and Web training only groups. Compared with usual care, the patients who had baseline systolic BP of 160 mm Hg or higher and received home BP monitoring and Web training plus pharmacist care had a greater net reduction in systolic BP (-13.2 mm Hg [95% CI, -19.2 to -7.1]; P < .001) and diastolic BP (-4.6 mm Hg [95% CI, -8.0 to -1.2]; P < .001), and improved BP control (relative risk, 3.32 [95% CI, 1.86 to 5.94]; P<.001). Pharmacist care management delivered through secure patient Web communications improved BP control in patients with hypertension. Trial Registration clinicaltrials.gov Identifier: NCT00158639.

A randomized trial of an acid-peptic disease management program in a managed care environment.

PubMed

Ofman, Joshua J; Segal, Richard; Russell, Wayne L; Cook, Deborah J; Sandhu, Meenu; Maue, Susan K; Lowenstein, Edward H; Pourfarzib, Ray; Blanchette, Erv; Ellrodt, Gray; Weingarten, Scott R

2003-06-01

To study the effectiveness of a disease management program for patients with acid-related disorders. A cluster-randomized clinical trial of 406 patients comparing a disease management program with "usual practice." Enrolled patients included those presenting with new dyspepsia and chronic users of antisecretory drugs in 8 geographically separate physician offices associated with the Orlando Health Care Group. There were 35 providers in the intervention group and 48 in the control group. The disease management program included evidence-based practice guidelines implemented by using physician champions, academic detailing, and multidisciplinary teams. Processes of care, patient symptoms, quality of life, costs, and work days lost were measured 6 months after patient enrollment. Compared with usual practice, disease management was associated with improvements in Helicobacter pylori testing (61% vs 9%; P = .001), use of recommended H pylori treatment regimens (96% vs 10%; P = .001), and discontinuation rates of proton pump therapy after treatment (70% vs 36%; P = .04). There were few differences in patient quality of life or symptoms between the 2 study groups. Disease management resulted in fewer days of antisecretory therapy (71.7 vs 88.1 days; P = .02) but no difference in total costs. This disease management program for patients with acid-related disorders led to improved processes of care. The effectiveness of such a program in other settings requires further study.

Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial.

PubMed

McBride, E; Hacking, B; O'Carroll, R; Young, M; Jahr, J; Borthwick, C; Callander, A; Berrada, Z

2016-11-01

This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) increased decision self-efficacy and foot-treatment adherence in patients with a diabetic foot ulcer. Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decision conflict and decision regret. Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation. An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. © 2016 Diabetes UK.

Screening and treatment of psychological distress in patients with metastatic colorectal cancer: study protocol of the TES trial.

PubMed

Schuurhuizen, Claudia S E W; Braamse, Annemarie M J; Beekman, Aartjan T F; Bomhof-Roordink, Hanna; Bosmans, Judith E; Cuijpers, Pim; Hoogendoorn, Adriaan W; Konings, Inge R H M; van der Linden, Mecheline H M; Neefjes, Elisabeth C W; Verheul, Henk M W; Dekker, Joost

2015-04-17

Psychological distress occurs frequently in patients with cancer. Psychological distress includes mild and severe forms of both anxious and depressive mood states. Literature indicates that effective management of psychological distress seems to require targeted selection of patients (T), followed by enhanced care (E), and the application of evidence based interventions. Besides, it is hypothesized that delivering care according to the stepped care (S) approach results in an affordable program. The aim of the current study is to evaluate the (cost)-effectiveness of the TES program compared to usual care in reducing psychological distress in patients with metastatic colorectal cancer (mCRC). This study is designed as a cluster randomized trial with 2 treatment arms: TES program for screening and treatment of psychological distress versus usual care. Sixteen hospitals participate in this study, recruiting patients with mCRC. Outcomes are evaluated at the beginning of chemotherapy and after 3, 10, 24, and 48 weeks. Primary outcome is the difference in treatment effect over time in psychological distress, assessed with the Hospital Anxiety and Depression Scale. Secondary outcomes include quality of life, patient evaluation of care, recognition and management of psychological distress, and societal costs. We created optimal conditions for an effective screening and treatment program for psychological distress in patients with mCRC. This involves targeted selection of patients, followed by enhanced and stepped care. Our approach will be thoroughly evaluated in this study. We expect that our results will contribute to the continuing debate on the (cost-) effectiveness of screening for and treatment of psychological distress in patients with cancer. This trial is registered in the Netherlands Trial Register NTR4034.

Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation.

PubMed

Desveaux, Laura; Beauchamp, Marla K; Lee, Annemarie; Ivers, Noah; Goldstein, Roger; Brooks, Dina

2016-05-11

This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments. Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise program or usual care using block randomization and stratifying for supplemental oxygen use. Patients in the intervention arm are asked to attend an exercise session at least twice per week at their local community facility where their progress is supervised by a case manager. Each exercise session includes a component of aerobic exercise, and activities designed to optimize balance, flexibility, and strength. All study participants will have access to routine follow-up appointments with their respiratory physician, and additional health care providers as part of their usual care. Assessments will be completed at baseline (post-PR), 6, and 12 months, and include measures of functional exercise capacity, quality of life, self-efficacy, and health care usage. Intervention effectiveness will be assessed by comparing functional exercise capacity between intervention and control groups. A mixed-methods process evaluation will be conducted to better understand intervention implementation, guided by Normalization Process Theory and the Consolidated Framework for Implementation Research. Based on results from our pilot work, we anticipate a maintenance of exercise capacity and improved health-related quality of life in the intervention group, compared with a decline in exercise capacity in the usual care group. Findings from this study will improve our understanding of the effectiveness of community-based exercise programs for maintaining benefits following PR in patients with COPD and provide information on how best to implement them. If effective, the intervention represents an opportunity to transition patients from institutionally-based rehabilitative management to community-based care. The results of the process evaluation will contribute to the science of translating evidence-based programs into regular practice.

Patient and carer experience of hospital-based rehabilitation from intensive care to hospital discharge: mixed methods process evaluation of the RECOVER randomised clinical trial

PubMed Central

Ramsay, Pam; Huby, Guro; Merriweather, Judith; Salisbury, Lisa; Rattray, Janice; Griffith, David; Walsh, Timothy

2016-01-01

Objectives To explore and compare patient/carer experiences of rehabilitation in the intervention and usual care arms of the RECOVER trial (ISRCTN09412438); a randomised controlled trial of a complex intervention of post-intensive care unit (ICU) acute hospital-based rehabilitation following critical illness. Design Mixed methods process evaluation including comparison of patients' and carers' experience of usual care versus the complex intervention. We integrated and compared quantitative data from a patient experience questionnaire (PEQ) with qualitative data from focus groups with patients and carers. Setting Two university-affiliated hospitals in Scotland. Participants 240 patients discharged from ICU who required ≥48 hours of mechanical ventilation were randomised into the trial (120 per trial arm). Exclusion criteria comprised: primary neurologic diagnosis, palliative care, current/planned home ventilation and age <18 years. 182 patients completed the PEQ at 3 months postrandomisation. 22 participants (14 patients and 8 carers) took part in focus groups (2 per trial group) at >3 months postrandomisation. Interventions A complex intervention of post-ICU acute hospital rehabilitation, comprising enhanced physiotherapy, nutritional care and information provision, case-managed by dedicated rehabilitation assistants (RAs) working within existing ward-based clinical teams, delivered between ICU discharge and hospital discharge. Comparator was usual care. Outcome measures A novel PEQ capturing patient-reported aspects of quality care. Results The PEQ revealed statistically significant between-group differences across 4 key intervention components: physiotherapy (p=0.039), nutritional care (p=0.038), case management (p=0.045) and information provision (p<0.001), suggesting greater patient satisfaction in the intervention group. Focus group data strongly supported and helped explain these findings. Specifically, case management by dedicated RAs facilitated greater access to physiotherapy, nutritional care and information that cut across disciplinary boundaries and staffing constraints. Patients highly valued its individualisation according to their needs, abilities and preferences. Conclusions Case management by dedicated RAs improves patients' experiences of post-ICU hospital-based rehabilitation and increases perceived quality of care. Trial registration number ISRCTN09412438. PMID:27481624

Blended care vs. usual care in the treatment of depressive symptoms and disorders in general practice [BLENDING]: study protocol of a non-inferiority randomized trial.

PubMed

Massoudi, Btissame; Blanker, Marco H; van Valen, Evelien; Wouters, Hans; Bockting, Claudi L H; Burger, Huibert

2017-06-13

The majority of patients with depressive disorders are treated by general practitioners (GPs) and are prescribed antidepressant medication. Patients prefer psychological treatments but they are under-used, mainly due to time constraints and limited accessibility. A promising approach to deliver psychological treatment is blended care, i.e. guided online treatment. However, the cost-effectiveness of blended care formatted as an online psychological treatment supported by the patients' own GP or general practice mental health worker (MHW) in routine primary care is unknown. We aim to demonstrate non-inferiority of blended care compared with usual care in patients with depressive symptoms or a depressive disorder in general practice. Additionally, we will explore the real-time course over the day of emotions and affect, and events within individuals during treatment. This is a pragmatic non-inferiority trial including 300 patients with depressive symptoms, recruited by collaborating GPs and MHWs. After inclusion, participants are randomized to either blended care or usual care in routine general practice. Blended care consists of the 'Act and Feel' treatment: an eight-week web-based program based on behavioral activation with integrated monitoring of depressive symptomatology and automatized feedback. GPs or their MHWs coach the participants through regular face-to-face or telephonic consultations with at least three sessions. Depressive symptomatology, health status, functional impairment, treatment satisfaction, daily activities and resource use are assessed during a follow-up period of 12 months. During treatment, real-time fluctuations in emotions and affect, and daily events will be rated using ecological momentary assessment. The primary outcome is the reduction of depressive symptoms from baseline to three months follow-up. We will conduct intention-to-treat analyses and supplementary per-protocol analyses. This trial will show whether blended care might be an appropriate treatment strategy for patients with depressive symptoms and depressive disorder in general practice. Netherlands Trial Register: NTR4757; 25 August 2014. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4757 . (Archived by WebCite® at http://www.webcitation.org/6mnXNMGef ).

Effectiveness of a multifaceted implementation strategy compared to usual care on low back pain guideline adherence among general practitioners.

PubMed

Suman, Arnela; Schaafsma, Frederieke G; van de Ven, Peter M; Slottje, Pauline; Buchbinder, Rachelle; van Tulder, Maurits W; Anema, Johannes R

2018-05-11

To improve patient care, and to reduce unnecessary referrals for diagnostic imaging and medical specialist care for low back pain, an evidence-based guideline for low back pain was developed in the Netherlands in 2010. The current study evaluated the effect of a multifaceted implementation strategy on guideline adherence among Dutch general practitioners. The implementation strategy included a multidisciplinary training, provision of educational material and an interactive website for healthcare professionals, supported by a multimedia eHealth intervention for patients with low back pain. Adherence was measured using performance indicators based on 3 months data extracted from the contacts with patients with low back pain recorded in the electronic medical records of participating general practitioners. Performance indicators were compared between two groups: a usual care group and an implementation group. Performance indicators were referrals to consultations with medical specialists, to diagnostic imaging, and to psychosocial and/or occupational physician consultations, and inquiries about psychosocial and occupational risk factors. The electronic medical records of 5130 patient contacts for LBP were analysed; 2453 patient contacts in the usual care group and 2677 patient contacts in the implementation group. Overall, rates of referral and of recorded inquiries regarding psychosocial and occupational risk factors remained low in both groups over time. The only statistically significant difference found was a reduction in the number of referrals to neurologists in the implementation group (from 100 (7%) to 50 (4%)) compared to the usual care group (from 48 (4%) to 50 (4%), (p < 0.01)). There were no other between-group differences in referrals. In the short term, the strategy did not result in improved guideline adherence among general practitioners, and it is not recommended for widespread use. However, baseline referral rates in participating practices were already low, possibly leaving only little room for improvement. Inquiries for psychosocial and occupational risk factors remained low and this leaves room for improvement. This trial is registered in the Netherlands Trial Register (NTR): NTR4329 . Registration date: December 20th, 2013.

A peptide derivatized cellulosic aerogel from cotton as a point of care diagnostic protease sensor

USDA-ARS?s Scientific Manuscript database

Lightweight aerogels are highly porous with usually very small pore size making them suitable for a variety of potential applications as sensors including deformation strain, humidity, organic vapors, thermal, and optical sensing properties. However, little has been reported on their use as biosenso...

Business as Usual? Not for These Middle-Grades Students

ERIC Educational Resources Information Center

Crawford, Heather; Wiest, Lynda

2011-01-01

A perpetual dilemma of schooling is how to help students develop skills needed for everyday life, including the work world. Quantitative literacy, also called numeracy, involves an ability to apply essential mathematics skills to authentic or near-authentic tasks. Carefully planned classroom activities can help students develop these important…

Testing the Effectiveness of Therapeutic Showering in Labor.

PubMed

Stark, Mary Ann

: Therapeutic showering is a holistic nursing intervention that is often available and supports physiologic labor. The purpose of this study was to compare the effectiveness of therapeutic showering with usual care during active labor. Research questions were as follows: Are there significant differences between women who showered 30 minutes during active labor and those who received usual labor care in anxiety, tension, relaxation, pain, discomfort, and coping? Is there a difference in use of obstetric interventions between groups? A convenience sample of healthy low-risk women in active labor was recruited (N = 32). A pretest posttest control group repeated-measures design was used. Participants were randomized to treatment group (n = 17), who showered for 30 minutes, or to control group (n = 14) who received usual labor care. Women evaluated pain, discomfort, anxiety, tension, coping, and relaxation at enrollment, again 15 minutes after entering the shower or receiving usual care, then again 30 minutes after entering the shower or receiving usual care. Chart reviews after delivery recorded obstetric interventions. The showering group had statistically significant decreases in pain, discomfort, anxiety and tension, and significant increase in relaxation. There were no differences in use of obstetric interventions. Therapeutic showering was effective in reducing pain, discomfort, anxiety, and tension while improving relaxation and supporting labor in this sample.

Economics of collaborative care for management of depressive disorders: a community guide systematic review.

PubMed

Jacob, Verughese; Chattopadhyay, Sajal K; Sipe, Theresa Ann; Thota, Anilkrishna B; Byard, Guthrie J; Chapman, Daniel P

2012-05-01

Major depressive disorders are frequently underdiagnosed and undertreated. Collaborative Care models developed from the Chronic Care Model during the past 20 years have improved the quality of depression management in the community, raising intervention cost incrementally above usual care. This paper assesses the economic efficiency of collaborative care for management of depressive disorders by comparing its economic costs and economic benefits to usual care, as informed by a systematic review of the literature. The economic review of collaborative care for management of depressive disorders was conducted in tandem with a review of effectiveness, under the guidance of the Community Preventive Services Task Force, a nonfederal, independent group of public health leaders and experts. Economic review methods developed by the Guide to Community Preventive Services were used by two economists to screen, abstract, adjust, and summarize the economic evidence of collaborative care from societal and other perspectives. An earlier economic review that included eight RCTs was included as part of the evidence. The present economic review expanded the evidence with results from studies published from 1980 to 2009 and included both RCTs and other study designs. In addition to the eight RCTs included in the earlier review, 22 more studies of collaborative care that provided estimates for economic outcomes were identified, 20 of which were evaluations of actual interventions and two of which were based on models. Of seven studies that measured only economic benefits of collaborative care in terms of averted healthcare or productivity loss, four found positive economic benefits due to intervention and three found minimal or no incremental benefit. Of five studies that measured both benefits and costs, three found lower collaborative care cost because of reduced healthcare utilization or enhanced productivity, and one found the same for a subpopulation of the intervention group. One study found that willingness to pay for collaborative care exceeded program costs. Among six cost-utility studies, five found collaborative care was cost effective. In two modeled studies, one showed cost effectiveness based on comparison of $/disability-adjusted life-year to annual per capita income; the other demonstrated cost effectiveness based on the standard threshold of $50,000/quality-adjusted life year, unadjusted for inflation. Finally, six of eight studies in the earlier review reported that interventions were cost effective on the basis of the standard threshold. The evidence indicates that collaborative care for management of depressive disorders provides good economic value. Published by Elsevier Inc.

Cost-utility analysis of a multidisciplinary strategy to manage osteoarthritis of the knee: economic evaluation of a cluster randomized controlled trial study.

PubMed

Marra, Carlo A; Grubisic, Maja; Cibere, Jolanda; Grindrod, Kelly A; Woolcott, John C; Gastonguay, Louise; Esdaile, John M

2014-06-01

To determine if a pharmacist-initiated multidisciplinary strategy provides value for money compared to usual care in participants with previously undiagnosed knee osteoarthritis. Pharmacies were randomly allocated to provide either 1) usual care and a pamphlet or 2) intervention care, which consisted of education, pain medication management by a pharmacist, physiotherapy-guided exercise, and communication with the primary care physician. Costs and quality-adjusted life-years (QALYs) were determined for patients assigned to each treatment and incremental cost-effectiveness ratios (ICERs) were determined. From the Ministry of Health perspective, the average patient in the intervention group generated slightly higher costs compared with usual care. Similar findings were obtained when using the societal perspective. The intervention resulted in ICERs of $232 (95% confidence interval [95% CI] -1,530, 2,154) per QALY gained from the Ministry of Health perspective and $14,395 (95% CI 7,826, 23,132) per QALY gained from the societal perspective, compared with usual care. A pharmacist-initiated, multidisciplinary program was good value for money from both the societal and Ministry of Health perspectives. Copyright © 2014 by the American College of Rheumatology.

Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial.

PubMed

Nicolaije, Kim A H; Ezendam, Nicole P M; Vos, M Caroline; Pijnenborg, Johanna M A; Boll, Dorry; Boss, Erik A; Hermans, Ralph H M; Engelhart, Karin C M; Haartsen, Joke E; Pijlman, Brenda M; van Loon-Baelemans, Ingrid E A M; Mertens, Helena J M M; Nolting, Willem E; van Beek, Johannes J; Roukema, Jan A; Zijlstra, Wobbe P; Kruitwagen, Roy F P M; van de Poll-Franse, Lonneke V

2015-11-01

This study was conducted to longitudinally assess the impact of an automatically generated survivorship care plan (SCP) on patient-reported outcomes in routine clinical practice. Primary outcomes were patient satisfaction with information and care. Secondary outcomes included illness perceptions and health care use. Twelve hospitals were randomly assigned to SCP care or usual care in a pragmatic, cluster randomized trial. Newly diagnosed patients with endometrial cancer completed questionnaires after diagnosis (n = 221; 75% response), 6 months (n = 158), and 12 months (n = 147). An SCP application was built in the Web-based ROGY (Registration System Oncological Gynecology). By clicking the SCP button, a patient-tailored SCP was generated. In the SCP care arm, 74% of patients received an SCP. They reported receiving more information about their treatment (mean [M] = 57, standard deviation [SD] = 20 v M = 47, SD = 24; P = .03), other services (M = 35, SD = 22 v M = 25, SD = 22; P = .03), and different places of care (M = 27, SD = 25 v M = 23, SD = 26; P = .04) than the usual care arm (scales, 0 to 100). However, there were no differences regarding satisfaction with information or care. Patients in the SCP care arm experienced more symptoms (M = 3.3, SD = 2.0 v M = 2.6, SD = 1.6; P = .03), were more concerned about their illness (M = 4.4, SD = 2.3 v M = 3.9, SD = 2.1; P = .03), were more affected emotionally (M = 4.0, SD = 2.2 v M = 3.7, SD = 2.2; P = .046), and reported more cancer-related contact with their primary care physician (M = 1.8, SD = 2.0 v M = 1.1, SD = 0.9; P = .003) than those in the usual care arm (scale, 1 to 10). These effects did not differ over time. The present trial showed no evidence of a benefit of SCPs on satisfaction with information and care. Furthermore, SCPs increased patients' concerns, emotional impact, experienced symptoms, and the amount of cancer-related contact with the primary care physician. Whether this may ultimately lead to more empowered patients should be investigated further. © 2015 by American Society of Clinical Oncology.

Nurse Jackie and the politics of care.

PubMed

McHugh, Kathleen

2012-01-01

This essay considers Nurse Jackie, one of several recent television shows, including HawthoRNe, and Mercy, that features a nurse as the main character. All 3 shows premiered in 2009 and challenged nursing's longstanding invisibility and misrepresentation on television. Although the plots of each show corrected problematic aspects of nursing's usual media representation, only Nurse Jackie remains on the air. In this paper, I analyze why Nurse Jackie succeeded where the other 2 shows did not, considering the representational politics of care on television and in the national context where health care remains a significant concern. Copyright © 2012 Elsevier Inc. All rights reserved.

Combined cognitive-strategy and task-specific training improves transfer to untrained activities in sub-acute stroke: An exploratory randomized controlled trial

PubMed Central

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2014-01-01

Purpose The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared to usual outpatient rehabilitation on activity and participation in people less than 3 months post stroke. Methods An exploratory, single blind, randomized controlled trial with a usual care control arm was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either Usual Care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self Efficacy Gauge. Results Thirty-five (35) eligible participants were randomized; 26 completed the intervention. Post-intervention, PQRS change scores demonstrated CO-OP had a medium effect over Usual Care on trained self-selected activities (d=0.5) and a large effect on untrained (d=1.2). At a 3 month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d=1.6) and untrained activities (d=1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and the Self-Efficacy Gauge. Conclusion CO-OP was associated with a large treatment effect on follow up performances of self-selected activities, and demonstrated transfer to untrained activities. A larger trial is warranted. PMID:25416738

Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial.

PubMed

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2015-07-01

The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared with usual outpatient rehabilitation on activity and participation in people <3 months poststroke. An exploratory, single-blind, randomized controlled trial, with a usual-care control arm, was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either usual care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self-Efficacy Gauge. A total of 35 eligible participants were randomized; 26 completed the intervention. Post intervention, PQRS change scores demonstrated that CO-OP had a medium effect over usual care on trained self-selected activities (d = 0.5) and a large effect on untrained activities (d = 1.2). At a 3-month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d = 1.6) and untrained activities (d = 1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and on the Self-Efficacy Gauge. CO-OP was associated with a large treatment effect on follow-up performances of self-selected activities and demonstrated transfer to untrained activities. A larger trial is warranted. © The Author(s) 2014.

Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial

PubMed Central

Huirne, Judith AF; Bouwsma, Esther VA; van Dongen, Johanna M; Terwee, Caroline B; van de Ven, Peter M; den Bakker, Chantal M; van der Meij, Suzan; van Baal, W Marchien; Leclercq, Wouter KG; Geomini, Peggy MAJ; Consten, Esther CJ; Schraffordt Koops, Steven E; van Kesteren, Paul JM; Stockmann, Hein BAC; ten Cate, A Dorien; Davids, Paul HP; Scholten, Petrus C; van den Heuvel, Baukje; Schaafsma, Frederieke G; Meijerink, Wilhelmus JHJ; Bonjer, H Jaap; Anema, Johannes R

2016-01-01

Background Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption. Objective With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care. Methods This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle. Results The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted. Conclusions We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower. ClinicalTrial Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy) PMID:28003177

Discharge Planning in Chronic Conditions

PubMed Central

McMartin, K

2013-01-01

Background Chronically ill people experience frequent changes in health status accompanied by multiple transitions between care settings and care providers. Discharge planning provides support services, follow-up activities, and other interventions that span pre-hospital discharge to post-hospital settings. Objective To determine if discharge planning is effective at reducing health resource utilization and improving patient outcomes compared with standard care alone. Data Sources A standard systematic literature search was conducted for studies published from January 1, 2004, until December 13, 2011. Review Methods Reports, randomized controlled trials, systematic reviews, and meta-analyses with 1 month or more of follow-up and limited to specified chronic conditions were examined. Outcomes included mortality/survival, readmissions and emergency department (ED) visits, hospital length of stay (LOS), health-related quality of life (HRQOL), and patient satisfaction. Results One meta-analysis compared individualized discharge planning to usual care and found a significant reduction in readmissions favouring individualized discharge planning. A second meta-analysis compared comprehensive discharge planning with postdischarge support to usual care. There was a significant reduction in readmissions favouring discharge planning with postdischarge support. However, there was significant statistical heterogeneity. For both meta-analyses there was a nonsignificant reduction in mortality between the study arms. Limitations There was difficulty in distinguishing the relative contribution of each element within the terms “discharge planning” and “postdischarge support.” For most studies, “usual care” was not explicitly described. Conclusions Compared with usual care, there was moderate quality evidence that individualized discharge planning is more effective at reducing readmissions or hospital LOS but not mortality, and very low quality evidence that it is more effective at improving HRQOL or patient satisfaction. Compared with usual care, there was low quality evidence that the discharge planning plus postdischarge support is more effective at reducing readmissions but not more effective at reducing hospital LOS or mortality. There was very low quality evidence that it is more effective at improving HRQOL or patient satisfaction. Plain Language Summary Chronically ill people experience frequent changes in their health status and multiple transitions between care settings and care providers (e.g., hospital to home). Discharge planning provides support services, follow-up activities and other interventions that span pre-hospital discharge to post-hospital settings. A review of the effects of different discharge plans was conducted. After searching for relevant studies, 11 studies were found that compared discharge planning with routine discharge care. This review indicates that: Individualized discharge planning reduces initial hospital length of stay and subsequent readmission to hospital but does not reduce mortality. The effect on health-related quality of life (HRQOL) or patient satisfaction is uncertain. Discharge planning plus postdischarge support reduces readmissions but does not reduce the initial hospital length of stay or mortality after discharge. The effect on HRQOL or patient satisfaction is uncertain. PMID:24167538

Interventions to increase attendance for diabetic retinopathy screening.

PubMed

Lawrenson, John G; Graham-Rowe, Ella; Lorencatto, Fabiana; Burr, Jennifer; Bunce, Catey; Francis, Jillian J; Aluko, Patricia; Rice, Stephen; Vale, Luke; Peto, Tunde; Presseau, Justin; Ivers, Noah; Grimshaw, Jeremy M

2018-01-15

Despite evidence supporting the effectiveness of diabetic retinopathy screening (DRS) in reducing the risk of sight loss, attendance for screening is consistently below recommended levels. The primary objective of the review was to assess the effectiveness of quality improvement (QI) interventions that seek to increase attendance for DRS in people with type 1 and type 2 diabetes.Secondary objectives were:To use validated taxonomies of QI intervention strategies and behaviour change techniques (BCTs) to code the description of interventions in the included studies and determine whether interventions that include particular QI strategies or component BCTs are more effective in increasing screening attendance;To explore heterogeneity in effect size within and between studies to identify potential explanatory factors for variability in effect size;To explore differential effects in subgroups to provide information on how equity of screening attendance could be improved;To critically appraise and summarise current evidence on the resource use, costs and cost effectiveness. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, Web of Science, ProQuest Family Health, OpenGrey, the ISRCTN, ClinicalTrials.gov, and the WHO ICTRP to identify randomised controlled trials (RCTs) that were designed to improve attendance for DRS or were evaluating general quality improvement (QI) strategies for diabetes care and reported the effect of the intervention on DRS attendance. We searched the resources on 13 February 2017. We did not use any date or language restrictions in the searches. We included RCTs that compared any QI intervention to usual care or a more intensive (stepped) intervention versus a less intensive intervention. We coded the QI strategy using a modification of the taxonomy developed by Cochrane Effective Practice and Organisation of Care (EPOC) and BCTs using the BCT Taxonomy version 1 (BCTTv1). We used Place of residence, Race/ethnicity/culture/language, Occupation, Gender/sex, Religion, Education, Socioeconomic status, and Social capital (PROGRESS) elements to describe the characteristics of participants in the included studies that could have an impact on equity of access to health services.Two review authors independently extracted data. One review author entered the data into Review Manager 5 and a second review author checked them. Two review authors independently assessed risks of bias in the included studies and extracted data. We rated certainty of evidence using GRADE. We included 66 RCTs conducted predominantly (62%) in the USA. Overall we judged the trials to be at low or unclear risk of bias. QI strategies were multifaceted and targeted patients, healthcare professionals or healthcare systems. Fifty-six studies (329,164 participants) compared intervention versus usual care (median duration of follow-up 12 months). Overall, DRS attendance increased by 12% (risk difference (RD) 0.12, 95% confidence interval (CI) 0.10 to 0.14; low-certainty evidence) compared with usual care, with substantial heterogeneity in effect size. Both DRS-targeted (RD 0.17, 95% CI 0.11 to 0.22) and general QI interventions (RD 0.12, 95% CI 0.09 to 0.15) were effective, particularly where baseline DRS attendance was low. All BCT combinations were associated with significant improvements, particularly in those with poor attendance. We found higher effect estimates in subgroup analyses for the BCTs 'goal setting (outcome)' (RD 0.26, 95% CI 0.16 to 0.36) and 'feedback on outcomes of behaviour' (RD 0.22, 95% CI 0.15 to 0.29) in interventions targeting patients, and 'restructuring the social environment' (RD 0.19, 95% CI 0.12 to 0.26) and 'credible source' (RD 0.16, 95% CI 0.08 to 0.24) in interventions targeting healthcare professionals.Ten studies (23,715 participants) compared a more intensive (stepped) intervention versus a less intensive intervention. In these studies DRS attendance increased by 5% (RD 0.05, 95% CI 0.02 to 0.09; moderate-certainty evidence).Fourteen studies reporting any QI intervention compared to usual care included economic outcomes. However, only five of these were full economic evaluations. Overall, we found that there is insufficient evidence to draw robust conclusions about the relative cost effectiveness of the interventions compared to each other or against usual care.With the exception of gender and ethnicity, the characteristics of participants were poorly described in terms of PROGRESS elements. Seventeen studies (25.8%) were conducted in disadvantaged populations. No studies were carried out in low- or middle-income countries. The results of this review provide evidence that QI interventions targeting patients, healthcare professionals or the healthcare system are associated with meaningful improvements in DRS attendance compared to usual care. There was no statistically significant difference between interventions specifically aimed at DRS and those which were part of a general QI strategy for improving diabetes care. This is a significant finding, due to the additional benefits of general QI interventions in terms of improving glycaemic control, vascular risk management and screening for other microvascular complications. It is likely that further (but smaller) improvements in DRS attendance can also be achieved by increasing the intensity of a particular QI component or adding further components.

Cost-effectiveness of multidisciplinary management of Tinnitus at a specialized Tinnitus centre

PubMed Central

Cima, Rilana; Joore, Manuela; Maes, Iris; Scheyen, Dyon; Refaie, Amr El; Baguley, David M; Vlaeyen, Johan WS; Anteunis, Lucien

2009-01-01

Background Tinnitus is a common chronic health condition that affects 10% to 20% of the general population. Among severe sufferers it causes disability in various areas. As a result of the tinnitus, quality of life is often impaired. At present there is no cure or uniformly effective treatment, leading to fragmentized and costly tinnitus care. Evidence suggests that a comprehensive multidisciplinary approach in treating tinnitus is effective. The main objective of this study is to examine the effectiveness, costs, and cost-effectiveness of a comprehensive treatment provided by a specialized tinnitus center versus usual care. This paper describes the study protocol. Methods/Design In a randomized controlled clinical trial 198 tinnitus patients will be randomly assigned to a specialized tinnitus care group or a usual care group. Adult tinnitus sufferers referred to the audiological centre are eligible. Included patients will be followed for 12 months. Primary outcome measure is generic quality of life (measured with the Health Utilities Index Mark III). Secondary outcomes are severity of tinnitus, general distress, tinnitus cognitions, tinnitus specific fear, and costs. Based on health state utility outcome data the number of patients to include is 198. Economic evaluation will be performed from a societal perspective. Discussion This is, to our knowledge, the first randomized controlled trial that evaluates a comprehensive treatment of tinnitus and includes a full economic evaluation from a societal perspective. If this intervention proves to be effective and cost-effective, implementation of this intervention is considered and anticipated. Trial Registration The trial has been registered at ClinicalTrial.gov. The trial registration number is NCT00733044 PMID:19210767

Effect of Pharmacy-Supported Transition-of-Care Interventions on 30-Day Readmissions: A Systematic Review and Meta-analysis.

PubMed

Rodrigues, Claire R; Harrington, Amanda R; Murdock, Nicole; Holmes, John T; Borzadek, Eliza Z; Calabro, Kristin; Martin, Jennifer; Slack, Marion K

2017-10-01

To describe pharmacy-supported transition-of-care (TOC) interventions and determine their effect on 30-day all-cause readmissions. MEDLINE/PubMed, EMBASE, International Pharmaceutical Abstracts, ABI Inform Complete, PsychINFO, Web of Science, Academic Search Complete, CINHAL, Cochrane library, OIASTER, ProQuest Dissertations & Theses, ClinicalTrials.gov , and relevant websites were searched from January 1, 1995, to December 31, 2015. PICOS+E criteria were utilized. Eligible studies reported pharmacy-supported TOC interventions compared with usual care in adult patients discharged to home within the United States. Studies were required to evaluate postdischarge outcomes (eg, rate of readmissions, hospital utilization). Randomized controlled trials, cohort studies, or controlled before-and-after studies were included. Two reviewers independently extracted data and evaluated study quality. A total of 56 articles were included in the systematic review (n = 61 858), of which 32 reported 30-day all-cause readmissions and were included in the meta-analysis. A taxonomy was developed to categorize targeted patients, intervention types, and pharmacy personnel as sole intervener. The meta-analysis demonstrated about a 32% reduction in the odds of readmission (odds ratio [OR] = 0.68; 95% CI = 0.61 to 0.75) observed for pharmacy-supported TOC interventions compared with usual care. Heterogeneity was identified ( I 2 = 55%; P < 0.001). A stratified meta-analysis showed that interventions with patient-centered follow-up reduced 30-day readmissions relative to studies without follow-up (OR = 0.70; CI = 0.63 to 0.78). Pharmacy-supported TOC programs were associated with a significant reduction in the odds of 30-day readmissions.

Chronic disease management interventions for people with chronic kidney disease in primary care: a systematic review and meta-analysis.

PubMed

Galbraith, Lauren; Jacobs, Casey; Hemmelgarn, Brenda R; Donald, Maoliosa; Manns, Braden J; Jun, Min

2018-01-01

Primary care providers manage the majority of patients with chronic kidney disease (CKD), although the most effective chronic disease management (CDM) strategies for these patients are unknown. We assessed the efficacy of CDM interventions used by primary care providers managing patients with CKD. The Medline, Embase and Cochrane Central databases were systematically searched (inception to November 2014) for randomized controlled trials (RCTs) assessing education-based and computer-assisted CDM interventions targeting primary care providers managing patients with CKD in the community. The efficacy of CDM interventions was assessed using quality indicators [use of angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), proteinuria measurement and achievement of blood pressure (BP) targets] and clinical outcomes (change in BP and glomerular filtration rate). Two independent reviewers evaluated studies for inclusion, quality and extracted data. Random effects models were used to estimate pooled odds ratios (ORs) and weighted mean differences for outcomes of interest. Five studies (188 clinics; 494 physicians; 42 852 patients with CKD) were included. Two studies compared computer-assisted intervention strategies with usual care, two studies compared education-based intervention strategies with computer-assisted intervention strategies and one study compared both these intervention strategies with usual care. Compared with usual care, computer-assisted CDM interventions did not increase the likelihood of ACEI/ARB use among patients with CKD {pooled OR 1.00 [95% confidence interval (CI) 0.83-1.21]; I2 = 0.0%}. Similarly, education-related CDM interventions did not increase the likelihood of ACEI/ARB use compared with computer-assisted CDM interventions [pooled OR 1.12 (95% CI 0.77-1.64); I2 = 0.0%]. Inconsistencies in reporting methods limited further pooling of data. To date, there have been very few randomized trials testing CDM interventions targeting primary care providers with the goal of improving care of people with CKD. Those conducted to date have shown minimal impact, suggesting that other strategies, or multifaceted interventions, may be required to enhance care for patients with CKD in the community. © The Author 2017. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Educational interventions for the management of cancer-related fatigue in adults.

PubMed

Bennett, Sally; Pigott, Amanda; Beller, Elaine M; Haines, Terry; Meredith, Pamela; Delaney, Christie

2016-11-24

Cancer-related fatigue is reported as the most common and distressing symptom experienced by patients with cancer. It can exacerbate the experience of other symptoms, negatively affect mood, interfere with the ability to carry out everyday activities, and negatively impact on quality of life. Educational interventions may help people to manage this fatigue or to cope with this symptom, and reduce its overall burden. Despite the importance of education for managing cancer-related fatigue there are currently no systematic reviews examining this approach. To determine the effectiveness of educational interventions for managing cancer-related fatigue in adults. We searched the Cochrane Central Register of Controlled Trials (CENTRAL), and MEDLINE, EMBASE, CINAHL, PsycINFO, ERIC, OTseeker and PEDro up to 1st November 2016. We also searched trials registries. We included randomised controlled trials (RCTs) of educational interventions focused on cancer-related fatigue where fatigue was a primary outcome. Studies must have aimed to evaluate the effect of educational interventions designed specifically to manage cancer-related fatigue, or to evaluate educational interventions targeting a constellation of physical symptoms or quality of life where fatigue was the primary focus. The studies could have compared educational interventions with no intervention or wait list controls, usual care or attention controls, or an alternative intervention for cancer-related fatigue in adults with any type of cancer. Two review authors independently screened studies for inclusion and extracted data. We resolved differences in opinion by discussion. Trial authors were contacted for additional information. A third independent person checked the data extraction. The main outcome considered in this review was cancer-related fatigue. We assessed the evidence using GRADE and created a 'Summary of Findings' table. We included 14 RCTs with 2213 participants across different cancer diagnoses. Four studies used only 'information-giving' educational strategies, whereas the remainder used mainly information-giving strategies coupled with some problem-solving, reinforcement, or support techniques. Interventions differed in delivery including: mode of delivery (face to face, web-based, audiotape, telephone); group or individual interventions; number of sessions provided (ranging from 2 to 12 sessions); and timing of intervention in relation to completion of cancer treatment (during or after completion). Most trials compared educational interventions to usual care and meta-analyses compared educational interventions to usual care or attention controls. Methodological issues that increased the risk of bias were evident including lack of blinding of outcome assessors, unclear allocation concealment in over half of the studies, and generally small sample sizes. Using the GRADE approach, we rated the quality of evidence as very low to moderate, downgraded mainly due to high risk of bias, unexplained heterogeneity, and imprecision.There was moderate quality evidence of a small reduction in fatigue intensity from a meta-analyses of eight studies (1524 participants; standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.52 to -0.04) comparing educational interventions with usual care or attention control. We found low quality evidence from twelve studies (1711 participants) that educational interventions had a small effect on general/overall fatigue (SMD -0.27, 95% CI -0.51 to -0.04) compared to usual care or attention control. There was low quality evidence from three studies (622 participants) of a moderate size effect of educational interventions for reducing fatigue distress (SMD -0.57, 95% CI -1.09 to -0.05) compared to usual care, and this could be considered clinically significant. Pooled data from four studies (439 participants) found a small reduction in fatigue interference with daily life (SMD -0.35, 95% CI -0.54 to -0.16; moderate quality evidence). No clear effects on fatigue were found related to type of cancer treatment or timing of intervention in relation to completion of cancer treatment, and there were insufficient data available to determine the effect of educational interventions on fatigue by stage of disease, tumour type or group versus individual intervention.Three studies (571 participants) provided low quality evidence for a reduction in anxiety in favour of the intervention group (mean difference (MD) -1.47, 95% CI -2.76 to -0.18) which, for some, would be considered clinically significant. Two additional studies not included in the meta-analysis also reported statistically significant improvements in anxiety in favour of the educational intervention, whereas a third study did not. Compared with usual care or attention control, educational interventions showed no significant reduction in depressive symptoms (four studies, 881 participants, SMD -0.12, 95% CI -0.47 to 0.23; very low quality evidence). Three additional trials not included in the meta-analysis found no between-group differences in the symptoms of depression. No between-group difference was evident in the capacity for activities of daily living or physical function when comparing educational interventions with usual care (4 studies, 773 participants, SMD 0.33, 95% CI -0.10 to 0.75) and the quality of evidence was low. Pooled evidence of low quality from two of three studies examining the effect of educational interventions compared to usual care found an improvement in global quality of life on a 0-100 scale (MD 11.47, 95% CI 1.29 to 21.65), which would be considered clinically significant for some.No adverse events were reported in any of the studies. Educational interventions may have a small effect on reducing fatigue intensity, fatigue's interference with daily life, and general fatigue, and could have a moderate effect on reducing fatigue distress. Educational interventions focused on fatigue may also help reduce anxiety and improve global quality of life, but it is unclear what effect they might have on capacity for activities of daily living or depressive symptoms. Additional studies undertaken in the future are likely to impact on our confidence in the conclusions.The incorporation of education for the management of fatigue as part of routine care appears reasonable. However, given the complex nature of this symptom, educational interventions on their own are unlikely to optimally reduce fatigue or help people manage its impact, and should be considered in conjunction with other interventions. Just how educational interventions are best delivered, and their content and timing to maximise outcomes, are issues that require further research.

The Effect of Perioperative E-Health Interventions on the Postoperative Course: A Systematic Review of Randomised and Non-Randomised Controlled Trials.

PubMed

van der Meij, Eva; Anema, Johannes R; Otten, René H J; Huirne, Judith A F; Schaafsma, Frederieke G

2016-01-01

E-health interventions have become increasingly popular, including in perioperative care. The objective of this study was to evaluate the effect of perioperative e-health interventions on the postoperative course. We conducted a systematic review and searched for relevant articles in the PUBMED, EMBASE, CINAHL and COCHRANE databases. Controlled trials written in English, with participants of 18 years and older who underwent any type of surgery and which evaluated any type of e-health intervention by reporting patient-related outcome measures focusing on the period after surgery, were included. Data of all included studies were extracted and study quality was assessed by using the Downs and Black scoring system. A total of 33 articles were included, reporting on 27 unique studies. Most studies were judged as having a medium risk of bias (n = 13), 11 as a low risk of bias, and three as high risk of bias studies. Most studies included patients undergoing cardiac (n = 9) or orthopedic surgery (n = 7). All studies focused on replacing (n = 11) or complementing (n = 15) perioperative usual care with some form of care via ICT; one study evaluated both type of interventions. Interventions consisted of an educational or supportive website, telemonitoring, telerehabilitation or teleconsultation. All studies measured patient-related outcomes focusing on the physical, the mental or the general component of recovery. 11 studies (40.7%) reported outcome measures related to the effectiveness of the intervention in terms of health care usage and costs. 25 studies (92.6%) reported at least an equal (n = 8) or positive (n = 17) effect of the e-health intervention compared to usual care. In two studies (7.4%) a positive effect on any outcome was found in favour of the control group. Based on this systematic review we conclude that in the majority of the studies e-health leads to similar or improved clinical patient-related outcomes compared to only face to face perioperative care for patients who have undergone various forms of surgery. However, due to the low or moderate quality of many studies, the results should be interpreted with caution.

REDUCING SUICIDAL IDEATION AND DEPRESSION IN OLDER PRIMARY CARE PATIENTS: 24-MONTH OUTCOMES OF THE PROSPECT STUDY

PubMed Central

Alexopoulos, George S.; Reynolds, Charles F.; Bruce, Martha L.; Katz, Ira R.; Raue, Patrick J.; Mulsant, Benoit H.; Oslin, David; Have, Thomas Ten

2010-01-01

Objective The PROSPECT Study evaluated the impact of a care management intervention on suicidal ideation and depression in older primary care patients. This is the first report of outcomes over a 2-year period. Method The subjects (N=599) were older (>=60 years) patients with major or minor depression selected after screening 9,072 randomly identified patients of 20 primary care practices randomly assigned to the PROSPECT intervention or usual care. The intervention consisted of services of 15 trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 24 months. Results Intervention patients had a higher likelihood to receive antidepressants and or psychotherapy (84.9–89% vs. 49–59%) and a 2.2 times greater decline in suicidal ideation than usual care patients over 24 months. Treatment response occurred earlier in intervention patients and continued to increase from the 18th to the 24th month, while there was no appreciable increase in usual care patients during the same period. Among patients with major depression, a greater number achieved remission in the intervention than the usual care group at 4 (26.6 vs. 15.2%), 8 (36% vs. 22.5%), and 24 (45.4% vs. 31.5%) months. Patients with minor depression had favorable outcomes regardless of treatment assignment. Conclusions Sustained collaborative care maintains high utilization of antidepressant treatment, reduces suicidal ideation, and improves the outcomes of major depression over two years. These observations suggest that sustained collaborative care increases depression-free days. PMID:19528195

Cost-effectiveness of Collaborative Care for Depression in Human Immunodeficiency Virus Clinics

PubMed Central

Fortney, John C; Gifford, Allen L; Rimland, David; Monson, Thomas; Rodriguez-Barradas, Maria C.; Pyne, Jeffrey M

2015-01-01

Objective To examine the cost-effectiveness of the HITIDES intervention. Design Randomized controlled effectiveness and implementation trial comparing depression collaborative care with enhanced usual care. Setting Three Veterans Health Administration (VHA) HIV clinics in the Southern US. Subjects 249 HIV-infected patients completed the baseline interview; 123 were randomized to the intervention and 126 to usual care. Intervention HITIDES consisted of an off-site HIV depression care team that delivered up to 12 months of collaborative care. The intervention used a stepped-care model for depression treatment and specific recommendations were based on the Texas Medication Algorithm Project and the VA/Department of Defense Depression Treatment Guidelines. Main outcome measure(s) Quality-adjusted life years (QALYs) were calculated using the 12-Item Short Form Health Survey, the Quality of Well Being Scale, and by converting depression-free days to QALYs. The base case analysis used outpatient, pharmacy, patient, and intervention costs. Cost-effectiveness was calculated using incremental cost effectiveness ratios (ICERs) and net health benefit (NHB). ICER distributions were generated using nonparametric bootstrap with replacement sampling. Results The HITIDES intervention was more effective and cost-saving compared to usual care in 78% of bootstrapped samples. The intervention NHB was positive and therefore deemed cost-effective using an ICER threshold of $50,000/QALY. Conclusions In HIV clinic settings this intervention was more effective and cost-saving compared to usual care. Implementation of off-site depression collaborative care programs in specialty care settings may be a strategy that not only improves outcomes for patients, but also maximizes the efficient use of limited healthcare resources. PMID:26102447

Blended E-health module on return to work embedded in collaborative occupational health care for common mental disorders: design of a cluster randomized controlled trial.

PubMed

Volker, Daniëlle; Vlasveld, Moniek C; Anema, Johannes R; Beekman, Aartjan Tf; Roijen, Leona Hakkaart-van; Brouwers, Evelien Pm; van Lomwel, A Gijsbert C; van der Feltz-Cornelis, Christina M

2013-01-01

Common mental disorders (CMD) have a major impact on both society and individual workers, so return to work (RTW) is an important issue. In The Netherlands, the occupational physician plays a central role in the guidance of sick-listed workers with respect to RTW. Evidence-based guidelines are available, but seem not to be effective in improving RTW in people with CMD. An intervention supporting the occupational physician in guidance of sick-listed workers combined with specific guidance regarding RTW is needed. A blended E-health module embedded in collaborative occupational health care is now available, and comprises a decision aid supporting the occupational physician and an E-health module, Return@Work, to support sick-listed workers in the RTW process. The cost-effectiveness of this intervention will be evaluated in this study and compared with that of care as usual. This study is a two-armed cluster randomized controlled trial, with randomization done at the level of occupational physicians. Two hundred workers with CMD on sickness absence for 4-26 weeks will be included in the study. Workers whose occupational physician is allocated to the intervention group will receive the collaborative occupational health care intervention. Occupational physicians allocated to the care as usual group will give conventional sickness guidance. Follow-up assessments will be done at 3, 6, 9, and 12 months after baseline. The primary outcome is duration until RTW. The secondary outcome is severity of symptoms of CMD. An economic evaluation will be performed as part of this trial. It is hypothesized that collaborative occupational health care intervention will be more (cost)-effective than care as usual. This intervention is innovative in its combination of a decision aid by email sent to the occupational physician and an E-health module aimed at RTW for the sick-listed worker.

National randomized controlled trial of virtual house calls for Parkinson disease.

PubMed

Beck, Christopher A; Beran, Denise B; Biglan, Kevin M; Boyd, Cynthia M; Dorsey, E Ray; Schmidt, Peter N; Simone, Richard; Willis, Allison W; Galifianakis, Nicholas B; Katz, Maya; Tanner, Caroline M; Dodenhoff, Kristen; Aldred, Jason; Carter, Julie; Fraser, Andrew; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Reichwein, Suzanne; Mari, Zoltan; Dunlop, Becky; Morgan, John C; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Mejia, Nicte I; Bwala, Grace; Nance, Martha; Shih, Ludy C; Singer, Carlos; Vargas-Parra, Silvia; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Dhall, Rohit; Hassan, Anhar; DeMello, Steven; Riggare, Sara S; Wicks, Paul; Achey, Meredith A; Elson, Molly J; Goldenthal, Steven; Keenan, H Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E Anna; Zhu, William

2017-09-12

To determine whether providing remote neurologic care into the homes of people with Parkinson disease (PD) is feasible, beneficial, and valuable. In a 1-year randomized controlled trial, we compared usual care to usual care supplemented by 4 virtual visits via video conferencing from a remote specialist into patients' homes. Primary outcome measures were feasibility, as measured by the proportion who completed at least one virtual visit and the proportion of virtual visits completed on time; and efficacy, as measured by the change in the Parkinson's Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings. A total of 927 individuals indicated interest, 210 were enrolled, and 195 were randomized. Participants had recently seen a specialist (73%) and were largely college-educated (73%) and white (96%). Ninety-five (98% of the intervention group) completed at least one virtual visit, and 91% of 388 virtual visits were completed. Quality of life did not improve in those receiving virtual house calls (0.3 points worse on a 100-point scale; 95% confidence interval [CI] -2.0 to 2.7 points; p = 0.78) nor did quality of care or caregiver burden. Each virtual house call saved patients a median of 88 minutes (95% CI 70-120; p < 0.0001) and 38 miles per visit (95% CI 36-56; p < 0.0001). Providing remote neurologic care directly into the homes of people with PD was feasible and was neither more nor less efficacious than usual in-person care. Virtual house calls generated great interest and provided substantial convenience. NCT02038959. This study provides Class III evidence that for patients with PD, virtual house calls from a neurologist are feasible and do not significantly change quality of life compared to in-person visits. The study is rated Class III because it was not possible to mask patients to visit type. © 2017 American Academy of Neurology.

Effects of a long-term lifestyle intervention program with Mediterranean diet and exercise for the management of patients with metabolic syndrome in a primary care setting.

PubMed

Gomez-Huelgas, R; Jansen-Chaparro, S; Baca-Osorio, A J; Mancera-Romero, J; Tinahones, F J; Bernal-López, M R

2015-06-01

The impact of a lifestyle intervention (LSI) program for the long-term management of subjects with metabolic syndrome in a primary care setting is not known. This 3-year prospective controlled trial randomized adult subjects with metabolic syndrome to receive intensive LSI or to usual care in a community health centre in Malaga, Spain. LSI subjects received instruction on Mediterranean diet and a regular aerobic exercise program by their primary care professionals. Primary outcome included changes from baseline on different components of metabolic syndrome (abdominal circumference, blood pressure, HDL-cholesterol, fasting plasma glucose and triglycerides). Among the 2,492 subjects screened, 601 subjects with metabolic syndrome (24.1%) were randomized to LSI (n = 298) or to usual care (n = 303); of them, a 77% and a 58%, respectively, completed the study. At the end of the study period, LSI resulted in significant differences vs. usual care in abdominal circumference (-0.4 ± 6 cm vs. + 2.1 ± 6.7 cm, p < 0.001), systolic blood pressure (-5.5 ± 15 mmHg vs. -0.6 ± 19 mmHg, p = 0.004), diastolic blood pressure (-4.6 ± 10 mmHg vs. -0.2 ± 13 mmHg, p < 0.001) and HDL-cholesterol (+4 ± 12 mg/dL vs. + 2 ± 12 mg/dL, p = 0.05); however, there were no differences in fasting plasma glucose and triglyceride concentration (-4 ± 35 mg/dl vs. -1 ± 32 mg/dl, p = 0.43 and -0.4 ± 83 mg/dl vs. +6 ± 113 mg/dl, p = 0.28). Intensive LSI counseling provided by primary care professionals resulted in significant improvements in abdominal circumference, blood pressure and HDL-cholesterol but had limited effects on glucose and triglyceride levels in patients with metabolic syndrome. Copyright © 2015 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Comparison of a computer assisted learning program to standard education tools in hospitalized heart failure patients.

PubMed

Dilles, Ann; Heymans, Valerie; Martin, Sandra; Droogné, Walter; Denhaerynck, Kris; De Geest, Sabina

2011-09-01

Education, coaching and guidance of patients are important components of heart failure management. The aim of this study was to compare a computer assisted learning (CAL) program with standard education (brochures and oral information from nurses) on knowledge and self-care in hospitalized heart failure patients. Satisfaction with the CAL program was also assessed in the intervention group. A quasi-experimental design was used, with a convenience sample of in-hospital heart failure patients. Knowledge and self-care were measured using the Dutch Heart Failure Knowledge Scale and the European Heart Failure Self-care Behaviour Scale at hospital admission, at discharge and after a 3-month follow-up. Satisfaction with the CAL program was assessed at hospital discharge using a satisfaction questionnaire. Within and between groups, changes in knowledge and self-care over time were tested using a mixed regression model. Of 65 heart failure patients screened, 37 were included in the study: 21 in the CAL group and 16 in the usual care group. No significant differences in knowledge (p=0.65) or self-care (p=0.40) could be found between groups. However, both variables improved significantly over time in each study group (p<0.0001). Both educational strategies increased knowledge and improved self-care. The design did not allow isolation of the effects of standard education usual care from CAL. Economic and clinical outcomes of both methods should be evaluated in further research. Copyright © 2010. Published by Elsevier B.V.

Effects of Dementia-Care Mapping on Residents and Staff of Care Homes: A Pragmatic Cluster-Randomised Controlled Trial

PubMed Central

van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M. M.; Donders, Rogier; Zuidema, Sytse U.; Koopmans, Raymond T. C. M.; Vernooij-Dassen, Myrra J. F. J.

2013-01-01

Background The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Methods Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents’ neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. Results 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI −2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Conclusions Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Trial Registration Dutch Trials Registry NTR2314. PMID:23844003

Effects of dementia-care mapping on residents and staff of care homes: a pragmatic cluster-randomised controlled trial.

PubMed

van de Ven, Geertje; Draskovic, Irena; Adang, Eddy M M; Donders, Rogier; Zuidema, Sytse U; Koopmans, Raymond T C M; Vernooij-Dassen, Myrra J F J

2013-01-01

The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents' neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI -2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Dutch Trials Registry NTR2314.

Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial

PubMed Central

Liang, Jenifer; Abramson, Michael J; Zwar, Nicholas; Russell, Grant; Holland, Anne E; Bonevski, Billie; Mahal, Ajay; van Hecke, Benjamin; Phillips, Kirsten; Eustace, Paula; Paul, Eldho; Petrie, Kate; Wilson, Sally; George, Johnson

2017-01-01

Introduction Up to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings. Methods and analysis A cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS — Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George’s Respiratory Questionnaire score of patients with COPD at 6 months from baseline. Ethics and dissemination This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 – 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time. Trial registration number ACTRN12614001155684; Pre-results. PMID:28928190

Interprofessional collaboration to improve professional practice and healthcare outcomes.

PubMed

Reeves, Scott; Pelone, Ferruccio; Harrison, Reema; Goldman, Joanne; Zwarenstein, Merrick

2017-06-22

Poor interprofessional collaboration (IPC) can adversely affect the delivery of health services and patient care. Interventions that address IPC problems have the potential to improve professional practice and healthcare outcomes. To assess the impact of practice-based interventions designed to improve interprofessional collaboration (IPC) amongst health and social care professionals, compared to usual care or to an alternative intervention, on at least one of the following primary outcomes: patient health outcomes, clinical process or efficiency outcomes or secondary outcomes (collaborative behaviour). We searched CENTRAL (2015, issue 11), MEDLINE, CINAHL, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform to November 2015. We handsearched relevant interprofessional journals to November 2015, and reviewed the reference lists of the included studies. We included randomised trials of practice-based IPC interventions involving health and social care professionals compared to usual care or to an alternative intervention. Two review authors independently assessed the eligibility of each potentially relevant study. We extracted data from the included studies and assessed the risk of bias of each study. We were unable to perform a meta-analysis of study outcomes, given the small number of included studies and their heterogeneity in clinical settings, interventions and outcomes. Consequently, we summarised the study data and presented the results in a narrative format to report study methods, outcomes, impact and certainty of the evidence. We included nine studies in total (6540 participants); six cluster-randomised trials and three individual randomised trials (1 study randomised clinicians, 1 randomised patients, and 1 randomised clinicians and patients). All studies were conducted in high-income countries (Australia, Belgium, Sweden, UK and USA) across primary, secondary, tertiary and community care settings and had a follow-up of up to 12 months. Eight studies compared an IPC intervention with usual care and evaluated the effects of different practice-based IPC interventions: externally facilitated interprofessional activities (e.g. team action planning; 4 studies), interprofessional rounds (2 studies), interprofessional meetings (1 study), and interprofessional checklists (1 study). One study compared one type of interprofessional meeting with another type of interprofessional meeting. We assessed four studies to be at high risk of attrition bias and an equal number of studies to be at high risk of detection bias.For studies comparing an IPC intervention with usual care, functional status in stroke patients may be slightly improved by externally facilitated interprofessional activities (1 study, 464 participants, low-certainty evidence). We are uncertain whether patient-assessed quality of care (1 study, 1185 participants), continuity of care (1 study, 464 participants) or collaborative working (4 studies, 1936 participants) are improved by externally facilitated interprofessional activities, as we graded the evidence as very low-certainty for these outcomes. Healthcare professionals' adherence to recommended practices may be slightly improved with externally facilitated interprofessional activities or interprofessional meetings (3 studies, 2576 participants, low certainty evidence). The use of healthcare resources may be slightly improved by externally facilitated interprofessional activities, interprofessional checklists and rounds (4 studies, 1679 participants, low-certainty evidence). None of the included studies reported on patient mortality, morbidity or complication rates.Compared to multidisciplinary audio conferencing, multidisciplinary video conferencing may reduce the average length of treatment and may reduce the number of multidisciplinary conferences needed per patient and the patient length of stay. There was little or no difference between these interventions in the number of communications between health professionals (1 study, 100 participants; low-certainty evidence). Given that the certainty of evidence from the included studies was judged to be low to very low, there is not sufficient evidence to draw clear conclusions on the effects of IPC interventions. Neverthess, due to the difficulties health professionals encounter when collaborating in clinical practice, it is encouraging that research on the number of interventions to improve IPC has increased since this review was last updated. While this field is developing, further rigorous, mixed-method studies are required. Future studies should focus on longer acclimatisation periods before evaluating newly implemented IPC interventions, and use longer follow-up to generate a more informed understanding of the effects of IPC on clinical practice.

Graded activity for low back pain in occupational health care: a randomized, controlled trial.

PubMed

Staal, J Bart; Hlobil, Hynek; Twisk, Jos W R; Smid, Tjabe; Köke, Albère J A; van Mechelen, Willem

2004-01-20

Low back pain is a common medical and social problem frequently associated with disability and absence from work. However, data on effective return to work after interventions for low back pain are scarce. To determine the effectiveness of a behavior-oriented graded activity program compared with usual care. Randomized, controlled trial. Occupational health services department of an airline company in the Netherlands. 134 workers who were absent from work because of low back pain were randomly assigned to either graded activity (n = 67) or usual care (n = 67). Graded activity, a physical exercise program based on operant-conditioning behavioral principles, to stimulate a rapid return to work. Outcomes were the number of days of absence from work because of low back pain, functional status (Roland Disability Questionnaire), and severity of pain (11-point numerical scale). The median number of days of absence from work over 6 months of follow-up was 58 days in the graded activity group and 87 days in the usual care group. From randomization onward, graded activity was effective after 50 days of absence from work (hazard ratio, 1.9 [95% CI, 1.2 to 3.2]; P = 0.009). The graded activity group was more effective in improving functional status and pain than the usual care group. The effects, however, were small and not statistically significant. Graded activity was more effective than usual care in reducing the number of days of absence from work because of low back pain.

Effect of patient navigation on satisfaction with cancer-related care

PubMed Central

Winters, Paul C.; Jean-Pierre, Pascal; Warren-Mears, Victoria; Post, Douglas; Van Duyn, Mary Ann S.; Fiscella, Kevin; Darnell, Julie; Freund, Karen M.

2015-01-01

Purpose Despite growing popularity of patient navigation (PN) as a means to improve cancer care quality and reduce cancer-related disparities, there are few well-designed controlled trials assessing the impact of PN on patient outcomes like satisfaction with care. The present controlled study examined effect of PN on satisfaction with cancer-related care. Methods Patients who presented with a symptom or abnormal screening test (n=1788) or definitive diagnosis (n=445) of breast, cervical, colorectal, or prostate cancer from eight Patient Navigator Research Program sites were included in one of two groups: intervention (PN) or comparison (usual care or usual care plus cancer educational materials). Trained patient navigators met with intervention group participants to help them assess and identify resources to address barriers to cancer diagnostic or treatment care. Using a validated instrument, we assessed participants' satisfaction with their cancer diagnostic or treatment care up to 3 months after diagnostic resolution of a cancer-related abnormality or within 3 months of initiation of cancer treatment. Results Overall, patients reported high satisfaction with diagnostic care and cancer treatment. There were no statistically significant differences between PN and control groups in satisfaction with cancer-related care (p>0.05). Hispanic and African American participants were less likely to report high satisfaction with cancer care when compared to White patients. Middle-aged participants with higher education, higher household income, private insurance, owning their own home, working full-time, and those whose primary language is English had higher satisfaction with cancer-related diagnostic care. Conclusions PN had no statistically significant effect on patients' satisfaction with cancer-related care. Further research is needed to define the patient populations who might benefit from PN, content of PN that is most useful, and services that might enhance PN. PMID:26438146

Following the Money: Factors Associated with the Cost of Treating High-Cost Medicare Beneficiaries

PubMed Central

Reschovsky, James D; Hadley, Jack; Saiontz-Martinez, Cynthia B; Boukus, Ellyn R

2011-01-01

Objective To identify factors associated with the cost of treating high-cost Medicare beneficiaries. Data Sources A national sample of 1.6 million elderly, Medicare beneficiaries linked to 2004–2005 Community Tracking Study Physician Survey respondents and local market data from secondary sources. Study Design Using 12 months of claims data from 2005 to 2006, the sample was divided into predicted high-cost (top quartile) and lower cost beneficiaries using a risk-adjustment model. For each group, total annual standardized costs of care were regressed on beneficiary, usual source of care physician, practice, and market characteristics. Principal Findings Among high-cost beneficiaries, health was the predominant predictor of costs, with most physician and practice and many market factors (including provider supply) insignificant or weakly related to cost. Beneficiaries whose usual physician was a medical specialist or reported inadequate office visit time, medical specialist supply, provider for-profit status, care fragmentation, and Medicare fees were associated with higher costs. Conclusions Health reform policies currently envisioned to improve care and lower costs may have small effects on high-cost patients who consume most resources. Instead, developing interventions tailored to improve care and lowering cost for specific types of complex and costly patients may hold greater potential for “bending the cost curve.” PMID:21306368

SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis.

PubMed

Everard, Mark L; Hind, Daniel; Ugonna, Kelechi; Freeman, Jennifer; Bradburn, Mike; Cooper, Cindy L; Cross, Elizabeth; Maguire, Chin; Cantrill, Hannah; Alexander, John; McNamara, Paul S

2014-12-01

Acute bronchiolitis is the commonest cause for hospitalisation in infancy. Supportive care remains the cornerstone of current management and no other therapy has been shown to influence the course of the disease. It has been suggested that adding nebulised hypertonic saline to usual care may shorten the duration of hospitalisation. To determine whether hypertonic saline does have beneficial effects we undertook an open, multi-centre parallel-group, pragmatic RCT in ten UK hospitals. Infants admitted to hospital with a clinical diagnosis of acute bronchiolitis and requiring oxygen therapy were randomised to receive usual care alone or nebulised 3% hypertonic saline (HS) administered 6-hourly. Randomisation was within 4 h of admission. The primary outcome was time to being assessed as 'fit' for discharge with secondary outcomes including time to discharge, incidence of adverse events together with follow up to 28 days assessing patient centred health related outcomes. A total of 317 infants were recruited to the study. 158 infants were randomised to HS (141 analysed) and 159 to standard care (149 analysed). There was no difference between the two arms in time to being declared fit for discharge (hazard ratio: 0-95, 95% CI: 0.75-1.20) nor to actual discharge (hazard ratio: 0.97, 95% CI: 0.76-1.23). There was no difference in adverse events. One infant in the HS group developed bradycardia with desaturation. This study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings. NCT01469845. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers.

PubMed

Wong, I K Y; Andriessen, A; Charles, H E; Thompson, D; Lee, D T F; So, W K W; Abel, M

2012-01-01

In Hong Kong, at the time of the study, compression treatment was not considered usual care for venous leg ulcer patients. This randomized controlled trial compared quality of life (QOL) aspects in venous leg ulcer patients of over 55-years of age, of short-stretch compression (SSB), four-layer compression bandaging (4LB) and usual care (UC) (moist wound healing dressing, no compression). Study period was 24-weeks, the primary outcome was the patient functional status, disease-specific and generic health-related QOL measures and ulcer healing rates, comparing week 1 vs. week 24 (end) results. Assessments included photogrammetry, Brief Pain Inventory, SF-12 Health Survey, Charing Cross Venous Ulcer Questionnaire and Frenchay Activity Index. Data analysis was performed using, where appropriate; Kaplan Meier and log rank chi-square and the repeated measures analysis of variance test. A total of 321 patients participated in the study, 45 (14%) withdrew for various reasons. Compression bandaging in both groups significantly reduced pain (P < 0.0001) and improved functional status and QOL. Healing rate at 24 weeks for both compression groups was significant (P < 0.001); for SSB this was 72.0% (77/107) vs. 67.3% in the 4LB group (72/107) and 29.0% (31/107) with usual care. The reduction in ulcer area from weeks 12 to 24 was significant only for SSB (P < 0.047). Compression was shown to be feasible for elderly community care patients in Hong Kong and is currently implemented as part of standard venous leg ulcer treatment. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

Coaching patients On Achieving Cardiovascular Health (COACH): a multicenter randomized trial in patients with coronary heart disease.

PubMed

Vale, Margarite J; Jelinek, Michael V; Best, James D; Dart, Anthony M; Grigg, Leeanne E; Hare, David L; Ho, Betty P; Newman, Robert W; McNeil, John J

Disease management programs in which drugs are prescribed by dietitians or nurses have been shown to improve the coronary risk factor profile in patients with coronary heart disease. However, those disease management programs in which drugs are not prescribed by allied health professionals have not improved coronary risk factor status. The objective of the Coaching patients On Achieving Cardiovascular Health (COACH) study was to determine whether dietitians or nurses who did not prescribe medications could coach patients with coronary heart disease to work with their physicians to achieve the target levels for their total cholesterol (TC) and other risk factors. Multicenter randomized controlled trial in which 792 patients from 6 university teaching hospitals underwent a stratified randomization by cardiac diagnosis within each hospital: 398 were assigned to usual care plus The COACH Program and 394 to usual care alone. Patients in The COACH Program group received regular personal coaching via telephone and mailings to achieve the target levels for their particular coronary risk factors. There was one coach per hospital. The primary outcome was the change in TC (DeltaTC) from baseline (in hospital) to 6 months after randomization. Secondary outcomes included measurement of a wide range of physical, nutritional, and psychological factors. The analysis was performed by intention to treat. The COACH Program achieved a significantly greater DeltaTC than usual care alone: the mean DeltaTC was 21 mg/dL (0.54 mmol/L) (95% confidence interval [CI], 16-25 mg/dL [0.42-0.65 mmol/L]) in The COACH Program vs 7 mg/dL (0.18 mmol/L) (95% CI, 3-11 mg/dL [0.07-0.29 mmol/L]) in the usual care group (P<.0001). Thus, the reduction in TC from baseline to 6 months after randomization was 14 mg/dL (0.36 mmol/L) (95% CI, 8-20 mg/dL [0.20-0.52 mmol/L]) greater in The COACH Program group than in the usual care group. Coaching produced substantial improvements in most of the other coronary risk factors and in patient quality of life. Coaching, delivered as The COACH Program, is a highly effective strategy in reducing TC and many other coronary risk factors in patients with coronary heart disease. Coaching has potential effectiveness in the whole area of chronic disease management.

Prenatal Education of Parents About Newborn Screening and Residual Dried Blood Spots: A Randomized Clinical Trial.

PubMed

Botkin, Jeffrey R; Rothwell, Erin; Anderson, Rebecca A; Rose, Nancy C; Dolan, Siobhan M; Kuppermann, Miriam; Stark, Louisa A; Goldenberg, Aaron; Wong, Bob

2016-06-01

Research clearly indicates that current approaches to newborn blood spot screening (NBS) education are ineffective. Incorporating NBS education into prenatal care is broadly supported by lay and professional opinion. To determine the efficacy and effect of prenatal education about newborn screening and use of residual dried blood spots (DBS) in research on parental knowledge, attitudes, and behaviors. A randomized clinical trial of prenatal educational interventions, with outcomes measured by survey at 2 to 4 weeks postpartum. Participants were recruited from obstetric clinics in Salt Lake City, Utah; San Francisco, California; and the Bronx, New York. Eligible women were English- or Spanish-speaking adults and did not have a high-risk pregnancy. A total of 901 women were enrolled. Participants who completed the follow-up survey included 212 women in the usual care group (70% retention), 231 in the NBS group (77% retention), and 221 women in the NBS + DBS group (75% retention). Those who completed the survey were similar across the 3 groups with respect to age, ethnicity, race, education, marital status, income, obstetric history, and language. Participants were randomized into 1 of 3 groups: usual care (n = 305), those viewing an NBS movie and brochure (n = 300), and those viewing both the NBS and DBS movies and brochures (n = 296). Two to four weeks postpartum, women completed a 91-item survey by telephone, addressing knowledge, attitudes, and behavior with respect to opting out of NBS or DBS for their child. A total of 901 women (mean age, 31 years) were randomized and 664 completed the follow-up survey. The total correct responses on the knowledge instrument in regard to NBS were 69% in the usual care group, 79% in the NBS group, and 75% in the NBS + DBS group, a significant between-group difference (P < .05). Although all groups showed strong support for NBS, the percentage of women who were "very supportive" was highest in the NBS group (94%), followed by the NBS + DBS group (86%) and was lowest in the usual care group (73%) (P < .001). The interventions were not associated with decisions to decline newborn screening or withdraw residual DBS. Nine women stated that they had declined NBS (all the usual care group; P < .001). With respect to DBS, 5 participants indicated that they contacted the health department to have their child's sample withdrawn after testing: 3 in the NBS + DBS group and 2 in the usual care group (P = .25). Educational interventions can be implemented in the prenatal clinic, using multimedia tools and electronic platforms. Prenatal education is effective in increasing postnatal knowledge and support for these programs. These results are relevant to other contexts in which residual clinical specimens and data are used for research purposes. clinicaltrials.gov Identifier: NCT02676245.

Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial.

PubMed

Chlan, Linda L; Weinert, Craig R; Heiderscheit, Annie; Tracy, Mary Fran; Skaar, Debra J; Guttormson, Jill L; Savik, Kay

2013-06-12

Alternatives to sedative medications, such as music, may alleviate the anxiety associated with ventilatory support. To test whether listening to self-initiated patient-directed music (PDM) can reduce anxiety and sedative exposure during ventilatory support in critically ill patients. Randomized clinical trial that enrolled 373 patients from 12 intensive care units (ICUs) at 5 hospitals in the Minneapolis-St Paul, Minnesota, area receiving acute mechanical ventilatory support for respiratory failure between September 2006 and March 2011. Of the patients included in the study, 86% were white, 52% were female, and the mean (SD) age was 59 (14) years. The patients had a mean (SD) Acute Physiology, Age and Chronic Health Evaluation III score of 63 (21.6) and a mean (SD) of 5.7 (6.4) study days. Self-initiated PDM (n = 126) with preferred selections tailored by a music therapist whenever desired while receiving ventilatory support, self-initiated use of noise-canceling headphones (NCH; n = 122), or usual care (n = 125). Daily assessments of anxiety (on 100-mm visual analog scale) and 2 aggregate measures of sedative exposure (intensity and frequency). Patients in the PDM group listened to music for a mean (SD) of 79.8 (126) (median [range], 12 [0-796]) minutes/day. Patients in the NCH group wore the noise-abating headphones for a mean (SD) of 34.0 (89.6) (median [range], 0 [0-916]) minutes/day. The mixed-models analysis showed that at any time point, patients in the PDM group had an anxiety score that was 19.5 points lower (95% CI, -32.2 to -6.8) than patients in the usual care group (P = .003). By the fifth study day, anxiety was reduced by 36.5% in PDM patients. The treatment × time interaction showed that PDM significantly reduced both measures of sedative exposure. Compared with usual care, the PDM group had reduced sedation intensity by -0.18 (95% CI, -0.36 to -0.004) points/day (P = .05) and had reduced frequency by -0.21 (95% CI, -0.37 to -0.05) points/day (P = .01). The PDM group had reduced sedation frequency by -0.18 (95% CI, -0.36 to -0.004) points/day vs the NCH group (P = .04). By the fifth study day, the PDM patients received 2 fewer sedative doses (reduction of 38%) and had a reduction of 36% in sedation intensity. Among ICU patients receiving acute ventilatory support for respiratory failure, PDM resulted in greater reduction in anxiety compared with usual care, but not compared with NCH. Concurrently, PDM resulted in greater reduction in sedation frequency compared with usual care or NCH, and greater reduction in sedation intensity compared with usual care, but not compared with NCH. clinicaltrials.gov Identifier: NCT00440700.

Population-based outreach versus care as usual to prevent suicide attempt: study protocol for a randomized controlled trial.

PubMed

Simon, Gregory E; Beck, Arne; Rossom, Rebecca; Richards, Julie; Kirlin, Beth; King, Deborah; Shulman, Lisa; Ludman, Evette J; Penfold, Robert; Shortreed, Susan M; Whiteside, Ursula

2016-09-15

Suicide remains the 10th-ranked most frequent cause of death in the United States, accounting for over 40,000 deaths per year. Nonfatal suicide attempts lead to over 200,000 hospitalizations and 600,000 emergency department visits annually. Recent evidence indicates that responses to the commonly used Patient Health Questionnaire (PHQ9) can identify outpatients who are at risk of suicide attempt and suicide death and that specific psychotherapy or Care Management programs can prevent suicide attempts in high-risk patients. Motivated by these developments, the NIMH-funded Mental Health Research Network has undertaken a multisite trial of two outreach programs to prevent suicide attempts among outpatients identified by routinely administered PHQ9 questionnaires. Outpatients who are at risk of suicide attempt are automatically identified using data from electronic health records (EHRs). Following a modified Zelen design, all those identified are assigned to continued usual care (i.e., no contact) or to be offered one of two population-based outreach programs. A Care Management intervention includes systematic outreach to assess suicide risk, EHR-based tools to implement risk-based care pathways, and care management to facilitate recommended follow-up. A Skills Training intervention includes interactive online training in Dialectical Behavior Therapy skills, supported by reminder and reinforcement messages from a skills coach. Each intervention supplements, rather than replaces, usual care; participants may receive any other services normally available. Interventions are delivered primarily by secure messaging through EHR patient portals. Suicide attempts and deaths following randomization are identified using state vital statistics data and health system EHR and insurance claim data. Primary evaluation will compare risk of suicide attempt or death over 18 months according to the initial assignment, regardless of intervention participation. Recruitment is underway in three health systems (Group Health Cooperative, HealthPartners, and Kaiser Permanente Colorado). Over 2500 participants have been randomized as of 1 March 2016, with enrollment averaging approximately 100 per week. Assessing the effectiveness of population-based suicide prevention requires adherence to the principles of pragmatic trials: population-based enrollment, accepting variable treatment participation, assessing outcomes using health record data, and analyses based on intent-to-treat. ClinicalTrials.gov registration # NCT02326883 , registered on 23 December 2014.

Comprehensive self management and routine monitoring in chronic obstructive pulmonary disease patients in general practice: randomised controlled trial.

PubMed

Bischoff, Erik W M A; Akkermans, Reinier; Bourbeau, Jean; van Weel, Chris; Vercoulen, Jan H; Schermer, Tjard R J

2012-11-28

To assess the long term effects of two different modes of disease management (comprehensive self management and routine monitoring) on quality of life (primary objective), frequency and patients' management of exacerbations, and self efficacy (secondary objectives) in patients with chronic obstructive pulmonary disease (COPD) in general practice. 24 month, multicentre, investigator blinded, three arm, pragmatic, randomised controlled trial. 15 general practices in the eastern part of the Netherlands. Patients with COPD confirmed by spirometry and treated in general practice. Patients with very severe COPD or treated by a respiratory physician were excluded. A comprehensive self management programme as an adjunct to usual care, consisting of four tailored sessions with ongoing telephone support by a practice nurse; routine monitoring as an adjunct to usual care, consisting of 2-4 structured consultations a year with a practice nurse; or usual care alone (contacts with the general practitioner at the patients' own initiative). The primary outcome was the change in COPD specific quality of life at 24 months as measured with the chronic respiratory questionnaire total score. Secondary outcomes were chronic respiratory questionnaire domain scores, frequency and patients' management of exacerbations measured with the Nijmegen telephonic exacerbation assessment system, and self efficacy measured with the COPD self-efficacy scale. 165 patients were allocated to self management (n=55), routine monitoring (n=55), or usual care alone (n=55). At 24 months, adjusted treatment differences between the three groups in mean chronic respiratory questionnaire total score were not significant. Secondary outcomes did not differ, except for exacerbation management. Compared with usual care, more exacerbations in the self management group were managed with bronchodilators (odds ratio 2.81, 95% confidence interval 1.16 to 6.82) and with prednisolone, antibiotics, or both (3.98, 1.10 to 15.58). Comprehensive self management or routine monitoring did not show long term benefits in terms of quality of life or self efficacy over usual care alone in COPD patients in general practice. Patients in the self management group seemed to be more capable of appropriately managing exacerbations than did those in the usual care group. Clinical trials NCT00128765.

Randomized clinical trial of an intravenous hydromorphone titration protocol versus usual care for management of acute pain in older emergency department patients.

PubMed

Chang, Andrew K; Bijur, Polly E; Davitt, Michelle; Gallagher, E John

2013-09-01

Opioid titration is an effective strategy for treating pain; however, titration is generally impractical in the busy emergency department (ED) setting. Our objective was to test a rapid, two-step, hydromorphone titration protocol against usual care in older patients presenting to the ED with acute severe pain. This was a prospective, randomized clinical trial of patients 65 years of age and older presenting to an adult, urban, academic ED with acute severe pain. The study was registered at http://www.clinicaltrials.gov (NCT01429285). Patients randomized to the hydromorphone titration protocol initially received 0.5 mg intravenous hydromorphone. Patients randomized to usual care received any dose of any intravenous opioid. At 15 min, patients in both groups were asked, 'Do you want more pain medication?' Patients in the hydromorphone titration group who answered 'yes' received a second dose of 0.5 mg intravenous hydromorphone. Patients in the usual care group who answered 'yes' had their ED attending physician notified, who then could administer any (or no) additional medication. The primary efficacy outcome was satisfactory analgesia defined a priori as the patient declining additional analgesia at least once when asked at 15 or 60 min after administration of the initial opioid. Dose was calculated in morphine equivalent units (MEU: 1 mg hydromorphone = 7 mg morphine). The need for naloxone to reverse adverse opioid effects was the primary safety outcome. 83.0 % of 153 patients in the hydromorphone titration group achieved satisfactory analgesia compared with 82.5 % of 166 patients in the usual care group (p = 0.91). Patients in the hydromorphone titration group received lower mean initial doses of opioids at baseline than patients in the usual care group (3.5 MEU vs. 4.7 MEU, respectively; p ≤ 0.001) and lower total opioids through 60 min (5.3 MEU vs. 6.0 MEU; p = 0.03). No patient needed naloxone. Low-dose titration of intravenous hydromorphone in increments of 0.5 mg provides comparable analgesia to usual care with less opioid over 60 min.

Early Physical Therapy vs Usual Care in Patients With Recent-Onset Low Back Pain: A Randomized Clinical Trial.

PubMed

Fritz, Julie M; Magel, John S; McFadden, Molly; Asche, Carl; Thackeray, Anne; Meier, Whitney; Brennan, Gerard

2015-10-13

Low back pain (LBP) is common in primary care. Guidelines recommend delaying referrals for physical therapy. To evaluate whether early physical therapy (manipulation and exercise) is more effective than usual care in improving disability for patients with LBP fitting a decision rule. Randomized clinical trial with 220 participants recruited between March 2011 and November 2013. Participants with no LBP treatment in the past 6 months, aged 18 through 60 years (mean age, 37.4 years [SD, 10.3]), an Oswestry Disability Index (ODI) score of 20 or higher, symptom duration less than 16 days, and no symptoms distal to the knee in the past 72 hours were enrolled following a primary care visit. All participants received education. Early physical therapy (n = 108) consisted of 4 physical therapy sessions. Usual care (n = 112) involved no additional interventions during the first 4 weeks. Primary outcome was change in the ODI score (range: 0-100; higher scores indicate greater disability; minimum clinically important difference, 6 points) at 3 months. Secondary outcomes included changes in the ODI score at 4-week and 1-year follow-up, and change in pain intensity, Pain Catastrophizing Scale (PCS) score, fear-avoidance beliefs, quality of life, patient-reported success, and health care utilization at 4-week, 3-month, and 1-year follow-up. One-year follow-up was completed by 207 participants (94.1%). Using analysis of covariance, early physical therapy showed improvement relative to usual care in disability after 3 months (mean ODI score: early physical therapy group, 41.3 [95% CI, 38.7 to 44.0] at baseline to 6.6 [95% CI, 4.7 to 8.5] at 3 months; usual care group, 40.9 [95% CI, 38.6 to 43.1] at baseline to 9.8 [95% CI, 7.9 to 11.7] at 3 months; between-group difference, -3.2 [95% CI, -5.9 to -0.47], P = .02). A significant difference was found between groups for the ODI score after 4 weeks (between-group difference, -3.5 [95% CI, -6.8 to -0.08], P = .045]), but not at 1-year follow-up (between-group difference, -2.0 [95% CI, -5.0 to 1.0], P = .19). There was no improvement in pain intensity at 4-week, 3-month, or 1-year follow-up (between-group difference, -0.42 [95% CI, -0.90 to 0.02] at 4-week follow-up; -0.38 [95% CI, -0.84 to 0.09] at 3-month follow-up; and -0.17 [95% CI, -0.62 to 0.27] at 1-year follow-up). The PCS scores improved at 4 weeks and 3 months but not at 1-year follow-up (between-group difference, -2.7 [95% CI, -4.6 to -0.85] at 4-week follow-up; -2.2 [95% CI, -3.9 to -0.49] at 3-month follow-up; and -0.92 [95% CI, -2.7 to 0.61] at 1-year follow-up). There were no differences in health care utilization at any point. Among adults with recent-onset LBP, early physical therapy resulted in statistically significant improvement in disability, but the improvement was modest and did not achieve the minimum clinically important difference compared with usual care. clinicaltrials.gov Identifier: NCT01726803.

Long-term clinical and cost-effectiveness of collaborative care (versus usual care) for people with mental-physical multimorbidity: cluster-randomised trial.

PubMed

Camacho, Elizabeth M; Davies, Linda M; Hann, Mark; Small, Nicola; Bower, Peter; Chew-Graham, Carolyn; Baguely, Clare; Gask, Linda; Dickens, Chris M; Lovell, Karina; Waheed, Waquas; Gibbons, Chris J; Coventry, Peter

2018-05-15

Collaborative care can support the treatment of depression in people with long-term conditions, but long-term benefits and costs are unknown.AimsTo explore the long-term (24-month) effectiveness and cost-effectiveness of collaborative care in people with mental-physical multimorbidity. A cluster randomised trial compared collaborative care (integrated physical and mental healthcare) with usual care for depression alongside diabetes and/or coronary heart disease. Depression symptoms were measured by the symptom checklist-depression scale (SCL-D13). The economic evaluation was from the perspective of the English National Health Service. 191 participants were allocated to collaborative care and 196 to usual care. At 24 months, the mean SCL-D13 score was 0.27 (95% CI, -0.48 to -0.06) lower in the collaborative care group alongside a gain of 0.14 (95% CI, 0.06-0.21) quality-adjusted life-years (QALYs). The cost per QALY gained was £13 069. In the long term, collaborative care reduces depression and is potentially cost-effective at internationally accepted willingness-to-pay thresholds.Declaration of interestNone.

Time for chronic disease care and management

PubMed Central

Montague, Terrence J; Gogovor, Amédé; Krelenbaum, Marilyn

2007-01-01

To manage the future costs and quality of care, a health strategy must move beyond the individual, acute care model and address the care of older people with chronic, and often multiple, diseases. This strategy must address the issue of care gaps, ie, the differences between best care and usual care. It should also embrace broad partnerships in which providers may be a cross-disciplinary team of nurses, physicians and pharmacists; the patient partners may include all patients in the community with a disease or group of diseases; and the system managers should work with all to seek improved long-term care and share the governance of interventions and resources. This partnership is activated by repeated and widely communicated measurements of actual practices and outcomes, facilitating rapid knowledge gain and translation, including unmasking the invisible wait list of unmeasured care gaps. It drives continuous improvement in practices and outcomes. The time is right for such care models. There is increasing evidence of their clinical and financial benefits. There is a clear and immediate opportunity to evaluate them as part of a health strategy for effective chronic care in our aging society. Things can be better. PMID:17932573

Time for chronic disease care and management.

PubMed

Montague, Terrence J; Gogovor, Amédé; Krelenbaum, Marilyn

2007-10-01

To manage the future costs and quality of care, a health strategy must move beyond the individual, acute care model and address the care of older people with chronic, and often multiple, diseases. This strategy must address the issue of care gaps, ie, the differences between best care and usual care. It should also embrace broad partnerships in which providers may be a cross-disciplinary team of nurses, physicians and pharmacists; the patient partners may include all patients in the community with a disease or group of diseases; and the system managers should work with all to seek improved long-term care and share the governance of interventions and resources. This partnership is activated by repeated and widely communicated measurements of actual practices and outcomes, facilitating rapid knowledge gain and translation, including unmasking the invisible wait list of unmeasured care gaps. It drives continuous improvement in practices and outcomes. The time is right for such care models. There is increasing evidence of their clinical and financial benefits. There is a clear and immediate opportunity to evaluate them as part of a health strategy for effective chronic care in our aging society. Things can be better.

Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

PubMed Central

Jayasena, Rajiv; Maiorana, Andrew; Dowling, Alison; Chen, Sheau Huey; Karunanithi, Mohan; Layland, Jamie; Edwards, Iain

2017-01-01

Introduction Chronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes. Methods and analysis An open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits. Ethics and dissemination The clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees. Trial registration number Registered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640). PMID:28993389

Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain.

PubMed

van der Roer, Nicole; van Tulder, Maurits; van Mechelen, Willem; de Vet, Henrica

2008-02-15

Economic evaluation from a societal perspective conducted alongside a randomized controlled trial with a follow-up of 52 weeks. To evaluate the cost effectiveness and cost utility of an intensive group training protocol compared with usual care physiotherapy in patients with nonspecific chronic low back pain. The intensive group training protocol combines exercise therapy, back school, and behavioral principles. Two studies found a significant reduction in absenteeism for a graded activity program in occupational health care. This program has not yet been evaluated in a primary care physiotherapy setting. Participating physical therapists in primary care recruited 114 patients with chronic nonspecific low back pain. Eligible patients were randomized to either the protocol group or the guideline group. Outcome measures included functional status (Roland Morris Disability Questionnaire), pain intensity (11-point numerical rating scale), general perceived effect and quality of life (EuroQol-5D). Cost data were measured with cost diaries and included direct and indirect costs related to low back pain. After 52 weeks, the direct health care costs were significantly higher for patients in the protocol group, largely due to the costs of the intervention. The mean difference in total costs amounted to [Euro sign] 233 (95% confidence interval: [Euro sign] -2.185; [Euro sign] 2.764). The cost-effectiveness planes indicated no significant differences in cost effectiveness between the 2 groups. The results of this economic evaluation showed no difference in total costs between the protocol group and the guideline group. The differences in effects were small and not statistically significant. At present, national implementation of the protocol is not recommended.

A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months). Methods/design This is a randomized controlled trial in which 142 participants will be recruited and randomized (with pre-stratification) to either the intervention group (IG) or control group (CG). The IG will participate in a self-management program consisting of six group sessions and an ehealth module. The CG is allowed to use all usual care available. The primary outcome of the study is the self-reported disability of arm, shoulder, and hand, measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes include: absenteeism, pain in the previous week, quality of life, catastrophizing pain, self-efficacy, workstyle, presenteeism, fatigue, the use of usual care, and limitations experienced on the job. Data are collected at baseline and at 3, 6, and 12 months follow-up. Discussion Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed. Trial registration The trial is registered with the Dutch Trial Register (http://www.trialregister.nlNTR3816): (January 2013). The first participant was randomized in September 2012. PMID:23958154

Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598

PubMed Central

Nassar, N; Roberts, CL; Raynes-Greenow, CH; Barratt, A; Peat, B

2007-01-01

Objectives To evaluate the effectiveness of a decision aid for women with a breech presentation compared with usual care. Design Randomised controlled trial. Setting Tertiary obstetric hospitals offering external cephalic version (ECV). Population Women with a singleton pregnancy were diagnosed antenatally with a breech presentation at term, and were clinically eligible for ECV. Methods Women were randomised to either receive a decision aid about the management options for breech presentation in addition to usual care or to receive usual care only with standard counselling from their usual pregnancy care provider. The decision aid comprised a 24-page booklet supplemented by a 30-minute audio-CD and worksheet that was designed for women to take home and review with a partner. Main outcome measures Decisional conflict (uncertainty), knowledge, anxiety and satisfaction with decision making, and were assessed using self-administered questionnaires. Results Compared with usual care, women reviewing the decision aid experienced significantly lower decisional conflict (mean difference −8.92; 95% CI −13.18, −4.66) and increased knowledge (mean difference 8.40; 95% CI 3.10, 13.71), were more likely to feel that they had enough information to make a decision (RR 1.30; 95% CI 1.14, 1.47), had no increase in anxiety and reported greater satisfaction with decision making and overall experience of pregnancy and childbirth. In contrast, 19% of women in the usual care group reported they would have made a different decision about their care. Conclusions A decision aid is an effective and acceptable tool for pregnant women that provides an important adjunct to standard counselling for the management of breech presentation. Please cite this paper as: Nassar N, Roberts C, Raynes-Greenow C, Barratt A, Peat B, on behalf of the Decision Aid for Breech Presentation Trial Collaborators. Evaluation of a decision aid for women with breech presentation at term: a randomised controlled trial [ISRCTN14570598]. BJOG 2007;114:325–333. PMID:17217360

Long-term follow-up of moderately hypercholesterolemic hypertensive patients following randomization to pravastatin vs. usual care: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT)

PubMed Central

Margolis, Karen L.; Davis, Barry R.; Baimbridge, Charles; Ciocon, Jerry O.; Cuyjet, Aloysius B.; Dart, Richard A.; Einhorn, Paula T.; Ford, Charles E.; Gordon, David; Hartney, Thomas J; Haywood, L. Julian; Holtzman, Jordan; Mathis, David E.; Oparil, Suzanne; Probstfield, Jeffrey L.; Simpson, Lara M.; Stokes, John D.; Wiegmann, Thomas B.; Williamson, Jeff D.

2015-01-01

A randomized, controlled, multicenter trial assigned well-controlled hypertensive participants ≥55 years, with moderate hypercholesterolemia to receive pravastatin (n=5170) or usual care (n=5185) for 4-8 years, when trial therapy was discontinued. Passive surveillance using national databases to ascertain deaths and hospitalizations continued for total follow-up of 8-13 years to assess whether mortality and morbidity differences persisted or new differences developed. During the post-trial period, fatal and nonfatal outcomes were available for 98% and 64% of participants, respectively. Primary outcome was all-cause mortality; secondary outcomes included cardiovascular mortality, coronary heart disease (CHD), stroke, heart failure, cardiovascular disease, and end-stage renal disease. No significant differences appeared in mortality for pravastatin versus usual care (hazard ratio [HR], 0.96; 95% confidence interval [CI], 0.89-1.03), or other secondary outcomes. Similar to the previously reported in-trial result, there was a significant treatment effect for CHD in Blacks (HR, 0.79; 95% CI, 0.64-0.98). However, the in-trial result showing a significant treatment by race effect did not remain significant over the entire follow-up (P=.08). These findings are consistent with evidence from other large trials that show statins prevent CHD and add evidence that they are effective for CHD prevention in Blacks. PMID:23889716

"Your Job Is to Take Care of Us": Teaching Our Way through the Boston Marathon Bombings

ERIC Educational Resources Information Center

Bentley, Dana Frantz

2015-01-01

The concept of social justice and critical thinking are prevalent topics in conversations about early childhood education. Usually, critical conversations around these practices tend to involve academics in discussion rather than include practitioners. In today's world, young children are frequently confronted with the realities of violence and…

Leading Learning in Our Times

ERIC Educational Resources Information Center

Trilling, Bernie

2010-01-01

Important tools that schools need to support a 21st century approach to teaching and learning include the usual suspects: the Internet, pen and paper, cell phones, educational games, tests and quizzes, good teachers, caring communities, educational funding, and loving parents. All of these items and more contribute to a 21st century education, but…

The clinical effects of Kinesio® Tex taping: A systematic review.

PubMed

Morris, D; Jones, D; Ryan, H; Ryan, C G

2013-05-01

Kinesio(®) Tex tape (KTT) is used in a variety of clinical settings. The purpose of this study was to investigate the effect of KTT from randomized controlled trials (RCTs) in the management of clinical conditions. A systematic literature search of CINAHL; MEDLINE; OVID; AMED; SCIENCE DIRECT; PEDRO; www.internurse.com; SPORT DISCUS; BRITISH NURSING INDEX; www.kinesiotaping.co.uk; www.kinesiotaping.com; COCHRANE CENTRAL REGISTER OF CLINICAL TRIALS; and PROQUEST was performed up to April 2012. The risk of bias and quality of evidence grading was performed using the Cochrane collaboration methodology. Eight RCTs met the full inclusion/exclusion criteria. Six of these included patients with musculoskeletal conditions; one included patients with breast-cancer-related lymphedema; and one included stroke patients with muscle spasticity. Six studies included a sham or usual care tape/bandage group. There was limited to moderate evidence that KTT is no more clinically effective than sham or usual care tape/bandage. There was limited evidence from one moderate quality RCT that KTT in conjunction with physiotherapy was clinically beneficial for plantar fasciitis related pain in the short term; however, there are serious questions around the internal validity of this RCT. There currently exists insufficient evidence to support the use of KTT over other modalities in clinical practice.

Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial.

PubMed

Curley, Martha A Q; Wypij, David; Watson, R Scott; Grant, Mary Jo C; Asaro, Lisa A; Cheifetz, Ira M; Dodson, Brenda L; Franck, Linda S; Gedeit, Rainer G; Angus, Derek C; Matthay, Michael A

2015-01-27

Protocolized sedation improves clinical outcomes in critically ill adults, but its effect in children is unknown. To determine whether critically ill children managed with a nurse-implemented, goal-directed sedation protocol experience fewer days of mechanical ventilation than patients receiving usual care. Cluster randomized trial conducted in 31 US pediatric intensive care units (PICUs). A total of 2449 children (mean age, 4.7 years; range, 2 weeks to 17 years) mechanically ventilated for acute respiratory failure were enrolled in 2009-2013 and followed up until 72 hours after opioids were discontinued, 28 days, or hospital discharge. Intervention PICUs (17 sites; n = 1225 patients) used a protocol that included targeted sedation, arousal assessments, extubation readiness testing, sedation adjustment every 8 hours, and sedation weaning. Control PICUs (14 sites; n = 1224 patients) managed sedation per usual care. The primary outcome was duration of mechanical ventilation. Secondary outcomes included time to recovery from acute respiratory failure, duration of weaning from mechanical ventilation, neurological testing, PICU and hospital lengths of stay, in-hospital mortality, sedation-related adverse events, measures of sedative exposure (wakefulness, pain, and agitation), and occurrence of iatrogenic withdrawal. Duration of mechanical ventilation was not different between the 2 groups (intervention: median, 6.5 [IQR, 4.1-11.2] days; control: median, 6.5 [IQR, 3.7-12.1] days). Sedation-related adverse events including inadequate pain and sedation management, clinically significant iatrogenic withdrawal, and unplanned endotracheal tube/invasive line removal were not significantly different between the 2 groups. Intervention patients experienced more postextubation stridor (7% vs 4%; P = .03) and fewer stage 2 or worse immobility-related pressure ulcers (<1% vs 2%; P = .001). In exploratory analyses, intervention patients had fewer days of opioid administration (median, 9 [IQR, 5-15] days vs 10 [IQR, 4-21] days; P = .01), were exposed to fewer sedative classes (median, 2 [IQR, 2-3] classes vs 3 [IQR, 2-4] classes; P < .001), and were more often awake and calm while intubated (median, 86% [IQR, 67%-100%] of days vs 75% [IQR, 50%-100%] of days; P = .004) than control patients, respectively; however, intervention patients had more days with any report of a pain score ≥ 4 (median, 50% [IQR, 27%-67%] of days vs 23% [IQR, 0%-46%] of days; P < .001) and any report of agitation (median, 60% [IQR, 33%-80%] vs 40% [IQR, 13%-67%]; P = .003), respectively. Among children undergoing mechanical ventilation for acute respiratory failure, the use of a sedation protocol compared with usual care did not reduce the duration of mechanical ventilation. Exploratory analyses of secondary outcomes suggest a complex relationship among wakefulness, pain, and agitation. clinicaltrials.gov Identifier: NCT00814099.

The costs and benefits of enhanced depression care to employers.

PubMed

Wang, Philip S; Patrick, Amanda; Avorn, Jerry; Azocar, Francisca; Ludman, Evette; McCulloch, Joyce; Simon, Gregory; Kessler, Ronald

2006-12-01

Although outreach and enhanced treatment interventions improve depression outcomes, uptake has been poor in part because purchasers lack information on their return on investment. To estimate the costs and benefits of enhanced depression care for workers from the societal and employer-purchaser perspectives. Cost-effectiveness and cost-benefit analyses using state-transition Markov models. Simulated movements between health states were based on probabilities drawn from the clinical literature. Hypothetical cohort of 40-year-old workers. Intervention Enhanced depression care consisting of a depression screen and care management for those depressed vs usual care. Our base-case cost-effectiveness analysis was from the societal perspective; costs and quality-adjusted life-years were used to compute the incremental cost-effectiveness of the intervention relative to usual care. A secondary cost-benefit analysis from the employer's perspective tracked monetary costs and monetary benefits accruing to employers during a 5-year time horizon. From the societal perspective, screening and depression care management for workers result in an incremental cost-effectiveness ratio of $19 976 per quality-adjusted life-year relative to usual care. These results are consistent with recent primary care effectiveness trials and within the range for medical interventions usually covered by employer-sponsored insurance. From the employer's perspective, enhanced depression care yields a net cumulative benefit of $2895 after 5 years. In 1-way and probabilistic sensitivity analyses, these findings were robust to a variety of assumptions. If these results can be replicated in effectiveness trials directly assessing effects on work outcomes, they suggest that enhanced treatment quality programs for depression are cost-beneficial to purchasers.

Homeless Veterans' Use of Peer Mentors and Effects on Costs and Utilization in VA Clinics.

PubMed

Yoon, Jean; Lo, Jeanie; Gehlert, Elizabeth; Johnson, Erin E; O'Toole, Thomas P

2017-06-01

The study compared health care utilization and costs among homeless veterans randomly assigned to peer mentors or usual care and described contacts with peer mentors. Homeless patients at four Department of Veterans Affairs clinics were randomly assigned to a peer mentor (N=195) or to usual care (N=180). Administrative data on utilization and costs over a six-month follow-up were combined with peer mentors' reports of patient contacts. Most patients (87%) in the peer mentor group had at least one peer contact. Patients in this group spent the largest proportions of time discussing housing and health issues with peer mentors and had more outpatient encounters than those in usual care, although differences were not significant. No other between-group differences were found in utilization or costs. Although significant impacts of peer mentors on health care patterns or costs were not detected, some patients had frequent contact with peer mentors.

Cost-effectiveness of prize-based incentives for stimulant abusers in outpatient psychosocial treatment programs.

PubMed

Olmstead, Todd A; Sindelar, Jody L; Petry, Nancy M

2007-03-16

To evaluate the cost-effectiveness of a prize-based intervention as an addition to usual care for stimulant abusers. This cost-effectiveness analysis is based on a randomized clinical trial implemented within the National Drug Abuse Treatment Clinical Trials Network. The trial was conducted at eight community-based outpatient psychosocial drug abuse treatment clinics. Four hundred and fifteen stimulant abusers were assigned to usual care (N=206) or usual care plus abstinence-based incentives (N=209) for 12 weeks. Participants randomized to the incentive condition earned the chance to draw for prizes for submitting substance negative samples; the number of draws earned increased with continuous abstinence time. Incremental cost-effectiveness ratios were estimated to compare prize-based incentives relative to usual care. The primary patient outcome was longest duration of confirmed stimulant abstinence (LDA). Unit costs were obtained via surveys administered at the eight participating clinics. Resource utilizations and patient outcomes were obtained from the clinical trial. Acceptability curves are presented to illustrate the uncertainty due to the sample and to provide policy relevant information. The incremental cost to lengthen the LDA by 1 week was 258 US dollars (95% confidence interval, 191-401 US dollars). Sensitivity analyses on several key parameters show that this value ranges from 163 to 269 US dollars. Compared with the usual care group, the incentive group had significantly longer LDAs and significantly higher costs.

Surgical vs Nonoperative Treatment for Lumbar Disk Herniation

PubMed Central

Weinstein, James N.; Lurie, Jon D.; Tosteson, Tor D.; Skinner, Jonathan S.; Hanscom, Brett; Tosteson, Anna N. A.; Herkowitz, Harry; Fischgrund, Jeffrey; Cammisa, Frank P.; Albert, Todd; Deyo, Richard A.

2008-01-01

Context For patients with lumbar disk herniation, the Spine Patient Outcomes Research Trial (SPORT) randomized trial intent-to-treat analysis showed small but not statistically significant differences in favor of diskectomy compared with usual care. However, the large numbers of patients who crossed over between assigned groups precluded any conclusions about the comparative effectiveness of operative therapy vs usual care. Objective To compare the treatment effects of diskectomy and usual care. Design, Setting, and Patients Prospective observational cohort of surgical candidates with imaging-confirmed lumbar intervertebral disk herniation who were treated at 13 spine clinics in 11 US states and who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003. Interventions Standard open diskectomy vs usual nonoperative care. Main Outcome Measures Changes from baseline in the Medical Outcomes Study Short-Form Health Survey (SF-36) bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons/MODEMS version). Results Of the 743 patients enrolled in the observational cohort, 528 patients received surgery and 191 received usual nonoperative care. At 3 months, patients who chose surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval, 10.8-18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6-19.2), and Oswestry Disability Index (mean change: surgery, −36.1 vs nonoperative care, −20.9; treatment effect, −15.2; 95% CI, −18.5. to −11.8). These differences narrowed somewhat at 2 years: bodily pain (mean change: surgery, 42.6 vs nonoperative care, 32.4; treatment effect, 10.2; 95% CI, 5.9-14.5), physical function (mean change: surgery, 43.9 vs nonoperavtive care 31.9; treatment effect, 12.0; 95% CI; 7.9-16.1), and Oswestry Disability Index (mean change: surgery −37.6 vs nonoperative care −24.2; treatment effect, −13.4; 95% CI, −17.0 to −9.7). Conclusions Patients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups. Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously. Trial Registration clinicaltrials.gov Identifier: NCT00000410 PMID:17119141

The protocol for a randomised controlled trial comparing intermittent and graded exercise to usual care for chronic fatigue syndrome patients.

PubMed

Broadbent, Suzanne; Coutts, Rosanne

2013-08-30

Chronic Fatigue Syndrome is a debilitating disorder with an unknown aetiology but suspected multifactorial origins. Common "triggers" include severe viral infections and emotional stress. Recent studies have also found evidence of immune dysfunction and elevated inflammatory cytokines in CFS patients, but there has been considerable variation in the outcome measures and magnitude of these studies. Currently, there is no cure for CFS but treatments include rest, specialist medical care, cognitive behavioural therapy, and graded (self-paced) exercise. To date, several studies have examined the efficacy of graded exercise with or without Cognitive Behavioural Therapy, with some success for patients. However, improvements in functional capacity have not necessarily correlated with improvements in immune function, fatigue or other symptoms. This 12-week pilot trial compares graded and intermittent exercise to normal care, measuring physiological outcomes, fatigue levels, immune function and wellness. 90 patients aged between 16 to 60 years, who meet the diagnostic criteria for CFS and have been diagnosed by their medical practitioner, will be randomly recruited into groups consisting of Intermittent exercise, Graded exercise and usual care (Control). The outcomes will be measured pre-study (Week 0) and post-study (Week 13). Primary outcomes are VO2peak, anaerobic threshold, peak power, levels of fatigue, immune cell (CD3+CD4+, CD3+CD8+, CD19+, CD 16+CD56+) concentrations and activation. Secondary outcomes include onset of secondary CFS symptoms (e.g. fever, swollen lymph nodes), wellness, mood and sleep patterns. Primary analysis will be based on intention to treat using logistic regression models to compare treatments. Quantitative data will be analysed using repeated measures ANOVA with a linear model, and Cohen's effect size. Qualitative data such as participants' responses (e.g. changes in mood and other reactions) following the exercise modalities will be read and sections demarcated. A code will be applied to each segment. A prevalence of codes will be considered thematically. The results of the trial will provide information about the efficacy of intermittent and graded exercise compared to usual care (rest and lifestyle recommendations), contributing to the evidence for best-practice CFS management. Australia and New Zealand Clinical Trials Registry ACTRN12612001241820.

Interventions to Improve Access to Primary Care for People Who Are Homeless: A Systematic Review

PubMed Central

2016-01-01

Background People who are homeless encounter barriers to primary care despite having greater needs for health care, on average, than people who are not homeless. We evaluated the effectiveness of interventions to improve access to primary care for people who are homeless. Methods We performed a systematic review to identify studies in English published between January 1, 1995, and July 8, 2015, comparing interventions to improve access to a primary care provider with usual care among people who are homeless. The outcome of interest was access to a primary care provider. The risk of bias in the studies was evaluated, and the quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. Results From a total of 4,047 citations, we identified five eligible studies (one randomized controlled trial and four observational studies). With the exception of the randomized trial, the risk of bias was considered high in the remaining studies. In the randomized trial, people who were homeless, without serious mental illness, and who received either an outreach intervention plus clinic orientation or clinic orientation alone, had improved access to a primary care provider compared with those receiving usual care. An observational study that compared integration of primary care and other services for people who are homeless with usual care did not observe any difference in access to a primary care provider between the two groups. A small observational study showed improvement among participants with a primary care provider after receiving an intervention consisting of housing and supportive services compared with the period before the intervention. The quality of the evidence was considered moderate for both the outreach plus clinic orientation and clinic orientation alone, and low to very low for the other interventions. Despite limitations, the literature identified reports of interventions developed to overcome barriers in access to primary care in people who are homeless. The interventions studied are complex and include multiple components that are consistent with proposed dimensions of access to care (availability, affordability, and acceptability). Conclusions Our systematic review of the literature identified various types of interventions that seek to improve access to primary care by attempting to address barriers to care encountered by people who are homeless. Moderate-quality evidence indicates that orientation to clinic services (either alone or combined with outreach) improves access to a primary care provider in adults who are homeless, without serious mental illness, and living in urban centres. PMID:27099645

Interventions to Improve Access to Primary Care for People Who Are Homeless: A Systematic Review.

PubMed

2016-01-01

People who are homeless encounter barriers to primary care despite having greater needs for health care, on average, than people who are not homeless. We evaluated the effectiveness of interventions to improve access to primary care for people who are homeless. We performed a systematic review to identify studies in English published between January 1, 1995, and July 8, 2015, comparing interventions to improve access to a primary care provider with usual care among people who are homeless. The outcome of interest was access to a primary care provider. The risk of bias in the studies was evaluated, and the quality of the evidence was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. From a total of 4,047 citations, we identified five eligible studies (one randomized controlled trial and four observational studies). With the exception of the randomized trial, the risk of bias was considered high in the remaining studies. In the randomized trial, people who were homeless, without serious mental illness, and who received either an outreach intervention plus clinic orientation or clinic orientation alone, had improved access to a primary care provider compared with those receiving usual care. An observational study that compared integration of primary care and other services for people who are homeless with usual care did not observe any difference in access to a primary care provider between the two groups. A small observational study showed improvement among participants with a primary care provider after receiving an intervention consisting of housing and supportive services compared with the period before the intervention. The quality of the evidence was considered moderate for both the outreach plus clinic orientation and clinic orientation alone, and low to very low for the other interventions. Despite limitations, the literature identified reports of interventions developed to overcome barriers in access to primary care in people who are homeless. The interventions studied are complex and include multiple components that are consistent with proposed dimensions of access to care (availability, affordability, and acceptability). Our systematic review of the literature identified various types of interventions that seek to improve access to primary care by attempting to address barriers to care encountered by people who are homeless. Moderate-quality evidence indicates that orientation to clinic services (either alone or combined with outreach) improves access to a primary care provider in adults who are homeless, without serious mental illness, and living in urban centres.

Cost-effectiveness of exercise therapy in the treatment of non-specific neck pain and low back pain: a systematic review with meta-analysis.

PubMed

Miyamoto, Gisela Cristiane; Lin, Chung-Wei Christine; Cabral, Cristina Maria Nunes; van Dongen, Johanna M; van Tulder, Maurits W

2018-04-20

To investigate the cost-effectiveness of exercise therapy in the treatment of patients with non-specific neck pain and low back pain. Systematic review of economic evaluations. The search was performed in 5 clinical and 3 economic electronic databases. We included economic evaluations performed alongside randomised controlled trials. Differences in costs and effects were pooled in a meta-analysis, if possible, and incremental cost-utility ratios (ICUR) were descriptively analysed. Twenty-two studies were included. On average, exercise therapy was associated with lower costs and larger effects for quality-adjusted life-year (QALY) in comparison with usual care for subacute and chronic low back pain from a healthcare perspective (based on ICUR). Exercise therapy had similar costs and effect for QALY in comparison with other interventions for neck pain from a societal perspective, and subacute and chronic low back pain from a healthcare perspective. There was limited or inconsistent evidence on the cost-effectiveness of exercise therapy compared with usual care for neck pain and acute low back pain, other interventions for acute low back pain and different types of exercise therapy for neck pain and low back pain. Exercise therapy seems to be cost-effective compared with usual care for subacute and chronic low back pain. Exercise therapy was not (more) cost-effective compared with other interventions for neck pain and low back pain. The cost-utility estimates are rather uncertain, indicating that more economic evaluations are needed. PROSPERO, CRD42017059025. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A pragmatic randomized controlled trial to evaluate the effectiveness of a facilitated exercise intervention as a treatment for postnatal depression: the PAM-PeRS trial.

PubMed

Daley, A J; Blamey, R V; Jolly, K; Roalfe, A K; Turner, K M; Coleman, S; McGuinness, M; Jones, I; Sharp, D J; MacArthur, C

2015-08-01

Postnatal depression affects about 10-15% of women in the year after giving birth. Many women and healthcare professionals would like an effective and accessible non-pharmacological treatment for postnatal depression. Women who fulfilled the International Classification of Diseases (ICD)-10 criteria for major depression in the first 6 months postnatally were randomized to receive usual care plus a facilitated exercise intervention or usual care only. The intervention involved two face-to-face consultations and two telephone support calls with a physical activity facilitator over 6 months to support participants to engage in regular exercise. The primary outcome was symptoms of depression using the Edinburgh Postnatal Depression Scale (EPDS) at 6 months post-randomization. Secondary outcomes included EPDS score as a binary variable (recovered and improved) at 6 and 12 months post-randomization. A total of 146 women were potentially eligible and 94 were randomized. Of these, 34% reported thoughts of self-harming at baseline. After adjusting for baseline EPDS, analyses revealed a -2.04 mean difference in EPDS score, favouring the exercise group [95% confidence interval (CI) -4.11 to 0.03, p = 0.05]. When also adjusting for pre-specified demographic variables the effect was larger and statistically significant (mean difference = -2.26, 95% CI -4.36 to -0.16, p = 0.03). Based on EPDS score a larger proportion of the intervention group was recovered (46.5% v. 23.8%, p = 0.03) compared with usual care at 6 months follow-up. This trial shows that an exercise intervention that involved encouragement to exercise and to seek out social support to exercise may be an effective treatment for women with postnatal depression, including those with thoughts of self-harming.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: the PROMOTE study.

PubMed

Hensel, Kendi L; Buchanan, Steve; Brown, Sarah K; Rodriguez, Mayra; Cruser, des Anges

2015-01-01

The purpose of this study was to evaluate the efficacy of osteopathic manipulative treatment (OMT) to reduce low back pain and improve functioning during the third trimester in pregnancy and to improve selected outcomes of labor and delivery. Pregnancy research on osteopathic manipulation optimizing treatment effects was a randomized, placebo-controlled trial of 400 women in their third trimester. Women were assigned randomly to usual care only (UCO), usual care plus OMT (OMT), or usual care plus placebo ultrasound treatment (PUT). The study included 7 treatments over 9 weeks. The OMT protocol included specific techniques that were administered by board-certified OMT specialists. Outcomes were assessed with the use of self-report measures for pain and back-related functioning and medical records for delivery outcomes. There were 136 women in the OMT group: 131 women in the PUT group and 133 women in the UCO group. Characteristics at baseline were similar across groups. Findings indicate significant treatment effects for pain and back-related functioning (P < .001 for both groups), with outcomes for the OMT group similar to that of the PUT group; however, both groups were significantly improved compared with the UCO group. For secondary outcome of meconium-stained amniotic fluid, there were no differences among the groups. OMT was effective for mitigating pain and functional deterioration compared with UCO; however, OMT did not differ significantly from PUT. This may be attributed to PUT being a more active treatment than intended. There was no higher likelihood of conversion to high-risk status based on treatment group. Therefore, OMT is a safe, effective adjunctive modality to improve pain and functioning during the third trimester. Copyright © 2015 Elsevier Inc. All rights reserved.

Effectiveness of very early workplace interventions to reduce sickness absence: a systematic review of the literature and meta-analysis.

PubMed

Vargas-Prada, Sergio; Demou, Evangelia; Lalloo, Drushca; Avila-Palencia, Ione; Sanati, Kaveh A; Sampere, Maite; Freer, Kerry; Serra, Consol; Macdonald, Ewan B

2016-07-01

The aim of this review was to investigate the effectiveness of workplace return-to-work (RTW) interventions delivered at very early stages (<15 days) of sickness absence (SA). A systematic literature search was conducted in PubMed, Health Management Information Consortium (HMIC), Cochrane library database, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychInfo and Embase. Using pre-established criteria, independent pairs of researchers carried out the study selection, quality appraisal and data extraction. Workplace interventions before day 15 of SA, were included. Primary outcome measures included rates of and time until RTW, productivity loss, and recurrences of SA. We found limited available evidence on the benefits of "very early" workplace interventions in terms of RTW after a SA episode compared to usual care. Only three randomized controlled trials classed as high or intermediate quality were identified. Early part-time sick leave together with appropriate job modifications led to a reduction in the duration and recurrence of SA. There is evidence of benefit of intervening during the first two weeks of SA for musculoskeletal disorders. Our review has identified a lack of evidence from the literature at this time point to support "very early" intervention compared to usual care. The methodological design of the studies, notably the extent and timing of usual care provided and variable compliance/crossover between groups could however explain the lack of demonstrated benefit. Consensus is required on the definition of "early" and "very early" interventions, and further research is recommended to improve understanding of the factors influencing when and how best to intervene for maximum gain.

Does the addition of two exercise-focussed home visits to usual care improve outcomes for patients with balance impairments? A randomized controlled trial.

PubMed

Whitbourne, Craig; Shields, Nora; Tacey, Mark; Koh, Kenneth Wz; Lawler, Katherine; Hill, Keith D

2018-03-01

To investigate whether two additional home visits improve outcomes for rehabilitation outpatients with balance impairments compared to usual care. Randomized controlled trial. Outpatient rehabilitation. Fifty with balance impairments. Both groups received usual care including weekly group exercise over eight weeks. The intervention group received two home visits to individualize home exercises. Primary outcome measure was the Balance Outcome Measure for Elder Rehabilitation (BOOMER) score, and secondary outcomes included force platform measures using the NeuroCom Balance Master ® , assessed at baseline, after intervention and three-month follow-up. There was no between-group difference for BOOMER score. There were significant between-group differences in favour of the intervention group for limits of stability reaction time at week 9 (mean difference (MD) -0.27, 95% confidence interval (CI) -0.44 to -0.09) and week 22 (MD -0.28, 95% CI -0.45 to -0.10) and for limits of stability maximal excursion at week 9 (MD 8.66, 95% CI 1.67 to 15.65) and week 22 (MD 14.58, 95% CI 7.59 to 21.57). Significant between-group differences favoured the control group for Clinical Test of Sensory Interaction of Balance at week 9 (MD 0.40, 95% CI 0.13 to 0.66) and week 22 (MD 0.45, 95% CI 0.18 to 0.72) and step quick turn time at week 9 (MD 0.56, 95% CI 0.02 to 1.10). Two exercise-focussed home visits improved some dynamic balance outcomes in older patients with balance impairments. Some outcomes showed significant improvements with small effect sizes in favour of the control group which may be chance findings or because they completed a standard home exercise programme.

The psychological contract: enhancing productivity and its implications for long-term care.

PubMed

Flannery, Raymond B

2002-01-01

When hired, a new employee is usually given a job description and an explanation of benefits. In addition, the employee will also have a psychological contract with the organization. This contract, often unstated, reflects the main source of the employee's motivation to work hard. This is true of all groups of employees, including long-term care staff. Common examples of psychological contracts for long-term care administrative staff include autonomy, social acceptance, and being in the forefront of cutting-edge research. An awareness of these psychological contracts can result in better "fits" between employee aspirations and relevant long-term care organization tasks so that productivity is enhanced. This article outlines the steps necessary to create these good fits in ways that benefit both the organization and its employees. These recommendations are of particular relevance to administrators and supervisors in long-term carefacilities.

Barriers to Care Among Transgender and Gender Nonconforming Adults.

PubMed

Gonzales, Gilbert; Henning-Smith, Carrie

2017-12-01

Policy Points: Transgender and gender nonconforming (GNC) adults may experience barriers to care for a variety of reasons, including discrimination and lack of awareness by providers in health care settings. In our analysis of a large, population-based sample, we found transgender and GNC adults were more likely to be uninsured and have unmet health care needs, and were less likely to have routine care, compared to cisgender (nontransgender) women. Our findings varied by gender identity. More research is needed on transgender and GNC populations, including on how public policy and provider awareness affects health care access and health outcomes differentially by gender identity. Very little population-based research has examined health and access to care among transgender populations. This study compared barriers to care between cisgender, transgender, and gender nonconforming (GNC) adults using data from a large, multistate sample. We used data from the 2014-2015 Behavioral Risk Factor Surveillance System to estimate the prevalence of having no health insurance, unmet medical care needs due to cost, no routine checkup, and no usual source of care for cisgender women (n = 183,370), cisgender men (n = 131,080), transgender women (n = 724), transgender men (n = 449), and GNC adults (n = 270). Logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (CI) for each barrier to care while adjusting for sociodemographic characteristics. Transgender and GNC adults were more likely to be nonwhite, sexual minority, and socioeconomically disadvantaged compared to cisgender adults. After controlling for sociodemographic characteristics, transgender women were more likely to have no health insurance (OR = 1.60; 95% CI = 1.07-2.40) compared to cisgender women; transgender men were more likely to have no health insurance (OR = 2.02; 95% CI = 1.25-3.25) and no usual source of care (OR = 1.84; 95% CI = 1.18-2.88); and GNC adults were more likely to have unmet medical care needs due to cost (OR = 1.93; 95% CI = 1.02-3.67) and no routine checkup in the prior year (OR = 2.41; 95% CI = 1.41-4.12). Transgender and GNC adults face barriers to health care that may be due to a variety of reasons, including discrimination in health care, health insurance policies, employment, and public policy or lack of awareness among health care providers on transgender-related health issues. © 2017 Milbank Memorial Fund.

Culture-specific programs for children and adults from minority groups who have asthma.

PubMed

Bailey, E J; Kruske, S G; Morris, P S; Cates, C J; Chang, A B

2008-04-16

People with asthma who come from minority groups have poorer asthma outcomes and more asthma related visits to Emergency Departments (ED). Various programmes are used to educate and empower people with asthma and these have previously been shown to improve certain asthma outcomes. Models of care for chronic diseases in minority groups usually include a focus of the cultural context of the individual and not just the symptoms of the disease. Therefore, questions about whether culturally specific asthma education programmes for people from minority groups are effective at improving asthma outcomes, are feasible and are cost-effective need to be answered. To determine whether culture-specific asthma programmes, in comparison to generic asthma education programmes or usual care, improve asthma related outcomes in children and adults with asthma who belong to minority groups. We searched the Cochrane Register of Controlled Trials (CENTRAL), the Cochrane Airways Group Specialised Register, MEDLINE, EMBASE, review articles and reference lists of relevant articles. The latest search was performed in March 2007. All randomised controlled trials (RCTs) comparing the use of culture-specific asthma education programmes with generic asthma education programmes, or usual care, in adults or children from minority groups who suffer from asthma. Two review authors independently selected, extracted and assessed the data for inclusion. We contacted authors for further information if required. Three studies were eligible for inclusion in the review. A total of 396 patients, aged from 7 to 59 years were included in the meta-analysis of data. Use of a culture-specific programme was superior to generic programmes or usual care, in improving asthma quality of life scores in adults, pooled WMD 0.25 (95% CI 0.09 to 0.41) and asthma knowledge scores in children, WMD 3.30 (95% CI 1.07 to 5.53). There was no significant difference between groups in occurrence of asthma exacerbations, but the width of the confidence interval means that effects on exacerbation rates cannot be ruled out, rate ratio 0.93 (95% CI 0.80 to 1.10). Culture-specific programmes for adults and children from minority groups with asthma, have been found to be more effective than generic programmes in improving some (Quality of Life and asthma knowledge) but not all asthma outcomes. This evidence is limited by the small number of included studies and the lack of reported outcomes. Further trials are required to answer this question conclusively.

The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol].

PubMed

Leach, Matthew J; Segal, Leonie; Esterman, Adrian; Armour, Caroline; McDermott, Robyn; Fountaine, Tim

2013-12-20

Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month's duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. This project responds to a need for robust evidence of the clinical and economic effectiveness of coordinated care for the management of diabetes in the Australian primary care setting. The outcomes of the study will have implications not only for diabetes management, but also for the management of other chronic diseases, both in Australia and overseas. Australian New Zealand Clinical Trials Registry (ACTRN12612000363886); World Health Organisation (U1111-1128-0481).

Cost-effectiveness of a program to prevent depression relapse in primary care.

PubMed

Simon, Gregory E; Von Korff, Michael; Ludman, Evette J; Katon, Wayne J; Rutter, Carolyn; Unützer, Jürgen; Lin, Elizabeth H B; Bush, Terry; Walker, Edward

2002-10-01

Evaluate the incremental cost-effectiveness of a depression relapse prevention program in primary care. Primary care patients initiating antidepressant treatment completed a standardized telephone assessment 6-8 weeks later. Those recovered from the current episode but at high risk for relapse (based on history of recurrent depression or dysthymia) were offered randomization to usual care or a relapse prevention intervention. The intervention included systematic patient education, two psychoeducational visits with a depression prevention specialist, shared decision-making regarding maintenance pharmacotherapy, and telephone and mail monitoring of medication adherence and depressive symptoms. Outcomes in both groups were assessed via blinded telephone assessments at 3, 6, 9, and 12 months and health plan claims and accounting data. Intervention patients experienced 13.9 additional depression-free days during a 12-month period (95% CI, -1.5 to 29.3). Incremental costs of the intervention were $273 (95% CI, $102 to $418) for depression treatment costs only and $160 (95% CI, -$173 to $512) for total outpatient costs. Incremental cost-effectiveness ratio was $24 per depression-free day (95% CI, -$59 to $496) for depression treatment costs only and $14 per depression-free day (95% CI, -$35 to $248) for total outpatient costs. A program to prevent depression relapse in primary care yields modest increases in days free of depression and modest increases in treatment costs. These modest differences reflect high rates of treatment in usual care. Along with other recent studies, these findings suggest that improved care of depression in primary care is a prudent investment of health care resources.

Effectiveness of a return-to-work program for workers without an employment contract, sick-listed due to common mental disorders.

PubMed

Lammerts, Lieke; Schaafsma, Frederieke G; Bonefaas-Groenewoud, Karin; van Mechelen, Willem; Anema, Johannes

2016-06-01

Both the presence of mental health problems and the absence of an employment contract have been related to long-term sickness absence and unemployment, indicating a need for return-to-work (RTW) interventions. Our aim was to study the effectiveness of a new participatory, supportive RTW program for workers without an employment contract, sick-listed 2-14 weeks due to a common mental disorder, in comparison with usual care. A participatory approach, integrated care and direct placement in a competitive job were part of the new program. The primary outcome measure was duration until first sustainable RTW in competitive employment. Cox regression analysis was applied to study this outcome. Secondary outcome measures were average working hours, duration until any type of employment, sickness benefit duration, and perceived health and functioning. In total, 186 participants were included in the study and randomly allocated to an intervention group (N=94), or control group (N= 92). A hazard ratio (HR) of 1.15 (95% CI 0.61-2.16) for duration until first sustainable RTW indicated no significant effect of allocation to the new program, compared to usual care. Furthermore, no significant differences were found in favor of the intervention group on any secondary outcome. Compared to usual care, the new program did not result in a significant shorter duration until first sustainable RTW. However, due to low protocol adherence, it remains unclear what the results would have been if the program had been executed according to protocol.

Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

PubMed

Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

2009-09-01

Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

A Randomized Pilot Study of Naturopathic Medicine in Multiple Sclerosis

PubMed Central

Calabrese, Carlo; Morris, Cynthia; Yadav, Vijayshree; Griffith, Debbie; Frank, Rachel; Oken, Barry S.; Baldauf-Wagner, Sara; Bourdette, Dennis

2008-01-01

Abstract Background Complementary and alternative medicine (CAM) use is high in people with multiple sclerosis (MS), yet there are limited reports on safety and effectiveness of CAM in MS. Naturopathic medicine encompasses a broad range of CAM modalities and may improve quality of life in patients with MS. Objective To assess quality of life in MS subjects who received interventions designed to “model” the “whole practice” of naturopathy. Design A pilot, randomized, controlled study with a 6-month intervention period. Participants Participants who met criteria for clinically definite MS. Interventions The 3 intervention arms were usual care, naturopathic medicine plus usual care, and MS education plus usual care. Outcome measures The primary outcome measure was quality of life (36-item short form health survey [SF-36]). Secondary outcome measures included fatigue (Modified Fatigue Impact Scale); depression (Beck Depression Inventory); cognition battery (Stroop test and Paced Auditory Serial Addition Test 3), and neurologic impairment (Expanded Disability Status Scale [EDSS] and Multiple Sclerosis Functional Composite). Adverse event reporting and laboratory measures were used to assess safety. Results Forty-five (45) participants (15 per group) were randomized and all completed the 6-month intervention. There were no significant differences between groups on any outcome measure. There was a trend in favoring the naturopathic group in the General Health subscale of the SF-36 (p = 0.11), Timed Walk (p = 0.11), and neurologic impairment (EDSS) (p = 0.07). There was a trend favoring the Education group in the Stroop attention test (p = 0.07). There was no difference between groups in adverse events or laboratory changes. Conclusions Naturopathic medicine combined with usual care for MS showed a trend in improvement in the General Health subscale of the SF-36, Timed Walk, and neurologic impairment. Evaluation of naturopathic medicine, as a multimodality regimen, warrants further investigation. PMID:18532899

The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol.

PubMed

Rasmussen, Helle Mätzke; Pedersen, Niels Wisbech; Overgaard, Søren; Hansen, Lars Kjaersgaard; Dunkhase-Heinl, Ulrike; Petkov, Yanko; Engell, Vilhelm; Baker, Richard; Holsgaard-Larsen, Anders

2015-12-07

Children with cerebral palsy (CP) often have an altered gait. Orthopaedic surgery, spasticity management, physical therapy and orthotics are used to improve the gait. Interventions are individually tailored and are planned on the basis of clinical examinations and standardised measurements to assess walking ('care as usual'). However, these measurements do not describe features in the gait that reflect underlying neuro-musculoskeletal impairments. This can be done with 3-dimensional instrumented gait analysis (IGA). The aim of this study is to test the hypothesis that improvements in gait following individually tailored interventions when IGA is used are superior to those following 'care as usual'. A prospective, single blind, randomised, parallel group study will be conducted. Children aged 5 to 8 years with spastic CP, classified at Gross Motor Function Classification System levels I or II, will be included. The interventions under investigation are: 1) individually tailored interdisciplinary interventions based on the use of IGA, and 2) 'care as usual'. The primary outcome is gait measured by the Gait Deviation Index. Secondary outcome measures are: walking performance (1-min walk test) and patient-reported outcomes of functional mobility (Pediatric Evaluation of Disability Inventory), health-related quality of life (The Pediatric Quality of Life Inventory Cerebral Palsy Module) and overall health, pain and participation (The Pediatric Outcome Data Collection Instrument). The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks; however, exclusively for the patient-reported outcomes. To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention based on the use of IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA. ClinicalTrials.gov NCT02160457 . Registered June 2, 2014.

Massage Therapy for Osteoarthritis of the Knee: A Randomized Dose-Finding Trial

PubMed Central

Perlman, Adam I.; Ali, Ather; Njike, Valentine Yanchou; Hom, David; Davidi, Anna; Gould-Fogerite, Susan; Milak, Carl; Katz, David L.

2012-01-01

Background In a previous trial of massage for osteoarthritis (OA) of the knee, we demonstrated feasibility, safety and possible efficacy, with benefits that persisted at least 8 weeks beyond treatment termination. Methods We performed a RCT to identify the optimal dose of massage within an 8-week treatment regimen and to further examine durability of response. Participants were 125 adults with OA of the knee, randomized to one of four 8-week regimens of a standardized Swedish massage regimen (30 or 60 min weekly or biweekly) or to a Usual Care control. Outcomes included the Western Ontario and McMaster Universities Arthritis Index (WOMAC), visual analog pain scale, range of motion, and time to walk 50 feet, assessed at baseline, 8-, 16-, and 24-weeks. Results WOMAC Global scores improved significantly (24.0 points, 95% CI ranged from 15.3–32.7) in the 60-minute massage groups compared to Usual Care (6.3 points, 95% CI 0.1–12.8) at the primary endpoint of 8-weeks. WOMAC subscales of pain and functionality, as well as the visual analog pain scale also demonstrated significant improvements in the 60-minute doses compared to usual care. No significant differences were seen in range of motion at 8-weeks, and no significant effects were seen in any outcome measure at 24-weeks compared to usual care. A dose-response curve based on WOMAC Global scores shows increasing effect with greater total time of massage, but with a plateau at the 60-minute/week dose. Conclusion Given the superior convenience of a once-weekly protocol, cost savings, and consistency with a typical real-world massage protocol, the 60-minute once weekly dose was determined to be optimal, establishing a standard for future trials. Trial Registration ClinicalTrials.gov NCT00970008 PMID:22347369

Physicians, the Affordable Care Act, and primary care: disruptive change or business as usual?

PubMed

Jacobson, Peter D; Jazowski, Shelley A

2011-08-01

The Patient Protection and Affordable Care Act 1 (ACA) presages disruptive change in primary care delivery. With expanded access to primary care for millions of new patients, physicians and policymakers face increased pressure to solve the perennial shortage of primary care practitioners. Despite the controversy surrounding its enactment, the ACA should motivate organized medicine to take the lead in shaping new strategies for meeting the nation's primary care needs. In this commentary, we argue that physicians should take the lead in developing policies to address the primary care shortage. First, physicians and medical professional organizations should abandon their long-standing opposition to non-physician practitioners (NPPs) as primary care providers. Second, physicians should re-imagine how primary care is delivered, including shifting routine care to NPPs while retaining responsibility for complex patients and oversight of the new primary care arrangements. Third, the ACA's focus on wellness and prevention creates opportunities for physicians to integrate population health into primary care practice.

Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials.

PubMed

Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen; Liu, Jian-Ping

2017-01-01

About 85.3% of hemolytic disease of the newborn (HDN) is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended "best" therapy for ABO incompatibility during pregnancy. To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. The protocol of this review was registered on the PROSPERO website (No. CRD42016038637).Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs) of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR) and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available. Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30).After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14) and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups. This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition.

Pharmacist Intervention for Blood Pressure Control in Patients with Diabetes and/or Chronic Kidney Disease.

PubMed

Anderegg, Maxwell D; Gums, Tyler H; Uribe, Liz; MacLaughlin, Eric J; Hoehns, James; Bazaldua, Oralia V; Ives, Timothy J; Hahn, David L; Coffey, Christopher S; Carter, Barry L

2018-03-01

The objectives of this study were to determine if hypertensive patients with comorbid diabetes mellitus (DM) and/or chronic kidney disease (CKD) receiving a pharmacist intervention had a greater reduction in mean blood pressure (BP) and improved BP control at 9 months compared with those receiving usual care; and compare Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) guideline and 2014 guideline (JNC 8) BP control rates in patients with DM and/or CKD. This cluster randomized trial included 32 medical offices in 15 states. Clinical pharmacists made treatment recommendations to physicians at intervention sites. This post hoc analysis evaluated mean BP and BP control rates in the intervention and control groups. The study included 335 patients (227 intervention, 108 control) when mean BP and control rates were evaluated by JNC 7 inclusion and control criteria. When JNC 8 inclusion and control criteria were applied, 241 patients (165 intervention, 76 control) remained and were included in the analysis. The pharmacist-intervention group had significantly greater mean systolic blood pressure reduction compared with usual care at 9 months (8.64 mm Hg; 95% confidence interval [CI] -12.8 to -4.49, p<0.001). The pharmacist-intervention group had significantly higher BP control at 9 months than usual care by either the JNC 7 or JNC 8 inclusion and control groups (adjusted odds ratio [OR] 1.97, 95% CI 1.01-3.86, p=0.0470 and OR 2.16, 95% CI 1.21-3.85, p=0.0102, respectively). This study demonstrated that a physician-pharmacist collaborative intervention was effective in reducing mean systolic BP and improving BP control in patients with uncontrolled hypertension with DM and/or CKD, regardless of which BP guidelines were used. © 2018 Pharmacotherapy Publications, Inc.

Oral administration of Chinese herbal medicine during gestation period for preventing hemolytic disease of the newborn due to ABO incompatibility: A systematic review of randomized controlled trials

PubMed Central

Cao, Huijuan; Wu, Ruohan; Han, Mei; Caldwell, Patrina Ha Yuen

2017-01-01

Background About 85.3% of hemolytic disease of the newborn (HDN) is caused by maternal-fetal ABO blood group incompatibility. However, there is currently no recommended “best” therapy for ABO incompatibility during pregnancy. Objectives To systematically assess the safety and effectiveness of oral Chinese herbal medicine (CHM) for preventing HDN due to ABO incompatibility. Methods The protocol of this review was registered on the PROSPERO website (No. CRD42016038637).Six databases were searched from inception to April 2016. Randomized controlled trials (RCTs) of CHM for maternal-fetal ABO incompatibility were included. The primary outcome was incidence of HDN. The Cochrane risk of bias tool was used to assess the methodological quality of included trials. Risk ratios (RR) and mean differences with 95% confidence interval were used as effect measures. Meta-analyses using Revman 5.3 software were conducted if there were sufficient trials without obvious clinical or statistical heterogeneity available. Results Totally 28 RCTs involving3413 women were included in the review. The majority of the trials had unclear or high risk of bias. Our study found that the rate of HDN and the incidence of neonatal jaundice might be 70% lower in the herbal medicine group compared with the usual care group (RR from 0.25 to 0.30).After treatment with herbal medicine, women were twice as likely to have antibody titers lower than 1:64 compared with women who received usual care(RR from 2.15 to 3.14) and the umbilical cord blood bilirubin level in the herbal medicine group was 4umol/L lower than in those receiving usual care. There was no difference in Apgar scores or birthweights between the two groups. Conclusions This review found very low-quality evidence that CHM prevented HDN caused by maternal-fetal ABO incompatibility. No firm conclusions can be drawn regarding the effectiveness or safety of CHM for this condition. PMID:28719639

The Cost-Effectiveness of Using PARO, a Therapeutic Robotic Seal, to Reduce Agitation and Medication Use in Dementia: Findings from a Cluster-Randomized Controlled Trial.

PubMed

Mervin, Merehau C; Moyle, Wendy; Jones, Cindy; Murfield, Jenny; Draper, Brian; Beattie, Elizabeth; Shum, David H K; O'Dwyer, Siobhan; Thalib, Lukman

2018-01-09

To examine the within-trial costs and cost-effectiveness of using PARO, compared with a plush toy and usual care, for reducing agitation and medication use in people with dementia in long-term care. An economic evaluation, nested within a cluster-randomized controlled trial. Twenty-eight facilities in South-East Queensland, Australia. A total of 415 residents, all aged 60 years or older, with documented diagnoses of dementia. Facilities were randomized to 1 of 3 groups: PARO (individual, nonfacilitated 15-minute sessions, 3 afternoons per week for 10 weeks); plush toy (as per PARO but with artificial intelligence disabled); and usual care. The incremental cost per Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) point averted from a provider's perspective. Australian New Zealand Clinical Trials Registry (BLINDED FOR REVIEW). For the within-trial costs, the PARO group was $50.47 more expensive per resident compared with usual care, whereas the plush toy group was $37.26 more expensive than usual care. There were no statistically significant between-group differences in agitation levels after the 10-week intervention. The point estimates of the incremental cost-effectiveness ratios were $13.01 for PARO and $12.85 for plush toy per CMAI-SF point averted relative to usual care. The plush toy used in this study offered marginally greater value for money than PARO in improving agitation. However, these costs are much lower than values estimated for psychosocial group activities and sensory interventions, suggesting that both a plush toy and the PARO are cost-effective psychosocial treatment options for agitation. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

Assertive Community Treatment for alcohol dependence (ACTAD): study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Alcohol dependence is a significant and costly problem in the UK yet only 6% of people a year receive treatment. Current service provision based on the treatment of acute episodes of illness and emphasising personal choice and motivation results in a small proportion of these patients engaging with alcohol treatment. There is a need for interventions targeted at the population of alcohol dependent patients who are hard to engage in conventional treatment. Assertive Community Treatment (ACT), a model of care based on assertive outreach, has been used for treating patients with severe mental illnesses and presents a promising avenue for engaging patients with primary alcohol dependence. So far there has been little research on this. Methods/Design In this single blind exploratory randomised controlled trial, a total of 90 alcohol dependent participants will be recruited from community addiction services. After completing a baseline assessment, they will be assigned to one of two conditions: (1) ACT plus care as usual, or (2) care as usual. Those allocated to the ACT plus care as usual will receive the same treatment that is routinely provided by services, plus a trained key worker who will provide ACT. ACT comprises intensive and assertive contact at least once a week, over 50% of contacts in the participant's home or local community, and comprehensive case management across social and health care, for a period of one year. All participants will be followed up at 6 months and 12 months to assess outcome post randomisation. The primary outcome measures will be alcohol consumption: mean drinks per drinking day and percentage of days abstinent measured by the Time Line Follow Back interview. Secondary outcome measures will include severity of alcohol dependence, alcohol related problems, motivation to change, social network involvement, quality of life, therapeutic relationship and service use. Other outcome variables are treatment engagement including completion of assessment, detoxification and aftercare. Discussion Results of this trial will help clarify the potential beneficial effects of ACT for people with alcohol dependence and provide information to design a definitive trial. Trial registration number ISRCTN: ISRCTN22775534 PMID:22348423

Management of type 2 diabetes in China: the Happy Life Club, a pragmatic cluster randomised controlled trial using health coaches

PubMed Central

Browning, Colette; Chapman, Anna; Yang, Hui; Liu, Shuo; Zhang, Tuohong; Enticott, Joanne C; Thomas, Shane A

2016-01-01

Objective To assess the effectiveness of a coach-led motivational interviewing (MI) intervention in improving glycaemic control, as well as clinical, psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus (T2DM) compared with usual care. Design Pragmatic cluster randomised controlled trial (RCT). Setting Community Health Stations (CHSs) in Fengtai district, Beijing, China. Participants Of the 41 randomised CHSs (21 intervention and 20 control), 21 intervention CHSs (372 participants) and 18 control CHSs (296 participants) started participation. Intervention Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS. Control participants received usual care only. Medical fees were waived for both groups. Outcome measures Outcomes were assessed at baseline, 6 and 12 months. Primary outcome measure was glycated haemoglobin (HbA1c). Secondary outcomes included a suite of anthropometric, blood pressure (BP), fasting blood, psychosocial and self-care measures. Results At 12 months, no differential treatment effect was found for HbA1c (adjusted difference 0.02, 95% CI −0.40 to 0.44, p=0.929), with both treatment and control groups showing significant improvements. However, two secondary outcomes: psychological distress (adjusted difference −2.38, 95% CI −4.64 to −0.12, p=0.039) and systolic BP (adjusted difference −3.57, 95% CI −6.08 to −1.05, p=0.005) were robust outcomes consistent with significant differential treatment effects, as supported in sensitivity analyses. Interestingly, in addition to HbA1c, both groups displayed significant improvements in triglycerides, LDL cholesterol and HDL cholesterol. Conclusions In line with the current Chinese primary healthcare reform, this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China, specifically addressing T2DM. Although a differential treatment effect was not observed for HbA1c, numerous outcomes (including HbA1c) improved in both groups, supporting the establishment of regular, free clinical health checks for people with T2DM in China. Trial registration number ISRCTN01010526; Pre-results. PMID:26944692

Patient-directed music therapy reduces anxiety and sedation exposure in mechanically-ventilated patients: a research critique.

PubMed

Gullick, Janice G; Kwan, Xiu Xian

2015-05-01

This research appraisal, guided by the CASP Randomised Controlled Trial Checklist, critiques a randomised, controlled trial of patient-directed music therapy compared to either noise-cancelling headphones or usual care. This study recruited 373 alert, mechanically-ventilated patients across five intensive care units in the United States. The Music Assessment Tool, administered by a music therapist, facilitated music selection by participants in the intervention group. Anxiety was measured using the VAS-A scale. Sedation exposure was measured by both sedation frequency and by sedation intensity using a daily sedation intensity score. Context for the data was supported by an environmental scan form recording unit activity and by written comments from nurses about the patient's responses to the protocol. Patient-directed music therapy allowed a significant reduction in sedation frequency compared to noise-cancelling headphones and usual care participants. Patient-directed music therapy led to significantly lower anxiety and sedation intensity compared to usual care, but not compared to noise-cancelling headphones. This is a robust study with clear aims and a detailed description of research methods and follow-up. While no participants were lost to follow-up, not all were included in the analysis: 37% did not have the minimum of two anxiety assessments for comparison and 23% were not included in sedation analysis. While some participants utilised the intervention or active control for many hours-per-day, half the music therapy participants listened for 12min or less per day and half of the noise-cancelling headphone participants did not appear to use them. While the results suggest that patient-directed music therapy and noise-cancelling headphones may be useful and cost-effective interventions that lead to an overall improvement in anxiety and sedation exposure, these may appeal to a subset of ICU patients. The self-directed use of music therapy and noise-cancelling headphones means these findings may not transfer to sedated or cognitively-impaired patients. Copyright © 2015 Australian College of Critical Care Nurses Ltd. Published by Elsevier Ltd. All rights reserved.

Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial

PubMed Central

Frias, Juan; Raja, Praveen; Kim, Yoona; Savage, George; Osterberg, Lars

2017-01-01

Background Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. Objective The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. Methods Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. Results Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean –21.8, SE 1.5 mm Hg vs mean –12.7, SE 2.8 mmHg; mean difference –9.1, 95% CI –14.0 to –3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). Conclusions For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. Trial Registration Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF) PMID:28698169

Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

PubMed

Forster, Anne; Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-08-01

We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. © 2015 Bradford Teaching Hospitals NHS Foundation Trust.

German diabetes disease management programs are appropriate for restructuring care according to the chronic care model: an evaluation with the patient assessment of chronic illness care instrument.

PubMed

Szecsenyi, Joachim; Rosemann, Thomas; Joos, Stefanie; Peters-Klimm, Frank; Miksch, Antje

2008-06-01

With the introduction of diabetes disease management programs (DMPs) in Germany, there is a necessity to evaluate whether patients receive care that is congruent to the Chronic Care Model (CCM) and evidence-based behavioral counseling. We examined differences as perceived and experienced by patients with type 2 diabetes between those enrolled in a DMP compared with patients receiving usual care in two federal states of Germany. A random, heterogeneous sample of 3,546 patients (59.3% female) received a mailed questionnaire from their regional health fund, including the German version of the Patient Assessment of Chonic Illness Care (PACIC) instrument, which had additional items for behavioral advice (5A). Two weeks later, a general reminder was sent out. A total of 1,532 questionnaires were returned (response rate 42.2%), and valid data could be obtained for 1,399 patients. Mean age of responders was 70.3 years, of which 53.6% were female. Overall, patients enrolled in a DMP scored significantly higher (3.21 of a possible 5) than patients not enrolled in a DMP (2.86) (P < 0.001). Significant differences in the same direction were found on all five subscales of the PACIC. For the 5A scales, similar differences were found for all five subscales plus the sum score (P < 0.001; mean for DMP = 3.08, mean for non-DMP = 2.78). DMPs, as currently established in primary care in Germany, may impact provided care significantly. The changes in daily practice that have been induced by the DMPs are recognized by patients as care that is more structured and that to a larger extent reflects the core elements of the CCM and evidence-based counseling compared with usual care.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial.

PubMed

DeBar, Lynn; Benes, Lindsay; Bonifay, Allison; Deyo, Richard A; Elder, Charles R; Keefe, Francis J; Leo, Michael C; McMullen, Carmit; Mayhew, Meghan; Owen-Smith, Ashli; Smith, David H; Trinacty, Connie M; Vollmer, William M

2018-04-01

Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) – Protocol for a pragmatic cluster randomized trial

PubMed Central

DeBar, Lynn; Benes, Lindsay; Bonifay, Allison; Deyo, Richard A.; Elder, Charles R.; Keefe, Francis J.; Leo, Michael C.; McMullen, Carmit; Mayhew, Meghan; Owen-Smith, Ashli; Smith, David H.; Trinacty, Connie M.; Vollmer, William M.

2018-01-01

Background Chronic pain is one of the most common, disabling, and expensive public health problems in the United States. Interdisciplinary pain management treatments that employ behavioral approaches have been successful in helping patients with chronic pain reduce symptoms and regain functioning. However, most patients lack access to such treatments. We are conducting a pragmatic clinical trial to test the hypothesis that patients who receive an interdisciplinary biopsychosocial intervention, the Pain Program for Active Coping and Training (PPACT), at their primary care clinic will have a greater reduction in pain impact in the year following than patients receiving usual care. Methods/design This is an effectiveness-implementation hybrid pragmatic clinical trial in which we randomize clusters of primary care providers and their patients with chronic pain who are on long-term opioid therapy to 1) receive an interdisciplinary behavioral intervention in conjunction with their current health care or 2) continue with current health care services. Our primary outcome is pain impact (a composite of pain intensity and pain-related interference) measured using the PEG, a validated three-item assessment. Secondary outcomes include pain-related disability, patient satisfaction, opioids dispensed and health care utilization. An economic evaluation assesses the resources and costs necessary to deliver the intervention and its cost-effectiveness compared with usual care. A formative evaluation employs mixed methods to understand the context for implementation in the participating health care systems. Discussion This trial will inform the feasibility of implementing interdisciplinary behavioral approaches to pain management in the primary care setting, potentially providing a more effective, safer, and more satisfactory alternative to opioid-based chronic pain treatment. Clinical Trials Registration Number: NCT02113592 PMID:29522897

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN).

PubMed

Thompson, Tom P; Callaghan, Lynne; Hazeldine, Emma; Quinn, Cath; Walker, Samantha; Byng, Richard; Wallace, Gary; Creanor, Siobhan; Green, Colin; Hawton, Annie; Annison, Jill; Sinclair, Julia; Senior, Jane; Taylor, Adrian H

2018-06-04

People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. ISRCTN80475744; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Early, Goal-Directed Therapy for Septic Shock - A Patient-Level Meta-Analysis.

PubMed

Rowan, Kathryn M; Angus, Derek C; Bailey, Michael; Barnato, Amber E; Bellomo, Rinaldo; Canter, Ruth R; Coats, Timothy J; Delaney, Anthony; Gimbel, Elizabeth; Grieve, Richard D; Harrison, David A; Higgins, Alisa M; Howe, Belinda; Huang, David T; Kellum, John A; Mouncey, Paul R; Music, Edvin; Peake, Sandra L; Pike, Francis; Reade, Michael C; Sadique, M Zia; Singer, Mervyn; Yealy, Donald M

2017-06-08

After a single-center trial and observational studies suggesting that early, goal-directed therapy (EGDT) reduced mortality from septic shock, three multicenter trials (ProCESS, ARISE, and ProMISe) showed no benefit. This meta-analysis of individual patient data from the three recent trials was designed prospectively to improve statistical power and explore heterogeneity of treatment effect of EGDT. We harmonized entry criteria, intervention protocols, outcomes, resource-use measures, and data collection across the trials and specified all analyses before unblinding. After completion of the trials, we pooled data, excluding the protocol-based standard-therapy group from the ProCESS trial, and resolved residual differences. The primary outcome was 90-day mortality. Secondary outcomes included 1-year survival, organ support, and hospitalization costs. We tested for treatment-by-subgroup interactions for 16 patient characteristics and 6 care-delivery characteristics. We studied 3723 patients at 138 hospitals in seven countries. Mortality at 90 days was similar for EGDT (462 of 1852 patients [24.9%]) and usual care (475 of 1871 patients [25.4%]); the adjusted odds ratio was 0.97 (95% confidence interval, 0.82 to 1.14; P=0.68). EGDT was associated with greater mean (±SD) use of intensive care (5.3±7.1 vs. 4.9±7.0 days, P=0.04) and cardiovascular support (1.9±3.7 vs. 1.6±2.9 days, P=0.01) than was usual care; other outcomes did not differ significantly, although average costs were higher with EGDT. Subgroup analyses showed no benefit from EGDT for patients with worse shock (higher serum lactate level, combined hypotension and hyperlactatemia, or higher predicted risk of death) or for hospitals with a lower propensity to use vasopressors or fluids during usual resuscitation. In this meta-analysis of individual patient data, EGDT did not result in better outcomes than usual care and was associated with higher hospitalization costs across a broad range of patient and hospital characteristics. (Funded by the National Institute of General Medical Sciences and others; PRISM ClinicalTrials.gov number, NCT02030158 .).

Receipt of Preventive Health Services in Young Adults

PubMed Central

Lau, Josephine S.; Adams, Sally H.; Irwin, Charles E.; Ozer, Elizabeth M.

2013-01-01

Objective To examine self-reported rates and disparities in delivery of preventive services to young adults. Design Population-based cross-sectional analysis. Multivariate logistic regression was used to examine how age, gender, race/ethnicity, income, insurance, and usual source of care influence the receipt of preventive services. Setting 2005 and 2007 California Health Interview Surveys (CHIS). Participants 3670 and 3621 young adults aged 18-26 years who responded to CHIS 2005 and 2007, respectively. Main Outcome Measures Self-reported receipt of flu vaccination, STD screening, cholesterol screening, diet counseling, exercise counseling and emotional health screening. Results Delivery rates ranged from 16.7% (flu vaccine) to 50.6% (cholesterol screening). Being female and having a usual source of care significantly increased receipt of services, with females more likely to receive STD screening (p<.001), cholesterol screening (p<.01), emotional health screening (p<.001), diet counseling (p<.01) and exercise counseling (p<.05) than males after controlling for age, race/ethnicity, income, insurance and usual source of care. Young adults with a usual source of care were more likely to receive a flu vaccine (p<.05), STD screening (p<.01), cholesterol screening (p<.001), diet counseling (p<.05) and exercise counseling (p<.05) than those without a usual source of care after adjusting for age, race/ethnicity, income, and insurance. Conclusions Rates of preventive service delivery are generally low. Greater efforts are needed to develop guidelines for young adults to increase the delivery of preventive care to this age group, and to address the gender and ethnic/racial disparities in preventive services delivery. PMID:23260833

Dementia And Physical Activity (DAPA) trial of moderate to high intensity exercise training for people with dementia: randomised controlled trial

PubMed Central

Sheehan, Bart; Atherton, Nicky; Nichols, Vivien; Collins, Helen; Mistry, Dipesh; Dosanjh, Sukhdeep; Slowther, Anne Marie; Khan, Iftekhar; Petrou, Stavros; Lall, Ranjit

2018-01-01

Abstract Objective To estimate the effect of a moderate to high intensity aerobic and strength exercise training programme on cognitive impairment and other outcomes in people with mild to moderate dementia. Design Multicentre, pragmatic, investigator masked, randomised controlled trial. Setting National Health Service primary care, community and memory services, dementia research registers, and voluntary sector providers in 15 English regions. Participants 494 people with dementia: 329 were assigned to an aerobic and strength exercise programme and 165 were assigned to usual care. Random allocation was 2:1 in favour of the exercise arm. Interventions Usual care plus four months of supervised exercise and support for ongoing physical activity, or usual care only. Interventions were delivered in community gym facilities and NHS premises. Main outcome measures The primary outcome was score on the Alzheimer’s disease assessment scale-cognitive subscale (ADAS-cog) at 12 months. Secondary outcomes included activities of daily living, neuropsychiatric symptoms, health related quality of life, and carer quality of life and burden. Physical fitness (including the six minute walk test) was measured in the exercise arm during the intervention. Results The average age of participants was 77 (SD 7.9) years and 301/494 (61%) were men. By 12 months the mean ADAS-cog score had increased to 25.2 (SD 12.3) in the exercise arm and 23.8 (SD 10.4) in the usual care arm (adjusted between group difference −1.4, 95% confidence interval −2.6 to −0.2, P=0.03). This indicates greater cognitive impairment in the exercise group, although the average difference is small and clinical relevance uncertain. No differences were found in secondary outcomes or preplanned subgroup analyses by dementia type (Alzheimer’s disease or other), severity of cognitive impairment, sex, and mobility. Compliance with exercise was good. Over 65% of participants (214/329) attended more than three quarters of scheduled sessions. Six minute walking distance improved over six weeks (mean change 18.1 m, 95% confidence interval 11.6 m to 24.6 m). Conclusion A moderate to high intensity aerobic and strength exercise training programme does not slow cognitive impairment in people with mild to moderate dementia. The exercise training programme improved physical fitness, but there were no noticeable improvements in other clinical outcomes. Trial registration Current Controlled Trials ISRCTN10416500. PMID:29769247

Usual medical treatments or levonorgestrel-IUS for women with heavy menstrual bleeding: long-term randomised pragmatic trial in primary care.

PubMed

Kai, Joe; Middleton, Lee; Daniels, Jane; Pattison, Helen; Tryposkiadis, Konstantinos; Gupta, Janesh

2016-12-01

Heavy menstrual bleeding (HMB) is a common, chronic problem affecting women and health services. However, long-term evidence on treatment in primary care is lacking. To assess the effectiveness of commencing the levonorgestrel-releasing intrauterine system (LNG-IUS) or usual medical treatments for women presenting with HMB in general practice. A pragmatic, multicentre, parallel, open-label, long term, randomised controlled trial in 63 primary care practices across the English Midlands. In total, 571 women aged 25-50 years, with HMB were randomised to LNG-IUS or usual medical treatment (tranexamic/mefenamic acid, combined oestrogen-progestogen, or progesterone alone). The primary outcome was the patient reported Menorrhagia Multi-Attribute Scale (MMAS, measuring effect of HMB on practical difficulties, social life, psychological and physical health, and work and family life; scores from 0 to 100). Secondary outcomes included surgical intervention (endometrial ablation/hysterectomy), general quality of life, sexual activity, and safety. At 5 years post-randomisation, 424 (74%) women provided data. While the difference between LNG-IUS and usual treatment groups was not significant (3.9 points; 95% confidence interval = -0.6 to 8.3; P = 0.09), MMAS scores improved significantly in both groups from baseline (mean increase, 44.9 and 43.4 points, respectively; P<0.001 for both comparisons). Rates of surgical intervention were low in both groups (surgery-free survival was 80% and 77%; hazard ratio 0.90; 95% CI = 0.62 to 1.31; P = 0.6). There was no difference in generic quality of life, sexual activity scores, or serious adverse events. Large improvements in symptom relief across both groups show treatment for HMB can be successfully initiated with long-term benefit and with only modest need for surgery. © British Journal of General Practice 2016.

Mud-Bath Therapy in Addition to Usual Care in Bilateral Knee Osteoarthritis: An Economic Evaluation Alongside a Randomized Controlled Trial.

PubMed

Ciani, Oriana; Pascarelli, Nicola Antonio; Giannitti, Chiara; Galeazzi, Mauro; Meregaglia, Michela; Fattore, Giovanni; Fioravanti, Antonella

2017-07-01

To perform a cost-effectiveness analysis of mud-bath therapy (MBT) in addition to usual treatment compared to usual treatment alone in patients with bilateral knee osteoarthritis (OA). An economic evaluation alongside a randomized controlled trial was conducted. Patients were randomly assigned to receive either a 2-week cycle of MBT in addition to their usual treatment or to continue routine care alone. The EuroQol 5-domain questionnaire was administered at baseline, 2 weeks, and at 3, 6, 9, and 12 months. Direct health care resource consumption data up until 12 months were derived from a daily diary given to patients and returned at prescheduled followup visits. A total of 103 patients were included (n = 53 for MBT patients; n = 50 for controls). Overall, patients in the MBT group accrued mean ± SD 0.835 ± 0.10 quality-adjusted life years (QALYs) compared to 0.753 ± 0.11 in the control group (P < 0.001). Average direct costs per patient (€303 versus €975; P < 0.001) were higher in the control group, primarily because of hospitalization for total knee replacement and use of intraarticular hyaluronic acid. Bootstrapping replications of costs and QALY sample distributions consistently indicated that the MBT therapy combined with standard therapy represents a dominant strategy as compared with standard therapy alone. The probability of MBT being cost-effective at standard cost-effectiveness thresholds (e.g., €20,000/QALY) is 100%. The results of this cost-effectiveness analysis support the use of MBT as midterm complementary therapy in the management of knee OA. © 2016, American College of Rheumatology.

Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study.

PubMed

Armour, Mike; Smith, Caroline A; Schabrun, Siobhan; Steiner, Genevieve Z; Zhu, Xiaoshu; Lawson, Kenny; Song, Jing

2018-01-01

Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30-50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP. We will include women aged 18-45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0-10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation. This is a two-armed, assessor blind, randomised controlled feasibility trial. Data will be compared at baseline and trial completion 8 weeks later. Outcomes from this feasibility study will inform a larger, fully powered clinical trial should the treatment show trends for potential effectiveness. Australian New Zealand Clinical Trials Registry, ACTRN12617000053325 (http://www.ANZCTR.org.au/ACTRN12617000053325.aspx).

Andrographis paniculata (Chuān Xīn Lián) for symptomatic relief of acute respiratory tract infections in adults and children: A systematic review and meta-analysis

PubMed Central

Wu, Ruo-Han; Logue, Martin; Blondel, Clara; Lai, Lily Yuen Wan; Stuart, Beth; Flower, Andrew; Fei, Yu-Tong; Moore, Michael; Shepherd, Jonathan; Liu, Jian-Ping

2017-01-01

Introduction Antimicrobial resistance (AMR) is a substantial threat to public health. Safe and effective alternatives are required to reduce unnecessary antibiotic prescribing. Andrographis Paniculata (A. Paniculata, Chuān Xīn Lián) has traditionally been used in Indian and Chinese herbal medicine for cough, cold and influenza, suggesting a role in respiratory tract infections (RTIs). This systematic review aimed to evaluate the clinical effectiveness and safety of A. Paniculata for symptoms of acute RTIs (ARTIs). Materials and methods English and Chinese databases were searched from their inception to March 2016 for randomised controlled trials (RCTs) evaluating oral A. Paniculata without language barriers (Protocol ID: CRD42016035679). The primary outcomes were improvement in ARTI symptoms and adverse events (AEs). A random effects model was used to pool the mean differences and risk ratio with 95% CI reported. Methodological quality was evaluated using the Cochrane risk of bias tool; two reviewers independently screened eligibility and extracted data. Results Thirty-three RCTs (7175 patients) were included. Most trials evaluated A. Paniculata (as a monotherapy and as a herbal mixture) provided commercially but seldom reported manufacturing or quality control details. A. Paniculata improved cough (n = 596, standardised mean difference SMD: -0.39, 95% confidence interval CI [-0.67, -0.10]) and sore throat (n = 314, SMD: -1.13, 95% CI [-1.37, -0.89]) when compared with placebo. A. Paniculata (alone or plus usual care) has a statistically significant effect in improving overall symptoms of ARTIs when compared to placebo, usual care, and other herbal therapies. Evidence also suggested that A. Paniculata (alone or plus usual care) shortened the duration of cough, sore throat and sick leave/time to resolution when compared versus usual care. No major AEs were reported and minor AEs were mainly gastrointestinal. The methodological quality of included trials was overall poor. Conclusions A. Paniculata appears beneficial and safe for relieving ARTI symptoms and shortening time to symptom resolution. However, these findings should be interpreted cautiously owing to poor study quality and heterogeneity. Well-designed trials evaluating the effectiveness and potential to reduce antibiotic use of A. Paniculata are warranted. PMID:28783743

PAin SoluTions In the Emergency Setting (PASTIES)--patient controlled analgesia versus routine care in emergency department patients with pain from traumatic injuries: randomised trial.

PubMed

Smith, Jason E; Rockett, Mark; S, Siobhan Creanor; Squire, Rosalyn; Hayward, Chris; Ewings, Paul; Barton, Andy; Pritchard, Colin; Eyre, Victoria; Cocking, Laura; Benger, Jonathan

2015-06-21

To determine whether patient controlled analgesia (PCA) is better than routine care in patients presenting to emergency departments with moderate to severe pain from traumatic injuries. Pragmatic, multicentre, parallel group, randomised controlled trial. Five English hospitals. 200 adults (71% (n = 142) male), aged 18 to 75 years, who presented to the emergency department requiring intravenous opioid analgesia for the treatment of moderate to severe pain from traumatic injuries and were expected to be admitted to hospital for at least 12 hours. PCA (n = 99) or nurse titrated analgesia (treatment as usual; n = 101). The primary outcome was total pain experienced over the 12 hour study period, derived by standardised area under the curve (scaled from 0 to 100) of each participant's hourly pain scores, captured using a visual analogue scale. Pre-specified secondary outcomes included total morphine use, percentage of study period in moderate/severe pain, percentage of study period asleep, length of hospital stay, and satisfaction with pain management. 200 participants were included in the primary analyses. Mean total pain experienced was 47.2 (SD 21.9) for the treatment as usual group and 44.0 (24.0) for the PCA group. Adjusted analyses indicated slightly (but not statistically significantly) lower total pain experienced in the PCA group than in the routine care group (mean difference 2.7, 95% confidence interval -2.4 to 7.8). Participants allocated to PCA used more morphine in total than did participants in the treatment as usual group (mean 44.3 (23.2) v 27.2 (18.2) mg; mean difference 17.0, 11.3 to 22.7). PCA participants spent, on average, less time in moderate/severe pain (36.2% (31.0) v 44.1% (31.6)), but the difference was not statistically significant. A higher proportion of PCA participants reported being perfectly or very satisfied compared with the treatment as usual group (86% (78/91) v 76% (74/98)), but this was also not statistically significant. PCA provided no statistically significant reduction in pain compared with routine care for emergency department patients with traumatic injuries. Trial registration European Clinical Trials Database EudraCT2011-000194-31; Current Controlled Trials ISRCTN25343280. © Smith et al 2015.

Long-term cost-effectiveness of collaborative care (vs usual care) for people with depression and comorbid diabetes or cardiovascular disease: a Markov model informed by the COINCIDE randomised controlled trial

PubMed Central

Camacho, Elizabeth M; Ntais, Dionysios; Coventry, Peter; Bower, Peter; Lovell, Karina; Chew-Graham, Carolyn; Baguley, Clare; Gask, Linda; Dickens, Chris; Davies, Linda M

2016-01-01

Objectives To evaluate the long-term cost-effectiveness of collaborative care (vs usual care) for treating depression in patients with diabetes and/or coronary heart disease (CHD). Setting 36 primary care general practices in North West England. Participants 387 participants completed baseline assessment (collaborative care: 191; usual care: 196) and full or partial 4-month follow-up data were captured for 350 (collaborative care: 170; usual care: 180). 62% of participants were male, 14% were non-white. Participants were aged ≥18 years, listed on a Quality and Outcomes Framework register for CHD and/or type 1 or 2 diabetes mellitus, with persistent depressive symptoms. Patients with psychosis or type I/II bipolar disorder, actively suicidal, in receipt of services for substance misuse, or already in receipt of psychological therapy for depression were excluded. Intervention Collaborative care consisted of evidence-based low-intensity psychological treatments, delivered over 3 months and case management by a practice nurse and a Psychological Well Being Practitioner. Outcome measures As planned, the primary measure of cost-effectiveness was the incremental cost-effectiveness ratio (cost per quality-adjusted life year (QALY)). A Markov model was constructed to extrapolate the trial results from short-term to long-term (24 months). Results The mean cost per participant of collaborative care was £317 (95% CI 284 to 350). Over 24 months, it was estimated that collaborative care was associated with greater healthcare usage costs (net cost £674 (95% CI −30 953 to 38 853)) and QALYs (net QALY gain 0.04 (95% CI −0.46 to 0.54)) than usual care, resulting in a cost per QALY gained of £16 123, and a likelihood of being cost-effective of 0.54 (willingness to pay threshold of £20 000). Conclusions Collaborative care is a potentially cost-effective long-term treatment for depression in patients with comorbid physical and mental illness. The estimated cost per QALY gained was below the threshold recommended by English decision-makers. Further, long-term primary research is needed to address uncertainty associated with estimates of cost-effectiveness. Trial registration number ISRCTN80309252; Post-results. PMID:27855101

Erase the battle lines: how to cut out conflicts with MCO case managers.

PubMed

1999-02-01

With managed care penetration increasing, it's more important than ever for hospital case managers to find ways to resolve the inevitable conflicts that arise with their managed care-based counterparts. Typical conflicts include struggles over authorization, vendor selection, lack of contact, and access to the patient. Some conflicts can be resolved simply by increasing the level of communication--usually by having managed care case managers stationed in the hospital itself. But even when contact is only by telephone, there are steps you can take to ease the tension. One way is simply to keep managed care case managers informed regarding such things as return admissions by problem patients. Effective discharge planning practices also can strengthen bonds, especially when it comes to patients with complex care needs.

Improving the efficacy of healthcare services for Aboriginal Australians.

PubMed

Gwynne, Kylie; Jeffries, Thomas; Lincoln, Michelle

2018-01-16

Objective The aim of the present systematic review was to examine the enablers for effective health service delivery for Aboriginal Australians. Methods This systematic review was undertaken in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Papers were included if they had data related to health services for Australian Aboriginal people and were published between 2000 and 2015. The 21 papers that met the inclusion criteria were assessed using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies. Seven papers were subsequently excluded due to weak methodological approaches. Results There were two findings in the present study: (1) that Aboriginal people fare worse than non-Aboriginal people when accessing usual healthcare services; and (2) there are five enablers for effective health care services for Australian Aboriginal people: cultural competence, participation rates, organisational, clinical governance and compliance, and availability of services. Conclusions Health services for Australian Aboriginal people must be tailored and implementation of the five enablers is likely to affect the effectiveness of health services for Aboriginal people. The findings of the present study have significant implications in directing the future design, funding, delivery and evaluation of health care services for Aboriginal Australians. What is known about the topic? There is significant evidence about poor health outcomes and the 10-year gap in life expectancy between Aboriginal and non-Aboriginal people, and limited evidence about improving health service efficacy. What does this paper add? This systematic review found that with usual health care delivery, Aboriginal people experience worse health outcomes. This paper identifies five strategies in the literature that improve the effectiveness of health care services intended for Aboriginal people. What are the implications for practitioners? Aboriginal people fare worse in both experience and outcomes when they access usual care services. Health services intended for Aboriginal people should be tailored using the five enablers to provide timely, culturally safe and high-quality care.

Integration of care for hypertension and diabetes: a scoping review assessing the evidence from systematic reviews and evaluating reporting.

PubMed

Yiu, Kristy C; Rohwer, Anke; Young, Taryn

2018-06-20

With the rise in pre-mature mortality rate from non-communicable disease (NCD), there is a need for evidence-based interventions. We evaluated existing systematic reviews on effectiveness of integration of healthcare services, in particular with focus on delivery of care designed to improve health and process outcomes in people with multi-morbidity, where at least one of the conditions was diabetes or hypertension. We searched MEDLINE, EMBASE, Cochrane Library, and Health Evidence to November 8, 2016 and consulted experts. One review author screened titles, abstracts and two review authors independently screened short listed full-texts and selected reviews for inclusion. We considered systematic reviews evaluating integration of care, compared to usual care, for people with multi-morbidity. One review author extracted data and another author verified it. Two review authors independently evaluated risk of bias using ROBIS and AMSTAR. Inter-rater reliability was analysed for ROBIS and AMSTAR using Cohen's kappa and percent agreement. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was used to assess reporting. We identified five systematic reviews on integration of care. Four reviews focused on comorbid diabetes and depression and two covered hypertension and comorbidities of cardiovascular disease, depression, or diabetes. Interventions were poorly described. The health outcomes evaluated included risk of all-cause mortality, measures of depression, cholesterol levels, HbA1c levels, effect of depression on HbA1c levels, symptom improvement, systolic blood pressure, and hypertension control. Process outcomes included access and utilisation of healthcare services, costs, and quality of care. Overall, three reviews had a low and medium risk of bias according to ROBIS and AMSTAR respectively, while two reviews had high risk of bias as judged by both ROBIS and AMSTAR. Findings have demonstrated that collaborative care in general resulted in better health and process outcomes when compared to usual care for both depression and diabetes and hypertension and diabetes. Several knowledge gaps were identified on integration of care for comorbidities with diabetes and/or hypertension: limited research on this topic for hypertension, limited reviews that included primary studies based in low-middle income countries, and limited reviews on collaborative care for communicable and NCDs.

Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial.

PubMed

Blödt, Susanne; Pach, Daniel; Eisenhart-Rothe, Sanna von; Lotz, Fabian; Roll, Stephanie; Icke, Katja; Witt, Claudia M

2018-02-01

Primary dysmenorrhea is common among women of reproductive age. Nonsteroidal anti-inflammatory drugs and oral contraceptives are effective treatments, although the failure rate is around 20% to 25%. Therefore additional evidence-based treatments are needed. In recent years, the use of smartphone applications (apps) has increased rapidly and may support individuals in self-management strategies. We aimed to investigate the effectiveness of app-based self-acupressure in women with menstrual pain. A 2-armed, randomized, pragmatic trial was conducted from December 2012 to April 2015 with recruitment until August 2014 in Berlin, Germany, among women aged 18 to 34 years with self-reported cramping pain of 6 or more on a numeric rating scale (NRS) for the worst pain intensity during the previous menstruation. After randomization, women performed either app-based self-acupressure (n = 111) or followed usual care only (n = 110) for 6 consecutive menstruation cycles. The primary outcome was the mean pain intensity (NRS 0-10) on the days with pain during the third menstruation. Secondary outcomes included worst pain intensity during menstruation, duration of pain, 50% responder rates (reduction of mean pain by at least 50%), medication intake, sick leave days, and body efficacy expectation assessed at the first, second, third, and sixth menstruation cycles. We included 221 women (mean age, 24.0 years; standard deviation [SD], 3.6 years). The mean pain intensity difference during the third menstruation was statistically significant in favor of acupressure (acupressure: 4.4; 95% confidence interval [CI], 4.0-4.7; usual care 5.0; 95% CI, 4.6-5.3; mean difference -0.6; 95% CI, - 1.2 to -0.1; P = .026). At the sixth cycle, the mean difference between the groups (-1.4; 95% CI, -2.0 to -0.8; P < .001) reached clinical relevance. At the third and sixth menstruation cycles, responder rates were 37% and 58%, respectively, in the acupressure group, in contrast to 23% and 24% in the usual care group. Moreover, the worst pain intensity (group difference -0.6; 95% CI, -1.2 to -0.02; and -1.4; 95% CI, -2.0 to -0.7), the number of days with pain (-0.4; 95% CI, -0.9 to -0.01; and -1.2; 95% CI, -1.6 to -0.7) and the proportion of women with pain medication at the third and sixth menstruation cycles (odds ratio [OR], 0.5; 95% CI, 0.3-0.9] and 0.3 (95% CI, 0.2-0.5) were lower in the acupressure group. At the third cycle, hormonal contraceptive use was more common in the usual care group than in the acupressure group (OR, 0.5; 95% CI, 0.3-0.97) but not statistically significantly different at the sixth cycle (OR, 0.6; 95% CI, 0.3-1.1]). The number of sick leave days and body efficacy expectation (self-efficacy scale) did not differ between groups. On a scale of 0 to 6, mean satisfaction with the intervention at the third cycle was 3.7 (SD 1.3), recommendation of the intervention to others 4.3 (1.5), appropriateness of acupressure for menstrual pain 3.9 (1.4), and application of acupressure for other pain 4.3 (1.5). The intervention was safe, and after the sixth cycle, two-thirds of the women (67.6%) still applied acupressure on all days with pain. Smartphone app-delivered self-acupressure resulted in a reduction of menstrual pain compared to usual care only. Effects were increasing over time, and adherence was good. Future trials should include comparisons with other active treatment options. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Health related quality of life and comorbidity. A descriptive analysis comparing EQ-5D dimensions of patients in the German disease management program for type 2 diabetes and patients in routine care.

PubMed

Ose, Dominik; Miksch, Antje; Urban, Elisabeth; Natanzon, Iris; Szecsenyi, Joachim; Kunz, Cornelia Ursula; Freund, Tobias

2011-08-02

The co-occurance of multiple medical conditions has a negative impact on health related quality of life (HRQoL) for patients with type 2 diabetes. These patients demand for intensified care programs. Participation in a disease management program (DMP) for type 2 diabetes has shown to counterbalance this effect. However, it remains unclear which dimensions of HRQoL are influenced by the DMP. The aim of this study was to explore the HRQoL dimensions of patients with type 2 diabetes in the German DMP and patients in routine care (RC). This analysis is part of a comparative evaluation of the German DMP for patients with type 2 diabetes. A questionnaire, including the HRQoL measure EQ-5D, was mailed to a random sample of 3,546 patients with type 2 diabetes (59.3% female). The EQ-5D dimensions were analyzed by grouping patients according to their participation in the German DMP for diabetes into DMP and RC. Compared to patients in DMP, patients in RC reported more problems for the dimensions mobility (P < 0.05), self care (P < 0.05) and performing usual activities (P < 0.01). Depending on the number of other conditions, remarkable differences for reporting "no problems" exist for patients with six or more comorbid conditions regarding the dimensions mobility (RC = 8.7%, DMP = 32.3%), self care (RC = 43.5%, DMP = 64.5%), usual activities (RC = 13.0%, DMP = 33.9%) and anxiety or depression (RC = 37.0%, DMP = 48.4%). Patients participating in the German DMP for type 2 diabetes mellitus show significantly higher ratings of their HRQoL in the dimensions mobility, self care and performing usual activities compared to patients in RC. This difference can also be observed in patients with significant comorbidities. As these dimensions are known to be essential for diabetes care, the German DMP may contribute to improved care even for comorbid diabetes patients.

Health related quality of life and comorbidity. A descriptive analysis comparing EQ-5D dimensions of patients in the German disease management program for type 2 diabetes and patients in routine care

PubMed Central

2011-01-01

Background The co-occurance of multiple medical conditions has a negative impact on health related quality of life (HRQoL) for patients with type 2 diabetes. These patients demand for intensified care programs. Participation in a disease management program (DMP) for type 2 diabetes has shown to counterbalance this effect. However, it remains unclear which dimensions of HRQoL are influenced by the DMP. The aim of this study was to explore the HRQoL dimensions of patients with type 2 diabetes in the German DMP and patients in routine care (RC). Methods This analysis is part of a comparative evaluation of the German DMP for patients with type 2 diabetes. A questionnaire, including the HRQoL measure EQ-5D, was mailed to a random sample of 3,546 patients with type 2 diabetes (59.3% female). The EQ-5D dimensions were analyzed by grouping patients according to their participation in the German DMP for diabetes into DMP and RC. Results Compared to patients in DMP, patients in RC reported more problems for the dimensions mobility (P < 0.05), self care (P < 0.05) and performing usual activities (P < 0.01). Depending on the number of other conditions, remarkable differences for reporting "no problems" exist for patients with six or more comorbid conditions regarding the dimensions mobility (RC = 8.7%, DMP = 32.3%), self care (RC = 43.5%, DMP = 64.5%), usual activities (RC = 13.0%, DMP = 33.9%) and anxiety or depression (RC = 37.0%, DMP = 48.4%). Conclusion Patients participating in the German DMP for type 2 diabetes mellitus show significantly higher ratings of their HRQoL in the dimensions mobility, self care and performing usual activities compared to patients in RC. This difference can also be observed in patients with significant comorbidities. As these dimensions are known to be essential for diabetes care, the German DMP may contribute to improved care even for comorbid diabetes patients. PMID:21810241

Physician Assistants and Nurse Practitioners as a Usual Source of Care

ERIC Educational Resources Information Center

Everett, Christine M.; Schumacher, Jessica R.; Wright, Alexandra; Smith, Maureen A.

2009-01-01

Purpose: To identify characteristics and outcomes of patients who use physician assistants and nurse practitioners (PA/NPs) as a usual source of care. Methods: Cross sectional analysis using the telephone and mail surveys of the Wisconsin Longitudinal Study (WLS), a prospective cohort study of Wisconsin high school graduates and selected siblings…

Home-based interventions for black patients with uncontrolled hypertension: a cluster randomized controlled trial

PubMed Central

Feldman, Penny H; McDonald, Margaret V; Barrón, Yolanda; Gerber, Linda M; Peng, Timothy R

2016-01-01

Aim: Assess the comparative effectiveness of two blood pressure (BP) control interventions for black patients with uncontrolled hypertension. Patients & methods: A total of 845 patients were enrolled in a three-arm cluster randomized trial. On admission of an eligible patient, field nurses were randomized to usual care, a basic or augmented intervention. Results: Across study arms there were no significant 12 months differences in BP control rates (primary outcome) (25% usual care, 26% basic intervention, 22% augmented intervention); systolic BP (143.8 millimeters of mercury [mmHg], 146.9 mmHG, 143.9 mmHG, respectively); medication intensification (47, 43, 54%, respectively); or self-management score (18.7, 18.7, 17.9, respectively). Adjusted systolic BP dropped more than 10 mmHg from baseline to 12 months (155.5–145.4 mmHg) among all study participants. Conclusion: Neither the augmented nor basic intervention was more effective than usual care in improving BP control, systolic BP, medication intensification or patient self-management. Usual home care yielded substantial improvements, creating a high comparative effectiveness threshold. Clinical Trial Registration: NCT00139490. PMID:26946952

Mammography Adherence in African-American Women: Results of a Randomized Controlled Trial.

PubMed

Gathirua-Mwangi, Wambui G; Monahan, Patrick O; Stump, Timothy; Rawl, Susan M; Skinner, Celette Sugg; Champion, Victoria L

2016-02-01

Breast cancer is the second leading cause of cancer mortality among women in the developed world. Mammography screening is especially important for African-Americans because they experience a greater mortality (OR = 1.38) than Caucasians despite having a lower incidence of breast cancer. The purpose of this study was to compare the effects of two interventions with usual care on mammography adherence among African-American women. A subsample of African-American women (n = 244) aged 41-65 years who had not had a mammogram in the last 15 months and no history of breast cancer was randomly assigned to receive (1) mailed interactive DVD, (2) computer-tailored telephone counseling, or (3) usual care. The DVD intervention was five times more effective than usual care for promoting mammography screening at 6 months follow-up among women who earned less than $30,000 (OR = 5.3). Compared to usual care, neither the DVD nor phone produced significant effects for women with household incomes >$30,000. Use of a mailed DVD for low-income African-American women may be an effective way to increase mammography adherence.

Young adults' health care utilization and expenditures prior to the Affordable Care Act.

PubMed

Lau, Josephine S; Adams, Sally H; Boscardin, W John; Irwin, Charles E

2014-06-01

To examine young adults' health care utilization and expenditures prior to the Affordable Care Act. We used 2009 Medical Expenditure Panel Survey to (1) compare young adults' health care utilization and expenditures of a full-spectrum of health services to children and adolescents and (2) identify disparities in young adults' utilization and expenditures, based on access (insurance and usual source of care) and other sociodemographic factors, including race/ethnicity and income. Young adults had (1) significantly lower rates of overall utilization (72%) than other age groups (83%-88%, p < .001), (2) the lowest rate of office-based utilization (55% vs. 67%-77%, p < .001) and (3) higher rate of emergency room visits compared with adolescents (15% vs. 12%, p < .01). Uninsured young adults had high out-of-pocket expenses. Compared with the young adults with private insurance, the uninsured spent less than half on health care ($1,040 vs. $2,150/person, p < .001) but essentially the same out-of-pocket expenses ($403 vs. $380/person, p = .57). Among young adults, we identified significant disparities in utilization and expenditures based on the presence/absence of a usual source of care, race/ethnicity, home language, and sex. Young adults may not be utilizing the health care system optimally by having low rates of office-based visits and high rates of emergency room visits. The Affordable Care Act provision of insurance for those previously uninsured or under-insured will likely increase their utilization and expenditures and lower their out-of-pocket expenses. Further effort is needed to address noninsurance barriers and ensure equal access to health services. Copyright © 2014 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Cluster Randomized Controlled Trial

PubMed Central

Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

2015-01-01

Background and Purpose— We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. Methods— A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Results— Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. Conclusions— This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. PMID:26152298

Effects of interventions on trajectories of health-related quality of life among older patients with hip fracture: a prospective randomized controlled trial.

PubMed

Tseng, Ming-Yueh; Liang, Jersey; Shyu, Yea-Ing L; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chen, Ching-Yen; Yang, Shu-Fang

2016-03-03

Health-related quality of life (HRQoL) has been used to assess subjects' prognosis and recovery following hip fracture. However, evidence is mixed regarding the effectiveness of interventions to improve HRQoL of elders with hip fracture. The purposes of this study were to identify distinct HRQoL trajectories and to evaluate the effects of two care models on these trajectories over 12 months following hip-fracture surgery. For this secondary analysis, data came from a randomized controlled trial of subjects with hip fracture receiving three treatment care models: interdisciplinary care (n = 97), comprehensive care (n = 91), and usual care (n = 93). Interdisciplinary care consisted of geriatric consultation, discharge planning, and 4 months of in-home rehabilitation. Comprehensive care consisted of interdisciplinary care plus management of malnutrition and depressive symptoms, fall prevention, and 12 months of in-home rehabilitation. Usual care included only in-hospital rehabilitation and occasional discharge planning, without geriatric consultation and in-home rehabilitation. Mental and physical HRQoL were measured at 1, 3, 6, and 12 months after discharge by the physical component summary scale (PCS) and mental component summary scale (MCS), respectively, of the Medical Outcomes Study Short Form 36, Taiwan version. Latent class growth modeling was used to identify PCS and MCS trajectories and to evaluate how they were affected by the interdisciplinary and comprehensive care models. We identified three quadratic PCS trajectories: poor PCS (n = 103, 36.6 %), moderate PCS (n = 96, 34.2 %), and good PCS (n = 82, 29.2 %). In contrast, we found three linear MCS trajectories: poor MCS (n = 39, 13.9 %), moderate MCS (n = 84, 29.9 %), and good MCS (n = 158, 56.2 %). Subjects in the comprehensive care and interdisciplinary care groups were more likely to experience a good PCS trajectory (b = 0.99, odds ratio [OR] = 2.69, confidence interval [CI] = 7.24-1.00, p = 0.049, and b = 1.32, OR = 3.75, CI = 10.53-1.33, p = 0.012, respectively) than those who received usual care. However, neither care model improved MCS. The interdisciplinary and comprehensive care models improved recovery from hip fracture by increasing subjects' odds for following a trajectory of good physical functioning after hospitalization. ClinicalTrials.gov ( NCT01350557 ).

Capgras syndrome related to diazepam treatment.

PubMed

Stewart, Jonathan T

2004-01-01

Capgras syndrome, the delusion that identical-appearing impostors have replaced familiar people, is an unusual phenomenon usually seen in schizophrenia or dementia. We recently cared for a 78 year old man who seemed to develop Capgras syndrome as an adverse reaction to diazepam. An iatrogenic cause should be considered in the differential diagnosis of any new delusion, including Capgras syndrome.

Differences in Osteoarthritis Self-Management Support Intervention Outcomes According to Race and Health Literacy

ERIC Educational Resources Information Center

Sperber, Nina R.; Bosworth, Hayden B.; Coffman, Cynthia J.; Lindquist, Jennifer H.; Oddone, Eugene Z.; Weinberger, Morris; Allen, Kelli D.

2013-01-01

We explored whether the effects of a telephone-based osteoarthritis (OA) self-management support intervention differed by race and health literacy. Participants included 515 veterans with hip and/or knee OA. Linear mixed models assessed differential effects of the intervention compared with health education (HE) and usual care (UC) on pain…

Interventions for preventing and treating pelvic and back pain in pregnancy.

PubMed

Pennick, Victoria; Liddle, Sarah D

2013-08-01

More than two-thirds of pregnant women experience low-back pain (LBP) and almost one-fifth experience pelvic pain. Pain increases with advancing pregnancy and interferes with work, daily activities and sleep. To assess the effects of interventions for preventing and treating pelvic and back pain in pregnancy. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (18 July 2012), identified related studies and reviews from the Cochrane Back Review Group search strategy to July 2012, and checked reference lists from identified reviews and studies. Randomised controlled trials (RCTs) of any treatment to prevent or reduce the incidence or severity of pelvic or back pain in pregnancy. Two review authors independently assessed risk of bias and extracted data. Quality of the evidence for outcomes was assessed using the five criteria outlined by the GRADE Working Group. We included 26 randomised trials examining 4093 pregnant women in this updated review. Eleven trials examined LBP (N = 1312), four examined pelvic pain (N = 661), and 11 trials examined lumbo-pelvic (LBP and pelvic) pain (N = 2120). Diagnoses ranged from self-reported symptoms to the results of specific tests. All interventions were added to usual prenatal care and unless noted, were compared to usual prenatal care. For LBP, there was low-quality evidence that in general, the addition of exercise significantly reduced pain (standardised mean difference (SMD) -0.80; 95% confidence interval (CI) -1.07 to -0.53; six RCTs, N = 543), and disability (SMD -0.56; 95% CI -0.89 to -0.23; two RCTs, N = 146); and water-based exercise significantly reduced LBP-related sick leave (risk ratio (RR) 0.40; 95% CI 0.17 to 0.92; one RCT, N = 241). Low-quality evidence from single trials suggested no significant difference in pain or function between two types of pelvic support belt, between osteopathic manipulation (OMT) and usual care or sham ultrasound (sham US). Very low-quality evidence suggested that a specially-designed pillow may relieve night pain better than a regular pillow. For pelvic pain, there was moderate-quality evidence that acupuncture significantly reduced evening pain better than exercise; both were better than usual care. Low-quality evidence from single trials suggested that adding a rigid belt to exercise improved average pain but not function; acupuncture was significantly better than sham acupuncture for improving evening pain and function, but not average pain; and evening pain relief was the same following either deep or superficial acupuncture. For lumbo-pelvic pain, there was moderate-quality evidence that an eight- to 20-week exercise program reduced the risk of women reporting lumbo-pelvic pain (RR 0.85; 95% CI 0.73 to 1.00; four RCTs, N = 1344); but a 16- to 20-week training program was no more successful than usual care at preventing pelvic pain (one RCT, N = 257). Low-quality evidence suggested that exercise significantly reduced lumbo-pelvic-related sick leave (RR 0.76; 95% CI 0.62 to 0.94, two RCTs, N = 1062), and improved function. Low-quality evidence from single trials suggested that OMT significantly reduced pain and improved function; either a multi-modal intervention that included manual therapy, exercise and education (MOM) or usual care significantly reduced disability, but only MOM improved pain and physical function; acupuncture improved pain and function more than usual care or physiotherapy; pain and function improved more when acupuncture was started at 26- rather than 20- weeks' gestation; and auricular (ear) acupuncture significantly improved these outcomes more than sham acupuncture.When reported, adverse events were minor and transient. Moderate-quality evidence suggested that acupuncture or exercise, tailored to the stage of pregnancy, significantly reduced evening pelvic pain or lumbo-pelvic pain more than usual care alone, acupuncture was significantly more effective than exercise for reducing evening pelvic pain, and a 16- to 20-week training program was no more successful than usual prenatal care at preventing pelvic or LBP. Low-quality evidence suggested that exercise significantly reduced pain and disability from LBP.There was low-quality evidence from single trials for other outcomes because of high risk of bias and sparse data; clinical heterogeneity precluded pooling. Publication bias and selective reporting cannot be ruled out.Physiotherapy, OMT, acupuncture, a multi-modal intervention, or the addition of a rigid pelvic belt to exercise seemed to relieve pelvic or back pain more than usual care alone. Acupuncture was more effective than physiotherapy at relieving evening lumbo-pelvic pain and disability and improving pain and function when it was started at 26- rather than 20-weeks' gestation, although the effects were small.There was no significant difference in LBP and function for different support belts, exercise, neuro emotional technique or spinal manipulation (SMT), or in evening pelvic pain between deep and superficial acupuncture.Very low-quality evidence suggested a specially-designed pillow may reduce night-time LBP.Further research is very likely to have an important impact on our confidence in the estimates of effect and is likely to change the estimates.  Future research would benefit from the introduction of an agreed classification system that can be used to categorise women according to presenting symptoms.

Health Heritage© a web-based tool for the collection and assessment of family health history: initial user experience and analytic validity.

PubMed

Cohn, W F; Ropka, M E; Pelletier, S L; Barrett, J R; Kinzie, M B; Harrison, M B; Liu, Z; Miesfeldt, S; Tucker, A L; Worrall, B B; Gibson, J; Mullins, I M; Elward, K S; Franko, J; Guterbock, T M; Knaus, W A

2010-01-01

A detailed family health history is currently the most potentially useful tool for diagnosis and risk assessment in clinical genetics. We developed and evaluated the usability and analytic validity of a patient-driven web-based family health history collection and analysis tool. Health Heritage(©) guides users through the collection of their family health history by relative, generates a pedigree, completes risk assessment, stratification, and recommendations for 89 conditions. We compared the performance of Health Heritage to that of Usual Care using a nonrandomized cohort trial of 109 volunteers. We contrasted the completeness and sensitivity of family health history collection and risk assessments derived from Health Heritage and Usual Care to those obtained by genetic counselors and genetic assessment teams. Nearly half (42%) of the Health Heritage participants reported discovery of health risks; 63% found the information easy to understand and 56% indicated it would change their health behavior. Health Heritage consistently outperformed Usual Care in the completeness and accuracy of family health history collection, identifying 60% of the elevated risk conditions specified by the genetic team versus 24% identified by Usual Care. Health Heritage also had greater sensitivity than Usual Care when comparing the identification of risks. These results suggest a strong role for automated family health history collection and risk assessment and underscore the potential of these data to serve as the foundation for comprehensive, cost-effective personalized genomic medicine. Copyright © 2010 S. Karger AG, Basel.

In-service training for health professionals to improve care of seriously ill newborns and children in low-income countries

PubMed Central

Opiyo, Newton; English, Mike

2015-01-01

Background A variety of in-service emergency care training courses are currently being promoted as a strategy to improve the quality of care provided to seriously ill newborns and children in low-income countries. Most courses have been developed in high-income countries. However, whether these courses improve the ability of health professionals to provide appropriate care in low-income countries remains unclear. This is the first update of the original review. Objectives To assess the effects of in-service emergency care training on health professionals' treatment of seriously ill newborns and children in low-income countries. Search methods For this update, we searched the Cochrane Database of Systematic Reviews, part of The Cochrane Library (http://www.cochranelibrary.com); MEDLINE, Ovid SP; EMBASE, Ovid SP; the Cochrane Central Register of Controlled Trials (CENTRAL), part of The Cochrane Library (http://www.cochranelibrary.com) (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register); Science Citation Index and Social Sciences Citation Index, Institute for Scientific Information (ISI) Web of Knowledge/Science and eight other databases. We performed database searches in February 2015. We also searched clinical trial registries, websites of relevant organisations and reference lists of related reviews. We applied no date, language or publication status restrictions when conducting the searches. Selection criteria Randomised trials, non-randomised trials, controlled before and after studies and interrupted-time-series studies that compared the effects of in-service emergency care training versus usual care were eligible for inclusion. We included only hospital-based studies and excluded community-based studies. Two review authors independently screened and selected studies for inclusion. Data collection and analysis Two review authors independently extracted data and assessed study risk of bias and confidence in effect estimates (certainty of evidence) for each outcome using GRADE (Grades of Recommendation, Assessment, Development and Evaluation). We described results and presented them in GRADE tables. Main results We identified no new studies in this update. Two randomised trials (which were included in the original review) met the review eligibility criteria. In the first trial, newborn resuscitation training compared with usual care improved provider performance of appropriate resuscitation (trained 66% vs usual care 27%, risk ratio 2.45, 95% confidence interval (CI) 1.75 to 3.42; moderate certainty evidence) and reduced inappropriate resuscitation (trained mean 0.53 vs usual care 0.92, mean difference 0.40, 95% CI 0.13 to 0.66; moderate certainty evidence). Effect on neonatal mortality was inconclusive (trained 28% vs usual care 25%, risk ratio 0.77, 95% CI 0.40 to 1.48; N = 27 deaths; low certainty evidence). Findings from the second trial suggest that essential newborn care training compared with usual care probably slightly improves delivery room newborn care practices (assessment of breathing, preparedness for resuscitation) (moderate certainty evidence). Authors' conclusions In-service neonatal emergency care courses probably improve health professionals' treatment of seriously ill babies in the short term. Further multi-centre randomised trials evaluating the effects of in-service emergency care training on long-term outcomes (health professional practice and patient outcomes) are needed. PLAIN LANGUAGE SUMMARY In-service training for health professionals to improve care of seriously ill newborns and children in low-income countries What question was the review asking? This is the first update of the original Cochrane review, whose objective was to find out whether additional emergency care training programmes can improve the ability of health workers in poor countries to care for seriously ill newborns and children admitted to hospitals. Researchers at The Cochrane Collaboration searched for all studies that could answer this question and found two relevant studies. What are the key messages? The review authors suggest that giving health professionals in poor countries additional training in emergency care probably improves their ability to care for seriously ill newborns. We need additional high-quality studies, including studies in which health professionals are trained to care for seriously ill older children. Background: training health professionals to care for seriously ill babies and children In poor countries, many babies and children with serious illnesses die even though they have been cared for in hospitals. One reason for this may be that health workers in these countries often are not properly trained to offer the care that these children need. In poor countries, children often become seriously ill because of conditions such as pneumonia, meningitis and diarrhoea, and may need emergency care. For newborn babies, the most common reason for emergency care is too little oxygen to the baby during birth. If this goes on for too long, the person delivering the baby has to help the baby breathe, and sometimes has to get the baby's heart rate back to normal. This is called neonatal resuscitation. Neonatal resuscitation is a skilled task, and the health worker needs proper training. As babies need to be resuscitated quickly, the health worker needs to know how to prepare for this before the baby is born. For instance, he or she needs to know how to prepare the room and proper equipment. Health workers in poor countries often do not have these skills, and these babies are likely to die. Babies can also be harmed if the health worker does not resuscitate the baby correctly. Several training programmes have been developed to teach health workers how to give emergency care to seriously ill babies and children. But most of these have been developed and tested in wealthy countries, and we don't know whether they would work in poor countries. What happens when health professionals in poor countries are given extra training? The review authors found two relevant studies. These studies compared the practices of health professionals who had been given extra training in the care of newborns with the practices of health professionals who did not receive extra training. In the first study, nurses at a maternity hospital in Kenya completed a one-day training course on how to resuscitate newborn babies. This course was adapted from the UK Resuscitation Council, and it included lectures and practical training. The study suggests that after these training courses: health professionals are probably more likely to resuscitate newborn babies correctly (moderate certainty of the evidence); and newborn babies may be less likely to die while being resuscitated (low certainty of the evidence). In the second study, doctors, nurses and midwives in five Sri Lankan hospitals were given a four-day training course on how to prepare for and provide care for newborns. This course was adapted from the World Health Organization (WHO) Training Modules on Essential Newborn Care and Breastfeeding, and included lectures, demonstrations, hands-on training and small group discussions. This study suggests that after these training courses: health professionals probably are more likely to be well prepared to resuscitate newborn babies (moderate certainty of the evidence). Unfortunately, the two studies followed up with health professionals for only two to three months after they received training. We therefore don't know if the benefits of the training courses lasted over time. The review authors found no studies that looked at the effects of training programmes on the care of older children. How up-to-date is this review? Review authors searched for studies that had been published up to February 2015. PMID:25968066

The utilization of video-conference shared medical appointments in rural diabetes care.

PubMed

Tokuda, Lisa; Lorenzo, Lenora; Theriault, Andre; Taveira, Tracey H; Marquis, Lynn; Head, Helene; Edelman, David; Kirsh, Susan R; Aron, David C; Wu, Wen-Chih

2016-09-01

To explore whether Video-Shared Medical Appointments (video-SMA), where group education and medication titration were provided remotely through video-conferencing technology would improve diabetes outcomes in remote rural settings. We conducted a pilot where a team of a clinical pharmacist and a nurse practitioner from Honolulu VA hospital remotely delivered video-SMA in diabetes to Guam. Patients with diabetes and HbA1c ≥7% were enrolled into the study during 2013-2014. Six groups of 4-6 subjects attended 4 weekly sessions, followed by 2 bi-monthly booster video-SMA sessions for 5 months. Patients with HbA1c ≥7% that had primary care visits during the study period but not referred/recruited for video-SMA were selected as usual-care comparators. We compared changes from baseline in HbA1c, blood-pressure, and lipid levels using mixed-effect modeling between video-SMA and usual care groups. We also analyzed emergency department (ED) visits and hospitalizations. Focus groups were conducted to understand patient's perceptions. Thirty-one patients received video-SMA and charts of 69 subjects were abstracted as usual-care. After 5 months, there was a significant decline in HbA1c in video-SMA vs. usual-care (9.1±1.9 to 8.3±1.8 vs. 8.6±1.4 to 8.7±1.6, P=0.03). No significant change in blood-pressure or lipid levels was found between the groups. Patients in the video-SMA group had significantly lower rates of ED visits (3.2% vs. 17.4%, P=0.01) than usual-care but similar hospitalization rates. Focus groups suggested patient satisfaction with video-SMA and increase in self-efficacy in diabetes self-care. Video-SMA is feasible, well-perceived and has the potential to improve diabetes outcomes in a rural setting. Published by Elsevier Ireland Ltd.

Effect of early supervised physiotherapy on recovery from acute ankle sprain: randomised controlled trial

PubMed Central

Day, Andrew G; Pelland, Lucie; Pickett, William; Johnson, Ana P; Aiken, Alice; Pichora, David R; Brouwer, Brenda

2016-01-01

Objective To assess the efficacy of a programme of supervised physiotherapy on the recovery of simple grade 1 and 2 ankle sprains. Design A randomised controlled trial of 503 participants followed for six months. Setting Participants were recruited from two tertiary acute care settings in Kingston, ON, Canada. Participants The broad inclusion criteria were patients aged ≥16 presenting for acute medical assessment and treatment of a simple grade 1 or 2 ankle sprain. Exclusions were patients with multiple injuries, other conditions limiting mobility, and ankle injuries that required immobilisation and those unable to accommodate the time intensive study protocol. Intervention Participants received either usual care, consisting of written instructions regarding protection, rest, cryotherapy, compression, elevation, and graduated weight bearing activities, or usual care enhanced with a supervised programme of physiotherapy. Main outcome measures The primary outcome of efficacy was the proportion of participants reporting excellent recovery assessed with the foot and ankle outcome score (FAOS). Excellent recovery was defined as a score ≥450/500 at three months. A difference of at least 15% increase in the absolute proportion of participants with excellent recovery was deemed clinically important. Secondary analyses included the assessment of excellent recovery at one and six months; change from baseline using continuous scores at one, three, and six months; and clinical and biomechanical measures of ankle function, assessed at one, three, and six months. Results The absolute proportion of patients achieving excellent recovery at three months was not significantly different between the physiotherapy (98/229, 43%) and usual care (79/214, 37%) arms (absolute difference 6%, 95% confidence interval −3% to 15%). The observed trend towards benefit with physiotherapy did not increase in the per protocol analysis and was in the opposite direction by six months. These trends remained similar and were never statistically or clinically important when the FAOS was analysed as a continuous change score. Conclusions In a general population of patients seeking hospital based acute care for simple ankle sprains, there is no evidence to support a clinically important improvement in outcome with the addition of supervised physiotherapy to usual care, as provided in this protocol. Trial registration ISRCTN 74033088 (www.isrctn.com/ISRCTN74033088) PMID:27852621

Can tailored interventions increase mammography use among HMO women?

PubMed

Lipkus, I M; Rimer, B K; Halabi, S; Strigo, T S

2000-01-01

Telephone counseling and tailored print communications have emerged as promising methods for promoting mammography screening. However, there has been little research testing, within the same randomized field trial, of the efficacy of these two methods compared to a high-quality usual care system for enhancing screening. This study addressed the question: Compared to usual care, is tailored telephone counseling more effective than tailored print materials for promoting mammography screening? Three-year randomized field trial. One thousand ninety-nine women aged 50 and older recruited from a health maintenance organization in North Carolina. Women were randomized to 1 of 3 groups: (1) usual care, (2) tailored print communications, and (3) tailored telephone counseling. Adherence to mammography screening based on self-reports obtained during 1995, 1996, and 1997. Compared to usual care alone, telephone counseling promoted a significantly higher proportion of women having mammograms on schedule (71% vs 61%) than did tailored print (67% vs 61%) but only after the first year of intervention (during 1996). Furthermore, compared to usual care, telephone counseling was more effective than tailored print materials at promoting being on schedule with screening during 1996 and 1997 among women who were off-schedule during the previous year. The effects of the intervention were most pronounced after the first intervention. Compared to usual care, telephone counseling seemed particularly effective at promoting change among nonadherent women, the group for whom the intervention was developed. These results suggest that telephone counseling, rather than tailored print, might be the preferred first-line intervention for getting nonadherent women on schedule for mammography screening. Many questions would have to be answered about why the tailored print intervention was not more powerful. Nevertheless, it is clear that additional interventions will be needed to maintain women's adherence to mammography. Medical Subject Headings (MeSH): mammography screening, telephone counseling, tailored print communications, barriers.

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

PubMed Central

Cherkin, Daniel C.; Sherman, Karen J.; Avins, Andrew L.; Erro, Janet H.; Ichikawa, Laura; Barlow, William E.; Delaney, Kristin; Hawkes, Rene; Hamilton, Luisa; Pressman, Alice; Khalsa, Partap S.; Deyo, Richard A.

2009-01-01

Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods 638 adults with chronic mechanical low back pain were randomized to: individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland Disability score, range: 0 to 23) and symptom bothersomeness (0 to 10 scale). Outcomes were assessed at baseline and after 8, 26 and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P<0.001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs. 39%, P<0.0001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P<0.0001). After one year, participants in the treatment groups were more likely than those receiving usual care group to experience clinically meaningful improvements in dysfunction (59% to 65% versus 50%, respectively, P=0.02) but not in symptoms (P>0.05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture’s purported mechanisms of action. It remains unclear whether acupuncture, or our simulated method of acupuncture, provide physiologically important stimulation or represent placebo or non-specific effects. PMID:19433697

Impact of a Usual Source of Care on Health Care Use, Spending, and Quality Among Adults With Mental Health Conditions.

PubMed

Fullerton, Catherine A; Witt, Whitney P; Chow, Clifton M; Gokhale, Manjusha; Walsh, Christine E; Crable, Erika L; Naeger, Sarah

2018-05-01

Physical comorbidities associated with mental health conditions contribute to high health care costs. This study examined the impact of having a usual source of care (USC) for physical health on health care utilization, spending, and quality for adults with a mental health condition using Medicaid administrative data. Having a USC decreased the probability of inpatient admissions and readmissions. It decreased expenditures on emergency department visits for physical health, 30-day readmissions, and behavioral health inpatient admissions. It also had a positive effect on several quality measures. Results underscore the importance of a USC for physical health and integrated care for adults with mental health conditions.

Generic care pathway for elderly patients in need of home care services after discharge from hospital: a cluster randomised controlled trial.

PubMed

Røsstad, Tove; Salvesen, Øyvind; Steinsbekk, Aslak; Grimsmo, Anders; Sletvold, Olav; Garåsen, Helge

2017-04-17

Improved discharge arrangements and targeted post-discharge follow-up can reduce the risk of adverse events after hospital discharge for elderly patients. Although more care is to shift from specialist to primary care, there are few studies on post-discharge interventions run by primary care. A generic care pathway, Patient Trajectory for Home-dwelling elders (PaTH) including discharge arrangements and follow-up by primary care, was developed and introduced in Central Norway Region in 2009, applying checklists at defined stages in the patient trajectory. In a previous paper, we found that PaTH had potential of improving follow-up in primary care. The aim of this study was to establish the effect of PaTH-compared to usual care-for elderly in need of home care services after discharge from hospital. We did an unblinded, cluster randomised controlled trial with 12 home care clusters. Outcomes were measured at the patient level during a 12-month follow-up period for the individual patient and analysed applying linear and logistic mixed models. Primary outcomes were readmissions within 30 days and functional level assessed by Nottingham extended ADL scale. Secondary outcomes were number and length of inpatient hospital care and nursing home care, days at home, consultations with the general practitioners (GPs), mortality and health related quality of life (SF-36). One-hundred and sixty-three patients were included in the PaTH group (six clusters), and 141 patients received care as usual (six clusters). We found no statistically significant differences between the groups for primary and secondary outcomes except for more consultations with the GPs in PaTH group (p = 0.04). Adherence to the intervention was insufficient as only 36% of the patients in the intervention group were assessed by at least three of the four main checklists in PaTH, but this improved over time. Lack of adherence to PaTH rendered the study inconclusive regarding the elderly's functional level, number of readmissions after hospital discharge, and health care utilisation except for more consultations with the GPs. A targeted exploration of prerequisites for implementation is recommended in the pre-trial phase of complex intervention studies. Clinical Trials.gov NCT01107119 , retrospectively registered 2010.04.18.

Acupuncture and Counselling for Depression in Primary Care: A Randomised Controlled Trial

PubMed Central

MacPherson, Hugh; Richmond, Stewart; Bland, Martin; Brealey, Stephen; Gabe, Rhian; Hopton, Ann; Keding, Ada; Lansdown, Harriet; Perren, Sara; Sculpher, Mark; Spackman, Eldon; Torgerson, David; Watt, Ian

2013-01-01

Background Depression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care. Methods and Findings In a randomised controlled trial, 755 patients with depression (Beck Depression Inventory BDI-II score ≥20) were recruited from 27 primary care practices in the North of England. Patients were randomised to one of three arms using a ratio of 2∶2∶1 to acupuncture (302), counselling (302), and usual care alone (151). The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of ten sessions for acupuncture and nine sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (−2.46, 95% CI −3.72 to −1.21) and counselling (−1.73, 95% CI −3.00 to −0.45), and over 12 months for acupuncture (−1.55, 95% CI −2.41 to −0.70) and counselling (−1.50, 95% CI −2.43 to −0.58). Differences between acupuncture and counselling were not significant. In terms of limitations, the trial was not designed to separate out specific from non-specific effects. No serious treatment-related adverse events were reported. Conclusions In this randomised controlled trial of acupuncture and counselling for patients presenting with depression, after having consulted their general practitioner in primary care, both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone. Trial Registration Controlled-Trials.com ISRCTN63787732 Please see later in the article for the Editors' Summary PMID:24086114

Economic evaluation of a brief education, self-management and upper limb exercise training in people with rheumatoid arthritis (EXTRA) programme: a trial-based analysis.

PubMed

Manning, Victoria L; Kaambwa, Billingsley; Ratcliffe, Julie; Scott, David L; Choy, Ernest; Hurley, Michael V; Bearne, Lindsay M

2015-02-01

The aim of this study was to conduct a cost-utility analysis of the Education, Self-management and Upper Limb Exercise Training in People with RA (EXTRA) programme compared with usual care. A within-trial incremental cost-utility analysis was conducted with 108 participants randomized to either the EXTRA programme (n = 52) or usual care (n = 56). A health care perspective was assumed for the primary analysis with a 36 week follow-up. Resource use information was collected on interventions, medication, primary and secondary care contacts, private health care and social care costs. Quality-adjusted life years (QALYs) were calculated from the EuroQol five-dimension three-level (EQ-5D-3L) questionnaire responses at baseline, 12 and 36 weeks. Compared with usual care, total QALYs gained were higher in the EXTRA programme, leading to an increase of 0.0296 QALYs. The mean National Health Service (NHS) costs per participant were slightly higher in the EXTRA programme (by £82), resulting in an incremental cost-effectiveness ratio of £2770 per additional QALY gained. Thus the EXTRA programme was cost effective from an NHS perspective when assessed against the threshold of £20 000-£30 000/QALY gained. Overall, costs were lower in the EXTRA programme compared with usual care, suggesting it was the dominant treatment option from a societal perspective. At a willingness-to-pay of £20 000/QALY gained, there was a 65% probability that the EXTRA programme was the most cost-effective option. These results were robust to sensitivity analyses accounting for missing data, changing the cost perspective and removing cost outliers. The physiotherapist-led EXTRA programme represents a cost-effective use of resources compared with usual care and leads to lower health care costs and work absence. International Standard Randomized Controlled Trial Number Register; http://www.controlled-trials.com/isrctn/ (ISRCTN14268051). © The Author 2014. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Exploring patients' treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets.

PubMed

Turner, Katrina M; Percival, John; Kessler, David; Donovan, Jenny

2017-06-15

The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not only to which treatment participants receive but also how they access and engage with their allocated treatment. Such differences could affect trial results. The aim of this study was to assess whether such differences exist and, if they do, to consider their implications for the design of future trials. Interview transcripts were sampled from data sets gathered during three qualitative studies, all of which had been nested within large, primary care depression trials. Each study had explored trial participants' views and experiences of treatments received following randomisation. Transcripts from 37 participants were purposefully sampled, 20 of which were from interviews held with individuals allocated to receive usual GP care. Data were analysed thematically. There was evidence of differences between trial arms across all three data sets. Intervention participants were willing and able to engage with the treatment to which they had been allocated. Randomisation had led to them embarking upon a clear treatment pathway and receiving care in a context where they felt comfortable discussing their mental health and had sufficient time to do so. Intervention participants also had continuity with and confidence in the practitioners they saw. A few usual-care participants talked about having continuity with and confidence in their GPs. However, most of the usual-care participants reported a reluctance to consult GPs about mental health, difficulties in securing treatment appointments, and little or no changes in care following randomisation. Additionally, most reported a lack of continuity of care and a lack confidence in the treatment available to them. There are important differences between usual-care and intervention arms that go beyond treatment received, and they relate to how participants experience accessing and engaging with their allocated care. As these differences could affect trial results, researchers may want to measure or reduce them in order to fully appreciate or control for the range of factors that might affect treatment outcomes.

Effectiveness and cost-effectiveness of implementing HIV testing in primary care in East London: protocol for an interrupted time series analysis.

PubMed

Leber, Werner; Beresford, Lee; Nightingale, Claire; Barbosa, Estela Capelas; Morris, Stephen; El-Shogri, Farah; McMullen, Heather; Boomla, Kambiz; Delpech, Valerie; Brown, Alison; Hutchinson, Jane; Apea, Vanessa; Symonds, Merle; Gilliham, Samantha; Creighton, Sarah; Shahmanesh, Maryam; Fulop, Naomi; Estcourt, Claudia; Anderson, Jane; Figueroa, Jose; Griffiths, Chris

2017-12-14

HIV remains underdiagnosed. Guidelines recommend routine HIV testing in primary care, but evidence on implementing testing is lacking. In a previous study, the Rapid HIV Assessment 2 (RHIVA2) cluster randomised controlled trial, we showed that providing training and rapid point-of-care HIV testing at general practice registration (RHIVA2 intervention) in Hackney led to cost-effective, increased and earlier diagnosis of HIV. However, interventions effective in a trial context may be less so when implemented in routine practice. We describe the protocol for an MRC phase IV implementation programme, evaluating the impact of rolling out the RHIVA2 intervention in a post-trial setting. We will use a longitudinal study to examine if the post-trial implementation in Hackney practices is effective and cost-effective, and a cross-sectional study to compare Hackney with two adjacent boroughs providing usual primary care (Newham) and an enhanced service promoting HIV testing in primary care (Tower Hamlets). Service evaluation using interrupted time series and cost-effectiveness analyses. We will include all general practices in three contiguous high HIV prevalence East London boroughs. All adults aged 16 and above registered with the practices will be included. The interventions to be examined are: a post-trial RHIVA2 implementation programme (including practice-based education and training, external quality assurance, incentive payments for rapid HIV testing and incorporation of rapid HIV testing in the sexual health Local Enhanced Service) in Hackney; the general practice sexual health Network Improved Service in Tower Hamlets and usual care in Newham. Coprimary outcomes are rates of HIV testing and new HIV diagnoses. The chair of the Camden and Islington NHS Research Ethics Committee, London, has endorsed this programme as an evaluation of routine care. Study results will be published in peer-reviewed journals and reported to commissioners. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Stepped Care to Optimize Pain care Effectiveness (SCOPE) trial study design and sample characteristics.

PubMed

Kroenke, Kurt; Krebs, Erin; Wu, Jingwei; Bair, Matthew J; Damush, Teresa; Chumbler, Neale; York, Tish; Weitlauf, Sharon; McCalley, Stephanie; Evans, Erica; Barnd, Jeffrey; Yu, Zhangsheng

2013-03-01

Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Although collaborative care interventions are well-established for conditions such as depression, fewer systems-based interventions have been tested for chronic pain. This paper describes the study design and baseline characteristics of the enrolled sample for the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial conducted in five primary care clinics. SCOPE has enrolled 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity and randomized them to either the stepped care intervention or usual care control group. Using a telemedicine collaborative care approach, the intervention couples automated symptom monitoring with a telephone-based, nurse care manager/physician pain specialist team to treat pain. The goal is to optimize analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects undergo comprehensive outcome assessments at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. The primary outcome is pain severity/disability, and secondary outcomes include pain beliefs and behaviors, psychological functioning, health-related quality of life and treatment satisfaction. Innovations of SCOPE include optimized analgesic management (including a stepped care approach, opioid risk stratification, and criteria-based medication adjustment), automated monitoring, and centralized care management that can cover multiple primary care practices. Published by Elsevier Inc.

Effect of a multifactorial fall-and-fracture risk assessment and management program on gait and balance performances and disability in hospitalized older adults: a controlled study.

PubMed

Trombetti, A; Hars, M; Herrmann, F; Rizzoli, R; Ferrari, S

2013-03-01

This controlled intervention study in hospitalized oldest old adults showed that a multifactorial fall-and-fracture risk assessment and management program, applied in a dedicated geriatric hospital unit, was effective in improving fall-related physical and functional performances and the level of independence in activities of daily living in high-risk patients. Hospitalization affords a major opportunity for interdisciplinary cooperation to manage fall-and-fracture risk factors in older adults. This study aimed at assessing the effects on physical performances and the level of independence in activities of daily living (ADL) of a multifactorial fall-and-fracture risk assessment and management program applied in a geriatric hospital setting. A controlled intervention study was conducted among 122 geriatric inpatients (mean ± SD age, 84 ± 7 years) admitted with a fall-related diagnosis. Among them, 92 were admitted to a dedicated unit and enrolled into a multifactorial intervention program, including intensive targeted exercise. Thirty patients who received standard usual care in a general geriatric unit formed the control group. Primary outcomes included gait and balance performances and the level of independence in ADL measured 12 ± 6 days apart. Secondary outcomes included length of stay, incidence of in-hospital falls, hospital readmission, and mortality rates. Compared to the usual care group, the intervention group had significant improvements in Timed Up and Go (adjusted mean difference [AMD] = -3.7s; 95 % CI = -6.8 to -0.7; P = 0.017), Tinetti (AMD = -1.4; 95 % CI = -2.1 to -0.8; P < 0.001), and Functional Independence Measure (AMD = 6.5; 95 %CI = 0.7-12.3; P = 0.027) test performances, as well as in several gait parameters (P < 0.05). Furthermore, this program favorably impacted adverse outcomes including hospital readmission (hazard ratio = 0.3; 95 % CI = 0.1-0.9; P = 0.02). A multifactorial fall-and-fracture risk-based intervention program, applied in a dedicated geriatric hospital unit, was effective and more beneficial than usual care in improving physical parameters related to the risk of fall and disability among high-risk oldest old patients.

Baseline Obesity Status Modifies Effectiveness of Adapted Diabetes Prevention Program Lifestyle Interventions for Weight Management in Primary Care

PubMed Central

Azar, Kristen M. J.; Xiao, Lan; Ma, Jun

2013-01-01

Objective. To examine whether baseline obesity severity modifies the effects of two different, primary care-based, technology-enhanced lifestyle interventions among overweight or obese adults with prediabetes and/or metabolic syndrome. Patients and Methods. We compared mean differences in changes from baseline to 15 months in clinical measures of general and central obesity among participants randomized to usual care alone (n = 81) or usual care plus a coach-led group (n = 79) or self-directed individual (n = 81) intervention, stratified by baseline body mass index (BMI) category. Results. Participants with baseline BMI 35+ had greater reductions in mean BMI, body weight (as percentage change), and waist circumference in the coach-led group intervention, compared to usual care and the self-directed individual intervention (P < 0.05 for all). In contrast, the self-directed intervention was more effective than usual care only among participants with baseline BMIs between 25 ≤ 35. Mean weight loss exceeded 5% in the coach-led intervention regardless of baseline BMI category, but this was achieved only among self-directed intervention participants with baseline BMIs <35. Conclusions. Baseline BMI may influence behavioral weight-loss treatment effectiveness. Researchers and clinicians should take an individual's baseline BMI into account when developing or recommending lifestyle focused treatment strategy. This trial is registered with ClinicalTrials.gov NCT00842426. PMID:24369008

[Caregivers' needs concerning mobility support of a family member with terminal cancer - a narrative review].

PubMed

Gattinger, Heidrun; Siegl, Eva; Senn, Beate; Hantikainen, Virpi

2014-06-01

Care for cancer patients is often provided by family caregivers. The terminal care period is usually associated with restricted mobility. The aim of this literature review is to analyse the needs of caregivers concerning mobility support and encouragement in everyday care of a cancer patient at the end of life. Relevant articles were identified via electronic database searches in Cochrane, PubMed, PsychINFO, ERIC, and CINAHL. Studies examining needs concerning mobility support and encouragement for terminal cancer care provided by family caregivers at home, published in English or German, have been included. The methodological quality of the included studies was assessed by two authors. A total of eleven studies with various designs have been included. The results show a need for information, guidance and support regarding mobility in two areas: i) activities of daily living including personal hygiene and ii) usage of equipment including transport. The literature review indicates that practical needs of family caregivers concerning mobility support and encouragement have been assessed unsystematically and not yet adequately studied. This should be done in future studies, in order to implement well-defined interventions for teaching nursing skills subsequently.

National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers

PubMed Central

Achey, Meredith A.; Beck, Christopher A.; Beran, Denise B.; Biglan, Kevin M.; Boyd, Cynthia M.; Schmidt, Peter N.; Simone, Richard; Willis, Allison W.; Galifianakis, Nicholas B.; Katz, Maya; Tanner, Caroline M.; Dodenhoff, Kristen; Ziman, Nathan; Aldred, Jason; Carter, Julie; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Mari, Zoltan; Morgan, John C.; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Bull, Michael T.; Mejia, Nicte I.; Bwala, Grace; Nance, Martha; Shih, Ludy; Anderson, Lauren; Singer, Carlos; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Cooper, Jessica; Webb, Sydney; Dhall, Rohit; Hassan, Anhar; Weis, Delana; DeMello, Steven; Riggare, Sara S.; Wicks, Paul; Smith, Joseph; Keenan, H. Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E. Anna; Zhu, William

2016-01-01

Abstract Background: Delivering specialty care remotely directly into people's homes can enhance access for and improve the healthcare of individuals with chronic conditions. However, evidence supporting this approach is limited. Materials and Methods: Connect.Parkinson is a randomized comparative effectiveness study that compares usual care of individuals with Parkinson's disease in the community with usual care augmented by virtual house calls with a Parkinson's disease specialist from 1 of 18 centers nationally. Individuals in the intervention arm receive four virtual visits from a Parkinson's disease specialist over 1 year via secure, Web-based videoconferencing directly into their homes. All study activities, including recruitment, enrollment, and assessments, are conducted remotely. Here we report on interest, feasibility, and barriers to enrollment in this ongoing study. Results: During recruitment, 11,734 individuals visited the study's Web site, and 927 unique individuals submitted electronic interest forms. Two hundred ten individuals from 18 states enrolled in the study from March 2014 to June 2015, and 195 were randomized. Most participants were white (96%) and college educated (73%). Of the randomized participants, 73% had seen a Parkinson's disease specialist within the previous year. Conclusions: Among individuals with Parkinson's disease, national interest in receiving remote specialty care directly into the home is high. Remote enrollment in this care model is feasible but is likely affected by differential access to the Internet. PMID:26886406

Managing facility risk: external threats and health care organizations.

PubMed

Reid, Daniel J; Reid, William H

2014-01-01

Clinicians and clinical administrators should have a basic understanding of physical and financial risk to mental health facilities related to external physical threat, including actions usually viewed as "terrorism" and much more common sources of violence. This article refers to threats from mentally ill persons and those acting out of bizarre or misguided "revenge," extortionists and other outright criminals, and perpetrators usually identified as domestic or international terrorists. The principles apply both to relatively small and contained acts (such as a patient or ex-patient attacking a staff member) and to much larger events (such as bombings and armed attack), and are relevant to facilities both within and outside the U.S. Patient care and accessibility to mental health services rest not only on clinical skills, but also on a place to practice them and an organized system supported by staff, physical facilities, and funding. Clinicians who have some familiarity with the non-clinical requirements for care are in a position to support non-clinical staff in preventing care from being interrupted by external threats or events such as terrorist activity, and/or to serve at the interface of facility operations and direct clinical care. Readers should note that this article is an introduction to the topic and cannot address all local, state and national standards for hospital safety, or insurance providers' individual facility requirements. Copyright © 2014 John Wiley & Sons, Ltd.

The lung in amyloidosis.

PubMed

Milani, Paolo; Basset, Marco; Russo, Francesca; Foli, Andrea; Palladini, Giovanni; Merlini, Giampaolo

2017-09-30

Amyloidosis is a disorder caused by misfolding of autologous protein and its extracellular deposition as fibrils, resulting in vital organ dysfunction and eventually death. Pulmonary amyloidosis may be localised or part of systemic amyloidosis.Pulmonary interstitial amyloidosis is symptomatic only if the amyloid deposits severely affect gas exchange alveolar structure, thus resulting in serious respiratory impairment. Localised parenchymal involvement may be present as nodular amyloidosis or as amyloid deposits associated with localised lymphomas. Finally, tracheobronchial amyloidosis, which is usually not associated with evident clonal proliferation, may result in airway stenosis.Because the treatment options for amyloidosis are dependent on the fibril protein type, the workup of all new cases should include accurate determination of the amyloid protein. Most cases are asymptomatic and need only a careful follow-up. Diffuse alveolar-septal amyloidosis is treated according to the underlying systemic amyloidosis. Nodular pulmonary amyloidosis is usually localised, conservative excision is usually curative and the long-term prognosis is excellent. Tracheobronchial amyloidosis is usually treated with bronchoscopic interventions or external beam radiation therapy. Copyright ©ERS 2017.

New diagnostic methods for pneumonia in the ICU.

PubMed

Douglas, Ivor S

2016-04-01

Pneumonia leading to severe sepsis and critical illness including respiratory failure remains a common and therapeutically challenging diagnosis. Current clinical approaches to surveillance, early detection, and conventional culture-based microbiology are inadequate for optimal targeted antibiotic treatment and stewardship. Efforts to enhance diagnosis of community-acquired and health care-acquired pneumonia, including ventilator-associated pneumonia (VAP), are the focus of recent studies reviewed here. Newer surveillance definitions are sensitive for pneumonia in the ICU including VAP but consistently underdetect patients that are clinically shown to have bacterial VAP based on clinical diagnostic criteria and response to antibiotic treatment. Routinely measured plasma biomarkers, including procalcitonin and C-reactive protein, lack sufficient precision and predictive accuracy to inform diagnosis. Novel rapid microbiological diagnostics, including nucleic-acid amplification, mass spectrometry, and fluorescence microscopy-based technologies are promising approaches for the future. Exhaled breath biomarkers, including measurement of volatile organic compounds, represent a future approach. The integration of novel diagnostics for rapid microbial identification, resistance phenotyping, and antibiotic sensitivity testing into usual care practice could significantly transform the care of patients and potentially inform significantly improved targeted antimicrobial selection, de-escalation, and stewardship.

Integrated IMR for Psychiatric and General Medical Illness for Adults Aged 50 or Older With Serious Mental Illness

PubMed Central

Bartels, Stephen J.; Pratt, Sarah I.; Mueser, Kim T.; Naslund, John A.; Wolfe, Rosemarie S.; Santos, Meghan; Xie, Haiyi; Riera, Erik G.

2016-01-01

Objectives Self-management is promoted as a strategy for improving outcomes for serious mental illness as well as for chronic general medical conditions. This study evaluated the feasibility and effectiveness of an eight-month program combining training in self-management for both psychiatric and general medical illness, including embedded nurse care management. Methods Participants were 71 middle-aged and older adults (mean age=60.3±6.5) with serious mental illness and chronic general medical conditions who were randomly assigned to receive integrated Illness Management and Recovery (I-IMR) (N=36) or usual care (N=35). Feasibility was determined by attendance at I-IMR and nurse sessions. Effectiveness outcomes were measured two and six months after the intervention (ten- and 14-month follow-ups) and included self-management of psychiatric and general medical illness, participation in psychiatric and general medical encounters, and self-reported acute health care utilization. Results I-IMR participants attended 15.8±9.5 I-IMR and 8.2±5.9 nurse sessions, with 75% attending at least ten I-IMR and five nurse sessions. Compared with usual care, I-IMR was associated with greater improvements in participant and clinician ratings for psychiatric illness self-management, greater diabetes self-management, and an increased preference for detailed diagnosis and treatment information during primary care encounters. The proportion of I-IMR participants with at least one psychiatric or general medical hospitalization decreased significantly between baseline and ten- and 14-month follow-ups. Conclusions I-IMR is a feasible intervention for this at-risk group and demonstrated potential effectiveness by improving self-management of psychiatric illness and diabetes and by reducing the proportion of participants requiring psychi atric or general medical hospitalizations. PMID:24292559

Availability of Care Concordant With Patient-centered Medical Home Principles Among Those With Chronic Conditions: Measuring Care Outcomes.

PubMed

Pourat, Nadereh; Charles, Shana A; Snyder, Sophie

2016-03-01

Care delivery redesign in the form of patient-centered medical home (PCMH) is considered as a potential solution to improve patient outcomes and reduce costs, particularly for patients with chronic conditions. But studies of prevalence or impact at the population level are rare. We aimed to assess whether desired outcomes indicating better care delivery and patient-centeredness were associated with receipt of care according to 3 important PCMH principles. We analyzed data from a representative population survey in California in 2009, focusing on a population with chronic condition who had a usual source of care. We used bivariate, logistic, and negative-binomial regressions. The indicators of PCMH concordant care included continuity of care (personal doctor), care coordination, and care management (individual treatment plan). Outcomes included flu shots, count of outpatient visits, any emergency department visit, timely provider communication, and confidence in self-care. We found that patients whose care was concordant with all 3 PCMH principles were more likely to receive flu shots, more outpatient care, and timely response from providers. Concordance with 2 principles led to some desired outcomes. Concordance with only 1 principle was not associated with desired outcomes. Patients who received care that met 3 key aspects of PCMH: coordination, continuity, and management, had better quality of care and more efficient use of the health care system.

Impact of an Asha intervention on depressive symptoms among rural women living with AIDS in India: comparison of the Asha-Life and Usual Care program.

PubMed

Nyamathi, Adeline; Salem, Benissa E; Meyer, Visha; Ganguly, Kalyan K; Sinha, Sanjeev; Ramakrishnan, Padma

2012-06-01

The purpose of this randomized pilot study is to conduct an intervention with 68 rural women living with AIDS to compare the effectiveness of two different programs on depressive symptoms. The trial was designed to assess the impact of the Asha-Life intervention engaging with an HIV-trained village woman, Asha (Accredited Social Health Activist), to participate in the care of women living with AIDS (WLA), along with other health care providers compared to a Usual Care group. Two high prevalence HIV/AIDS villages in rural Andhra Pradesh, which were demographically alike and served by distinct Public Health Centers, were selected randomly from a total of 16 villages. The findings of this study demonstrated that the Asha-Life participants significantly reduced their depressive symptom scores compared to the Usual Care participants. Moreover, women living with AIDS who demonstrated higher depressive symptom scores at baseline had greater reduction in their depressive symptoms than women with lower scores.

Systems for the management of respiratory disease in primary care--an international series: United Kingdom.

PubMed

Worth, Allison; Pinnock, Hilary; Fletcher, Monica; Hoskins, Gaylor; Levy, Mark L; Sheikh, Aziz

2011-03-01

The UK National Health Service (NHS) is essentially publicly funded through general taxation. Challenges facing the NHS include the rise in prevalence of long-term conditions and financial pressures. NATIONAL POLICY TRENDS: Political devolution within the UK has led to variations in the way services are organised and delivered between the four nations. PRIMARY CARE RESPIRATORY SERVICES IN THE UK: Primary care is the first point of contact with services. Most respiratory conditions are managed here, including prevention, diagnosis, treatment and palliative care. Respiratory disease accounts for more primary care consultations than any other type of illness, with 24 million consultations annually. Equitable access to care is an ongoing challenge: telehealthcare is being tried as a possible solution for monitoring of asthma and COPD. REFERRAL AND ACCESS TO SPECIALIST CARE: Referrals for specialist advice are usually to a secondary care respiratory physician, though respiratory General Practitioners with a Special Interest (GPwSIs) are an option in some localities. Prevalence of asthma and COPD is high. Asthma services are predominantly nurse-led. Self-management strategies are widely promoted but poorly implemented. COPD is high on the policy agenda with a shift in focus to preventive lung health and longterm condition management.

Specific exercises reduce brace prescription in adolescent idiopathic scoliosis: a prospective controlled cohort study with worst-case analysis.

PubMed

Negrini, Stefano; Zaina, Fabio; Romano, Michele; Negrini, Alessandra; Parzini, Silvana

2008-06-01

To compare the effect of Scientific Exercises Approach to Scoliosis (SEAS) exercises with "usual care" rehabilitation programmes in terms of the avoidance of brace prescription and prevention of curve progression in adolescent idiopathic scoliosis. Prospective controlled cohort observational study. Seventy-four consecutive outpatients with adolescent idiopathic scoliosis, mean 15 degrees (standard deviation 6) Cobb angle, 12.4 (standard deviation 2.2) years old, at risk of bracing who had not been treated previously. Thirty-five patients were included in the SEAS exercises group and 39 in the usual physiotherapy group. The primary outcome included the number of braced patients, Cobb angle and the angle of trunk rotation. There were 6.1% braced patients in the SEAS exercises group vs 25.0% in the usual physiotherapy group. Failures of treatment in the worst-case analysis were 11.5% and 30.8%, respectively. In both cases the differences were statistically significant. Cobb angle improved in the SEAS exercises group, but worsened in the usual physiotherapy group. In the SEAS exercises group, 23.5% of patients improved and 11.8% worsened, while in the usual physiotherapy group 11.1% improved and 13.9% worsened. These data confirm the effectiveness of exercises in patients with scoliosis who are at high risk of progression. Compared with non-adapted exercises, a specific and personalized treatment (SEAS) appears to be more effective.

Early adversity and neural correlates of executive function: implications for academic adjustment.

PubMed

McDermott, Jennifer M; Westerlund, Alissa; Zeanah, Charles H; Nelson, Charles A; Fox, Nathan A

2012-02-15

Early adversity can negatively impact the development of cognitive functions, although little is known about whether such effects can be remediated later in life. The current study examined one facet of executive functioning - inhibitory control - among children who experienced institutional care and explored the impact of a foster care intervention within the context of the Bucharest Early Intervention Project (BEIP). Specifically, a go/nogo task was administered when children were eight years old and behavioral and event-related potential (ERP) measures were collected. Results revealed that children assigned to care as usual (i.e. institutional care) were less accurate and exhibited slower neural responses compared to children assigned to the foster care intervention and children who had never been institutionalized. However, children in both the care as usual and foster care groups exhibited diminished attention processing of nogo cues as assessed via P300 amplitude. Foster care children also showed differential reactivity between correct and error responses via the error-related negativity (ERN) as compared to children in the care as usual group. Combined, the results highlight perturbations in neural sources of behavioral and attention problems among children experiencing early adversity. Potential implications for academic adjustment in at risk children are discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Aquatic exercise for residential aged care adults with dementia: benefits and barriers to participation.

PubMed

Henwood, Timothy; Neville, Christine; Baguley, Chantelle; Beattie, Elizabeth

2017-09-01

Pilot work by our group has demonstrated that aquatic exercise has valuable functional and psychosocial benefits for adults living in the residential aged care setting with dementia. The aim of the currents study was to advance this work by delivering the Watermemories Swimming Club aquatic exercise program to a more representative population of older, institutionalized adults with dementia. The benefits of 12 weeks of twice weekly participation in the Watermemories Swimming Club aquatic exercise program were assessed among an exercise and usual care control group of residential aged care adults with advanced dementia. A battery of physical and psychosocial measures were collected before and after the intervention period, and program implementation was also investigated. Seven residential aged care facilities of 24 approached, agreed to participate and 56 residents were purposefully allocated to exercise or control. Twenty-three participants per group were included in the final analysis. Both groups experienced decreases in skeletal muscle index and lean mass (p < 0.001), but exercise stifled losses in muscle strength and transition into sarcopenic. Behavioral and psychological symptoms of dementia and activities of daily living approached significance (p = 0.06) with positive trends observed across other psychosocial measures. This study demonstrates the value of exercise participation, and specifically aquatic exercise in comparison to usual care for older, institutionalized adults with advanced dementia. However, it also highlights a number of barriers to participation. To overcome these barriers and ensure opportunity to residents increased provider and sector support is required.