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.

Resident Characteristics Related to the Lack of Morning Care Provision in Long-Term Care

ERIC Educational Resources Information Center

Simmons, Sandra F.; Durkin, Daniel W.; Rahman, Anna N.; Choi, Leena; Beuscher, Linda; Schnelle, John F.

2013-01-01

Purpose: The purpose of this study was to examine usual long-term care (LTC) practices related to 3 aspects of morning care and determine if there were resident characteristics related to the lack of care. Design and Methods: Participants were 169 long-stay residents in 4 community LTC facilities who required staff assistance with either transfer…

Effectiveness of Problem-Solving Therapy for Older, Primary Care Patients with Depression: Results from the IMPACT Project

ERIC Educational Resources Information Center

Arean, Patricia; Hegel, Mark; Vannoy, Steven; Fan, Ming-Yu; Unuzter, Jurgen

2008-01-01

Purpose: We compared a primary-care-based psychotherapy, that is, problem-solving therapy for primary care (PST-PC), to community-based psychotherapy in treating late-life major depression and dysthymia. Design and Methods: The data here are from the IMPACT study, which compared collaborative care within a primary care clinic to care as usual in…

Evaluation of a combined lifestyle intervention for overweight and obese patients in primary health care: a quasi-experimental design.

PubMed

Verberne, Lisa D M; Hendriks, Marike R C; Rutten, Geert M; Spronk, Inge; Savelberg, Hans H C M; Veenhof, Cindy; Nielen, Mark M J

2016-12-01

Combined lifestyle interventions (CLIs) are designed to reduce risk factors for lifestyle-related diseases through increasing physical activity and improvement of dietary behaviour. To evaluate the effects of a CLI for overweight and obese patients on lifestyle-related risk factors and health care consumption, in comparison to usual care. Data on anthropometric and metabolic measurements, morbidity, drugs prescriptions and general practitioner (GP) consultations were extracted from electronic health records (timeframe: July 2009-August 2013). Using a quasi-experimental design, health outcomes of 127 patients who participated in a 1-year CLI were compared to a group of 254 matched patients that received usual care. Baseline to post-intervention changes in health outcomes between intervention and comparison group were evaluated using mixed model analyses. Compared to baseline, both groups showed reductions in body mass index (BMI), blood pressure, total cholesterol and low density lipoprotein cholesterol in year post-intervention. For these outcome measures, no significant differences in changes were observed between intervention and comparison group. A significant improvement of 0.08 mmol/l in high density lipoprotein (HDL) cholesterol was observed for the intervention group above the comparison group (P < 0.01). No significant intergroup differences were shown in drugs prescriptions and number of GP consultations. A CLI for overweight and obese patients in primary health care resulted in similar effects on health outcomes compared to usual care. Only an improvement on HDL cholesterol was shown. This study indicates that implementation and evaluation of a lifestyle intervention in primary health care is challenging due to political and financial barriers. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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

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.

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.

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

Long-term Clinical and Cost Outcomes of a Pharmacist-managed Risk Factor Management Clinic in Singapore: An Observational Study.

PubMed

Tan, She Hui; Kng, Kwee Keng; Lim, Sze Mian; Chan, Alexandre; Loh, Jason Kwok Kong; Lee, Joyce Yu-Chia

2017-12-01

Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clinic (RFMP) in an acute care setting through the comparison of clinical (improvement in glycosylated hemoglobin level) and cost outcomes with patients receiving usual care. This single-center, observational study included patients aged ≥21 years old and diagnosed with type 2 diabetes mellitus (DM) who received care within the cardiology department of a tertiary institution between January 1, 2014, and December 31, 2015. The intervention group comprised patients who attended the RFMP for 3 to 6 months, and the usual-care group comprised patients who received standard cardiologist care. Univariate analysis and multiple linear regression were conducted to analyze the clinical and cost outcomes. A total of 142 patients with DM (71 patients in the intervention group and 71 patients in the usual-care group) with similar baseline characteristics were included. After adjusting for differences in baseline systolic blood pressure and triglyceride levels, the mean reduction in glycosylated hemoglobin level at 6 months from baseline in the intervention group was significantly lower by 0.78% compared with the usual-care group. Patients in the usual-care group had a significantly higher risk of hospital admissions within the 12 months from baseline compared with the intervention group (odds ratio, 3.84 [95% CI, 1.17-12.57]; P = 0.026). Significantly lower mean annual direct medical costs were also observed in the intervention group (US $8667.03 [$17,416.20] vs US $56,665.02 [$127,250.10]; P = 0.001). The pharmacist-managed RFMP exhibited improved clinical outcomes and reduced health care costs compared with usual care within a tertiary institute. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

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

Are psychological treatments for depression in primary care cost-effective?

PubMed

Bosmans, Judith E; van Schaik, Digna J F; de Bruijne, Martine C; van Hout, Hein P J; van Marwijk, Harm W J; van Tulder, Maurits W; Stalman, Wim A B

2008-03-01

Depression is a highly prevalent condition that is associated with high levels of work absenteeism and high health care costs. Most patients are treated in primary care. A large group of patients prefers psychological treatments to antidepressants. To systematically review the evidence for the cost-effectiveness of psychological treatments, psychotherapy and counselling, in comparison with usual care or antidepressant treatment in adult primary care patients with depression. A computer-assisted search of MEDLINE, EMBASE, CINAHL, PsycINFO, and the Cochrane Library was carried out. Two independent reviewers selected studies for the review, extracted data and assessed the methodological quality of the included studies. Seven studies were included in the review. Forms of psychotherapy that were evaluated were cognitive behavioural therapy, interpersonal psychotherapy and couple therapy. Usual care generally consisted of care as usually provided by the general practitioner. No conclusion can be drawn on the cost-effectiveness of the above mentioned forms of psychotherapy in comparison with usual care or antidepressant treatment. The cost-effectiveness of counselling in comparison with usual care and antidepressant therapy is yet to be established. Meta-analyses showed that psychotherapy was significantly more expensive than usual care, but not significantly more expensive than antidepressant treatment. Counselling was associated with no statistically significant differences in costs and effects in comparison with usual care in the pooled analysis. Based on this review, no firm conclusions on the cost-effectiveness of psychotherapy and counselling in primary care can be drawn. Most studies had methodological shortcomings, which limit the generalisibility of the results. Given the reluctance of patients to use antidepressants and the large economic impact of depression, policy makers have a need for well designed and sufficiently powered economic evaluations of psychological treatments. The available evidence seems to indicate that psychotherapy has more substantial clinical effects than counselling. Therefore, the emphasis should be on economic evaluations of forms of psychotherapy that have proved to be clinically effective. There are indications that the cost-effectiveness of depression treatment on the whole may be improved by incorporating psychological treatments into enhanced care models, tailored to the needs of individual patients and/or by providing them by trained nurses instead of psychologists or psychotherapists. Further research should investigate these patient tailored, stepped care treatment modalities for depression treatment.

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

Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial.

PubMed

Margolis, Karen L; Kerby, Tessa J; Asche, Stephen E; Bergdall, Anna R; Maciosek, Michael V; O'Connor, Patrick J; Sperl-Hillen, JoAnn M

2012-07-01

Patients with high blood pressure (BP) visit a physician an average of 4 times or more per year in the U.S., yet BP is controlled in fewer than half. Practical, robust and sustainable models are needed to improve BP in patients with uncontrolled hypertension. The Home Blood Pressure Telemonitoring and Case Management to Control Hypertension study (HyperLink) is a cluster-randomized trial designed to determine whether an intervention that combines home BP telemonitoring with pharmacist case management improves BP control compared to usual care at 6 and 12 months in patients with uncontrolled hypertension. Secondary outcomes are maintenance of BP control at 18 months, patient satisfaction with their health care, and costs of care. HyperLink enrolled 450 hypertensive patients with uncontrolled BP from 16 primary care clinics. Eight clinics were randomized to provide usual care (UC) to their patients (n=222) and 8 were randomized to provide the telemonitoring intervention (TI) (n=228). TI patients received home BP telemonitors that internally store and electronically transmit BP data to a secure database. Pharmacist case managers adjust antihypertensive therapy based on the home BP data under a collaborative practice agreement with the clinics' primary care teams. The length of the intervention is 12 months, with follow-up to 18 months to determine the durability of the intervention. We will test in a real primary care setting whether combining BP telemonitoring and pharmacist case management can achieve and maintain high rates of BP control compared to usual care. Copyright © 2012 Elsevier Inc. All rights reserved.

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

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.

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

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

Multidisciplinary outpatient care program for patients with chronic low back pain: design of a randomized controlled trial and cost-effectiveness study [ISRCTN28478651].

PubMed

Lambeek, Ludeke C; Anema, Johannes R; van Royen, Barend J; Buijs, Peter C; Wuisman, Paul I; van Tulder, Maurits W; van Mechelen, Willem

2007-09-20

Chronic low back pain (LBP) is a major public and occupational health problem, which is associated with very high costs. Although medical costs for chronic LBP are high, most costs are related to productivity losses due to sick leave. In general, the prognosis for return to work (RTW) is good but a minority of patients will be absent long-term from work. Research shows that work related problems are associated with an increase in seeking medical care and sick leave. Usual medical care of patients is however, not specifically aimed at RTW. The objective is to present the design of a randomized controlled trial, i.e. the BRIDGE-study, evaluating the effectiveness in improving RTW and cost-effectiveness of a multidisciplinary outpatient care program situated in both primary and outpatient care setting compared with usual clinical medical care for patients with chronic LBP. The design is a randomized controlled trial with an economic evaluation alongside. The study population consists of patients with chronic LBP who are completely or partially sick listed and visit an outpatient clinic of one of the participating hospitals in Amsterdam (the Netherlands). Two interventions will be compared. 1. a multidisciplinary outpatient care program consisting of a workplace intervention based on participatory ergonomics, and a graded activity program using cognitive behavioural principles. 2. usual care provided by the medical specialist, the occupational physician, the patient's general practitioner and allied health professionals. The primary outcome measure is sick leave duration until full RTW. Sick leave duration is measured monthly by self-report during one year. Data on sick leave during one-year follow-up are also requested form the employers. Secondary outcome measures are pain intensity, functional status, pain coping, patient satisfaction and quality of life. Outcome measures are assessed before randomization and 3, 6, and 12 months later. All statistical analysis will be performed according to the intension-to-treat principle. Usual care of primary and outpatient health services isn't directly aimed at RTW, therefore it is desirable to look for care which is aimed at RTW. Research shows that several occupational interventions in primary care are aimed at RTW. They have shown a significant reduction of sick leave for employee with LBP. If a comparable reduction of sick leave duration of patients with chronic LBP of who attend an outpatient clinic can be achieved, such reductions will be obviously substantial for the Netherlands and will have a considerable impact.

Is patient flow more efficient in Urgent Care Collaborations?

PubMed

van Gils-van Rooij, Elisabeth S J; Meijboom, Berthold R; Broekman, Sjoerd M; Yzermans, Christoffel J; de Bakker, Dingenus H

2018-02-01

Emergency Departments and out-of-hours General Practitioner services collaborate increasingly in Urgent Care Collaborations (UCCs) by sharing one combined entrance and joint triage. The aim of this study is to examine the difference between UCCs and providers who operate separately with respect to the efficiency of patient flow. This study had a cross-sectional observational design comparing three regions with UCC with three regions with usual care. Outcome measures were efficiency of patient flow, defined as a reducing length of stay (LOS), waiting time (WT) and the mean number of handovers. Data were obtained from electronic medical records. LOS (median 34:00 vs. 38:52 min) and WT (median 14:00 vs. 18:43 min) were statistically significantly longer in UCCs compared with usual care. This difference is mainly explained by the prolonged LOS and WT for consulting a General Practitioner. The mean number of interunit handovers was larger in UCCs. The results indicate that, on average, UCCs do not enhance the efficiency of patient flow. The median LOS and WT are longer in UCCs and more handovers occur in UCCs compared with usual care.

Implementing collaborative primary care for depression and posttraumatic stress disorder: design and sample for a randomized trial in the U.S. military health system.

PubMed

Engel, Charles C; Bray, Robert M; Jaycox, Lisa H; Freed, Michael C; Zatzick, Doug; Lane, Marian E; Brambilla, Donald; Rae Olmsted, Kristine; Vandermaas-Peeler, Russ; Litz, Brett; Tanielian, Terri; Belsher, Bradley E; Evatt, Daniel P; Novak, Laura A; Unützer, Jürgen; Katon, Wayne J

2014-11-01

War-related trauma, posttraumatic stress disorder (PTSD), depression and suicide are common in US military members. Often, those affected do not seek treatment due to stigma and barriers to care. When care is sought, it often fails to meet quality standards. A randomized trial is assessing whether collaborative primary care improves quality and outcomes of PTSD and depression care in the US military health system. The aim of this study is to describe the design and sample for a randomized effectiveness trial of collaborative care for PTSD and depression in military members attending primary care. The STEPS-UP Trial (STepped Enhancement of PTSD Services Using Primary Care) is a 6 installation (18 clinic) randomized effectiveness trial in the US military health system. Study rationale, design, enrollment and sample characteristics are summarized. Military members attending primary care with suspected PTSD, depression or both were referred to care management and recruited for the trial (2592), and 1041 gave permission to contact for research participation. Of those, 666 (64%) met eligibility criteria, completed baseline assessments, and were randomized to 12 months of usual collaborative primary care versus STEPS-UP collaborative care. Implementation was locally managed for usual collaborative care and centrally managed for STEPS-UP. Research reassessments occurred at 3-, 6-, and 12-months. Baseline characteristics were similar across the two intervention groups. STEPS-UP will be the first large scale randomized effectiveness trial completed in the US military health system, assessing how an implementation model affects collaborative care impact on mental health outcomes. It promises lessons for health system change. Copyright © 2014 Elsevier Inc. All rights reserved.

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

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

Effectiveness and cost-effectiveness of a self-management training for patients with chronic and treatment resistant anxiety or depressive disorders: design of a multicenter randomized controlled trial.

PubMed

Zoun, Maringa H H; Koekkoek, Bauke; Sinnema, Henny; Muntingh, Anna D T; van Balkom, Anton J L M; Schene, Aart H; Smit, Filip; Spijker, Jan

2016-07-07

Many patients with anxiety or depressive disorders achieve no remission of their symptoms after evidence-based treatment algorithms. They develop a chronic course of the disorder. Current care for these patients usually consists of long-term supportive contacts with a community psychiatric nurse and pharmacological management by a psychiatrist. Data on the effectiveness of these treatments is lacking. A psychosocial rehabilitation approach, where self-management is an increasingly important part, could be more suitable. It focuses on the restoration of functioning and enhancement of patients' autonomy and responsibility. Treatment with this focus, followed by referral to primary care, may be more (cost-)effective. A multicenter randomized controlled trial is designed for twelve participating specialized outpatient mental health services in the Netherlands. Patients with chronic and treatment resistant anxiety or depressive disorders, currently receiving supportive care in specialized outpatient mental health care, are asked to participate. After inclusion, patients receive the baseline questionnaire and are randomized to the intervention group or the usual care control group. The intervention focuses on rehabilitation and self-management and is provided by a trained community psychiatric nurse, followed by referral to primary care. Measurements take place at 6, 12, and 18 months after baseline. This study evaluates both the effectiveness (on quality of life, symptom severity, and empowerment), and cost-effectiveness of the intervention compared to usual care. In addition, a questionnaire is designed to get insight in which self-management strategies patients use to manage their disorder, and in the experiences of patients with the change of care setting. In this study we evaluate the effectiveness and cost-effectiveness of a self-management intervention for patients with chronic and treatment resistant anxiety or depressive disorders in specialized outpatient mental health care. The results of this study may provide a first 'proof-of-concept' in this under-researched but important field, and might be relevant for a large group of patients in the context of a transition of the Dutch health care system. Netherlands Trial Register: NTR3335 , registered 7 March 2012.

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.

Mobile Health Technology for Atrial Fibrillation Management Integrating Decision Support, Education, and Patient Involvement: mAF App Trial.

PubMed

Guo, Yutao; Chen, Yundai; Lane, Deirdre A; Liu, Lihong; Wang, Yutang; Lip, Gregory Y H

2017-12-01

Mobile Health technology for the management of patients with atrial fibrillation is unknown. The simple mobile AF (mAF) App was designed to incorporate clinical decision-support tools (CHA 2 DS 2 -VASc [Congestive heart failure, Hypertension, Age ≥75 years, Diabetes Mellitus, Prior Stroke or TIA, Vascular disease, Age 65-74 years, Sex category], HAS-BLED [Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly], SAMe-TT 2 R 2 [Sex, Age <60 years, Medical history, Treatment, Tobacco use, Race] scores), educational materials, and patient involvement strategies with self-care protocols and structured follow-up. Patients with atrial fibrillation were randomized into 2 groups (mAF App vs usual care) in a cluster randomized design pilot study. Patients' knowledge, quality of life, drug adherence, and anticoagulation satisfaction were evaluated at baseline, 1 month, and 3 months. Usability, feasibility, and acceptability of the mAF App were assessed at 1 month. A total of 113 patients were randomized to mAF App intervention (mean age, 67.4 years; 57.5% were male; mean follow-up, 69 days), and 96 patients were randomized to usual care (mean age, 70.9 years; 55.2% were male; mean follow-up, 95 days). More than 90% of patients reported that the mAF App was easy, user-friendly, helpful, and associated with significant improvements in knowledge compared with the usual care arm (P values for trend <.05). Drug adherence and anticoagulant satisfaction were significantly better with the mAF App versus usual care (all P < .05). Quality of life scores were significantly increased in the mAF App arm versus usual care, with anxiety and depression reduced (all P < .05). The pilot mAFA Trial is the first prospective randomized trial of Mobile Health technology in patients with atrial fibrillation, demonstrating that the mAF App, integrating clinical decision support, education, and patient-involvement strategies, significantly improved knowledge, drug adherence, quality of life, and anticoagulation satisfaction. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Healthy work environments for the ageing nursing workforce.

PubMed

Stichler, Jaynelle F

2013-10-01

The aim of this article is to describe the physical challenges that ageing nurses experience and the facility design features that can promote healthy work environments to motivate nurses to continue working. Older nurses are working longer and beyond the usual retirement age. They often experience chronic fatigue and the usual physical and cognitive changes associated with aging. Nursing is a physically demanding profession and many older nurses work in pain while providing direct patient care. The literature is replete with studies focusing on the organisational factors that retain older nurses, but little research addresses design factors that facilitate nurses working longer and more safely in direct patient care. Electronic databases in medicine, nursing, psychology, and architecture were searched and evidence-based, non-evidence-based, and review articles and government and organisational newsletters were evaluated. Hospital design can help address the physical work challenges that older nurses experience. Older nurses have a wealth of knowledge and expertise, and the design of nursing units can optimize their work experience. Nurse Managers must participate in design efforts and advocate designs that support aging nurses. © 2013 John Wiley & Sons Ltd.

Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression.

PubMed

Gardiner, Paula; Lestoquoy, Anna Sophia; Gergen-Barnett, Katherine; Penti, Brian; White, Laura F; Saper, Robert; Fredman, Lisa; Stillman, Sarah; Lily Negash, N; Adelstein, Pamela; Brackup, Ivy; Farrell-Riley, Christine; Kabbara, Karim; Laird, Lance; Mitchell, Suzanne; Bickmore, Timothy; Shamekhi, Ameneh; Liebschutz, Jane M

2017-03-01

Given the public health crisis of opioid overprescribing for pain, there is a need for evidence-based non pharmacological treatment options that effectively reduce pain and depression. We aim to examine the effectiveness of the Integrative Medical Group Visits (IMGV) model in reducing chronic pain and depressive symptoms, as well as increasing pain self-management. This paper details the study design and implementation of an ongoing randomized controlled trial of the IMGV model as compared to primary care visits. The research aims to determine if the IMGV model is effective in achieving: a) a reduction in self-reported pain and depressive symptoms and 2) an improvement in the self-management of pain, through increasing pain self-efficacy and reducing use of self-reported pain medication. We intend to recruit 154 participants to be randomized in our intervention, the IMGV model (n=77) and to usual care (n=77). Usual care of chronic pain through pharmacological treatment has mixed evidence of efficacy and may not improve quality of life or functional status. We aim to conduct a randomized controlled trial to evaluate the effectiveness of the IMGV model as compared to usual care in reducing self-reported pain and depressive symptoms as well as increasing pain management skills. Copyright © 2016 Elsevier Inc. 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 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.

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.

Longitudinal Changes in Access to Health Care by Immigrant Status among Older Adults: The Importance of Health Insurance as a Mediator

ERIC Educational Resources Information Center

Choi, Sunha

2011-01-01

Purpose: This longitudinal study examined the role of health insurance in access to health care among older immigrants. Design and Methods: Using data from the Second Longitudinal Study of Aging, the longitudinal trajectories of having a usual source of care were compared between 3 groups (all 70+ years): (a) late-life immigrants with less than 15…

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.

Organisational design for an integrated oncological department

PubMed Central

Meiss-de Haas, Ch.L.; Falkmann, H.; Douma, J.; van Gassel, J.G.; Peters, W.G.; van Mierlo, R.; van Turnhout, J.M.; Verhagen, C.A.H.H.V.M.; Schrijvers, A.J.P.

2001-01-01

Abstract Objective The outcomes of a Strength, Weakness, Opportunities and Threat (SWOT) analysis of three Integrated Oncological Departments were compared with their present situation three years later to define factors that can influence a successful implementation and development of an Integrated Oncological Department in- and outside (i.e. home care) the hospital. Research design Comparative Qualitative Case Study. Methods Auditing based on care-as-usual norms by an external, experienced auditing committee. Research setting Integrated Oncological Departments of three hospitals. Results Successful multidisciplinary care in an integrated, oncological department needs broad support inside the hospital and a well-defined organisational plan. PMID:16896411

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

Practical Telemedicine for Veterans with Persistently Poor Diabetes Control: A Randomized Pilot Trial.

PubMed

Crowley, Matthew J; Edelman, David; McAndrew, Ann T; Kistler, Susan; Danus, Susanne; Webb, Jason A; Zanga, Joseph; Sanders, Linda L; Coffman, Cynthia J; Jackson, George L; Bosworth, Hayden B

2016-05-01

Telemedicine-based diabetes management improves outcomes versus clinic care but is seldom implemented by healthcare systems. In order to advance telemedicine-based management as a practical option for veterans with persistent poorly controlled diabetes mellitus (PPDM) despite clinic-based care, we evaluated a comprehensive telemedicine intervention that we specifically designed for delivery using existing Veterans Health Administration (VHA) clinical staffing and equipment. We conducted a 6-month randomized trial among 50 veterans with PPDM; all maintained hemoglobin A1c (HbA1c) levels continuously >9.0% for >1 year despite clinic-based management. Participants received usual care or a telemedicine intervention combining telemonitoring, medication management, self-management support, and depression management; existing VHA clinical staff delivered the intervention. Using linear mixed models, we examined HbA1c, diabetes self-care (measured by the Self-Care Inventory-Revised questionnaire), depression, and blood pressure. At baseline, the model-estimated common HbA1c intercept was 10.5%. By 6 months, estimated HbA1c had improved by 1.3% for intervention participants and 0.3% for usual care (estimated difference, -1.0%, 95% confidence interval [CI], -2.0%, 0.0%; p = 0.050). Intervention participants' diabetes self-care (estimated difference, 7.0; 95% CI, 0.1, 14.0; p = 0.047), systolic blood pressure (-7.7 mm Hg; 95% CI, -14.8, -0.6; p = 0.035), and diastolic blood pressure (-5.6 mm Hg; 95% CI, -9.9, -1.2; p = 0.013) were improved versus usual care by 6 months. Depressive symptoms were similar between groups. A comprehensive telemedicine intervention improved outcomes among veterans with PPDM despite clinic-based care. Because we specifically designed this intervention with scalability in mind, it may represent a practical, real-world strategy to reduce the burden of poor diabetes control among veterans.

Evaluating the capabilities model of dementia care: a non-randomized controlled trial exploring resident quality of life and care staff attitudes and experiences.

PubMed

Moyle, Wendy; Venturato, Lorraine; Cooke, Marie; Murfield, Jenny; Griffiths, Susan; Hughes, Julian; Wolf, Nathan

2016-07-01

This 12 month, Australian study sought to compare the Capabilities Model of Dementia Care (CMDC) with usual long-term care (LTC), in terms of (1) the effectiveness of the CMDC in assisting care staff to improve Quality Of Life (QOL) for older people with dementia; and (2) whether implementation of the CMDC improved staff attitudes towards, and experiences of working and caring for the person with dementia. A single blind, non-randomized controlled trial design, involving CMDC intervention group (three facilities) and a comparison usual LTC practice control group (one facility), was conducted from August 2010 to September 2011. Eighty-one staff members and 48 family members of a person with dementia were recruited from these four LTC facilities. At baseline, 6 and 12 months, staff completed a modified Staff Experiences of Working with Demented Residents questionnaire (SEWDR), and families completed the Quality of Life - Alzheimer's Disease questionnaire (QOL-AD). LTC staff in the usual care group reported significantly lower SEWDR scores (i.e. less work satisfaction) than those in the CMDC intervention group at 12 months (p = 0.005). Similarly, family members in the comparison group reported significantly lower levels of perceived QOL for their relative with dementia (QOL-AD scores) than their counterparts in the CMDC intervention group at 12 months (p = 0.012). Although the study has a number of limitations the CMDC appears to be an effective model of dementia care - more so than usual LTC practice. The CMDC requires further evaluation with participants from a diverse range of LTC facilities and stages of cognitive impairment.

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

Intention to Discontinue Care Among Primary Care Patients

PubMed Central

Federman, Alex D; Cook, E Francis; Phillips, Russell S; Puopolo, Ann Louise; Haas, Jennifer S; Brennan, Troyen A; Burstin, Helen R

2001-01-01

BACKGROUND Specific elements of health care process and physician behavior have been shown to influence disenrollment decisions in HMOs, but not in outpatient settings caring for patients with diverse types of insurance coverage. OBJECTIVE To examine whether physician behavior and process of care affect patients' intention to return to their usual health care practice. DESIGN Cross-sectional patient survey and medical record review. SETTING Eleven academically affiliated primary care medicine practices in the Boston area. PATIENTS 2,782 patients with at least one visit in the preceding year. MEASUREMENT Unwillingness to return to the usual health care practice. RESULTS Of the 2,782 patients interviewed, 160 (5.8%) indicated they would not be willing to return. Two variables correlated significantly with unwillingness to return after adjustment for demographics, health status, health care utilization, satisfaction with physician's technical skill, site of care, and clustering of patients by provider: dissatisfaction with visit duration (odds ratio [OR], 3.2; 95% confidence interval [CI], 1.4 to 7.4) and patient reports that the physician did not listen to what the patient had to say (OR, 8.8; 95% CI, 2.5 to 30.7). In subgroup analysis, patients who were prescribed medications at their last visit but who did not receive an explanation of the purpose of the medication were more likely to be unwilling to return (OR, 4.9; 95% CI, 1.8 to 13.3). CONCLUSION Failure of physicians to acknowledge patient concerns, provide explanations of care, and spend sufficient time with patients may contribute to patients' decisions to discontinue care at their usual site of care. PMID:11679034

The feasibility of a randomised controlled trial to compare the cost-effectiveness of palliative cardiology or usual care in people with advanced heart failure: Two exploratory prospective cohorts

PubMed Central

McSkimming, Paula; McConnachie, Alex; Geue, Claudia; Millerick, Yvonne; Briggs, Andrew; Hogg, Karen

2018-01-01

Background: The effectiveness of cardiology-led palliative care is unknown; we have insufficient information to conduct a full trial. Aim: To assess the feasibility (recruitment/retention, data quality, variability/sample size estimation, safety) of a clinical trial of palliative cardiology effectiveness. Design: Non-randomised feasibility. Setting/participants: Unmatched symptomatic heart failure patients on optimal cardiac treatment from (1) cardiology-led palliative service (caring together group) and (2) heart failure liaison service (usual care group). Outcomes/safety: Symptoms (Edmonton Symptom Assessment Scale), Kansas City Cardiomyopathy Questionnaire, performance, understanding of disease, anticipatory care planning, cost-effectiveness, survival and carer burden. Results: A total of 77 participants (caring together group = 43; usual care group = 34) were enrolled (53% men; mean age 77 years (33–100)). The caring together group scored worse in Edmonton Symptom Assessment Scale (43.5 vs 35.2) and Kansas City Cardiomyopathy Questionnaire (35.4 vs 39.9). The caring together group had a lower consent/screen ratio (1:1.7 vs 1: 2.8) and few died before approach (0.08% vs 16%) or declined invitation (17% vs 37%). Data quality: At 4 months, 74% in the caring together group and 71% in the usual care group provided data. Most attrition was due to death or deterioration. Data quality in self-report measures was otherwise good. Safety: There was no difference in survival. Symptoms and quality of life improved in both groups. A future trial requires 141 (202 allowing 30% attrition) to detect a minimal clinical difference (1 point) in Edmonton Symptom Assessment Scale score for breathlessness (80% power). More participants (176; 252 allowing 30% attrition) are needed to detect a 10.5 change in Kansas City Cardiomyopathy Questionnaire score (80% power; minimum clinical difference = 5). Conclusion: A trial to test the clinical effectiveness (improvement in breathlessness) of cardiology-led palliative care is feasible. PMID:29688127

Patient Decision Aids Improve Decision Quality and Patient Experience and Reduce Surgical Rates in Routine Orthopaedic Care: A Prospective Cohort Study.

PubMed

Sepucha, Karen; Atlas, Steven J; Chang, Yuchiao; Dorrwachter, Janet; Freiberg, Andrew; Mangla, Mahima; Rubash, Harry E; Simmons, Leigh H; Cha, Thomas

2017-08-02

Patient decision aids are effective in randomized controlled trials, yet little is known about their impact in routine care. The purpose of this study was to examine whether decision aids increase shared decision-making when used in routine care. A prospective study was designed to evaluate the impact of a quality improvement project to increase the use of decision aids for patients with hip or knee osteoarthritis, lumbar disc herniation, or lumbar spinal stenosis. A usual care cohort was enrolled before the quality improvement project and an intervention cohort was enrolled after the project. Participants were surveyed 1 week after a specialist visit, and surgical status was collected at 6 months. Regression analyses adjusted for clustering of patients within clinicians and examined the impact on knowledge, patient reports of shared decision-making in the visit, and surgical rates. With 550 surveys, the study had 80% to 90% power to detect a difference in these key outcomes. The response rates to the 1-week survey were 70.6% (324 of 459) for the usual care cohort and 70.2% (328 of 467) for the intervention cohort. There was no significant difference (p > 0.05) in any patient characteristic between the 2 cohorts. More patients received decision aids in the intervention cohort at 63.6% compared with the usual care cohort at 27.3% (p = 0.007). Decision aid use was associated with higher knowledge scores, with a mean difference of 18.7 points (95% confidence interval [CI], 11.4 to 26.1 points; p < 0.001) for the usual care cohort and 15.3 points (95% CI, 7.5 to 23.0 points; p = 0.002) for the intervention cohort. Patients reported more shared decision-making (p = 0.009) in the visit with their surgeon in the intervention cohort, with a mean Shared Decision-Making Process score (and standard deviation) of 66.9 ± 27.5 points, compared with the usual care cohort at 62.5 ± 28.6 points. The majority of patients received their preferred treatment, and this did not differ by cohort or decision aid use. Surgical rates were lower in the intervention cohort for those who received the decision aids at 42.3% compared with 58.8% for those who did not receive decision aids (p = 0.023) and in the usual care cohort at 44.3% for those who received decision aids compared with 55.7% for those who did not receive them (p = 0.45). The quality improvement project successfully integrated patient decision aids into a busy orthopaedic clinic. When used in routine care, decision aids are associated with increased knowledge, more shared decision-making, and lower surgical rates. There is increasing pressure to design systems of care that inform and involve patients in decisions about elective surgery. In this study, the authors found that patient decision aids, when used as part of routine orthopaedic care, were associated with increased knowledge, more shared decision-making, higher patient experience ratings, and lower surgical rates.

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

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

Effects of Structured Versus Usual Care on Renal Endpoint in Type 2 Diabetes: The SURE Study

PubMed Central

Chan, Juliana C.; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T.; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K.; Yeung, Vincent T.; Leung, Wilson Y.; Tong, Peter C.

2009-01-01

OBJECTIVE Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. RESEARCH DESIGN AND METHODS A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150–350 μmol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 μmol/l or dialysis). RESULTS Of these 205 patients (mean ± SD age 65 ± 7.2 years; disease duration 14 ± 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 ± 12 vs. 71 ± 12 mmHg, respectively, P = 0.02; A1C 7.3 ± 1.3 vs. 8.0 ± 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained ≥3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained ≥3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21–0.86] compared with that of those who attained ≤2 targets (n = 114). CONCLUSIONS Attainment of multiple treatment targets reduced the renal end point and death in type 2 diabetes. In addition to protocol, audits and feedback are needed to improve outcomes. PMID:19460913

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

A Point-of-Purchase Intervention Featuring In-Person Supermarket Education Affects Healthful Food Purchases

ERIC Educational Resources Information Center

Milliron, Brandy-Joe; Woolf, Kathleen; Appelhans, Bradley M.

2012-01-01

Objective: This study tested the efficacy of a multicomponent supermarket point-of-purchase intervention featuring in-person nutrition education on the nutrient composition of food purchases. Design: The design was a randomized trial comparing the intervention with usual care (no treatment). Setting and Participants: A supermarket in a…

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.

A Comparison of the Effects of 2 Types of Massage and Usual Care on Chronic Low Back Pain: A Randomized, Controlled Trial

PubMed Central

Cherkin, Daniel C.; Sherman, Karen J.; Kahn, Janet; Wellman, Robert; Cook, Andrea J.; Johnson, Eric; Erro, Janet; Delaney, Kristin; Deyo, Richard A.

2013-01-01

Background Few studies have evaluated the effectiveness of massage for back pain. Objective To evaluate the effectiveness of two types of massage for chronic back pain. Design Single-blind parallel group randomized controlled trial. Setting Integrated health care delivery system in Seattle area. Patients 401 persons 20 to 65 years of age with non-specific chronic low back pain. Interventions Ten treatments over 10 weeks of Structural Massage (intended to identify and alleviate musculoskeletal contributors to pain through focused soft-tissue manipulation) (n=132) or Relaxation Massage (intended to decrease pain and dysfunction by inducing relaxation) (n=136). Treatments provided by 27 experienced licensed massage therapists. Comparison group received continued usual care (n=133). Study presented as comparison of usual care with two types of massage. Measurements Primary outcomes were the Roland Disability Questionnaire (RDQ) and the Symptom Bothersomeness scale measured at 10 weeks. Outcomes also measured after 26 and 52 weeks. Results At 10 weeks, the massage groups had similar functional outcomes that were superior to those for usual care. The adjusted mean RDQ scores were 2.9 and 2.4 points lower for the relaxation and structural massage groups, respectively, compared to usual care (95% CIs: [1.8, 4.0] and [1.4, 3.5]). Adjusted mean symptom bothersomeness scores were 1.7 points and 1.4 points lower with relaxation and structural massage, respectively, versus usual care (95% CIs: [1.2, 2.2] and [0.8, 1.9]). The beneficial effects of relaxation massage on function (but not on symptom reduction) persisted at 52 weeks, but were small. Limitations Restricted to single site; therapists and patients not blinded to treatment. Conclusions This study confirms the results of smaller trials that massage is an effective treatment for chronic back pain with benefits lasting at least 6 months, and also finds no evidence of a clinically-meaningful difference in the effectiveness of two distinct types of massage. Primary Funding Source National Center for Complementary and Alternative Medicine PMID:21727288

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.

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

System Transformation Under the California Mental Health Services Act: Implementation of Full-Service Partnerships in L.A. County.

PubMed

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

2017-06-01

The study evaluated the effect of California's Mental Health Services Act (MHSA) on the structure, volume, location, and patient centeredness of Los Angeles County public mental health services. This prospective mixed-methods study (2006-2013) was based in five Los Angeles County public mental health clinics, all with usual care and three with full-service partnerships (FSPs). FSPs are MHSA-funded programs designed to "do whatever it takes" to provide intensive, recovery-oriented, team-based, integrated services for clients with severe mental illness. FSPs were compared with usual care on outpatient services received (claims data) and on organizational climate, recovery orientation, and provider-client working alliance (surveys and semistructured interviews), with regression adjustment for client and provider characteristics. In the first year after admission, FSP clients (N=174) received significantly more outpatient services than did usual care clients (N=298) (5,238 versus 1,643 minutes, p<.001), and a larger proportion of these services were field based (22% versus 2%, p<.001). Compared with usual care clients, FSP clients reported more recovery-oriented services (p<.001) and a better provider-client working alliance (p=.01). Compared with usual care providers (N=130), FSP providers (N=42) reported more stress (p<.001) and lower morale (p<.001). 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 their needs and goals.

Patient Acceptability of the Yorkshire Dialysis Decision Aid (YoDDA) Booklet: A Prospective Non-Randomized Comparison Study Across 6 Predialysis Services.

PubMed

Winterbottom, Anna E; Gavaruzzi, Teresa; Mooney, Andrew; Wilkie, Martin; Davies, Simon J; Crane, Dennis; Tupling, Ken; Baxter, Paul D; Meads, David M; Mathers, Nigel; Bekker, Hilary L

2016-01-01

♦ Patients are satisfied with their kidney care but want more support in making dialysis choices. Predialysis leaflets vary across services, with few being sufficient to enable patients' informed decision making. We describe the acceptability of a patient decision aid and feasibility of evaluating its effectiveness within usual predialysis practice. ♦ Prospective non-randomized comparison design, Usual Care or Usual Care Plus Yorkshire Dialysis Decision Aid Booklet (+YoDDA), in 6 referral centers (Yorkshire-Humber, UK) for patients with sustained deterioration of kidney function. Consenting (C) patients completed questionnaires after predialysis consultation (T1), and 6 weeks later (T2). Measures assessed YoDDA's utility to support patients' decisions and integration within usual care. ♦ Usual Care (n = 105) and +YoDDA (n = 84) participant characteristics were similar: male (62%), white (94%), age (mean = 62.6; standard deviation [SD] 14.4), kidney disease severity (glomerular filtration rate [eGFR] mean = 14.7; SD 3.7); decisional conflict was < 25; choice-preference for home versus hospital dialysis approximately 50:50. Patients valued receiving YoDDA, reading it on their own (96%), and sharing it with family (72%). The +YoDDA participants had higher scores for understanding kidney disease, reasoning about options, feeling in control, sharing their decision with family. Study engagement varied by center (estimated range 14 - 49%; mean 45%); participants varied in completion of decision quality measures. ♦ Receiving YoDDA as part of predialysis education was valued and useful to patients with worsening kidney disease. Integrating YoDDA actively within predialysis programs will meet clinical guidelines and patient need to support dialysis decision making in the context of patients' lifestyle. Copyright © 2016 International Society for Peritoneal Dialysis.

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).

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.

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.

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

Enhancing Shared Decision Making Through Carefully Designed Interventions That Target Patient And Provider Behavior.

PubMed

Tai-Seale, Ming; Elwyn, Glyn; Wilson, Caroline J; Stults, Cheryl; Dillon, Ellis C; Li, Martina; Chuang, Judith; Meehan, Amy; Frosch, Dominick L

2016-04-01

Patient-provider communication and shared decision making are essential for primary care delivery and are vital contributors to patient experience and health outcomes. To alleviate communication shortfalls, we designed a novel, multidimensional intervention aimed at nudging both patients and primary care providers to communicate more openly. The intervention was tested against an existing intervention, which focused mainly on changing patients' behaviors, in four primary care clinics involving 26 primary care providers and 300 patients. Study results suggest that compared to usual care, both the novel and existing interventions were associated with better patient reports of how well primary care providers engaged them in shared decision making. Future research should build on the work in this pilot to rigorously examine the comparative effectiveness and scalability of these interventions to improve shared decision making at the point of care. Project HOPE—The People-to-People Health Foundation, Inc.

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.

Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program

PubMed Central

Hewitt, Jennifer; Refshauge, Kathryn M; Goodall, Stephen; Henwood, Timothy; Clemson, Lindy

2014-01-01

Introduction Falls are common among older adults. It is reported that approximately 60% of residents of aged care facilities fall each year. This is a major cause of morbidity and mortality, and a significant burden for health care providers and the health system. Among community dwelling older adults, exercise appears to be an effective countermeasure, but data are limited and inconsistent among studies in residents of aged care communities. This trial has been designed to evaluate whether the SUNBEAM program (Strength and Balance Exercise in Aged Care) reduces falls in residents of aged care facilities. Research question Is the program more effective and cost-effective than usual care for the prevention of falls? Design Single-blinded, two group, cluster randomized trial. Participants and setting 300 residents, living in 20 aged care facilities. Intervention Progressive resistance and balance training under the guidance of a physiotherapist for 6 months, then facility-guided maintenance training for 6 months. Control Usual care. Measurements Number of falls, number of fallers, quality of life, mobility, balance, fear of falling, cognitive well-being, resource use, and cost-effectiveness. Measurements will be taken at baseline, 6 months, and 12 months. Analysis The number of falls will be analyzed using a Poisson mixed model. A logistic mixed model will be used to analyze the number of residents who fall during the study period. Intention-to-treat analysis will be used. Discussion This study addresses a significant shortcoming in aged care research, and has potential to impact upon a substantial health care problem. Outcomes will be used to inform care providers, and guide health care policies. PMID:24591821

No more 'business as usual' with audit and feedback interventions: towards an agenda for a reinvigorated intervention.

PubMed

Ivers, Noah M; Sales, Anne; Colquhoun, Heather; Michie, Susan; Foy, Robbie; Francis, Jill J; Grimshaw, Jeremy M

2014-01-17

Audit and feedback interventions in healthcare have been found to be effective, but there has been little progress with respect to understanding their mechanisms of action or identifying their key 'active ingredients.' Given the increasing use of audit and feedback to improve quality of care, it is imperative to focus further research on understanding how and when it works best. In this paper, we argue that continuing the 'business as usual' approach to evaluating two-arm trials of audit and feedback interventions against usual care for common problems and settings is unlikely to contribute new generalizable findings. Future audit and feedback trials should incorporate evidence- and theory-based best practices, and address known gaps in the literature. We offer an agenda for high-priority research topics for implementation researchers that focuses on reviewing best practices for designing audit and feedback interventions to optimize effectiveness.

Effects of PMTO in Foster Families with Children with Behavior Problems: A Randomized Controlled Trial.

PubMed

Maaskant, Anne M; van Rooij, Floor B; Overbeek, Geertjan J; Oort, Frans J; Arntz, Maureen; Hermanns, Jo M A

2017-01-01

The present randomized controlled trial examined the effectiveness of Parent Management Training Oregon for foster parents with foster children (aged 4-12) with severe externalizing behavior problems in long-term foster care arrangements. Foster children's behavior problems are challenging for foster parents and increase the risk of placement breakdown. There is little evidence for the effectiveness of established interventions to improve child and parent functioning in foster families. The goal of Parent Management Training Oregon, a relatively long and intensive (6-9 months, with weekly sessions) parent management training, is to reduce children's problem behavior through improvement of parenting practices. We specifically investigated whether Parent Management Training Oregon is effective to reduce foster parenting stress. A significant effect of Parent Management Training Oregon, compared to Care as Usual was expected on reduced parenting stress improved parenting practices, and on reduced child behavior problems. Multi-informant (foster mothers, foster fathers, and teachers) data were used from 86 foster families (46 Parent Management Training Oregon, 40 Care as Usual) using a pre-posttest design. Multilevel analyses based on the intention to treat principle (retention rate 73 %) showed that Parent Management Training Oregon, compared to Care as Usual, reduced general levels of parenting stress as well as child related stress and parent-related stress (small to medium effect sizes). The clinical significance of this effect was, however, limited. Compared to a decrease in the Care as Usual group, Parent Management Training Oregon helped foster mothers to maintain parental warmth (small effect size). There were no other effects of Parent Management Training Oregon on self-reported parenting behaviors. Child behavior problems were reduced in both conditions, indicating no additive effects of Parent Management Training Oregon to Care as Usual on child functioning. The potential implication of reduced foster parenting stress for placement stability is discussed.

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.

Marketing depression care management to employers: design of a randomized controlled trial.

PubMed

Rost, Kathryn M; Marshall, Donna

2010-03-16

Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. By addressing the 'value to whom?' question, the study advances knowledge about one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy healthcare products on the basis of value and not exclusively on the basis of cost. If value-based marketing increases depression product purchase rates over usual care, this study will provide encouragement to market new healthcare products on the basis of the product's value to the purchaser as well as the recipient of care. NCT01013220.

Marketing depression care management to employers: design of a randomized controlled trial

PubMed Central

2010-01-01

Background Randomized trials demonstrate that depression care management can improve clinical and work outcomes sufficiently for selected employers to realize a return on investment. Employers can now purchase depression products that provide depression care management, defined as employee screening, education, monitoring, and clinician feedback for all depressed employees. We developed an intervention to encourage employers to purchase a depression product that offers the type, intensity, and duration of care management shown to improve clinical and work outcomes. Methods In a randomized controlled trial conducted with 360 employers of 30 regional business coalitions, the research team proposes to compare the impact of a value-based marketing intervention to usual-care marketing on employer purchase of depression products. The study will also identify mediators and organizational-level moderators of intervention impact. Employers randomized to the value-based condition receive a presentation encouraging them to purchase depression products scientifically shown to benefit the employee and the employer. Employers randomized to the usual-care condition receive a presentation encouraging them to monitor and improve quality indicators for outpatient depression treatment. Because previous research demonstrates that the usual-care intervention will have little to no impact on employer purchasing, depression product purchasing rates in the usual-care condition capture vendor efforts to market depression products to employers in both conditions while the value-based intervention is being conducted. Employers in both conditions are also provided free technical assistance to undertake the actions each presentation encourages. The research team will use intent-to-treat models of all available data to evaluate intervention impact on the purchase of depression products using a cumulative incidence analysis of 12- and 24-month data. Discussion By addressing the 'value to whom?' question, the study advances knowledge about one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy healthcare products on the basis of value and not exclusively on the basis of cost. If value-based marketing increases depression product purchase rates over usual care, this study will provide encouragement to market new healthcare products on the basis of the product's value to the purchaser as well as the recipient of care. Trial Registration Clinical Trials Registration Number: NCT01013220 PMID:20233448

Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol

PubMed Central

2014-01-01

Background Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver. Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. Methods/design Design: Controlled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Study area: Primary Health Care network (9 PHCTs). Study participants: Primary informal caregivers of patients receiving home health care from participating PHCTs. Sample: Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. Intervention: a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Control: Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request. Data analysis Dependent variables: Caregiver burden (short-form Zarit test), caregivers’ social support (Medical Outcomes Study), and caregivers’ reported quality of life (SF-12) Independent variables: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test). Discussion If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice. Trial registration Clinical trials registrar: NCT02065427 PMID:24666438

Study protocol: a multi-professional team intervention of physical activity referrals in primary care patients with cardiovascular risk factors—the Dalby lifestyle intervention cohort (DALICO) study

PubMed Central

2012-01-01

Background The present study protocol describes the trial design of a primary care intervention cohort study, which examines whether an extended, multi-professional physical activity referral (PAR) intervention is more effective in enhancing and maintaining self-reported physical activity than physical activity prescription in usual care. The study targets patients with newly diagnosed hypertension and/or type 2 diabetes. Secondary outcomes include: need of pharmacological therapy; blood pressure/plasma glucose; physical fitness and anthropometric variables; mental health; health related quality of life; and cost-effectiveness. Methods/Design The study is designed as a long-term intervention. Three primary care centres are involved in the study, each constituting one of three treatment groups: 1) Intervention group (IG): multi-professional team intervention with PAR, 2) Control group A (CA): physical activity prescription in usual care and 3) Control group B: treatment as usual (retrospective data collection). The intervention is based on self-determination theory and follows the principles of motivational interviewing. The primary outcome, physical activity, is measured with the International Physical Activity Questionnaire (IPAQ) and expressed as metabolic equivalent of task (MET)-minutes per week. Physical fitness is estimated with the 6-minute walk test in IG only. Variables such as health behaviours; health-related quality of life; motivation to change; mental health; demographics and socioeconomic characteristics are assessed with an electronic study questionnaire that submits all data to a patient database, which automatically provides feed-back to the health-care providers on the patients’ health status. Cost-effectiveness of the intervention is evaluated continuously and the intermediate outcomes of the intervention are extrapolated by economic modelling. Discussions By helping patients to overcome practical, social and cultural obstacles and increase their internal motivation for physical activity we aim to improve their physical health in a long-term perspective. The targeted patients belong to a patient category that is supposed to benefit from increased physical activity in terms of improved physiological values, mental status and quality of life, decreased risk of complications and maybe a decreased need of medication. PMID:22726659

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

Do Evidence-Based Youth Psychotherapies Outperform Usual Clinical Care? A Multilevel Meta-Analysis

PubMed Central

Weisz, John R.; Kuppens, Sofie; Eckshtain, Dikla; Ugueto, Ana M.; Hawley, Kristin M.; Jensen-Doss, Amanda

2013-01-01

Context Research across four decades has produced numerous empirically-tested evidence-based psychotherapies (EBPs) for youth psychopathology, developed to improve upon usual clinical interventions. Advocates argue that these should replace usual care; but do the EBPs produce better outcomes than usual care? Objective This question was addressed in a meta-analysis of 52 randomized trials directly comparing EBPs to usual care. Analyses assessed the overall effect of EBPs vs. usual care, and candidate moderators; multilevel analysis was used to address the dependency among effect sizes that is common but typically unaddressed in psychotherapy syntheses. Data Sources The PubMed, PsychINFO, and Dissertation Abstracts International databases were searched for studies from January 1, 1960 – December 31, 2010. Study Selection 507 randomized youth psychotherapy trials were identified. Of these, the 52 studies that compared EBPs to usual care were included in the meta-analysis. Data Extraction Sixteen variables (participant, treatment, and study characteristics) were extracted from each study, and effect sizes were calculated for all EBP versus usual care comparisons. Data Synthesis EBPs outperformed usual care. Mean effect size was 0.29; the probability was 58% that a randomly selected youth receiving an EBP would be better off after treatment than a randomly selected youth receiving usual care. Three variables moderated treatment benefit: Effect sizes decreased for studies conducted outside North America, for studies in which all participants were impaired enough to qualify for diagnoses, and for outcomes reported by people other than the youths and parents in therapy. For certain key groups (e.g., studies using clinically referred samples and diagnosed samples), significant EBP effects were not demonstrated. Conclusions EBPs outperformed usual care, but the EBP advantage was modest and moderated by youth, location, and assessment characteristics. There is room for improvement in EBPs, both in the magnitude and range of their benefit, relative to usual care. PMID:23754332

Self-management intervention to improve self-care and quality of life in heart failure patients.

PubMed

Tung, Heng-Hsin; Lin, Chun-Yu; Chen, Kuei-Ying; Chang, Chien-Jung; Lin, Yu-Ping; Chou, Cheng-Hui

2013-01-01

Self-management intervention is a good method to improve self-care ability, as such, to promote quality of life. However, the research focused on self-management intervention in heart failure patients in Taiwan is very limited. Therefore, the purposes of this study were to test the effectiveness of self-management intervention in patients with heart failure in Taiwan and examine the relationship between self-care ability and quality of life. A quasi-experimental design was used in this study with convenience sampling. Of the 82 subjects participating in this study, 40 of them chose to join the experimental (self-management intervention plus usual care) and 42 of them chose to join control (usual care) group. Three questionnaires were used to collect the data, which were the demographic questionnaire, the self-care questionnaire (Self-Care of HF Index V 6), and the quality of life questionnaire (Minnesota Living with Heart Failure Questionnaire). To examine the effectiveness of the intervention, self-care ability and quality of life were measured, using a pretest, 1- and 2-month follow-up assessment. Generalized estimation equations (GEE) were used to compare changes over time among groups for outcomes to ensure the effectiveness of the intervention. This study confirmed the effectiveness of the self-management intervention. The clinical provider should increase the awareness of the importance of self-management skills and self-care ability especially for heart failure patients. The designated disease-specific self-management patient book and individualize intervention should be dispensing and implementing. © 2012 Wiley Periodicals, Inc.

Examining the Hospital Elder Life Program in a rehabilitation setting: a pilot feasibility study.

PubMed

Huson, Kelsey; Stolee, Paul; Pearce, Nancy; Bradfield, Corrie; Heckman, George A

2016-07-18

The Hospital Elder Life Program (HELP) has been shown to effectively prevent delirium and functional decline in older patients in acute care, but has not been examined in a rehabilitation setting. This pilot study examined potential successes and implementation factors of the HELP in a post-acute rehabilitation hospital setting. A mixed methods (quantitative and qualitative) evaluation, incorporating a repeated measures design, was used. A total of 100 patients were enrolled; 58 on the pilot intervention unit and 42 on a usual care unit. Group comparisons were made using change scores (pre-post intervention) on outcome measures between pilot unit patients and usual care patients (separate analyses compared usual care patients with pilot unit patients who did or did not receive the HELP). Qualitative data were collected using focus group and individual interviews, and analyzed using emergent coding procedures. Delirium prevalence reduced from 10.9 % (n = 6) to 2.5 % (n = 1) in the intervention group, while remaining the same in the usual care group (2.5 % at both measurement points). Those who received the HELP showed greater improvement on cognitive and functional outcomes, particularly short-term memory and recall, and a shorter average length of stay than patients who did not. Participant groups discussed perceived barriers, benefits, and recommendations for further implementation of the HELP in a rehabilitation setting. This study adds to the limited research on delirium and the effectiveness of the HELP in post-acute rehabilitation settings. The HELP was found to be feasible and have potential benefits for reduced delirium and improved outcomes among rehabilitation patients.

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

[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.

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/.

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 Family Value of Information, Community Support, and Experience Study: Rationale, Design, and Methods of a "Family-Centered" Research Study.

PubMed

Reeves, Gloria M; Wehring, Heidi J; Connors, Kathleen M; Bussell, Kristin; Schiffman, Jason; Medoff, Deborah R; Tsuji, Thomas; Walker, Jane; Brown, Alicia; Strobeck, Danielle; Clough, Tammy; Rush, Caitlin B; Riddle, Mark A; Love, Raymond C; Zachik, Albert; Hoagwood, Kimberly; Olin, S Serene; Stephan, Sharon; Okuzawa, Nana; Edwards, Sarah; Baquet, Claudia; dosReis, Susan

2015-12-01

The Patient Protection and Affordable Care Act focuses on improving consumer engagement and patient-centered care. This article describes the design and rationale of a study targeting family engagement in pediatric mental health services. The study is a 90-day randomized trial of a telephone-delivered Family Navigator services versus usual care for parents of Medicaid-insured youth younger than 13 years with serious mental illness. Youth are identified through a pediatric antipsychotic medication preauthorization program. Family Navigators offer peer support to empower and engage parents in their child's recovery. Outcomes include parent report of empowerment, social support, satisfaction with child mental health services, and child functioning as well as claims-based measures of psychotherapy service utilization and antipsychotic medication dosage. The focus on "family-centered" care in this study is strongly supported by the active role of consumers in study design and implementation.

Treatment of pregnancy-related pelvic girdle and/or low back pain after delivery design of a randomized clinical trial within a comprehensive prognostic cohort study [ISRCTN08477490

PubMed Central

Bastiaenen, Caroline HG; de Bie, Rob A; Wolters, Pieter MJC; Vlaeyen, Johan WS; Bastiaanssen, Janneke M; Klabbers, Aldegonda BA; Heuts, Annie; van den Brandt, Piet A; Essed, Gerard GM

2004-01-01

Background Pregnancy-related pelvic girdle and/or low back pain is a controversial syndrome because insight in etiology and prognosis is lacking. The controversy relates to factors eliciting pain and some prognostic factors such as the interpretation of pain at the symphysis. Recent research about treatment strategies also reflects those various opinions, in fact suggesting there is professional uncertainty about the optimal approach. Currently, physiotherapists often prescribe a pain-contingent treatment regime of relative rest and avoiding several day-to-day activities. Additionally, treatment more often includes an exercise program to guide rectification of the muscle imbalance and alignment of the pelvic girdle. Effectiveness of those interventions is not proven and the majority of the studies are methodologically flawed. Investigators draw particular attention to biomedical factors but there is growing evidence that important prognostic issues such as biopsychosocial factors appear to be even more important as point of action in a treatment program. Methods/design This pragmatic randomized controlled trial is designed to evaluate the effectiveness of a tailor-made treatment program with respect to biopsychosocial factors in primary care. The effect of the experimental intervention and usual care are evaluated as they are applied in primary health care. The trial is embedded in a cohort study that is designed as a longitudinal, prospective study, which studies prevalence, etiology, severity and prognosis during pregnancy until one year after delivery. The present paper focuses on choices regarding recruitment procedures, in-/exclusion criteria and the development of a well-timed intervention. Discussion This section briefly discusses the actions taken to minimize bias in the design, the proper time-window for the experimental intervention and the contrast between the experimental intervention and usual care. PMID:15619331

Systems of support to increase colorectal cancer screening and follow-up rates (SOS): design, challenges, and baseline characteristics of trial participants.

PubMed

Green, Beverly B; Wang, C Y; Horner, Kathryn; Catz, Sheryl; Meenan, Richard T; Vernon, Sally W; Carrell, David; Chubak, Jessica; Ko, Cynthia; Laing, Sharon; Bogart, Andy

2010-11-01

Screening decreases colorectal cancer (CRC) morbidity and mortality, yet remains underutilized. Screening breakdowns arise from lack of uptake and failure to follow-up after a positive screening test. Systems of support to increase colorectal cancer screening and follow-up (SOS) is a randomized trial designed to increase: (1) CRC screening and (2) follow-up of positive screening tests. The Chronic Care Model and the Preventive Health Model inform study design. The setting is a large nonprofit healthcare organization. In part-1 study, patients age 50-75 due for CRC screening are randomized to one of 4 study conditions. Arm 1 receives usual care. Arm 2 receives automated support (mailed information about screening choices and fecal occult blood tests (FOBT)). Arm 3 receives automated and assisted support (a medical assistant telephone call). Arm 4 receives automated, assisted, and care management support (a registered nurse provides behavioral activation and coordination of care). In part-2, study patients with a positive FOBT or adenomas on flexible sigmoidoscopy are randomized to receive either usual care or nurse care management. Primary outcomes are: 1) the proportion with CRC screening, 2) the proportion with a complete diagnostic evaluation after a positive screening test. We sent recruitment letters to 15,414 patients and 4675 were randomized. Randomly assigned treatment groups were similar in age, sex, race, education, self-reported health, and CRC screening history. We will determine the effectiveness and cost effectiveness of stepped increases in systems of support to increase CRC screening and follow-up after a positive screening test over 2years. Copyright © 2010 Elsevier Inc. All rights reserved.

77 FR 51850 - Agency Information Collection: Emergency Submission for OMB Review (PACT: Clinical Innovation...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-27

..., et al., 1993), VA Form 10-0532g. i. The Brief COPE (Carver, 1997), VA Form 10-0532h. j. Depression... PCM on depression and anxiety relative to usual care. This data collection's model has been designed...

Immediate chest X-ray for patients at risk of lung cancer presenting in primary care: randomised controlled feasibility trial

PubMed Central

Neal, Richard D; Barham, Allan; Bongard, Emily; Edwards, Rhiannon Tudor; Fitzgibbon, Jim; Griffiths, Gareth; Hamilton, Willie; Hood, Kerenza; Nelson, Annmarie; Parker, David; Porter, Cath; Prout, Hayley; Roberts, Kirsty; Rogers, Trevor; Thomas-Jones, Emma; Tod, Angela; Yeo, Seow Tien; Hurt, Chris N

2017-01-01

Background: Achieving earlier stage diagnosis is one option for improving lung cancer outcomes in the United Kingdom. Patients with lung cancer typically present with symptoms to general practitioners several times before referral or investigation. Methods: We undertook a mixed methods feasibility individually randomised controlled trial (the ELCID trial) to assess the feasibility and inform the design of a definitive, fully powered, UK-wide, Phase III trial of lowering the threshold for urgent investigation of suspected lung cancer. Patients over 60, with a smoking history, presenting with new chest symptoms to primary care, were eligible to be randomised to intervention (urgent chest X-ray) or usual care. Results: The trial design and materials were acceptable to GPs and patients. We randomised 255 patients from 22 practices, although the proportion of eligible patients who participated was lower than expected. Survey responses (89%), and the fidelity of the intervention (82% patients X-rayed within 3 weeks) were good. There was slightly higher anxiety and depression in the control arm in participants aged >75. Three patients (1.2%) were diagnosed with lung cancer. Conclusions: We have demonstrated the feasibility of individually randomising patients at higher risk of lung cancer, to a trial offering urgent investigation or usual care. PMID:28072761

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.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

Therapeutic touch and agitation in individuals with Alzheimer's disease.

PubMed

Hawranik, Pamela; Johnston, Pat; Deatrich, Judith

2008-06-01

Limited effective strategies exist to alleviate or treat disruptive behaviors in people with Alzheimer's disease. Fifty-one residents of a long-term care facility with Alzheimer's disease were randomly assigned to one of three intervention groups. A multiple time series, blinded, experimental design was used to compare the effectiveness of therapeutic touch, simulated therapeutic touch, and usual care on disruptive behavior. Three forms of disruptive behavior comprised the dependent variables: physical aggression, physical nonaggression, and verbal agitation. Physical nonaggressive behaviors decreased significantly in those residents who received therapeutic touch compared with those who received the simulated version and the usual care. No significant differences in physically aggressive and verbally agitated behaviors were observed across the three study groups. The study provided preliminary evidence for the potential for therapeutic touch in dealing with agitated behaviors by people with dementia. Researchers and practitioners must consider a broad array of strategies to deal with these behaviors.

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.

Technology-enhanced practice for patients with chronic cardiac disease: home implementation and evaluation.

PubMed

Brennan, Patricia Flatley; Casper, Gail R; Burke, Laura J; Johnson, Kathy A; Brown, Roger; Valdez, Rupa S; Sebern, Marge; Perez, Oscar A; Sturgeon, Billie

2010-01-01

This 3-year field experiment engaged 60 nurses and 282 patients in the design and evaluation of an innovative home-care nursing model, referred to as technology-enhanced practice (TEP). Nurses using TEP augmented the usual care with a web-based resource (HeartCareII) that provided patients with self-management information, self-monitoring tools, and messaging services. Patients exposed to TEP demonstrated better quality of life and self-management of chronic heart disease during the first 4 weeks, and were no more likely than patients in usual care to make unplanned visits to a clinician or hospital. Both groups demonstrated the same long-term symptom management and achievements in health status. This project provides new evidence that the purposeful creation of patient-tailored web resources within a hospital portal is possible; that nurses have difficulty with modifying their practice routines, even with a highly-tailored web resource; and that the benefits of this intervention are more discernable in the early postdischarge stages of care. Copyright © 2010 Elsevier Inc. All rights reserved.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial.

PubMed

Walker, Bruce F; Losco, Barrett; Clarke, Brenton R; Hebert, Jeff; French, Simon; Stomski, Norman J

2011-10-31

Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998.

Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. Methods One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998 PMID:22040597

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

Progression of Kidney Disease in Moderately Hypercholesterolemic, Hypertensive Patients Randomized to Pravastatin Versus Usual Care: A Report From the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

PubMed Central

Rahman, Mahboob; Baimbridge, Charles; Davis, Barry R.; Barzilay, Joshua; Basile, Jan N.; Henriquez, Mario A.; Huml, Anne; Kopyt, Nelson; Louis, Gail T.; Pressel, Sara L.; Rosendorff, Clive; Sastrasinh, Sithiporn; Stanford, Carol

2009-01-01

Background Dyslipidemia is common in patients with chronic kidney disease. The role of statin therapy on the progression of kidney disease is unclear. Study Design Prospective randomized clinical trial, post hoc analyses. Setting and participants 10,060 participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) (lipid-lowering component) stratified by baseline eGFR: <60, 60–89, ≥90 mL/min/1.73 m2. Mean follow-up was 4.8 years. Intervention Randomized, pravastatin 40 mg/day or usual care. Outcomes and measurements Total cholesterol, HDL- and LDL-cholesterol; end stage renal disease (ESRD), estimated glomerular filtration rate (eGFR). Results Through year six, total cholesterol declined in the pravastatin (−20.7%) and usual care groups (−11.2%). No significant differences were seen between the groups for rates of ESRD (1.36 vs 1.45/100 patient years, P=0.9), composite endpoints of ESRD and 50% or 25% decline in eGFR, or rate of change of eGFR. Findings were consistent across eGFR strata. In patients with eGFR≥90 mL/min/1.73 m2, the pravastatin arm tended to have a higher eGFR. Limitations Proteinuria data unavailable, post hoc analyses, unconfirmed validity of the Modification of Diet in Renal Disease Study equation in normal eGFR range, statin drop-in rate in usual care group with small cholesterol differential between groups. Conclusions In hypertensive patients with moderate dyslipidemia and reduced eGFR, pravastatin was not superior to usual care in preventing clinical renal outcomes. This was consistent across the strata of baseline eGFR. However, benefit from statin therapy may depend on degree of cholesterol reduction achieved. PMID:18676075

Substantial improvement of primary cardiovascular prevention by a systematic score-based multimodal approach: A randomized trial: The PreFord-Study.

PubMed

Gysan, Detlef Bernd; Millentrup, Stefanie; Albus, Christian; Bjarnason-Wehrens, Birna; Latsch, Joachim; Gohlke, Helmut; Herold, Gerd; Wegscheider, Karl; Heming, Christian; Seyfarth, Melchior; Predel, Hans-Georg

2017-09-01

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees ( n = 4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE ≥ 5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT ( n = 224) or to usual care ( n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25-1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18-0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.).

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.

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 ...

Putting health status guided COPD management to the test: protocol of the MARCH study.

PubMed

Kocks, Janwillem; de Jong, Corina; Berger, Marjolein Y; Kerstjens, Huib A M; van der Molen, Thys

2013-07-04

Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow limitation that is not fully reversible and usually progressive. Current guidelines, among which the Dutch, have so far based their management strategy mainly on lung function impairment as measured by FEV1, while it is well known that FEV1 has a poor correlation with almost all features of COPD that matter to patients. Based on this discrepancy the GOLD 2011 update included symptoms and impact in their treatment algorithm proposal. Health status measures capture both symptoms and impact and could therefore be used as a standardized way to capture the information a doctor could otherwise only collect by careful history taking and recording. We hypothesize that a treatment algorithm that is based on a simple validated 10 item health status questionnaire, the Clinical COPD Questionnaire (CCQ), improves health status (as measured by SGRQ) and classical COPD outcomes like exacerbation frequency, patient satisfaction and health care utilization compared to usual care based on guidelines. This hypothesis will be tested in a randomized controlled trial (RCT) following 330 patients for two years. During this period general practitioners will receive treatment advices every four months that are based on the patient's health status (in half of the patients, intervention group) or on lung function (the remaining half of the patients, usual care group). During the design process, the selection of outcomes and the development of the treatment algorithm were challenging. This is discussed in detail in the manuscript to facilitate researchers in designing future studies in this changing field of implementation research. Netherlands Trial Register, NTR2643.

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

Cost of a Group Translation of the Diabetes Prevention Program

PubMed Central

Lawlor, Michael S.; Blackwell, Caroline S.; Isom, Scott P.; Katula, Jeffrey A.; Vitolins, Mara Z.; Morgan, Timothy M.; Goff, David C.

2013-01-01

Background Although numerous studies have translated the Diabetes Prevention Program lifestyle intervention into various settings, no study to date has reported a formal cost analysis. Purpose To describe costs associated with the Healthy Living Partnerships to Prevent Diabetes (HELP PD) trial. Design HELP PD was a 24-month RCT testing the impact of a lifestyle weight-loss intervention administered through a diabetes education program and delivered by community health workers (CHWs) on blood glucose and body weight among prediabetics. Setting/participants In all, 301 participants with prediabetes were randomized in Forsyth County NC. Data reported in these analyses were collected in 2007–2011 and analyzed in 2011–2012. Intervention The lifestyle weight-loss group had a 7% weight loss goal achieved and maintained by caloric restriction and increased physical activity. The usual care group received two visits with a registered dietitian and monthly newsletters. Main outcome measures Measures are direct medical costs, direct nonmedical costs and indirect costs over the 2-year study period. Research costs are excluded. Results The direct medical cost (in 2010 dollars) to identify one participant was $16.85. Direct medical costs per capita for participants in the usual care group were $142 and $850 for lifestyle weight-loss participants. Per capita direct costs of care outside the study were $7454 for the usual care group and $5177 for the lifestyle weight-loss group. Per capita direct nonmedical costs were $12,881 for the usual care group and $13,836 for the lifestyle weight-loss group. The lifestyle weight-loss group in HELP PD cost $850 in direct medical costs for 2 years, compared to $2631 in direct medical costs for the first 2 years of DPP. Conclusions A community-based translation of the DPP can be delivered effectively and with reduced costs. PMID:23498303

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

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.

Comprehensive and subacute care interventions improve health-related quality of life for older patients after surgery for hip fracture: a randomised controlled trial.

PubMed

Shyu, Yea-Ing L; Liang, Jersey; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chou, Shih-Wei; Chen, Ching-Yen; Yang, Ching-Tzu

2013-08-01

Elderly patients with hip fracture have been found to benefit from subacute care interventions that usually comprise usual care with added geriatric intervention, early rehabilitation, and supported discharge. However, no studies were found on the effects of combining subacute care and health-maintenance interventions on health outcomes for elders with hip fracture. To compare the effects of an interdisciplinary comprehensive care programme with those of subacute care and usual care programmes on health-related quality of life (HRQoL) for elderly patients with hip fracture. Randomised controlled trial. A 3000-bed medical centre in northern Taiwan. Patients with hip fracture (N=299) were randomised into three groups: subacute care (n=101), comprehensive care (n=99), and usual care (n=99). Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning. Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls. Usual care included only 1-2 in-hospital rehabilitation sessions, discharge planning without environmental assessment, no geriatric consultation, and no in-home rehabilitation. HRQoL was measured using the Medical Outcomes Study Short-Form 36 Taiwan version at 1, 3, 6, and 12 months after discharge. Participants in the comprehensive care group improved more in physical function, role physical, general health and mental health than those in the usual care group. The subacute care group had greater improvement in physical function, role physical, vitality, and social function than the usual care group. The intervention effects for both comprehensive and subacute care increased over time, specifically from 6 months after hip fracture onward, and reached a maximum at 12 months following discharge. Both comprehensive care and subacute care programmes may improve health outcomes of elders with hip fracture. Our results may provide a reference for health care providers in countries using similar programmes with Chinese/Taiwanese immigrant populations. Copyright © 2012 Elsevier Ltd. All rights reserved.

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).

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.

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

Electroacupuncture to treat painful diabetic neuropathy: study protocol for a three-armed, randomized, controlled pilot trial

PubMed Central

2013-01-01

Background The purpose of this study is to conduct a basic analysis of the effectiveness and safety of electroacupuncture in the treatment of painful diabetic neuropathy (PDN) as compared to placebo and usual care and to evaluate the feasibility of large-scale clinical research. Methods/design This study is a protocol for a three-armed, randomized, patient-assessor-blinded (to the type of treatment), controlled pilot trial. Forty-five participants with a ≥ six month history of PDN and a mean weekly pain score of ≥ 4 on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) will be assigned to the electroacupuncture group (n = 15), sham group (n = 15) or usual care group (n = 15). The participants assigned to the electroacupuncture group will receive electroacupuncture (remaining for 30 minutes with a mixed current of 2 Hz/120 Hz and 80% of the bearable intensity) at 12 standard acupuncture points (bilateral ST36, GB39, SP9, SP6, LR3 and GB41) twice per week for eight weeks (a total of 16 sessions) as well as the usual care. The participants in the sham group will receive sham electroacupuncture (no electrical current will be passed to the needle, but the light will be seen, and the sound of the pulse generator will be heard by the participants) at non-acupuncture points as well as the usual care. The participants in the usual care group will not receive electroacupuncture treatment during the study period and will receive only the usual care. The follow-up will be in the 5th, 9th and 17th weeks after random allocation. The PI-NRS score assessed at the ninth week will be the primary outcome measurement used in this study. The Short-Form McGill Pain Questionnaire (SF-MPQ), a sleep disturbance score (11-point Likert scale), the Short-Form 36v2 Health Survey (SF-36), the Beck Depression Inventory (BDI) and the Patient Global Impression of Change (PGIC) will be used as outcome variables to evaluate the effectiveness of the acupuncture. Safety will be assessed at every visit. Discussion The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN. Trial registration Clinical Research information Service. Unique identifier: KCT0000466. PMID:23866906

The cost effectiveness of an early transition from hospital to nursing home for stroke patients: design of a comparative study

PubMed Central

2010-01-01

Background As the incidence of stroke has increased, its impact on society has increased accordingly, while it continues to have a major impact on the individual. New strategies to further improve the quality, efficiency and logistics of stroke services are necessary. Early discharge from hospital to a nursing home with an adequate rehabilitation programme could help to optimise integrated care for stroke patients. The objective is to describe the design of a non-randomised comparative study evaluating early admission to a nursing home, with multidisciplinary assessment, for stroke patients. The study is comprised of an effect evaluation, an economic evaluation and a process evaluation. Methods/design The design involves a non-randomised comparative trial for two groups. Participants are followed for 6 months from the time of stroke. The intervention consists of a redesigned care pathway for stroke patients. In this care pathway, patients are discharged from hospital to a nursing home within 5 days, in comparison with 12 days in the usual situation. In the nursing home a structured assessment takes place, aimed at planning adequate rehabilitation. People in the control group receive the usual care. The main outcome measures of the effect evaluation are quality of life and daily functioning. In addition, an economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention as well as the experiences and opinions of patients and professionals. Discussion The results of this study will provide information about the cost effectiveness of the intervention and its effects on clinical outcomes and quality of life. Relevant strengths and weaknesses of the study are addressed in this article. Trial registration Current Controlled Trails ISRCTN58135104 PMID:20504313

A pilot trial of a telecommunications system in sleep apnea management.

PubMed

DeMolles, Deborah A; Sparrow, David; Gottlieb, Daniel J; Friedman, Robert

2004-08-01

Continuous positive airway pressure (CPAP) is an effective therapy for obstructive sleep apnea syndrome (OSAS), although many patients have difficulty adhering to this therapy. The purpose of this study was to investigate the effectiveness of totally automated telephone technology in improving adherence to prescribed CPAP therapy. This pilot study was a randomized clinical trial in 30 patients being started on CPAP therapy for OSAS. Patients were randomly assigned to use of a computer telephone system designed to improve CPAP adherence (telephone-linked communications for CPAP [TLC-CPAP]) in addition to usual care (n = 15) or to usual care alone (n = 15) for a period of 2 months. TLC-CPAP is a computer-based system that monitors patients' self-reported behavior and provides education and reinforcement through a structured dialogue. A sleep symptoms checklist and the Functional Outcomes of Sleep Questionnaire were administered at study entry and at 2-month follow up. Hours of CPAP use at effective mask pressure were measured by the CPAP device, stored in its memory, and retrieved at the 2-month visit. At 2 months, patients randomized to TLC-CPAP had fewer reported sleep-related symptoms (9.4 vs. 13.4, P = 0.047) than those receiving usual care. The average nightly CPAP use in the TLC-CPAP group was 4.4 hours compared with 2.9 hours (P = 0.076) in the usual-care group. This pilot study suggests that patients with OSAS started on CPAP and a concurrently administered automated education and counseling system had better CPAP adherence and better control of OSAS symptoms.

The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients.

PubMed

Walker, Jane; Cassidy, Jim; Sharpe, Michael

2009-03-30

Depression Care for People with Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting. A two arm parallel group multi-centre randomised controlled trial. TRIAL PROCEDURES: 500 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of cancer (of various types); an estimated life expectancy of twelve months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is 'treatment response' measured at 24 week outcome data collection. 'Treatment response' will be defined as a reduction of 50% or more in the patient's baseline depression score, measured using the 20-item Symptom Checklist (SCL-20D). Secondary outcomes include remission of major depressive disorder, depression severity and patients' self-rated improvement of depression. Current controlled trials ISRCTN40568538 TRIAL HYPOTHESES: (1) Depression Care for People with Cancer as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline SCL-20D score at 24 weeks. (2) Depression Care for People with Cancer as a supplement to usual care will cost more than usual care alone but will be more cost effective in achieving improvements in patients' depression and quality of life.

STI in remote communities: improved and enhanced primary health care (STRIVE) study protocol: a cluster randomised controlled trial comparing ‘usual practice’ STI care to enhanced care in remote primary health care services in Australia

PubMed Central

2013-01-01

Background Despite two decades of interventions, rates of sexually transmissible infections (STI) in remote Australian Aboriginal communities remain unacceptably high. Routine notifications data from 2011 indicate rates of chlamydia and gonorrhoea among Aboriginal people in remote settings were 8 and 61 times higher respectively than in the non-Indigenous population. Methods/design STRIVE is a stepped-wedge cluster randomised trial designed to compare a sexual health quality improvement program (SHQIP) to usual STI clinical care delivered in remote primary health care services. The SHQIP is a multifaceted intervention comprising annual assessments of sexual health service delivery, implementation of a sexual health action plan, six-monthly clinical service activity data reports, regular feedback meetings with a regional coordinator, training and financial incentive payments. The trial clusters comprise either a single community or several communities grouped together based on geographic proximity and cultural ties. The primary outcomes are: prevalence of chlamydia, gonorrhoea and trichomonas in Aboriginal residents aged 16–34 years, and performance in clinical management of STIs based on best practice indicators. STRIVE will be conducted over five years comprising one and a half years of trial initiation and community consultation, three years of trial conditions, and a half year of data analysis. The trial was initiated in 68 remote Aboriginal health services in the Northern Territory, Queensland and Western Australia. Discussion STRIVE is the first cluster randomised trial in STI care in remote Aboriginal health services. The trial will provide evidence to inform future culturally appropriate STI clinical care and control strategies in communities with high STI rates. Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12610000358044 PMID:24016143

Case Management in Primary Care for Frequent Users of Health Care Services: A Mixed Methods Study.

PubMed

Hudon, Catherine; Chouinard, Maud-Christine; Dubois, Marie-France; Roberge, Pasquale; Loignon, Christine; Tchouaket, Éric; Lambert, Mireille; Hudon, Émilie; Diadiou, Fatoumata; Bouliane, Danielle

2018-05-01

This study aimed to evaluate the effects of the V1SAGES case management intervention (Vulnerable Patients in Primary Care: Nurse Case Management and Self-management Support) for frequent users of health care services with chronic disease and complex care needs on psychological distress and patient activation. We used a 2-phase sequential mixed methods design. The first phase was a pragmatic randomized controlled trial with intention-to-treat analysis that measured the effects of the intervention compared with usual care on psychological distress and patient activation before and after 6 months. The second phase had a qualitative descriptive design and entailed thematic analysis of in-depth interviews (25 patients, 6 case management nurses, 9 health managers) and focus groups (8 patients' spouses, 21 family physicians) to understand stakeholders' perceived effects of the intervention on patients. A total of 247 patients were randomized into the intervention group (n = 126) or the control group (n = 121). Compared with usual care, the intervention reduced psychological distress (odds ratio = 0.43; 95% CI, 0.19-0.95, P = .04), but did not have any significant effect on patient activation ( P = .43). Qualitative results suggested that patients and their spouses benefitted from the case management intervention, gaining a sense of security, and stakeholders noted better patient self-management of health. Together, our study's quantitative and qualitative results suggest that case management reduces psychological distress, making patients and caregivers feel more secure, whereas impact on self-management is unclear. Case management is a promising avenue to improve outcomes among frequent users of health care with complex needs. © 2018 Annals of Family Medicine, Inc.

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.

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

Cost-effectiveness of a vocational enablement protocol for employees with hearing impairment; design of a randomized controlled trial

PubMed Central

2012-01-01

Background Hearing impairment at the workplace, and the resulting psychosocial problems are a major health problem with substantial costs for employees, companies, and society. Therefore, it is important to develop interventions to support hearing impaired employees. The objective of this article is to describe the design of a randomized controlled trial evaluating the (cost-) effectiveness of a Vocational Enablement Protocol (VEP) compared with usual care. Methods/Design Participants will be selected with the 'Hearing and Distress Screener'. The study population will consist of 160 hearing impaired employees. The VEP intervention group will be compared with usual care. The VEP integrated care programme consists of a multidisciplinary assessment of auditory function, work demands, and personal characteristics. The goal of the intervention is to facilitate participation in work. The primary outcome measure of the study is 'need for recovery after work'. Secondary outcome measures are coping with hearing impairment, distress, self-efficacy, psychosocial workload, job control, general health status, sick leave, work productivity, and health care use. Outcome measures will be assessed by questionnaires at baseline, and 3, 6, 9, and 12 months after baseline. The economic evaluation will be performed from both a societal and a company perspective. A process evaluation will also be performed. Discussion Interventions addressing occupational difficulties of hearing impaired employees are rare but highly needed. If the VEP integrated care programme proves to be (cost-) effective, the intervention can have an impact on the well-being of hearing impaired employees, and thereby, on the costs for the company as well for the society. Trial registration Netherlands Trial Register (NTR): NTR2782 PMID:22380920

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.

Comprehensive care improves health outcomes among elderly Taiwanese patients with hip fracture.

PubMed

Shyu, Yea-Ing L; Liang, Jersey; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Yang, Ching-Tzu; Chou, Shih-Wei; Chen, Ching-Yen

2013-02-01

Few studies have investigated the effects of care models that combine interdisciplinary care with nutrition consultation, depression management, and fall prevention in older persons with hip fracture. The purpose of this study was to compare the effects of a comprehensive care program with those of interdisciplinary care and usual care for elderly patients with hip fracture. A randomized experimental trial was used to explore outcomes for 299 elderly patients with hip fracture receiving three treatment care models: interdisciplinary care (n = 101), comprehensive care (n = 99), and usual care (n = 99). Interdisciplinary care included geriatric consultation, continuous rehabilitation, and discharge planning with post-hospital services. Comprehensive care consisted of interdisciplinary care plus nutrition consultation, depression management, and fall prevention. Usual care included only in-hospital rehabilitation without geriatric consultation, in-home rehabilitation, and home environmental assessment. Participants in the comprehensive care group had better self-care ability (odds ratio, OR = 3.19, p < .01) and less risk of depression (OR = 0.48, p < .01) than those who received usual care. The comprehensive care group had less risk of depression (OR = 0.51, p < .05) and of malnutrition (OR = 0.48, p < .05) than the interdisciplinary care group during the first year following discharge. Older persons with hip fracture benefitted more from the comprehensive care program than from interdisciplinary care and usual care. Older persons with hip fracture benefitted more from comprehensive care including interdisciplinary care and nutrition consultation, depression management, and fall prevention than simply interdisciplinary care.

Design of the Coordinated Anxiety Learning and Management (CALM) Study: Innovations in Collaborative Care for Anxiety Disorders

PubMed Central

Sullivan, Greer; Craske, Michelle G; Sherbourne, Cathy; Edlund, Mark J; Rose, Raphael D; Golinelli, Daniela; Chavira, Denise A; Bystritsky, Alexander; Stein, Murray B; Roy-Byrne, Peter P

2007-01-01

Background: Despite a marked increase in persons seeking help for anxiety disorders, the care provided may not be evidence-based, especially when delivered by non-specialists. Since anxiety disorders are most often treated in primary care, quality improvement interventions are needed there. Research Design: A randomized controlled trial of a collaborative care effectiveness intervention for anxiety disorders. Subjects: Approximately 1040 adult primary care patients with one of four anxiety disorders (generalized anxiety disorder, panic disorder, posttraumatic stress disorder, or social anxiety disorder), recruited from four national sites. Intervention: Anxiety clinical specialists deliver education and behavioral activation to intervention patients and monitor their symptoms. Intervention patients choose cognitive behavioral therapy, anti-anxiety medications, or both, in a “stepped care” treatment that varies according to clinical need. Control patients receive usual care from their primary care clinician. CALM's innovations include the flexibility to treat any one of four anxiety disorders, co-occurring depression, and/or alcohol abuse; its use of on-site clinicians to conduct initial assessments, and its computer-assisted psychotherapy delivery. Evaluation: Anxiety symptoms, functioning, satisfaction with care, and health care utilization are assessed at 6-month intervals. Conclusion: CALM was designed for clinical effectiveness and easy dissemination in a variety of primary care settings. PMID:17888803

Toward Evidence-Based Transport of Evidence-Based Treatments: MST as an Example

ERIC Educational Resources Information Center

Schoenwald, Sonja K.

2008-01-01

This article describes the journey toward evidence-based transport and implementation in usual care settings of Multisystemic Therapy (MST) for youth with drug abuse and behavioral problems (Henggeler, Schoenwald, Borduin, Rowland, & Cunningham, 1998). Research and experience informing the design of the MST transport strategy, progress in…

Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: Design of a randomised trial

PubMed Central

de Graaf, L Esther; Gerhards, Sylvia AH; Evers, Silvia MAA; Arntz, Arnoud; Riper, Heleen; Severens, Johan L; Widdershoven, Guy; Metsemakers, Job FM; Huibers, Marcus JH

2008-01-01

Background Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost-) effectiveness of online computerised cognitive behavioural therapy for depression in primary care. Methods/Design In a randomised trial we will compare (a) computerised cognitive behavioural therapy with (b) treatment as usual by a GP, and (c) computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18–65) will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000). Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life. Discussion Although computerised cognitive behavioural therapy is a promising treatment for depression in primary care, more research is needed. The effectiveness of online computerised cognitive behavioural therapy without support remains to be evaluated as well as the effects of computerised cognitive behavioural therapy in combination with usual GP care. Economic evaluation is also needed. Methodological strengths and weaknesses are discussed. Trial registration The study has been registered at the Netherlands Trial Register, part of the Dutch Cochrane Centre (ISRCTN47481236). PMID:18590518

Costs of terminal patients who receive palliative care or usual care in different hospital wards.

PubMed

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

2010-11-01

In addition to the effectiveness of hospital care models for terminal patients, policy makers and health care payers are concerned about their costs. This study aims to measure the hospital costs of treating terminal patients in Belgium from the health care payer perspective. Also, this study compares the costs of palliative and usual care in different types of hospital wards. A multicenter, retrospective cohort study compared costs of palliative care with usual care in acute hospital wards and with care in palliative care units. The study enrolled terminal patients from a representative sample of hospitals. Health care costs included fixed hospital costs and charges relating to medical fees, pharmacy and other charges. Data sources consisted of hospital accountancy data and invoice data. Six hospitals participated in the study, generating a total of 146 patients. The findings showed that palliative care in a palliative care unit was more expensive than palliative care in an acute ward due to higher staffing levels in palliative care units. Palliative care in an acute ward is cheaper than usual care in an acute ward. This study suggests that palliative care models in acute wards 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. This finding emphasizes the importance of the timely recognition of the need for palliative care in terminal patients treated in acute wards.

Improving Diaper Performance for Extremely Low-Birth-Weight Infants.

PubMed

Sanchez, Veronica; Maladen-Percy, Michelle; Gustin, Jennifer; Tally, Amy; Gibb, Roger; Ogle, Julie; Kenneally, Dianna C; Carr, Andrew N

2018-06-01

Extremely low-birth-weight (ELBW) infants face significant diapering challenges compared with their full-term peers, due to immature musculature, nervous system, and skin development. Advances in medical care has increased an ELBW infant's rate of survival, which creates a growing need for diapers to better serve these infants. Aim of research. The objective of this study was to identify and confirm the requirements for optimal diaper performance from the neonatal intensive care unit nurses' perspective, as well as to assess in-hospital performance to determine if new features improved key developmental care parameters. Two surveys were shared among nurses to address study objectives. Study 1 (N = 151) was designed for neonatal intensive care unit nurses to identify key requirements for ELBW diapers and rate the performance of existing ELBW diapers. Study 2 (N = 99) assessed in-hospital performance of the test diaper compared with the usual diaper, under normal usage conditions. Findings/results. The majority of nurses agreed that ELBW diapers must fit appropriately between the legs so that hips and legs are not spread apart and that ELBW diapers need to be flexible between the legs for positioning. Of the nurses-infant pair responses, 93% ( P < .0001) preferred the test ELBW diaper over their usual diaper. Findings suggest that nurses should be included in the product design process to ensure both their needs and the needs of an infant are being met. Nurses are considering how diaper features may affect both acute and long-term medical outcomes, and this information provides necessary guidance to diaper manufacturers and designers when developing better-performing diapers.

Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care. Methods/Design Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year. Discussion There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown. Trial registration Reference number ISRCTN49117867. PMID:24422876

Design of a prototype device for remote patient care with mild cognitive impairment

NASA Astrophysics Data System (ADS)

Sanchez-Ocampo, M.; Segura-Giraldo, B.; Floréz-Hurtado, R.; Cortés-Aguirre, C.

2016-04-01

This paper describes the design of a prototype telecare system, which allows to provide home care to patients with mild cognitive impairment and thus ensures their permanence in their usual environment. Telecare is oriented towards people who require constant attention due to conditions of advanced age, illness, physical risk or limited capabilities. Telecare offers these people a greater degree of independence. QFD methodology is used to develop electronic devices intended to monitor the environment and physiological state of the user continuously, providing communication between the telecare system and a monitoring center in order to take the most appropriate actions in any abnormal event.

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

Limited Impact on Health and Access to Care for 19- to 25-Year-Olds Following the Patient Protection and Affordable Care Act

PubMed Central

Kotagal, Meera; Carle, Adam C.; Kessler, Larry G.; Flum, David R.

2014-01-01

IMPORTANCE The Patient Protection and Affordable Care Act (PPACA) allowed young adults to remain on their parents’ insurance until 26 years of age. Reports indicate that this has expanded health coverage. OBJECTIVE To evaluate coverage, access to care, and health care use among 19- to 25-year-olds compared with 26- to 34-year-olds following PPACA implementation. DESIGN, SETTING, AND PARTICIPANTS Data from the Behavior Risk Factor Surveillance System and the National Health Interview Survey, which provide nationally representative measures of coverage, access to care, and health care use, were used to conduct the study among participants aged 19 to 25 years (young adults) and 26 to 34 years (adults) in 2009 and 2012. EXPOSURE Self-reported health insurance coverage. MAIN OUTCOMES AND MEASURES Health status, presence of a usual source of care, and ability to afford medications, dental care, or physician visits. RESULTS Health coverage increased between 2009 and 2012 for 19- to 25-year-olds (68.3% to 71.7%). Using a difference-in-differences (DID) approach, after adjustment, the likelihood of having a usual source of care decreased in both groups but more significantly for 26- to 34-year-olds (DID, 2.8%; 95% CI, 0.45 to 5.15). There was no significant change in health status for 19- to 25-year-olds compared with 26- to 34-year-olds (DID, −0.5%; 95% CI, −1.87 to 0.87). There was no significant change for 19- to 25-year-olds compared with 26- to 34-year-olds in the percentage who reported receiving a routine checkup in the past year (DID, 0.3%; 95% CI, −2.25 to 2.85) or in the ability to afford prescription medications (DID, −0.4%; 95% CI, −2.93 to 1.93), dental care (DID, −2.6%; 95% CI, −5.61 to 0.61), or physician visits (DID, −1.7%; 95% CI, −3.66 to 0.26). There was also no change in the percentage who reported receiving a flu shot (DID, 1.9; 95% CI, −1.93 to 4.93). Insured individuals were more likely to report having a usual source of care and a recent routine checkup and were more likely to be able to afford health care than uninsured individuals. CONCLUSIONS AND RELEVANCE Implementation of the PPACA was associated with increased health insurance coverage for 19- to 25-year-olds without significant changes in perceived health care affordability or health status. Although the likelihood of having a usual source of care declined between 2009 and 2012 for all, this decrease was smaller among 19- to 25-year-olds, and younger adults were more likely than 26- to 34-year-olds to have a usual source of care. PMID:25200181

Comparing counselling models for the hazardous use of alcohol at the Swedish National Alcohol Helpline: study protocol for a randomised controlled trial.

PubMed

Säfsten, Eleonor; Forsell, Yvonne; Ramstedt, Mats; Galanti, Maria Rosaria

2017-06-06

Hazardous and harmful consumption of alcohol is a leading cause of preventable disease and premature deaths. Modifying the amount and pattern of risky alcohol consumption conveys substantial benefits to individuals and to society at large. Telephone helplines provide a feasible alternative to face-to-face counselling in order to increase the reach of brief interventions aiming at modifying the hazardous and harmful use of alcohol. However, there is a lack of studies on the implementation and evaluation of population-based telephone services for the prevention and treatment of alcohol misuse. A randomised controlled trial was designed to compare a brief, structured intervention to usual care within the Swedish National Alcohol Helpline (SAH), concerning their effectiveness on decreasing the hazardous use of alcohol. Between May 2015 and December 2017, about 300 callers are to be individually randomised with a 1:1 ratio to a brief, structured intervention (n = 150) or to usual care (n = 150). The brief, structured intervention consists of the delivery of a self-help booklet followed by one proactive call from SAH counsellors to monitor and give feedback about the client's progression. Callers assigned to usual care receive telephone counselling according to existing practice, i.e., motivational interviewing in a tailored and client-driven combination of proactive and reactive calls. The primary outcome is defined as a change from a higher to a lower AUDIT risk-level category between baseline and follow-up. General linear modeling will be used to calculate risk ratios of the outcome events. The primary analysis will follow an intention-to-treat (ITT) approach. The trial is designed to evaluate the effectiveness in decreasing the hazardous and harmful consumption of alcohol of a brief, structured intervention compared to usual care when delivered at the SAH. The results of the study will be used locally to improve the effectiveness of the service provided at the SAH. Additionally, they will expand the evidence base about optimal counselling models in population-based telephone services for alcohol misuse prevention and treatment. ISRCNT.com, ID: ISRCTN13160878 . Retrospectively registered on 18 January 2016.

Alerts in electronic medical records to promote a colorectal cancer screening programme: a cluster randomised controlled trial in primary care

PubMed Central

Guiriguet, Carolina; Muñoz-Ortiz, Laura; Burón, Andrea; Rivero, Irene; Grau, Jaume; Vela-Vallespín, Carmen; Vilarrubí, Mercedes; Torres, Miquel; Hernández, Cristina; Méndez-Boo, Leonardo; Toràn, Pere; Caballeria, Llorenç; Macià, Francesc; Castells, Antoni

2016-01-01

Background Participation rates in colorectal cancer screening are below recommended European targets. Aim To evaluate the effectiveness of an alert in primary care electronic medical records (EMRs) to increase individuals’ participation in an organised, population-based colorectal cancer screening programme when compared with usual care. Design and setting Cluster randomised controlled trial in primary care centres of Barcelona, Spain. Method Participants were males and females aged 50–69 years, who were invited to the first round of a screening programme based on the faecal immunochemical test (FIT) (n = 41 042), and their primary care professional. The randomisation unit was the physician cluster (n = 130) and patients were blinded to the study group. The control group followed usual care as per the colorectal cancer screening programme. In the intervention group, as well as usual care, an alert to health professionals (cluster level) to promote screening was introduced in the individual’s primary care EMR for 1 year. The main outcome was colorectal cancer screening participation at individual participant level. Results In total, 67 physicians and 21 619 patients (intervention group) and 63 physicians and 19 423 patients (control group) were randomised. In the intention-to-treat analysis screening participation was 44.1% and 42.2% respectively (odds ratio 1.08, 95% confidence interval [CI] = 0.97 to 1.20, P = 0.146). However, in the per-protocol analysis screening uptake in the intervention group showed a statistically significant increase, after adjusting for potential confounders (OR, 1.11; 95% CI = 1.02 to 1.22; P = 0.018). Conclusion The use of an alert in an individual’s primary care EMR is associated with a statistically significant increased uptake of an organised, FIT-based colorectal cancer screening programme in patients attending primary care centres. PMID:27266861

Study protocol for iQuit in Practice: a randomised controlled trial to assess the feasibility, acceptability and effectiveness of tailored web- and text-based facilitation of smoking cessation in primary care.

PubMed

Sutton, Stephen; Smith, Susan; Jamison, James; Boase, Sue; Mason, Dan; Prevost, A Toby; Brimicombe, James; Sloan, Melanie; Gilbert, Hazel; Naughton, Felix

2013-04-10

Primary care is an important setting for smoking cessation interventions. There is evidence for the effectiveness of tailored interventions for smoking cessation, and text messaging interventions for smoking cessation show promise. The intervention to be evaluated in this trial consists of two components: (1) a web-based program designed to be used by a practice nurse or other smoking cessation advisor (SCA); the program generates a cessation advice report that is highly tailored to relevant characteristics of the smoker; and (2) a three-month programme of automated tailored text messages sent to the smoker's mobile phone. The objectives of the trial are to assess the acceptability and feasibility of the intervention and to estimate the short-term effectiveness of the intervention in increasing the quit rate compared with usual care alone. The design is a two parallel group randomised controlled trial (RCT). 600 smokers who want to quit will be recruited in up to 30 general practices in the East of England. During a consultation with an SCA, they will be individually randomised by computer program to usual care (Control) or to usual care plus the iQuit system (Intervention). At the four-week follow-up appointment, the SCA will record smoking status and measure carbon monoxide level. There will be two further follow-ups, at eight weeks and six months from randomisation date, by postal questionnaire sent from and returned to the study centre or by telephone interview conducted by a research interviewer. The primary outcome will be self-reported abstinence for at least two weeks at eight weeks. A sample size of 300 per group would give 80% power to detect an increase in quit rate from 20% to 30% (alpha = 0.05, 2-sided test). The main analyses of quit rates will be conducted on an intention-to-treat basis, making the usual assumption that participants lost to follow up are smoking. This trial will focus on acceptability, feasibility and short-term effectiveness. The findings will be used to refine the intervention and to inform the decision to proceed to a pragmatic trial to estimate longer-term effectiveness and cost-effectiveness. ISRCTN56702353.

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.

A smartphone application to support recovery from alcoholism: A randomized controlled trial

PubMed Central

Gustafson, David H.; McTavish, Fiona M.; Chih, Ming-Yuan; Atwood, Amy K.; A. Johnson, Roberta; G. Boyle, Michael; S. Levy, Michael; Driscoll, Hilary; M. Chisholm, Steven; Dillenburg, Lisa; Isham, Andrew; Shah, Dhavan

2014-01-01

Importance: Patients leaving treatment for alcohol-use disorders (AUDs) are not typically offered evidence-based continuing care, although research suggests that continuing care is associated with better outcomes. A smartphone-based application could provide effective continuing care. Objective: To determine whether patients leaving residential treatment for AUDs with a smartphone application to support recovery have fewer risky drinking days than control-group patients. Design: An un-blinded randomized controlled trial. Patients were randomized to treatment as usual or treatment as usual plus a smartphone with A-CHESS, an application designed to improve continuing care for AUDs. “A-CHESS” stands for Addiction – Comprehensive Health Enhancement Support System. Setting: Three residential programs operated by one treatment organization in the Midwestern US and 2 residential programs operated by one organization in the Northeastern US. Participants: 349 patients who met the criteria for DSM-IV alcohol dependence when they entered residential treatment. 179 were randomized to the control group and 170 to the treatment group. Intervention: Treatment as usual varied across programs; none offered patients coordinated continuing care after discharge. A-CHESS provides monitoring, information, communication, and support services to patients, including ways for patients and counselors to stay in contact. The intervention lasted 8 months and the follow-up period lasted 4 months. Main Outcome Measure: Risky drinking days—the number of days during which a patient’s drinking in a 2-hour period exceeded, for men, 4 standard drinks and for women, 3 standard drinks. Patients were asked to report their risky drinking days in the previous 30 days on surveys taken 4, 8, and 12 months after discharge from residential treatment. Results: For the 8 months of the intervention and 4 months of follow-up, patients in the A-CHESS group reported significantly fewer risky drinking days than patients in the control group (M = 1.39 vs. 2.75, respectively; P = .003; 95% CI [.46, 2.27]). Conclusions and Relevance: The findings suggest that a multi-featured smartphone application may have significant benefit to patients in continuing care for AUDs. Trial registration: clinicaltrials.gov Identifier: NCT01003119 PMID:24671165

A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality vs. Enhanced Care as Usual for Suicidal Soldiers

DTIC Science & Technology

2015-04-01

Army position, policy or decision unless so designated by other documentation. Table of Contents Page Introduction...Narrative that briefly (one paragraph) describes the subject, purpose and scope of the research. This study is designed to investigate the...accomplishing any of the tasks. Statistical tests of significance shall be applied to all data whenever possible. Figures and graphs referenced in the text

Study design to evaluate cognitive behavioral therapy among a diverse sample of adults with a first-time DUI offense.

PubMed

Chan Osilla, Karen; Watkins, Katherine E; Kulesza, Magdalena; Flórez, Karen; Lara-Greenberg, Marielena; Miles, Jeremy N V

2016-03-31

Driving under the influence (DUI) of alcohol is a major public health concern, and many individuals continue to drink and drive even after being convicted of a DUI offense. Latinos, in particular, are disproportionately likely to be arrested for a DUI, have higher rates of recidivism, and are more likely to die in alcohol-related accidents than non-Latino Whites. Latinos also experience significant disparities in accessing alcohol-related treatment. This study protocol paper describes a randomized trial of cognitive behavioral therapy (CBT) compared to usual care in DUI programs for individuals with a first-time offense and at-risk drinking. We will utilize a two-group randomized design where individuals enrolled in a DUI program with a first-time conviction will be randomized to CBT (n = 150) or usual care (n = 150). Participants will be assessed at baseline, immediately post-treatment, and 6-months post-treatment. Recidivism data will be collected using administrative data within 2 years post-treatment. This project has the potential to benefit a large population of vulnerable individuals who are at risk of DUI recidivism. It also develops a new model of care by providing treatment in DUI programs to reduce disparities associated with poor treatment access. Trial registration NCT02588703.

Cost-effectiveness of an internet-based perioperative care programme to enhance postoperative recovery in gynaecological patients: economic evaluation alongside a stepped-wedge cluster-randomised trial

PubMed Central

Bosmans, Judith E; van Dongen, Johanna M; Brölmann, Hans A M; Anema, Johannes R; Huirne, Judith A F

2018-01-01

Objectives To evaluate the cost-effectiveness and cost-utility of an internet-based perioperative care programme compared with usual care for gynaecological patients. Design Economic evaluation from a societal perspective alongside a stepped-wedge cluster-randomised controlled trial with 12 months of follow-up. Setting Secondary care, nine hospitals in the Netherlands, 2011–2014. Participants 433 employed women aged 18–65 years scheduled for a hysterectomy and/or laparoscopic adnexal surgery. Intervention The intervention comprised an internet-based care programme aimed at improving convalescence and preventing delayed return to work (RTW) following gynaecological surgery and was sequentially rolled out. Depending on the implementation phase of their hospital, patients were allocated to usual care (n=206) or to the intervention (n=227). Main outcome measures The primary outcome was duration until full sustainable RTW. Secondary outcomes were quality-adjusted life years (QALYs), health-related quality of life and recovery. Results At 12 months, there were no statistically significant differences in total societal costs (€−647; 95% CI €−2116 to €753) and duration until RTW (−4.1; 95% CI −10.8 to 2.6) between groups. The incremental cost-effectiveness ratio (ICER) for RTW was 56; each day earlier RTW in the intervention group was associated with cost savings of €56 compared with usual care. The probability of the intervention being cost-effective was 0.79 at a willingness-to-pay (WTP) of €0 per day earlier RTW, which increased to 0.97 at a WTP of €76 per day earlier RTW. The difference in QALYs gained over 12 months between the groups was clinically irrelevant resulting in a low probability of cost-effectiveness for QALYs. Conclusions Considering that on average the costs of a day of sickness absence are €230, the care programme is considered cost-effective in comparison with usual care for duration until sustainable RTW after gynaecological surgery for benign disease. Future research should indicate whether widespread implementation of this care programme has the potential to reduce societal costs associated with gynaecological surgery. Trial registration number NTR2933; Results. PMID:29358423

Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study.

PubMed

Koehler, Friedrich; Winkler, Sebastian; Schieber, Michael; Sechtem, Udo; Stangl, Karl; Böhm, Michael; Boll, Herbert; Baumann, Gert; Honold, Marcus; Koehler, Kerstin; Gelbrich, Goetz; Kirwan, Bridget-Anne; Anker, Stefan D

2011-05-03

This study was designed to determine whether physician-led remote telemedical management (RTM) compared with usual care would result in reduced mortality in ambulatory patients with chronic heart failure (HF). We enrolled 710 stable chronic HF patients in New York Heart Association functional class II or III with a left ventricular ejection fraction ≤35% and a history of HF decompensation within the previous 2 years or with a left ventricular ejection fraction ≤25%. Patients were randomly assigned (1:1) to RTM or usual care. Remote telemedical management used portable devices for ECG, blood pressure, and body weight measurements connected to a personal digital assistant that sent automated encrypted transmission via cell phones to the telemedical centers. The primary end point was death from any cause. The first secondary end point was a composite of cardiovascular death and hospitalization for HF. Baseline characteristics were similar between the RTM (n=354) and control (n=356) groups. Of the patients assigned to RTM, 287 (81%) were at least 70% compliant with daily data transfers and no break for >30 days (except during hospitalizations). The median follow-up was 26 months (minimum 12), and was 99.9% complete. Compared with usual care, RTM had no significant effect on all-cause mortality (hazard ratio, 0.97; 95% confidence interval, 0.67 to 1.41; P=0.87) or on cardiovascular death or HF hospitalization (hazard ratio, 0.89; 95% confidence interval, 0.67 to 1.19; P=0.44). In ambulatory patients with chronic HF, RTM compared with usual care was not associated with a reduction in all-cause mortality. URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00543881.

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.

The efficacy of interactive, motion capture-based rehabilitation on functional outcomes in an inpatient stroke population: a randomized controlled trial

PubMed Central

Cannell, John; Jovic, Emelyn; Rathjen, Amy; Lane, Kylie; Tyson, Anna M; Callisaya, Michele L; Smith, Stuart T; Ahuja, Kiran DK; Bird, Marie-Louise

2017-01-01

Objective: To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Design: Randomized controlled clinical trial. Setting: Two subacute hospital rehabilitation units in Australia. Participants: In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. Interventions: Both groups received functional retraining and individualized programs for up to an hour, on weekdays for 8–40 sessions (dose matched). For the intervention group, this individualized program used motivating virtual reality rehabilitation and novel gesture controlled interactive motion capture software. For usual care, the individualized program was delivered in a group class on one unit and by rehabilitation assistant 1:1 on the other. Main measures: Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. Results: Participants (mean 22 days post-stroke) attended mean 14 sessions. Both groups improved (mean (95% confidence interval)) on primary outcome functional reach (usual care 3.3 (0.6 to 5.9), intervention 4.1 (−3.0 to 5.0) cm) with no difference between groups (P = 0.69) on this or any secondary measures. No differences between the rehabilitation units were seen except in lateral reach (less affected side) (P = 0.04). No adverse events were recorded during therapy. Conclusion: Interactive, motion capture rehabilitation for inpatients post stroke produced functional improvements that were similar to those achieved by usual care stroke rehabilitation, safely delivered by either a physical therapist or a rehabilitation assistant. PMID:28719977

Tag Team Tech: What Makes Google Tick.

ERIC Educational Resources Information Center

Janes, Joseph

2002-01-01

The Google search engine is growing in popularity and usually shines in performance ratings. This article summarizes findings from a technical paper written by Google's developers in 1998 before anyone had seen Google. Suggests that a careful reader of the paper will be rewarded with a deeper appreciation of the designers' ideas and…

From Zero Tolerance to a Culture of Care

ERIC Educational Resources Information Center

Cassidy, Wanda

2005-01-01

Zero tolerance policies stem from the culture of fear that pervades many schools today--fear of violence, bullying, and unruly behaviour. The code of conduct is clearly spelled out and if students disobey, the retribution is swift--usually suspension or expulsion. The rules are designed to apply equally to everyone, irrespective of age, gender,…

Randomized Trial of Drug Abuse Treatment-Linkage Strategies

ERIC Educational Resources Information Center

Sorenson, James L.; Masson, Carmen L.; Delucchi, Kevin; Sporer, Karl; Barnett, Paul G.; Mitsuishi, Fumi; Lin, Christine; Song, Yong; Chen, TeChieh; Hall, Sharon M.

2005-01-01

A clinical trial contrasted 2 interventions designed to link opioid-dependent hospital patients to drug abuse treatment. The 126 out-of-treatment participants were randomly assigned to (a) case management, (b) voucher for free methadone maintenance treatment (MMT), (c) case management plus voucher, or (d) usual care. Services were provided for 6…

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

Family-Centered Care in Juvenile Justice Institutions: A Mixed Methods Study Protocol.

PubMed

Simons, Inge; Mulder, Eva; Rigter, Henk; Breuk, René; van der Vaart, Wander; Vermeiren, Robert

2016-09-12

Treatment and rehabilitation interventions in juvenile justice institutions aim to prevent criminal reoffending by adolescents and to enhance their prospects of successful social reintegration. There is evidence that these goals are best achieved when the institution adopts a family-centered approach, involving the parents of the adolescents. The Academic Workplace Forensic Care for Youth has developed two programs for family-centered care for youth detained in groups for short-term and long-term stay, respectively. The overall aim of our study is to evaluate the family-centered care program in the first two years after the first steps of its implementation in short-term stay groups of two juvenile justice institutions in the Netherlands. The current paper discusses our study design. Based on a quantitative pilot study, we opted for a study with an explanatory sequential mixed methods design. This pilot is considered the first stage of our study. The second stage of our study includes concurrent quantitative and qualitative approaches. The quantitative part of our study is a pre-post quasi-experimental comparison of family-centered care with usual care in short-term stay groups. The qualitative part of our study involves in-depth interviews with adolescents, parents, and group workers to elaborate on the preceding quantitative pilot study and to help interpret the outcomes of the quasi-experimental quantitative part of the study. We believe that our study will result in the following findings. In the quantitative comparison of usual care with family-centered care, we assume that in the latter group, parents will be more involved with their child and with the institution, and that parents and adolescents will be more motivated to take part in therapy. In addition, we expect family-centered care to improve family interactions, to decrease parenting stress, and to reduce problem behavior among the adolescents. Finally, we assume that adolescents, parents, and the staff of the institutions will be more satisfied with family-centered care than with usual care. In the qualitative part of our study, we will identify the needs and expectations in family-centered care as well as factors influencing parental participation. Insight in these factors will help to further improve our program of family-centered care and its implementation in practice. Our study results will be published over the coming years. A juvenile justice institution is a difficult setting to evaluate care programs. A combination of practice-based research methods is needed to address all major implementation issues. The study described here takes on the challenge by means of practice-based research. We expect the results of our study to contribute to the improvement of care for adolescents detained in juvenile justice institutions, and for their families.

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.

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

Pelvic floor muscle training is not effective in women with UI in pregnancy: a randomised controlled trial.

PubMed

Woldringh, Clara; van den Wijngaart, Mary; Albers-Heitner, Pytha; Lycklama à Nijeholt, August A B; Lagro-Janssen, Toine

2007-04-01

The objective of this study was to test the short- and long-term effects of pelvic floor muscle training (PFMT) during pregnancy in women at risk, i.e. women who were already affected by urinary incontinence (UI) during pregnancy. The intervention consisted of three sessions of PFMT between week 23 and 30 during pregnancy and one session 6 weeks after delivery, combined with written information. The research design was a randomised, controlled trial with four follow-ups up to 1 year after delivery. Participants in the study were 264 otherwise healthy women with UI during pregnancy, allocated at random to the intervention (112) or usual care (152) group. The main outcome measure was a UI severity scale and a 7-day bladder diary. No effect of pelvic floor muscle training was shown in this study at (half) a year after pregnancy. UI decreased strongly after pregnancy, irrespective of usual care or PMFT during pregnancy. For most women, usual care appears to be sufficient. The results support a 'wait and see' policy: wait for the urinary incontinence to take its natural course and see if, for women still incontinent half a year after pregnancy, pelvic floor muscle training is effective.

A breast-feeding promotion and support program a randomized trial in The Netherlands.

PubMed

Kools, Els J; Thijs, Carel; Kester, Arnold D M; van den Brandt, Piet A; de Vries, Hein

2005-01-01

In the Netherlands, the initiation rate of breast-feeding (BF) was 80% in 2002, but only 35% of the mothers continued to breast-feed for 3 months. This study examined the effectiveness of a breast-feeding promotion program to increase the continuation of breast-feeding. A cluster-randomized intervention trial was used. Ten child health care centers in three regions of the home health care were randomly allocated to the program or usual care. Elements in the program were health counseling, measures to enhance cooperation, early signaling of breast-feeding problems and continuity of care, and lactation consultancy. Pregnant mothers who applied for home health care in the intervention or usual care regions were enrolled and were followed up from pregnancy until 6 months postpartum (n = 683). The primary outcome measure was the continuation of breast-feeding until at least 3 months. The 3-month breast-feeding rate was 32% in the intervention and 38% in the control groups (OR = 0.79, 95% CI = 0.58-1.08). The program was not effective. We discuss possible explanations from the design and execution of the trial and give some points for improvement of our program, such as the categories of caregivers involved and the number and duration of contacts after parturition.

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

Beyond usual care: the economic consequences of expanding treatment options in early pregnancy loss.

PubMed

Dalton, Vanessa K; Liang, Angela; Hutton, David W; Zochowski, Melissa K; Fendrick, A Mark

2015-02-01

The objective of this study was to estimate the economic consequences of expanding options for early pregnancy loss (EPL) treatment beyond expectant management and operating room surgical evacuation (usual care). We constructed a decision model using a hypothetical cohort of women undergoing EPL management within a 30 day horizon. Treatment options under the usual care arm include expectant management and surgical uterine evacuation in an operating room (OR). Treatment options under the expanded care arm included all evidence-based safe and effective treatment options for EPL: expectant management, misoprostol treatment, surgical uterine evacuation in an office setting, and surgical uterine evacuation in an OR. Probabilities of entering various treatment pathways were based on previously published observational studies. The cost per case was US $241.29 lower for women undergoing treatment in the expanded care model as compared with the usual care model (US $1033.29 per case vs US $1274.58 per case, expanded care and usual care, respectively). The model was the most sensitive to the failure rate of the expectant management arm, the cost of the OR surgical procedure, the proportion of women undergoing an OR surgical procedure under usual care, and the additional cost per patient associated with implementing and using the expanded care model. This study demonstrates that expanding women's treatment options for EPL beyond what is typically available can result in lower direct medical expenditures. Copyright © 2015 Elsevier Inc. All rights reserved.

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.

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.

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.

Enhanced interdisciplinary care improves self-care ability and decreases emergency department visits for older Taiwanese patients over 2 years after hip-fracture surgery: A randomised controlled trial.

PubMed

Shyu, Yea-Ing L; Liang, Jersey; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chou, Shih-Wei; Chen, Ching-Yen; Yang, Ching-Tzu

2016-04-01

Little evidence is available on the longer-term effects (beyond 12 months) of intervention models consisting of hip fracture-specific care in conjunction with management of malnutrition, depression, and falls. To compare the relative effects of an interdisciplinary care, and a comprehensive care programme with those of usual care for elderly patients with a hip fracture on self-care ability, health care use, and mortality. Randomised experimental trial. A 3000-bed medical centre in northern Taiwan. Patients with hip fracture aged 60 years or older (N=299). Patients were randomly assigned to three groups: comprehensive care (n=99), interdisciplinary care (n=101), and usual care (control) (n=99). Usual care entailed only one or two in-hospital rehabilitation sessions. Interdisciplinary care included not only hospital rehabilitation, but also geriatric consultation, discharge planning, and 4-month in-home rehabilitation. Building upon interdisciplinary care, comprehensive care extended in-home rehabilitation to 12 months and added management of malnutrition and depressive symptoms, and fall prevention. Patients' self-care ability was measured by activities of daily living and instrumental activities of daily living using the Chinese Barthel Index and Chinese version Instrumental Activities of Daily Living scale, respectively. Outcomes were assessed before discharge, and 1, 3, 6, 12, 18, 24 months following hip fracture. Hierarchical linear models were used to analyse health outcomes and health care utilisation, including emergency department visit and hospital re-admission. The comprehensive care group had better performance trajectories for both measures of activities of daily living and fewer emergency department visits than the usual care group, but no difference in hospital readmissions. The interdisciplinary care and usual care groups did not differ in trajectories of self-care ability and service utilisation. The three groups did not differ in mortality during the 2-year follow-up. Comprehensive care, with enhanced rehabilitation, management of malnutrition and depressive symptoms, and fall prevention, improved self-care ability and decreased emergency department visits for elders up to 2 years after hip-fracture surgery, above and beyond the effects of usual care and interdisciplinary care. Copyright © 2015 Elsevier Ltd. All rights reserved.

Design of Alarm Sound of Home Care Equipment Based on Age-related Auditory Sense

NASA Astrophysics Data System (ADS)

Shibano, Jun-Ichi; Tadano, Shigeru; Kaneko, Hirotaka

A wide variety of home care equipment has been developed to support the independent lifestyle and care taking of elderly persons. Almost all of the equipment has an alarm designed to alert a care person or to sound a warning in case of an emergency. Due to the fact that aging human beings' senses physiologically, weaken and deteriorate, each alarm's sound must be designed to account for the full range of elderly person's hearing loss. Since the alarms are usually heard indoors, it is also necessary to evaluate the relationship between the basic characteristics of the sounds and living area's layout. In this study, we investigated the sounds of various alarms of the home care equipment based on both the age-related hearing characteristics of elderly persons and the propagation property of the sounds indoors. As a result, it was determined that the hearing characteristics of elderly persons are attuned to sounds which have a frequency from 700Hz to 1kHz, and it was learned that the indoor absorption ratio of sound is smallest when the frequency is 1kHz. Therefore, a frequency of 1kHz is good for the alarm sound of home care equipment. A flow chart to design the alarm sound of home care equipment was proposed, taking into account the extent of age-related auditory sense deterioration.

The effectiveness of Stepping Stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual.

PubMed

Kleefman, Marijke; Jansen, Daniëlle E M C; Reijneveld, Sijmen A

2011-08-30

Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of children with a mild intellectual disability. Netherlands Trial Register (NTR): NTR2624.

Design and implementation of the Exercise for Health trial -- a pragmatic exercise intervention for women with breast cancer.

PubMed

Hayes, Sandra; Rye, Sheree; Battistutta, Diana; Yates, Patsy; Pyke, Chris; Bashford, John; Eakin, Elizabeth

2011-07-01

Exercise for Health was a pragmatic, randomised, controlled trial comparing the effect of an eight-month exercise intervention on function, treatment-related side effects and quality of life following breast cancer, compared with usual care. The intervention commenced six weeks post-surgery, and two modes of delivering the same intervention was compared with usual care. The purpose of this paper is to describe the study design, along with outcomes related to recruitment, retention and representativeness, and intervention participation. Women newly diagnosed with breast cancer and residing in a major metropolitan city of Queensland, Australia, were eligible to participate. Consenting women were randomised to a face-to-face-delivered exercise group (FtF, n = 67), telephone-delivered exercise group (Tel, n = 67) or usual care group (UC, n = 60) and were assessed pre-intervention (5-weeks post-surgery), mid-intervention (6 months post-surgery) and 10 weeks post-intervention (12 months post-surgery). Each intervention arm entailed 16 sessions with an Exercise Physiologist. Of 318 potentially eligible women, 63% (n = 200) agreed to participate, with a 12-month retention rate of 93%. Participants were similar to the Queensland breast cancer population with respect to disease characteristics, and the randomisation procedure was mostly successful at attaining group balance, with the few minor imbalances observed unlikely to influence intervention effects given balance in other related characteristics. Median participation was 14 (min and max: 0 and 16) and 13 (min and max: 3 and 16) intervention sessions for the FtF and Tel, respectively, with 68% of those in Tel and 82% in FtF participating in at least 75% of sessions. Participation in both intervention arms during and following treatment for breast cancer was feasible and acceptable to women. Future work, designed to inform translation into practice, will evaluate the quality of life, clinical, psychosocial and behavioural outcomes associated with each mode of delivery. Copyright © 2011 Elsevier Inc. All rights reserved.

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.

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.

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.

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

Contingency contracting with delinquents: effects of a brief training manual on staff contract negotiation and writing skills.

PubMed

Welch, S J; Holborn, S W

1988-01-01

A brief training manual was developed for the purpose of teaching child-care workers to contingency contract with delinquent youths living in residential care facilities. The manual was designed to require minimal supplementary training by a professional. In Experiment 1 a multiple baseline design was used to assess the effect of the manual on 4 child-care workers' contract negotiation and writing behaviors. Experiment 2 consisted of four A-B systematic replications. Behaviors were assessed within the context of analogue training simulations and generalization tests with delinquent youths. Results from the analogue simulations indicated that the manual was successful in increasing both types of behaviors to a level of proficiency that equaled or surpassed that of behaviorally trained graduate students, and results from the generalization tests indicated that the child-care workers were able to apply their newly acquired contracting skills with delinquent youths. Procedural reliability varied across child-care workers, but was usually high.

Contingency contracting with delinquents: effects of a brief training manual on staff contract negotiation and writing skills.

PubMed Central

Welch, S J; Holborn, S W

1988-01-01

A brief training manual was developed for the purpose of teaching child-care workers to contingency contract with delinquent youths living in residential care facilities. The manual was designed to require minimal supplementary training by a professional. In Experiment 1 a multiple baseline design was used to assess the effect of the manual on 4 child-care workers' contract negotiation and writing behaviors. Experiment 2 consisted of four A-B systematic replications. Behaviors were assessed within the context of analogue training simulations and generalization tests with delinquent youths. Results from the analogue simulations indicated that the manual was successful in increasing both types of behaviors to a level of proficiency that equaled or surpassed that of behaviorally trained graduate students, and results from the generalization tests indicated that the child-care workers were able to apply their newly acquired contracting skills with delinquent youths. Procedural reliability varied across child-care workers, but was usually high. PMID:3225253

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.

Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program.

PubMed

Hewitt, Jennifer; Refshauge, Kathryn M; Goodall, Stephen; Henwood, Timothy; Clemson, Lindy

2014-01-01

Falls are common among older adults. It is reported that approximately 60% of residents of aged care facilities fall each year. This is a major cause of morbidity and mortality, and a significant burden for health care providers and the health system. Among community dwelling older adults, exercise appears to be an effective countermeasure, but data are limited and inconsistent among studies in residents of aged care communities. This trial has been designed to evaluate whether the SUNBEAM program (Strength and Balance Exercise in Aged Care) reduces falls in residents of aged care facilities. Is the program more effective and cost-effective than usual care for the prevention of falls? Single-blinded, two group, cluster randomized trial. 300 residents, living in 20 aged care facilities. Progressive resistance and balance training under the guidance of a physiotherapist for 6 months, then facility-guided maintenance training for 6 months. Usual care. Number of falls, number of fallers, quality of life, mobility, balance, fear of falling, cognitive well-being, resource use, and cost-effectiveness. Measurements will be taken at baseline, 6 months, and 12 months. The number of falls will be analyzed using a Poisson mixed model. A logistic mixed model will be used to analyze the number of residents who fall during the study period. Intention-to-treat analysis will be used. This study addresses a significant shortcoming in aged care research, and has potential to impact upon a substantial health care problem. Outcomes will be used to inform care providers, and guide health care policies.

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial.

PubMed

Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

2013-10-25

A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care--CLiAC) was developed to improve managers' leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed. The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services. Australian New Zealand Clinical Trials Registry (ACTRN12611001070921).

Integrated Design Software Predicts the Creep Life of Monolithic Ceramic Components

NASA Technical Reports Server (NTRS)

1996-01-01

Significant improvements in propulsion and power generation for the next century will require revolutionary advances in high-temperature materials and structural design. Advanced ceramics are candidate materials for these elevated-temperature applications. As design protocols emerge for these material systems, designers must be aware of several innate features, including the degrading ability of ceramics to carry sustained load. Usually, time-dependent failure in ceramics occurs because of two different, delayedfailure mechanisms: slow crack growth and creep rupture. Slow crack growth initiates at a preexisting flaw and continues until a critical crack length is reached, causing catastrophic failure. Creep rupture, on the other hand, occurs because of bulk damage in the material: void nucleation and coalescence that eventually leads to macrocracks which then propagate to failure. Successful application of advanced ceramics depends on proper characterization of material behavior and the use of an appropriate design methodology. The life of a ceramic component can be predicted with the NASA Lewis Research Center's Ceramics Analysis and Reliability Evaluation of Structures (CARES) integrated design programs. CARES/CREEP determines the expected life of a component under creep conditions, and CARES/LIFE predicts the component life due to fast fracture and subcritical crack growth. The previously developed CARES/LIFE program has been used in numerous industrial and Government applications.

Study protocol for a comparative effectiveness trial of two models of perinatal integrated psychosocial assessment: the PIPA project.

PubMed

Reilly, Nicole; Black, Emma; Chambers, Georgina M; Schmied, Virginia; Matthey, Stephen; Farrell, Josephine; Kingston, Dawn; Bisits, Andrew; Austin, Marie-Paule

2017-07-20

Studies examining psychosocial and depression assessment programs in maternity settings have not adequately considered the context in which psychosocial assessment occurs or how broader components of integrated care, including clinician decision-making aids, may optimise program delivery and its cost-effectiveness. There is also limited evidence relating to the diagnostic accuracy of symptom-based screening measures used in this context. The Perinatal Integrated Psychosocial Assessment (PIPA) Project was developed to address these knowledge gaps. The primary aims of the PIPA Project are to examine the clinical- and cost-effectiveness of two alternative models of integrated psychosocial care during pregnancy: 'care as usual' (the SAFE START model) and an alternative model (the PIPA model). The acceptability and perceived benefit of each model of care from the perspective of both pregnant women and their healthcare providers will also be assessed. Our secondary aim is to examine the psychometric properties of a number of symptom-based screening tools for depression and anxiety when used in pregnancy. This is a comparative-effectiveness study comparing 'care as usual' to an alternative model sequentially over two 12-month periods. Data will be collected from women at Time 1 (initial antenatal psychosocial assessment), Time 2 (2-weeks after Time 1) and from clinicians at Time 3 for each condition. Primary aims will be evaluated using a between-groups design, and the secondary aim using a within group design. The PIPA Project will provide evidence relating to the clinical- and cost- effectiveness of psychosocial assessment integrated with electronic clinician decision making prompts, and referral options that are tailored to the woman's psychosocial risk, in the maternity care setting. It will also address research recommendations from the Australian (2011) and NICE (2015) Clinical Practice Guidelines. ACTRN12617000932369.

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.

The cost effectiveness of an early transition from hospital to nursing home for stroke patients: design of a comparative study.

PubMed

Heijnen, Ron W H; Evers, Silvia M A A; van der Weijden, Trudy D E M; Limburg, Martien; Schols, Jos M G A

2010-05-26

As the incidence of stroke has increased, its impact on society has increased accordingly, while it continues to have a major impact on the individual. New strategies to further improve the quality, efficiency and logistics of stroke services are necessary. Early discharge from hospital to a nursing home with an adequate rehabilitation programme could help to optimise integrated care for stroke patients.The objective is to describe the design of a non-randomised comparative study evaluating early admission to a nursing home, with multidisciplinary assessment, for stroke patients. The study is comprised of an effect evaluation, an economic evaluation and a process evaluation. The design involves a non-randomised comparative trial for two groups. Participants are followed for 6 months from the time of stroke. The intervention consists of a redesigned care pathway for stroke patients. In this care pathway, patients are discharged from hospital to a nursing home within 5 days, in comparison with 12 days in the usual situation. In the nursing home a structured assessment takes place, aimed at planning adequate rehabilitation. People in the control group receive the usual care. The main outcome measures of the effect evaluation are quality of life and daily functioning. In addition, an economic evaluation will be performed from a societal perspective. A process evaluation will be carried out to evaluate the feasibility of the intervention as well as the experiences and opinions of patients and professionals. The results of this study will provide information about the cost effectiveness of the intervention and its effects on clinical outcomes and quality of life. Relevant strengths and weaknesses of the study are addressed in this article. Current Controlled Trails ISRCTN58135104.

Nevasic audio program for the prevention of chemotherapy induced nausea and vomiting: A feasibility study using a randomized controlled trial design.

PubMed

Moradian, Saeed; Walshe, Catherine; Shahidsales, Soodabeh; Ghavam Nasiri, Mohammad Reza; Pilling, Mark; Molassiotis, Alexander

2015-06-01

Pharmacological therapy is only partially effective in preventing or treating chemotherapy induced nausea and vomiting (CINV). Therefore, exploring the complementary role of non-pharmacological approaches used in addition to pharmacological agents is important. Nevasic uses specially constructed audio signals hypothesized to generate an antiemetic reaction. The aim of this study was to examine the feasibility of conducting a randomized controlled trial (RCT) to evaluate the effectiveness of Nevasic to control CINV. A mixed methods design incorporating an RCT and focus group interviews. For the RCT, female breast cancer patients were randomized to receive either Nevasic plus usual care, music plus usual care, or usual care only. Data were analysed using descriptive statistics and linear mixed-effects models. Five focus group interviews were conducted to obtain participants' views regarding the acceptability of the interventions in the trial. 99 participants were recruited to the RCT and 15 participated in focus group interviews. Recruitment targets were achieved. Issues of Nevasic acceptability were highlighted as weaknesses of the program. This study did not detect any evidence for the effectiveness of Nevasic; however, the results showed statistically significant less use of anti-emetics (p = 0.003) and borderline non-significant improvement in quality of life (p = 0.06). Conducting a non-pharmacological intervention using such an audio program is feasible, although difficulties and limitations exist with its use. Further studies are required to investigate the effectiveness of Nevasic from perspectives such as anti-emetic use, as well as its overall effect on the levels of nausea and vomiting. Copyright © 2014 Elsevier Ltd. All rights reserved.

Place Atrium to Water Seal (PAWS): Assessing Wall Suction Versus No Suction for Chest Tubes After Open Heart Surgery.

PubMed

Kruse, Tamara; Wahl, Sharon; Guthrie, Patricia Finch; Sendelbach, Sue

2017-08-01

Traditionally chest tubes are set to -20 cm H 2 O wall suctioning until removal to facilitate drainage of blood, fluid, and air from the pleural or mediastinal space in patients after open heart surgery. However, no clear evidence supports using wall suction in these patients. Some studies in patients after pulmonary surgery indicate that using chest tubes with a water seal is safer, because this practice decreases duration of chest tube placement and eliminates air leaks. To show that changing chest tubes to a water seal after 12 hours of wall suction (intervention) is a safe alternative to using chest tubes with wall suction until removal of the tubes (usual care) in patients after open heart surgery. A before-and-after quality improvement design was used to evaluate the differences between the 2 chest tube management approaches in chest tube complications, output, and duration of placement. A total of 48 patients received the intervention; 52 received usual care. The 2 groups (intervention vs usual care) did not differ significantly in complications (0 vs 2 events; P = .23), chest tube output (H 1 = 0.001, P = .97), or duration of placement (median, 47 hours for both groups). Changing chest tubes from wall suction to water seal after 12 hours of wall suction is a safe alternative to using wall suctioning until removal of the tubes. ©2017 American Association of Critical-Care Nurses.

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.

The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

PubMed Central

2011-01-01

Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of children with a mild intellectual disability. Trial registration Netherlands Trial Register (NTR): NTR2624 PMID:21878093

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.

Effect of Physician Notification Regarding Nonadherence to Colorectal Cancer Screening on Patient Participation in Fecal Immunochemical Test Cancer Screening

PubMed Central

Pogu, Corinne; Le Donné, Delphine; Latour, Chloé; Bianco, Gaelle; Nanin, France; Cowppli-Bony, Anne; Gaultier, Aurélie; Nguyen, Jean-Michel

2017-01-01

Importance Increasing participation in fecal screening tests is a major challenge in countries that have implemented colorectal cancer (CRC) screening programs. Objective To determine whether providing general practitioners (GPs) a list of patients who are nonadherent to CRC screening enhances patient participation in fecal immunochemical testing (FIT). Design, Setting, and Participants A 3-group, cluster-randomized study was conducted from July 14, 2015, to July 14, 2016, on the west coast of France, with GPs in 801 practices participating and involving adult patients (50-74 years) who were at average risk of CRC and not up-to-date with CRC screening. The final follow-up date was July 14, 2016. Interventions General practitioners were randomly assigned to 1 of 3 groups: 496 received a list of patients who had not undergone CRC screening (patient-specific reminders group, 10 476 patients), 495 received a letter describing region-specific CRC screening adherence rates (generic reminders group, 10 606 patients), and 455 did not receive any reminders (usual care group, 10 147 patients). Main Outcomes and Measures The primary end point was patient participation in CRC screening 1 year after the intervention. Results Among 1482 randomized GPs (mean age, 53.4 years; 576 women [38.9%]), 1446 participated; of the 33 044 patients of these GPs (mean age, 59.7 years; 17 949 women [54.3%]), follow-up at 1 year was available for 31 229 (94.5%). At 1 year, 24.8% (95% CI, 23.4%-26.2%) of patients in the specific reminders group, 21.7% (95% CI, 20.5%-22.8%) in the generic reminders group, and 20.6% (95% CI, 19.3%-21.8%) in the usual care group participated in the FIT screening. The between-group differences were 3.1% (95% CI, 1.3%-5.0%) for the patient-specific reminders group vs the generic reminders group, 4.2% (95% CI, 2.3%-6.2%) for the patient-specific reminders group vs the usual care group, and 1.1% (95% CI, −0.6% to 2.8%) for generic reminders group vs the usual care group. Conclusions and Relevance Providing French GPs caring for adults at average risk of CRC with a list of their patients who were not up-to-date with their CRC screening resulted in a small but significant increase in patient participation in FIT screening at 1 year compared with patients who received usual care. Providing GPs with generic reminders about regional rates of CRC screening did not increase screening rates compared with usual care. Trial Registration clinicaltrials.gov Identifier: NCT02515344 PMID:28873160

Long-Term Effects of Bereavement and Caregiver Intervention on Dementia Caregiver Depressive Symptoms

ERIC Educational Resources Information Center

Haley, William E.; Bergman, Elizabeth J.; Roth, David L.; McVie, Theresa; Gaugler, Joseph E.; Mittelman, Mary S.

2008-01-01

Purpose: The purpose of this study was to examine the joint effects of bereavement and caregiver intervention on caregiver depressive symptoms. Design and Methods: Alzheimer's caregivers from a randomized trial of an enhanced caregiver support intervention versus usual care who had experienced the death of their spouse (n = 254) were repeatedly…

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.

Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Bipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals. Pharmacists can contribute to the management of BD-I, mainly with the use of effective and safe drugs, and improve the patient’s life quality through pharmaceutical care. Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses; however, to our knowledge, there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD. The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I. Methods/design Randomized, controlled, prospective, single-center clinical trial with duration of 12 months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic. Patients diagnosed with BD-I aged between 18 and 65 years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic (Antioquia, Colombia) will be included. Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists, or into the control group who will receive usual care and verbal-written counseling regarding BD. Study outcomes will be assessed at baseline and at 3, 6, 9, and 12 months after randomization. The primary outcome will be to measure the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits. Effectiveness, safety, adherence, and quality of life will be assessed as secondary outcomes. Statistical analyses will be performed using two-tailed McNemar tests, Pearson chi-square tests, and Student’s t-tests; a P value <0.05 will be considered as statistically significant. Discussion As far as we know, this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals, solution of drug-related problems, and adherence. Trial registration Registration number NCT01750255 on August 6, 2012. First patient randomized on 24 November 2011. PMID:24885673

The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial.

PubMed

Bhattacharya, Debi; Aldus, Clare F; Barton, Garry; Bond, Christine M; Boonyaprapa, Sathon; Charles, Ian S; Fleetcroft, Robert; Holland, Richard; Jerosch-Herold, Christina; Salter, Charlotte; Shepstone, Lee; Walton, Christine; Watson, Steve; Wright, David J

2016-07-01

Medication organisation devices (MODs) provide compartments for a patient's medication to be organised into the days of the week and the recommended times the medication should be taken. To define the optimal trial design for testing the clinical effectiveness and cost-effectiveness of MODs. The feasibility study comprised a systematic review and focus groups to inform a randomised controlled trial (RCT) design. The resulting features were tested on a small scale, using a 2 × 2 factorial design to compare MODs with usual packaging and to compare weekly with monthly supply. The study design was then evaluated. Potential participants were identified by medical practices. Aged over 75 years, prescribed at least three solid oral dosage form medications, unintentionally non-adherent and self-medicating. Participants were excluded if deemed by their health-care team to be unsuitable. One of three MODs widely used in routine clinical practice supplied either weekly or monthly. To identify the most effective method of participant recruitment, to estimate the prevalence of intentional and unintentional non-adherence in an older population, to provide a point estimate of the effect size of MODs relative to usual care and to determine the feasibility and acceptability of trial participation. The systematic review included MOD studies of any design reporting medication adherence, health and social outcomes, resource utilisation or dispensing or administration errors. Focus groups with patients, carers and health-care professionals supplemented the systematic review to inform the RCT design. The resulting design was implemented and then evaluated through questionnaires and group discussions with participants and health-care professionals involved in trial delivery. Studies on MODs are largely of poor quality. The relationship between adherence and health outcomes is unclear. Of the limited studies reporting health outcomes, some reported a positive relationship while some reported increased hospitalisations associated with MODs. The pre-trial focus groups endorsed the planned study design, but suggested a minimum recruitment age of 50-60 years. A total of 35.4% of patients completing the baseline questionnaire were excluded because they already used a MOD. Active recruitment yielded a higher consent rate, but passive recruitment was more cost-effective. The prevalence of intentional non-adherence was 24.7% [n = 71, 95% confidence interval (CI) 19.7% to 29.6%] of participants. Of the remaining 76 participants, 46.1% (95% CI 34.8% to 57.3%) were unintentionally non-adherent. There was no indication of a difference in adherence between the study arms. Participants reported a high level of satisfaction with the design. Five adverse/serious adverse events were identified in the MOD study arms and none was identified in the control arms. There was no discernible difference in health economic outcomes between the four study arms; the mean intervention cost was £20 per month greater for MOD monthly relative to usual supply monthly. MOD provision to unintentionally non-adherent older people may cause medication-related adverse events. The primary outcome for a definitive MOD trial should be health outcomes. Such a trial should recruit patients by postal invitation and recruit younger patients. A study examining the association between MOD initiation and adverse effects is necessary and a strategy to safely introduce MODs should be explored. A definitive study testing the clinical effectiveness and cost-effectiveness of MODs is also required. Current Controlled Trials ISRCTN 30626972 and UKCRN 12739. This project was funded by National Institute for Health Research (NIHR) Health Technology Assessment Programme and will be published in full in Health Technology Assessment; Vol. 20, No. 50. See the NIHR Journals Library website for further project information.

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

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.…

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

Effect of exercise referral schemes in primary care on physical activity and improving health outcomes: systematic review and meta-analysis

PubMed Central

Taylor, A H; Fox, K R; Hillsdon, M; Anokye, N; Campbell, J L; Foster, C; Green, C; Moxham, T; Mutrie, N; Searle, J; Trueman, P; Taylor, R S

2011-01-01

Objective To assess the impact of exercise referral schemes on physical activity and health outcomes. Design Systematic review and meta-analysis. Data sources Medline, Embase, PsycINFO, Cochrane Library, ISI Web of Science, SPORTDiscus, and ongoing trial registries up to October 2009. We also checked study references. Study selection Design: randomised controlled trials or non-randomised controlled (cluster or individual) studies published in peer review journals. Population: sedentary individuals with or without medical diagnosis. Exercise referral schemes defined as: clear referrals by primary care professionals to third party service providers to increase physical activity or exercise, physical activity or exercise programmes tailored to individuals, and initial assessment and monitoring throughout programmes. Comparators: usual care, no intervention, or alternative exercise referral schemes. Results Eight randomised controlled trials met the inclusion criteria, comparing exercise referral schemes with usual care (six trials), alternative physical activity intervention (two), and an exercise referral scheme plus a self determination theory intervention (one). Compared with usual care, follow-up data for exercise referral schemes showed an increased number of participants who achieved 90-150 minutes of physical activity of at least moderate intensity per week (pooled relative risk 1.16, 95% confidence intervals 1.03 to 1.30) and a reduced level of depression (pooled standardised mean difference −0.82, −1.28 to −0.35). Evidence of a between group difference in physical activity of moderate or vigorous intensity or in other health outcomes was inconsistent at follow-up. We did not find any difference in outcomes between exercise referral schemes and the other two comparator groups. None of the included trials separately reported outcomes in individuals with specific medical diagnoses.Substantial heterogeneity in the quality and nature of the exercise referral schemes across studies might have contributed to the inconsistency in outcome findings. Conclusions Considerable uncertainty remains as to the effectiveness of exercise referral schemes for increasing physical activity, fitness, or health indicators, or whether they are an efficient use of resources for sedentary people with or without a medical diagnosis. PMID:22058134

Effects of music listening on anxiety and physiological responses in patients undergoing awake craniotomy.

PubMed

Wu, Pao-Yuan; Huang, Mei-Lin; Lee, Wen-Ping; Wang, Chi; Shih, Whei-Mei

2017-06-01

The purpose of this study was to explore the effects of music listening on the level of anxiety and physiological responses for awake craniotomy. An experimental design with randomization was applied in this study. Participants in experimental group (19 patients) selected and listened music at their preferences in the waiting room and throughout the entire surgical procedure in addition to usual care while control group (19 patients) only gave usual care. State-Trait Anxiety Inventory (STAI), heartbeat, breathing, and blood pressure were collected for analysis. The results of this study showed that after music listening, there was significant decrease in the level of anxiety (p<.001). The findings also showed that the music intervention significantly reduced heartbeat rate 84.5 (p<.004), systolic pressure 42 (p<.001), and diastolic pressure 38 (p<.001) over time. We concluded that music listening is associated with a decreased level of anxiety and distress after awake craniotomy patients. The results of this study can provide perioperative nursing care in providing music listening when patients were in the waiting room and during surgery to reduce the anxiety so as to reach the goal of human care and improve perioperative nursing care. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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

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.

Preventing sickness absenteeism among employees with common mental disorders or stress-related symptoms at work: Design of a cluster randomized controlled trial of a problem-solving based intervention versus care-as-usual conducted at the Occupational Health Services.

PubMed

Bergström, G; Lohela-Karlsson, M; Kwak, L; Bodin, L; Jensen, I; Torgén, M; Nybergh, L

2017-05-12

Common mental disorders (CMDs) are among the leading causes of sick leave in Sweden and other OECD countries. They result in suffering for the individual and considerable financial costs for the employer and for society at large. The occupational health service (OHS) can offer interventions in which both the individual and the work situation are taken into account. The aim of this paper is to describe the design of a study evaluating the effectiveness of an intervention given at the OHS to employees with CMDs or stress-related symptoms at work. In addition, intervention fidelity and its relation to the outcome will be assessed in a process analysis. The study is designed as a cluster randomized trial in which the participating OHS consultants are randomized into either delivering the intervention or performing care as usual. Employees with CMDs or stress-related symptoms at work are recruited consecutively by the OHS consultants. The intervention aims to improve the match between the employee and the job situation. Interviews are held individually with the employee and the nearest supervisor, after which a joint meeting with both the employee and the supervisor takes place. A participatory approach is applied by which the supervisor and the employee are guided by the OHS consultant and encouraged to actively take part in problem solving concerning the work situation. Outcomes will be assessed at baseline and at six and 12 months. A long-term follow-up at 3 years will also be performed. The primary outcome is registered sickness absence during a 1-year period after study inclusion. Secondary outcomes are mental health and work ability. The intervention's cost effectiveness, compared to treatment as usual, both for society and for the employer will be evaluated. A process evaluation by both the OHS consultants and the employee will be carried out. The study includes analyses of the effectiveness of the intervention (clinical and economic) as well as an analysis of its implementation at the participating OHSs. Possible methodological challenges such as selection bias and risk of contamination between OHS consultants delivering the experimental condition and consultants giving usual care are discussed. ClinicalTrials NCT02563743 Sep 28 2015.

Telemonitoring based service redesign for the management of uncontrolled hypertension: multicentre randomised controlled trial

PubMed Central

Hanley, Janet; Wild, Sarah; Pagliari, Claudia; Paterson, Mary; Lewis, Steff; Sheikh, Aziz; Krishan, Ashma; Stoddart, Andrew; Padfield, Paul

2013-01-01

Objective To determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure. Design Multicentre randomised controlled trial. Setting 20 primary care practices in south east Scotland. Participants 401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥135/85 mm Hg but ≤210/135 mm Hg). Intervention Self measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months. Main outcome measures Blinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation. Results 200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study. Conclusions Supported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective. Trial registration Current Controlled Trials ISRCTN72614272. PMID:23709583

Intraarticular Facet Injections for Low Back Pain: Design Considerations, Consensus Methodology to Develop the Protocol for a Randomized Controlled Trial.

PubMed

Mars, Tom; Ellard, David R; Antrobus, James H L; Cairns, Melinda; Underwood, Martin; Haywood, Kirstie; Keohane, Susie; Sandhu, Harbinder; Griffiths, Frances

2015-01-01

Since the publication of guidelines by the UK National Institute for Health and Care Excellence (NICE) and the American Pain Society guidelines for low back pain in 2009 there have been deep divisions in the pain treatment community about the use of therapeutic intraarticular facet joint injections. While evidence for the effectiveness or not of intraarticular facet joint injections remains sparse, uncertainty will remain. The Warwick feasibility study, along with a concurrent study with a different design led by another group, aims to provide a stable platform from which the effectiveness and cost effectiveness of intraarticular facet joint injections added to normal care could be evaluated in randomized controlled trials (RCTs). To reach consensus on key design considerations for the Warwick facet feasibility study from which the study protocol and working manuals will be developed. A consensus conference involving expert professionals and lay members. Preliminary work identified 5 key design considerations for deliberation at our consensus conference. Three concerned patient assessment and treatment: diagnosis of possible facet joint pain, interaarticular facet joint injection technique, and best usual care. Two concerned trial analysis: a priori sub-groups and minimally important difference and are reported elsewhere. We did systematic evidence reviews of the design considerations and summarized the evidence. Our design questions and evidence summaries were distributed to all delegates. This formed the basis for discussions on the day. Clinical experts in all aspects of facet joint injection from across the UK along with lay people were invited via relevant organizations. Nominal group technique was used in 15 facilitated initial small group discussions. Further discussion and ranking was undertaken in plenary. All small group and plenary results were recorded and checked and verified post conference. Where necessary participants were contacted via email to resolve outstanding issues. Fifty-two delegates attended the conference with lay people and all relevant professions represented. Consensus was reached on the details of how to assess patients for facet joint pain, undertake the injections, and deliver usual care. Where post conference checking of results revealed errors in calculating ranking results on the day, consensus was reached by email consultation. All but 3 delegates agreed to be associated with the outcome. Allocating one day for discussing a wide range of topics imposed time pressure on discussion and calculation of the numerous rankings. Through the use of an evidence-based, systematic, inclusive, and transparent process we have established consensus from expert health professionals in the UK, with lay input, on the clinical assessment of suspected facet joint pain, interaarticular injection for facet joint pain, and best usual care for use in a feasibility study for a proposed pragmatic clinical trial of interaarticular facet joint injections. This provides a strong basis for a clinical trial that will be acceptable to the pain treatment community.

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.

A Randomized Clinical Trial of the Collaborative Assessment and Management of Suicidality vs. Enhanced Care as Usual for Suicidal Soldiers

DTIC Science & Technology

2016-04-01

are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by...paragraph) describes the subject, purpose and scope of the research. This study is designed to investigate the effectiveness of a novel clinical... tests of significance shall be applied to all data whenever possible. Figures and graphs referenced in the text may be embedded in the text or

Active Pattern Factor Control for Gas Turbine Engines

NASA Technical Reports Server (NTRS)

May, James E.

1998-01-01

Small variations in fuel/air mixture ratios within gas turbine combustors can result in measurable, and potentially detrimental, exit thermal gradients. Thermal gradients can increase emissions, as well as shorten the design life of downstream turbomachinery, particularly stator vanes. Uniform temperature profiles are usually sought through careful design and manufacturing of related combustor components. However, small componentto-component variations as well as numerous aging effects degrade system performance. To compensate for degraded thermal performance, researchers are investigating active, closed-loop control schemes.

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.

Evaluation of a multicomponent programme for the management of musculoskeletal pain and depression in primary care: a cluster-randomised clinical trial (the DROP study).

PubMed

Aragonès, Enric; López-Cortacans, Germán; Caballero, Antonia; Piñol, Josep Ll; Sánchez-Rodríguez, Elisabet; Rambla, Concepció; Tomé-Pires, Catarina; Miró, Jordi

2016-03-16

Chronic musculoskeletal pain and depression are very common in primary care patients. Furthermore, they often appear as comorbid conditions, resulting in additive effect on adverse health outcomes. On the basis of previous studies, we hypothesise that depression and chronic musculoskeletal pain may benefit from an integrated management programme at primary care level. We expect positive effects on both physical and psychological distress of patients. To determine whether a new programme for an integrated approach to chronic musculoskeletal pain and depression leads to better outcomes than usual care. Cluster-randomised controlled trial involving two arms: a) control arm (usual care); and b) intervention arm, where patients participate in a programme for an integrated approach to the pain-depression dyad. Primary care centres in the province of Tarragona, Catalonia, Spain, Participants: We will recruit 330 patients aged 18-80 with moderate or severe musculoskeletal pain (Brief Pain Inventory, average pain subscale ≥5) for at least 3 months, and with criteria for major depression (DSM-IV). A multicomponent programme according to the chronic care model. The main components are care management, optimised antidepressant treatment, and a psychoeducational group action. Blind measurements: The patients will be monitored through blind telephone interviews held at 0, 3, 6 and 12 months. Severity of pain and depressive symptoms, pain and depression treatment response rates, and depression remission rates. The outcomes will be analysed on an intent-to-treat basis and the analysis units will be the individual patients. This analysis will consider the effect of the study design on any potential lack of independence between observations made within the same cluster. The protocol was approved by the Research Ethics Committee of the Jordi Gol Primary Care Research Institute (IDIAP), Barcelona, (P14/142). This project strengthens and improves treatment approaches for a major comorbidity in primary care. The design of the intervention takes into account its applicability under typical primary care conditions, so that if the programme is found to be effective it will be feasible to apply it in a generalised manner. ClinicalTrials.gov: NCT02605278 ; Registered 28 September, 2015.

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

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

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.

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.

Utilization of a multidisciplinary team for inpatient diabetes care.

PubMed

Pollom, Robyn K; Pollom, R Daniel

2004-01-01

Diabetes is often noted as a secondary diagnosis when patients are admitted to the hospital for care. Patients admitted to critical care areas are usually more ill and require aggressive glucose control. Often the education and self-care management skills needed for home management are overlooked until discharge, which can cause an increased length of stay. There is a feeling of frustration among nurses who are unable to adequately meet the needs of these patients and their families. In one community hospital setting, they have designed a model that identifies patient needs on admission and utilizes a multidisciplinary team. Beginning the "discharge" process early in the admission will ensure that a timely discharge with a well-trained patient will occur.

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.

A Model of Integrative Care for Low-Back Pain

PubMed Central

Buring, Julie E.; Hrbek, Andrea L.; Davis, Roger B.; Connelly, Maureen T.; Cherkin, Daniel C.; Levy, Donald B.; Cunningham, Mark; O'Connor, Bonnie; Post, Diana E.

2012-01-01

Abstract Objectives While previous studies focused on the effectiveness of individual complementary and alternative medical (CAM) therapies, the value of providing patients access to an integrated program involving multiple CAM and conventional therapies remains unknown. The objective of this study is to explore the feasibility and effects of a model of multidisciplinary integrative care for subacute low-back pain (LBP) in an academic teaching hospital. Design This was a pilot randomized trial comparing an individualized program of integrative care (IC) plus usual care to usual care (UC) alone for adults with LBP. Subjects Twenty (20) individuals with LPB of 3–12 weeks' duration were recruited from an occupational health clinic and community health center. Interventions Participants were randomized to 12 weeks of individualized IC plus usual care versus UC alone. IC was provided by a trained multidisciplinary team offering CAM therapies and conventional medical care. Outcome measures The outcome measures were symptoms (pain, bothersomeness), functional status (Roland-Morris score), SF-12, worry, and difficulty performing three self-selected activities. Results Over 12 weeks, participants in the IC group had a median of 12.0 visits (range 5–25). IC participants experienced significantly greater improvements at 12 weeks than those receiving UC alone in symptom bothersomeness (p=0.02) and pain (p=0.005), and showed greater improvement in functional status (p=0.08). Rates of improvement were greater for patients in IC than UC in functional status (p=0.02), bothersomeness (p=0.002), and pain scores (p=0.001). Secondary outcomes of self-selected most challenging activity, worry, and the SF-12 also showed improvement in the IC group at 12 weeks. These differences persisted at 26 weeks, but were no longer statistically significant. Conclusions It was feasible for a multidisciplinary, outpatient IC team to deliver coordinated, individualized intervention to patients with subacute LBP. Results showed a promising trend for benefit of treating patients with persistent LBP with this IC model, and warrant evaluation in a full-scale study. PMID:22455544

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.

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.

Holding Abusers Accountable: An Elder Abuse Forensic Center Increases Criminal Prosecution of Financial Exploitation

ERIC Educational Resources Information Center

Navarro, Adria E.; Gassoumis, Zachary D.; Wilber, Kathleen H.

2013-01-01

Purpose: Despite growing awareness of elder abuse, cases are rarely prosecuted. The aim of this study was to examine the effectiveness of an elder abuse forensic center compared with usual care to increase prosecution of elder financial abuse. Design and Methods: Using one-to-one propensity score matching, cases referred to the Los Angeles County…

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

Preventing Child Behavior Problems and Substance Use: The Pathways Home Foster Care Reunification Intervention

PubMed Central

DeGarmo, David S.; Reid, John B.; Fetrow, Becky A.; Fisher, Philip A.; Antoine, Karla D.

2013-01-01

This paper evaluated the Pathways Home manualized selective preventive intervention designed to prevent reunification failures once children are returned home to their biological parent(s) after first time stays in foster care (n = 101). The theoretically based intervention focused on support and parent management practices designed to prevent the development of child behavior problems including internalizing and externalizing problems, and substance use. Intent to treat analyses employed probability growth curve approaches for repeated telephone assessments over 16 weeks of intervention. Findings showed that relative to services as usual reunification families, the Pathways Home families demonstrated better parenting strategies that were in turn associated with reductions in problem behaviors over time. Growth in problem behaviors in turn predicted foster care re-entry. Maternal substance use cravings were a risk factor for growth in problem behaviors that were buffered by participation in the Pathways Home intervention. PMID:23914130

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 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.

Cost minimization analysis of a store-and-forward teledermatology consult system.

PubMed

Pak, Hon S; Datta, Santanu K; Triplett, Crystal A; Lindquist, Jennifer H; Grambow, Steven C; Whited, John D

2009-03-01

The aim of this study was to perform a cost minimization analysis of store-and-forward teledermatology compared to a conventional dermatology referral process (usual care). In a Department of Defense (DoD) setting, subjects were randomized to either a teledermatology consult or usual care. Accrued healthcare utilization recorded over a 4-month period included clinic visits, teledermatology visits, laboratories, preparations, procedures, radiological tests, and medications. Direct medical care costs were estimated by combining utilization data with Medicare reimbursement rates and wholesale drug prices. The indirect cost of productivity loss for seeking treatment was also included in the analysis using an average labor rate. Total and average costs were compared between groups. Teledermatology patients incurred $103,043 in total direct costs ($294 average), while usual-care patients incurred $98,365 ($283 average). However, teledermatology patients only incurred $16,359 ($47 average) in lost productivity cost while usual-care patients incurred $30,768 ($89 average). In total, teledermatology patients incurred $119,402 ($340 average) and usual-care patients incurred $129,133 ($372 average) in costs. From the economic perspective of the DoD, store-and-forward teledermatology was a cost-saving strategy for delivering dermatology care compared to conventional consultation methods when productivity loss cost is taken into consideration.

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.

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.

A novel approach to quality improvement in a safety-net practice: concurrent peer review visits.

PubMed

Fiscella, Kevin; Volpe, Ellen; Winters, Paul; Brown, Melissa; Idris, Amna; Harren, Tricia

2010-12-01

Concurrent peer review visits are structured office visits conducted by clinician peers of the primary care clinician that are specifically designed to reduce competing demands, clinical inertia, and bias. We assessed whether a single concurrent peer review visit reduced clinical inertia and improved control of hypertension, hyperlipidemia, and diabetes control among underserved patients. We conducted a randomized encouragement trial to evaluate concurrent peer review visits with a community health center. Seven hundred twenty-seven patients with hypertension, hyperlipidemia, and/or diabetes who were not at goal for systolic blood pressure (SBP), low-density lipoprotein cholesterol (LDL-C), and/or glycated hemoglobin (A1c) were randomly assigned to an invitation to participate in a concurrent peer review visit or to usual care. We compared change in these measures using mixed models and rates of therapeutic intensification during concurrent peer review visits with control visits. One hundred seventy-one patients completed a concurrent peer review visit. SBP improved significantly (p < .01) more among those completing concurrent peer review visits than among those who failed to respond to a concurrent peer review invitation or those randomized to usual care. There were no differences seen for changes in LDL-C or A1c. Concurrent peer review visits were associated with statistically significant greater clinician intensification of blood pressure (p < .001), lipid (p < .001), and diabetes (p < .005) treatment than either for control visits for patients in either the nonresponse group or usual care group. Concurrent peer review visits represent a promising strategy for improving blood pressure control and improving therapeutic intensification in community health centers.

An Economic Evaluation of Colorectal Cancer Screening in Primary Care Practice

PubMed Central

Meenan, Richard T.; Anderson, Melissa L.; Chubak, Jessica; Vernon, Sally W.; Fuller, Sharon; Wang, Ching-Yun; Green, Beverly B.

2015-01-01

Introduction Recent colorectal cancer screening studies focus on optimizing adherence. This study evaluated the cost effectiveness of interventions using electronic health records (EHRs), automated mailings, and stepped support increases to improve 2-year colorectal cancer screening adherence. Methods Analyses were based on a parallel-design, randomized trial in which three stepped interventions (EHR-linked mailings [“automated”], automated plus telephone assistance [“assisted”], or automated and assisted plus nurse navigation to testing completion or refusal [navigated”]) were compared to usual care. Data were from August 2008–November 2011 with analyses performed during 2012–2013. Implementation resources were micro-costed; research and registry development costs were excluded. Incremental cost-effectiveness ratios (ICERs) were based on number of participants current for screening per guidelines over 2 years. Bootstrapping examined robustness of results. Results Intervention delivery cost per participant current for screening ranged from $21 (automated) to $27 (navigated). Inclusion of induced testing costs (e.g., screening colonoscopy) lowered expenditures for automated (ICER=−$159) and assisted (ICER=−$36) relative to usual care over 2 years. Savings arose from increased fecal occult blood testing, substituting for more expensive colonoscopies in usual care. Results were broadly consistent across demographic subgroups. More intensive interventions were consistently likely to be cost effective relative to less intensive interventions, with willingness to pay values of $600–$1,200 for an additional person current for screening yielding ≥80% probability of cost effectiveness. Conclusions Two-year cost effectiveness of a stepped approach to colorectal cancer screening promotion based on EHR data is indicated, but longer-term cost effectiveness requires further study. PMID:25998922

[Designer drugs in Finland].

PubMed

Tacke, Ulrich; den Hollander, Bjørnar; Simojoki, Kaarlo; Korpi, Esa R; Pihlainen, Katja; Alho, Hannu

2011-01-01

Designer drugs are synthetic psychotropic drugs which are marketed as "legal drugs". Their emergence, rapid spreading and unpredictable effects have challenged the health and substance abuse care. The slow process of classification of an abusable drug has provided too many possibilities for spreading the designer drugs. Once a certain substance receives an illegal drugs classification, dealers and users usually move to another, slightly different molecule that is still legal. In Finland, the Narcotics Act has been amended to the effect that the addition of a new substance to the illegal drug list does not require an amendment to the law.

Effects of the hospital-based palliative care team on the care for cancer patients: an evaluation study.

PubMed

Kao, Chi-Yin; Hu, Wen-Yu; Chiu, Tai-Yuan; Chen, Ching-Yu

2014-02-01

The hospital-based palliative care team model has been implemented in most Western countries, but this model is new in Taiwan and there is little research to evaluate its outcomes. The purpose of this study was to evaluate the effects of the hospital-based palliative care team on the care for cancer patients. The design was a quasi-experimental study with a pretest-posttest design. A medical center, National Taiwan University Hospital in Taipei, Taiwan. Cancer patients were excluded after the hospital-based palliative care team visited if they were unable to give informed consent, were not well enough to finish the baseline assessment, were likely to die within 24h or would be discharged within 24h, or could not communicate in Mandarin or Taiwanese. A sample of 60 patients who consulted the hospital-based palliative care team was recruited. Patients recruited to the study were divided to receive the usual care only (control group, n=30) or the usual care plus visits from the hospital-based palliative care team (intervention group, n=30). Data were collected using questionnaires including the Symptom Distress Scale, Hospital Anxiety and Depression Scale, Spiritual Well-Being Scale, and Social Support Scale at the initial assessment and one week later. Comparison between groups revealed that the degree change for edema, fatigue, dry mouth, abdominal distention, and spiritual well-being in the intervention group showed significant improvement compared to the control group (p<0.05). However, there was no difference between groups on measures of anxiety, depression and feeling of social support. Within group analysis showed patients' pain score, dyspnea, and dysphagia improved in both groups (p<0.05). In addition, the average degree of constipation and insomnia in the control group declined from baseline (p<0.05), while the degree of edema, fatigue, dry mouth, appetite loss, abdominal distention, and dizziness decreased significantly in the intervention group (p<0.05). The findings indicated the hospital-based palliative care team can improve the care for patients in relation to symptom management and spiritual well-being. The hospital-based palliative care team is a good care model for patients and worth implementing in clinical practice in Taiwan. The results also provide a general understanding about how the hospital-based palliative care team works in Taiwanese culture. Copyright © 2013 Elsevier Ltd. All rights reserved.

Cost-effectiveness of acupuncture in an employee population: A retrospective analysis.

PubMed

Borah, Bijan J; Naessens, James M; Glasgow, Amy E; Bauer, Brent A; Chon, Tony Y

2017-04-01

To determine whether acupuncture is a cost-effective adjunct to usual care for Mayo Clinic employees and their dependents experiencing pain symptoms. Retrospective review of the medical and billing records of 466 employee-patients and their dependents who had received acupuncture as part of their care and 466 propensity score-matched control patients. Usual care in combination with acupuncture compared with usual care alone. The primary outcome measure was the total costs of care for all medical care and pharmacy services incurred from 1year before the index visit to 14 months after the index date. Secondary outcomes included the number of hospital visits, total inpatient days, emergency department visits, primary care or general medicine office visits, specialty office visits, and physical therapy services. Pain scores (patient-rated scores from 0 to 10) were extracted from the medical record, if available. Costs of care were similar between the 2 groups. No cost savings were noted for the acupuncture group. Several limitations to the study may have precluded a finding of cost-effectiveness. Future studies should include prospective evaluation of costs and other outcomes in a comparison between acupuncture and usual care in a randomized control trial. Copyright © 2017 Elsevier Ltd. All rights reserved.

Pain Coping Skills Training for Patients with Elevated Pain Catastrophizing who are Scheduled for Knee Arthroplasty: A Quasi-Experimental Study

PubMed Central

Riddle, Daniel L.; Keefe, Francis J.; Nay, William T.; McKee, Daphne; Attarian, David E.; Jensen, Mark P.

2011-01-01

Objectives To (1) describe a behavioral intervention designed for patients with elevated pain catastrophizing who are scheduled for knee arthroplasty, and (2) use a quasi-experimental design to evaluate the potential efficacy of the intervention on pain severity, catastrophizing cognitions, and disability. Design Quasi-experimental non-equivalent control group design with a 2 month follow-up. Setting Two university-based Orthopedic Surgery departments. Participants Adults scheduled for knee replacement surgery who reported elevated levels of pain catastrophizing. Patients were recruited from two clinics and were assessed prior to surgery and 2 months following surgery. Intervention A group of 18 patients received a psychologist directed pain coping skills training intervention comprising 8 sessions and the other group, a historical cohort of 45 patients, received usual care. Main Outcome Measures WOMAC Pain and Disability scores as well as scores on the Pain Catastrophizing Scale. Results Two months following surgery, the patients who received pain coping skills training reported significantly greater reductions in pain severity and catastrophizing, and greater improvements in function as compared to the usual care cohort. Conclusion Pain catastrophizing is known to increase risk of poor outcome following knee arthroplasty. The findings provide preliminary evidence that the treatment may be highly efficacious for reducing pain, catastrophizing, and disability, in patients reporting elevated catastrophizing prior to knee arthroplasty. A randomized clinical trial is warranted to confirm these effects. PMID:21530943

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.

[New integrated care model for older people admitted to Intermediate Care Units in Catalonia: A quasi-experimental study protocol].

PubMed

Santaeugènia, Sebastià J; García-Lázaro, Manuela; Alventosa, Ana María; Gutiérrez-Benito, Alícia; Monterde, Albert; Cunill, Joan

To evaluate the clinical effectiveness of an intermediate care model based on a system of care focused on integrated care pathways compared to the traditional model of geriatric care (usual care) in Catalonia. The design is a quasi-experimental pre-post non-randomised study with non-synchronous control group. The intervention consists of the development and implementation of integrated care pathways and the creation of specialised interdisciplinary teams in each of the processes. The two groups will be compared for demographic, clinical variables on admission and discharge, geriatric syndromes, and use of resources. This quasi-experimental study, aims to assess the clinical impact of the transformation of a traditional model of geriatric care to an intermediate care model in an integrated healthcare organisation. It is believed that the results of this study may be useful for future randomised controlled studies. Copyright © 2016 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

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

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

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.

Cost-effectiveness of a nurse-led internet-based vascular risk factor management programme: economic evaluation alongside a randomised controlled clinical trial

PubMed Central

Greving, J P; Kaasjager, H A H; Vernooij, J W P; Hovens, M M C; Wierdsma, J; Grandjean, H M H; van der Graaf, Y; de Wit, G A; Visseren, F L J

2015-01-01

Objective To assess the cost-effectiveness of an internet-based, nurse-led vascular risk factor management programme in addition to usual care compared with usual care alone in patients with a clinical manifestation of a vascular disease. Design Cost-effectiveness analysis alongside a randomised controlled trial (the Internet-based vascular Risk factor Intervention and Self-management (IRIS) study). Setting Multicentre trial in a secondary and tertiary healthcare setting. Participants 330 patients with a recent clinical manifestation of atherosclerosis in the coronary, cerebral, or peripheral arteries and with ≥2 treatable vascular risk factors not at goal. Intervention The intervention consisted of a personalised website with an overview and actual status of patients’ vascular risk factors, and mail communication with a nurse practitioner via the website for 12 months. The intervention combined self-management support, monitoring of disease control and pharmacotherapy. Main outcome measures Societal costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness. Results Patients experienced equal health benefits, that is, 0.86 vs 0.85 QALY (intervention vs usual care) at 1 year. Adjusting for baseline differences, the incremental QALY difference was −0.014 (95% CI −0.034 to 0.007). The intervention was associated with lower total costs (€4859 vs €5078, difference €219, 95% CI −€2301 to €1825). The probability that the intervention is cost-effective at a threshold value of €20 000/QALY, is 65%. At mean annual cost of €220 per patient, the intervention is relatively cheap. Conclusions An internet-based, nurse-led intervention in addition to usual care to improve vascular risk factors in patients with a clinical manifestation of a vascular disease does not result in a QALY gain at 1 year, but has a small effect on vascular risk factors and is associated with lower costs. Trial registration number NCT00785031. PMID:25995238

The HEART Pathway randomized trial: identifying emergency department patients with acute chest pain for early discharge.

PubMed

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

2015-03-01

The HEART Pathway is a decision aid designed to identify emergency department patients with acute chest pain for early discharge. No randomized trials have compared the HEART Pathway with usual care. Adult emergency department patients with symptoms related to acute coronary syndrome without ST-elevation on ECG (n=282) were randomized to the HEART Pathway or usual care. In the HEART Pathway arm, emergency department providers used the HEART score, a validated decision aid, and troponin measures at 0 and 3 hours to identify patients for early discharge. Usual care was based on American College of Cardiology/American Heart Association guidelines. The primary outcome, objective cardiac testing (stress testing or angiography), and secondary outcomes, index length of stay, early discharge, and major adverse cardiac events (death, myocardial infarction, or coronary revascularization), were assessed at 30 days by phone interview and record review. Participants had a mean age of 53 years, 16% had previous myocardial infarction, and 6% (95% confidence interval, 3.6%-9.5%) had major adverse cardiac events within 30 days of randomization. Compared with usual care, use of the HEART Pathway decreased objective cardiac testing at 30 days by 12.1% (68.8% versus 56.7%; P=0.048) and length of stay by 12 hours (9.9 versus 21.9 hours; P=0.013) and increased early discharges by 21.3% (39.7% versus 18.4%; P<0.001). No patients identified for early discharge had major adverse cardiac events within 30 days. The HEART Pathway reduces objective cardiac testing during 30 days, shortens length of stay, and increases early discharges. These important efficiency gains occurred without any patients identified for early discharge suffering MACE at 30 days. URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01665521. © 2015 American Heart Association, Inc.

Assessing sample representativeness in randomized controlled trials: application to the National Institute of Drug Abuse Clinical Trials Network.

PubMed

Susukida, Ryoko; Crum, Rosa M; Stuart, Elizabeth A; Ebnesajjad, Cyrus; Mojtabai, Ramin

2016-07-01

To compare the characteristics of individuals participating in randomized controlled trials (RCTs) of treatments of substance use disorder (SUD) with individuals receiving treatment in usual care settings, and to provide a summary quantitative measure of differences between characteristics of these two groups of individuals using propensity score methods. Design Analyses using data from RCT samples from the National Institute of Drug Abuse Clinical Trials Network (CTN) and target populations of patients drawn from the Treatment Episodes Data Set-Admissions (TEDS-A). Settings Multiple clinical trial sites and nation-wide usual SUD treatment settings in the United States. A total of 3592 individuals from 10 CTN samples and 1 602 226 individuals selected from TEDS-A between 2001 and 2009. Measurements The propensity scores for enrolling in the RCTs were computed based on the following nine observable characteristics: sex, race/ethnicity, age, education, employment status, marital status, admission to treatment through criminal justice, intravenous drug use and the number of prior treatments. Findings The proportion of those with ≥ 12 years of education and the proportion of those who had full-time jobs were significantly higher among RCT samples than among target populations (in seven and nine trials, respectively, at P < 0.001). The pooled difference in the mean propensity scores between the RCTs and the target population was 1.54 standard deviations and was statistically significant at P < 0.001. In the United States, individuals recruited into randomized controlled trials of substance use disorder treatments appear to be very different from individuals receiving treatment in usual care settings. Notably, RCT participants tend to have more years of education and a greater likelihood of full-time work compared with people receiving care in usual care settings. © 2016 Society for the Study of Addiction.

Accessing VA Healthcare During Large-Scale Natural Disasters.

PubMed

Der-Martirosian, Claudia; Pinnock, Laura; Dobalian, Aram

2017-01-01

Natural disasters can lead to the closure of medical facilities including the Veterans Affairs (VA), thus impacting access to healthcare for U.S. military veteran VA users. We examined the characteristics of VA patients who reported having difficulty accessing care if their usual source of VA care was closed because of natural disasters. A total of 2,264 veteran VA users living in the U.S. northeast region participated in a 2015 cross-sectional representative survey. The study used VA administrative data in a complex stratified survey design with a multimode approach. A total of 36% of veteran VA users reported having difficulty accessing care elsewhere, negatively impacting the functionally impaired and lower income VA patients.

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.

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.

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.

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).

Disparities in access to medical care for individuals with vision impairment.

PubMed

Spencer, Christine; Frick, Kevin; Gower, Emily W; Kempen, John H; Wolff, Jennifer L

2009-01-01

We investigated the relationship between blindness and vision impairment and access to medical care. Pooled data from the Medical Expenditure Panel Survey (MEPS) years 2002-2004 were used to identify non-institutionalized individuals over the age of 40 with either self-reported blindness, vision impairment, or no vision impairment (n = 40,643). Differences in access to care measures by vision status were assessed, after adjusting for the complex sampling design of the MEPS, using either two-sided z-tests or two-sided t-tests. Individuals with blindness and vision impairment report having more access problems related to cost of care, availability of insurance coverage, transportation issues, and refusal of services by providers, although they do not report lower rates of having a usual source of care compared to those without vision impairment. The results suggest that access to care for individuals with blindness and vision impairment is problematic, for reasons that are amenable to policy interventions.

A Randomized Clinical Trial of a Telephone Depression Intervention to Reduce Employee Presenteeism and Absenteeism

PubMed Central

Lerner, Debra; Adler, David A.; Rogers, William H.; Chang, Hong; Greenhill, Annabel; Cymerman, Elina; Azocar, Francisca

2015-01-01

Objectives The study tested an intervention aimed at improving work functioning among middle-aged and older adults with depression and work limitations. Methods A randomized clinical trial allocated an initial sample of 431 eligible employed adults (age ≥45) to a work-focused intervention (WFI) or usual care. Inclusion criteria were depression as measured by the Patient Health Questionnaire–9 (PHQ-9) and at-work limitations indicated by a productivity loss score ≥5% on the Work Limitations Questionnaire (WLQ). Study sites included 19 employers and five related organizations. Telephone-based counseling provided three integrated modalities: care coordination, cognitive-behavioral therapy strategy development, and work coaching and modification. Effectiveness (change in productivity loss scores from preintervention to four months postintervention) was tested with mixed models adjusted for confounders. Secondary outcomes included change in WLQ work performance scales, self-reported absences, and depression. Results Of 1,227 eligible employees (7% of screened), 431 (35%) enrolled and 380 completed the study (12% attrition). At-work productivity loss improved 44% in the WFI group versus 13% in usual care (difference in change, p<.001). WFI group scores on the four WLQ scales improved 44% to 47%, significantly better than in usual care (p<.001 for each scale). Absence days declined by 53% in the WFI group versus 13% in usual care (difference in change, p<.001). Mean PHQ-9 depression symptom severity scores declined 51% for WFI versus 26% for usual care (difference in change, p<.001). Conclusions The WFI was more effective than usual care at four-month follow-up. Given increasing efforts to provide more patient-centered, value-based care, the WFI could be an important resource. PMID:25726984

A randomized clinical trial of a telephone depression intervention to reduce employee presenteeism and absenteeism.

PubMed

Lerner, Debra; Adler, David A; Rogers, William H; Chang, Hong; Greenhill, Annabel; Cymerman, Elina; Azocar, Francisca

2015-06-01

The study tested an intervention aimed at improving work functioning among middle-aged and older adults with depression and work limitations. A randomized clinical trial allocated an initial sample of 431 eligible employed adults (age ≥45) to a work-focused intervention (WFI) or usual care. Inclusion criteria were depression as measured by the Patient Health Questionnaire-9 (PHQ-9) and at-work limitations indicated by a productivity loss score ≥5% on the Work Limitations Questionnaire (WLQ). Study sites included 19 employers and five related organizations. Telephone-based counseling provided three integrated modalities: care coordination, cognitive-behavioral therapy strategy development, and work coaching and modification. Effectiveness (change in productivity loss scores from preintervention to four months postintervention) was tested with mixed models adjusted for confounders. Secondary outcomes included change in WLQ work performance scales, self-reported absences, and depression. Of 1,227 eligible employees (7% of screened), 431 (35%) enrolled and 380 completed the study (12% attrition). At-work productivity loss improved 44% in the WFI group versus 13% in usual care (difference in change, p<.001). WFI group scores on the four WLQ scales improved 44% to 47%, significantly better than in usual care (p<.001 for each scale). Absence days declined by 53% in the WFI group versus 13% in usual care (difference in change, p<.001). Mean PHQ-9 depression symptom severity scores declined 51% for WFI versus 26% for usual care (difference in change, p<.001). The WFI was more effective than usual care at four-month follow-up. Given increasing efforts to provide more patient-centered, value-based care, the WFI could be an important resource.

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

Impact of care pathways for in-hospital management of COPD exacerbation: a systematic review.

PubMed

Lodewijckx, C; Sermeus, W; Panella, M; Deneckere, S; Leigheb, F; Decramer, M; Vanhaecht, K

2011-11-01

In-hospital management of COPD exacerbation is suboptimal, and outcomes are poor. Care pathways are a possible strategy for optimizing care processes and outcomes. The aim of the literature review was to explore characteristics of existing care pathways for in-hospital management of COPD exacerbations and to address their impact on performance of care processes, clinical outcomes, and team functioning. A literature search was conducted for articles published between 1990 and 2010 in the electronic databases of Medline, CINAHL, EMBASE, and Cochrane Library. Main inclusion criteria were (I) patients hospitalized for a COPD exacerbation; (II) implementation and evaluation of a care pathway; (III) report of original research, including experimental and quasi experimental designs, variance analysis, and interviews of professionals and patients about their perception on pathway effectiveness. Four studies with a quasi experimental design were included. Three studies used a pre-post test design; the fourth study was a non randomized controlled trial comparing an experimental group where patients were treated according to a care pathway with a control group where usual care was provided. The four studied care pathways were multidisciplinary structured care plans, outlining time-specific clinical interventions and responsibilities by discipline. Statistic analyses were rarely performed, and the trials used very divergent indicators to evaluate the impact of the care pathways. The studies described positive effects on blood sampling, daily weight measurement, arterial blood gas measurement, referral to rehabilitation, feelings of anxiety, length of stay, readmission, and in-hospital mortality. Research on COPD care pathways is very limited. The studies described few positive effects of the care pathways on diagnostic processes and on clinical outcomes. Though due to limited statistical analysis and weak design of the studies, the internal validity of results is limited. Therefore, based on these studies the impact of care pathways on COPD exacerbation is inconclusive. These findings indicate the need for properly designed research like a cluster randomized controlled trial to evaluate the impact of COPD care pathways on performance of care processes, clinical outcomes, and teamwork. Copyright © 2011 Elsevier Ltd. All rights reserved.

Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial.

PubMed

van der Zweerde, Tanja; Lancee, Jaap; Slottje, Pauline; Bosmans, Judith; Van Someren, Eus; Reynolds, Charles; Cuijpers, Pim; van Straten, Annemieke

2016-04-02

Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often. Offering CBT-I in an online format may increase access. Many studies have shown that online CBT for insomnia is effective. However, these studies have all been performed in general population samples recruited through media. This protocol article presents the design of a study aimed at establishing feasibility, effectiveness and cost-effectiveness of a guided online intervention (i-Sleep) for patients suffering from insomnia that seek help from their general practitioner as compared to care-as-usual. In a pragmatic randomized controlled trial, adult patients with insomnia disorder recruited through general practices are randomized to a 5-session guided online treatment, which is called "i-Sleep", or to care-as-usual. Patients in the care-as-usual condition will be offered i-Sleep 6 months after inclusion. An ancillary clinician, known as the psychological well-being practitioner who works in the GP practice (PWP; in Dutch: POH-GGZ), will offer online support after every session. Our aim is to recruit one hundred and sixty patients. Questionnaires, a sleep diary and wrist actigraphy will be administered at baseline, post intervention (at 8 weeks), and at 6 months and 12 months follow-up. Effectiveness will be established using insomnia severity as the main outcome. Cost-effectiveness and cost-utility (using costs per quality adjusted life year (QALY) as outcome) will be conducted from a societal perspective. Secondary measures are: sleep diary, daytime consequences, fatigue, work and social adjustment, anxiety, alcohol use, depression and quality of life. The results of this trial will help establish whether online CBT-I is (cost-) effective and feasible in general practice as compared to care-as-usual. If it is, then quality of care might be increased because implementation of i-Sleep makes it easier to adhere to insomnia guidelines. Strengths and limitations are discussed. Netherlands Trial register NTR 5202 (registered April 17(st) 2015).

Telemonitoring-based service redesign for the management of uncontrolled hypertension (HITS): cost and cost-effectiveness analysis of a randomised controlled trial

PubMed Central

Stoddart, Andrew; Hanley, Janet; Wild, Sarah; Pagliari, Claudia; Paterson, Mary; Lewis, Steff; Sheikh, Aziz; Krishan, Ashma; Padfield, Paul; McKinstry, Brian

2013-01-01

Objectives To compare the costs and cost-effectiveness of managing patients with uncontrolled blood pressure (BP) using telemonitoring versus usual care from the perspective of the National Health Service (NHS). Design Within trial post hoc economic evaluation of data from a pragmatic randomised controlled trial using an intention-to-treat approach. Setting 20 socioeconomically diverse general practices in Lothian, Scotland. Participants 401 primary care patients aged 29–95 with uncontrolled daytime ambulatory blood pressure (ABP) (≥135/85, but <210/135 mm Hg). Intervention Participants were centrally randomised to 6 months of a telemonitoring service comprising of self-monitoring of BP transmitted to a secure website for review by the attending nurse/doctor and patient, with optional automated patient decision-support by text/email (n=200) or usual care (n-201). Randomisation was undertaken with minimisation for age, sex, family practice, use of three or more hypertension drugs and self-monitoring history. Main outcome measures Mean difference in total NHS costs between trial arms and blinded assessment of mean cost per 1 mm Hg systolic BP point reduced. Results Home telemonitoring of BP costs significantly more than usual care (mean difference per patient £115.32 (95% CI £83.49 to £146.63; p<0.001)). Increased costs were due to telemonitoring service costs, patient training and additional general practitioner and nurse consultations. The mean cost of systolic BP reduction was £25.56/mm Hg (95% CI £16.06 to £46.89) per patient. Conclusions Over the 6-month trial period, supported telemonitoring was more effective at reducing BP than usual care but also more expensive. If clinical gains are maintained, these additional costs would be very likely to be compensated for by reductions in the cost of future cardiovascular events. Longer-term modelling of costs and outcomes is required to fully examine the cost-effectiveness implications. Trial registration International Standard Randomised Controlled Trials, number ISRCTN72614272. PMID:23793650

The role of self-regulatory skills and automaticity on the effectiveness of a brief weight loss habit-based intervention: secondary analysis of the 10 top tips randomised trial.

PubMed

Kliemann, Nathalie; Vickerstaff, Victoria; Croker, Helen; Johnson, Fiona; Nazareth, Irwin; Beeken, Rebecca J

2017-09-05

Habit-interventions are designed to promote the automaticity of healthy behaviours and may also enhance self-regulatory skills during the habit-formation process. A recent trial of habit-based advice for weight loss (10 Top Tips; 10TT), found that patients allocated to 10TT lost significantly more weight over 3 months than those allocated to usual care, and reported greater increases in automaticity for the target behaviours. The current study aimed to test the hypothesis that i) 10TT increased self-regulatory skills more than usual care, and ii) that self-regulatory skills and automaticity changes mediated the effect of 10TT on weight loss. 537 obese patients from 14 primary care practices in the UK were randomized to receive 10TT or usual care. Patients in the 10TT group received a leaflet containing tips for weight loss and healthy habits formation, a self-monitoring log book and a wallet-sized shopping guide on how to read food labels. Patients were weighed and completed validated questionnaires for self-regulation and automaticity at baseline and 3-month follow-up. Within-group and Between-group effects were explored using Paired T-test and ANCOVA, respectively. Mediation was assessed using bootstrapping to estimate indirect effects and the sobel test. Over 3 months patients who were given 10TT reported greater increases in self-regulatory skills (Mean difference: .08; 95% CI .01; .15) than those who received usual care. Changes in self-regulatory skills and automaticity over 3 months mediated the effect of the intervention on weight loss (β = .52, 95% Bias Corrected CI .17; .91). As hypothesised, 10TT enhanced self-regulatory skills and changes in self-regulatory skills and automaticity mediated the effect of the intervention on weight loss. This supports the proposition that self-regulatory training and habit formation are important features of weight loss interventions. This study was prospectively registered with the International Standard Randomised Controlled Trials ( ISRCTN16347068 ) on 26 September 2011.

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 .).

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.

The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

PubMed Central

2013-01-01

Background A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Methods Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster-level analysis. The overall costs and benefits of the program will also be assessed. Discussion The outcomes of the trial have the potential to inform actions to enhance leadership and management capabilities of the aged care workforce, address pressing issues about workforce shortages, and increase the quality of aged care services. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12611001070921) PMID:24160714

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.

Co-designing technologies in the context of hypertension care: Negotiating participation and technology use in design meetings.

PubMed

Lundin, Mona; Mäkitalo, Åsa

2017-01-01

Research Interest: In this article, we take an interest in the new kind of relation that has been claimed to be urgently required between health services and patients. Co-production of health services implies fundamental changes in the ways medical care is organized and delivered. Usually, technologies are put forth as potential solutions to problems that might occur when establishing such new relations. The aim of this study is to scrutinize how different perspectives were brought into the discussions as the concrete design and use of a mobile phone application were introduced, and how participants anticipated and negotiated their own participation in the design project. This article reports results from an explorative study of a co-design project in hypertension care wherein health professionals and patients were invited to co-design some features of the application they were later to use. The study shows that new practices of self-treatment are not likely to take place without the cooperation of patients, since they are to provide the observational data necessary for the professionals' work. The negotiations are needed to balance patients' concerns of being monitored by technology and their needs of being in control of their everyday lives and activities.

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

[Prehospital medical care organization during the 2003 G8 summit: a new concept of Mobile Medical Squadrons (MMS)].

PubMed

Carron, P-N; Yersin, B; Fishman, D; Ribordy, V

2005-06-01

The occurrence of the 2003 G8 summit in Evian and the threat of major civil riots or even terrorist attacks in the Swiss neighbourhood forced us to imagine a new system of rescue and medical care in case of numerous victims. Previous occurrences of the G8 in Europe or America have demonstrated the need of flexible and mobile structures, able to respond quickly to crowd movements, unlike the usual static structure of rescue systems designed for major accidents. We developed a new concept of Mobile Medical Squadrons (MMS) consisting of several vehicles and medical care and rescue human resources. In our concept, each MMS consisted of 3 emergency doctors, 5 paramedics and 9 first-aid workers. They were designed to handle 15 patients, with a large autonomy in terms of rescue, medical care, evacuation and medical authority. The equipment included medical, resuscitation, simple decontamination, evacuation and communication materials. The MMS were dispatched four times during the G8 summit following civil riots. They took care of 12 injured patients. The concept of MMS as a reinforcement of the existing rescue and health care resources appears as a new flexible, a modular and useful concept for the medical management of collective prehospital emergency situations. Its use is suggested instead of the traditional static concept of rescue systems designed for major accidents.

Evaluation of a practice team-supported exposure training for patients with panic disorder with or without agoraphobia in primary care - study protocol of a cluster randomised controlled superiority trial

PubMed Central

2014-01-01

Background Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders. A large number of patients with these conditions are treated by general practitioners in primary care. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study compares a practice team-supported, self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness. Methods/Design This is a cluster randomised controlled superiority trial with a two-arm parallel group design. General practices represent the units of randomisation. General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after six months (T1), and at follow-up after twelve months (T2). The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory (BAI). To detect a standardised effect size of 0.35 at T1, 222 patients from 37 general practices are included in each group. Secondary outcomes include anxiety-related clinical parameters and health-economic costs. Trial registration Current Controlled Trials [http://ISCRTN64669297] PMID:24708672

Improving hypertension management through pharmacist prescribing; the rural alberta clinical trial in optimizing hypertension (Rural RxACTION): trial design and methods

PubMed Central

2011-01-01

Background Patients with hypertension continue to have less than optimal blood pressure control, with nearly one in five Canadian adults having hypertension. Pharmacist prescribing is gaining favor as a potential clinically efficacious and cost-effective means to improve both access and quality of care. With Alberta being the first province in Canada to have independent prescribing by pharmacists, it offers a unique opportunity to evaluate outcomes in patients who are prescribed antihypertensive therapy by pharmacists. Methods The study is a randomized controlled trial of enhanced pharmacist care, with the unit of randomization being the patient. Participants will be randomized to enhanced pharmacist care (patient identification, assessment, education, close follow-up, and prescribing/titration of antihypertensive medications) or usual care. Participants are patients in rural Alberta with undiagnosed/uncontrolled blood pressure, as defined by the Canadian Hypertension Education Program. The primary outcome is the change in systolic blood pressure between baseline and 24 weeks in the enhanced-care versus usual-care arms. There are also three substudies running in conjunction with the project examining different remuneration models, investigating patient knowledge, and assessing health-resource utilization amongst patients in each group. Discussion To date, one-third of the required sample size has been recruited. There are 15 communities and 17 pharmacists actively screening, recruiting, and following patients. This study will provide high-level evidence regarding pharmacist prescribing. Trial Registration Clinicaltrials.gov NCT00878566. PMID:21834970

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.

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.

Is Specialized Integrated Treatment for Comorbid Anxiety, Depression and Alcohol Dependence Better than Treatment as Usual in a Public Hospital Setting?

PubMed

Morley, K C; Baillie, A; Leung, S; Sannibale, C; Teesson, M; Haber, P S

2016-07-01

To assess the effectiveness of a 12 week specialized, integrated intervention for alcohol dependence with comorbid anxiety and/or mood disorder using a randomized design in an outpatient hospital setting. Out of 86 patients meeting the inclusion criteria for alcohol dependence with suspicion of comorbid anxiety and/or depressive disorder, 57 completed a 3-week stabilization period (abstinence or significantly reduced consumption). Of these patients, 37 (65%) met a formal diagnostic assessment of an anxiety and/or depressive disorder and were randomized to either (a) integrated intervention (cognitive behavioural therapy) for alcohol, anxiety and/or depression, or (b) usual counselling care for alcohol problems. Intention-to-treat analyses revealed a beneficial treatment effect of integrated treatment relative to usual counselling care for the number of days to relapse (χ(2) = 6.42, P < 0.05) and lapse (χ(2) = 10.73, P < 0.01). In addition, there was a significant interaction effect of treatment and time for percentage days of abstinence (P < 0.05). For heavy drinking days, the treatment effect was mediated by changes in DASS anxiety (P < 0.05). There were no significant treatment interaction effects for DASS depression or anxiety symptoms. These results provide support for integrated care in improving drinking outcomes for patients with alcohol dependence and comorbid depression/anxiety disorder. ClinicalTrials.gov Identifier: NCT01941693. © The Author 2015. Medical Council on Alcohol and Oxford University Press. All rights reserved.

The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol

PubMed Central

2013-01-01

Background 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. Methods/Design 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. Discussion 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. Trial registration Australian New Zealand Clinical Trials Registry (ACTRN12612000363886); World Health Organisation (U1111-1128-0481). PMID:24359432

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…

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.

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

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.

[Realization of design regarding experimental research in the clinical real-world research].

PubMed

He, Q; Shi, J P

2018-04-10

Real world study (RWS), a further verification and supplement for explanatory randomized controlled trial to evaluate the effectiveness of intervention measures in real clinical environment, has increasingly become the focus in the field of research on medical and health care services. However, some people mistakenly equate real world study with observational research, and argue that intervention and randomization cannot be carried out in real world study. In fact, both observational and experimental design are the basic designs in real world study, while the latter usually refers to pragmatic randomized controlled trial and registry-based randomized controlled trial. Other nonrandomized controlled and adaptive designs can also be adopted in the RWS.

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.

A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis—the CopenHeartIE trial protocol

PubMed Central

Rasmussen, Trine Bernholdt; Zwisler, Ann-Dorthe; Sibilitz, Kirstine Lærum; Risom, Signe Stelling; Bundgaard, Henning; Gluud, Christian; Moons, Philip; Winkel, Per; Thygesen, Lau Caspar; Hansen, Jane Lindschou; Norekvål, Tone Merete; Berg, Selina Kikkenborg

2012-01-01

Introduction Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20–40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeartIE trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE. Methods and analysis We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences. Ethics and dissemination The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1-2011-129) and the Danish Data Protection Agency (no 2007-58-0015). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. Registration Clinicaltrials.gov identifier: NCT01512615. PMID:23175738

A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis--the CopenHeartIE trial protocol.

PubMed

Rasmussen, Trine Bernholdt; Zwisler, Ann-Dorthe; Sibilitz, Kirstine Lærum; Risom, Signe Stelling; Bundgaard, Henning; Gluud, Christian; Moons, Philip; Winkel, Per; Thygesen, Lau Caspar; Hansen, Jane Lindschou; Norekvål, Tone Merete; Berg, Selina Kikkenborg

2012-01-01

Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20-40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeart(IE) trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE. We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences. The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1-2011-129) and the Danish Data Protection Agency (no 2007-58-0015). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. Clinicaltrials.gov identifier: NCT01512615.

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.

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

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.

An intervention program with the aim to improve and maintain work productivity for workers with rheumatoid arthritis: design of a randomized controlled trial and cost-effectiveness study

PubMed Central

2012-01-01

Background Workers with rheumatoid arthritis (RA) often experience restrictions in functioning at work and participation in employment. Strategies to maintain work productivity exist, but these interventions do not involve the actual workplace. Therefore the aim of this study is to investigate the (cost)effectiveness of an intervention program at the workplace on work productivity for workers with RA. Methods/design This study is a randomized controlled trial (RCT) in specialized rheumatology treatment centers in or near Amsterdam, the Netherlands. Randomisation to either the control or the intervention group is performed at patient level. Both groups will receive care as usual by the rheumatologist, and patients in the intervention group will also take part in the intervention program. The intervention program consists of two components; integrated care, including a participatory workplace intervention. Integrated care involves a clinical occupational physician, who will act as care manager, to coordinate the care. The care manager has an intermediate role between clinical and occupational care. The participatory workplace intervention will be guided by an occupational therapist, and involves problem solving by the patient and the patients’ supervisor. The aim of the workplace intervention is to achieve consensus between patient and supervisor concerning feasible solutions for the obstacles for functioning at work. Data collection will take place at baseline and after 6 and 12 months by means of a questionnaire. The primary outcome measure is work productivity, measured by hours lost from work due to presenteeism. Secondary outcome measures include sick leave, quality of life, pain and fatigue. Cost-effectiveness of the intervention program will be evaluated from the societal perspective. Discussion Usual care of primary and outpatient health services is not aimed at improving work productivity. Therefore it is desirable to develop interventions aimed at improving functioning at work. If the intervention program will be (cost)effective, substantial improvements in work productivity might be obtained among workers with RA at lower costs. Results are expected in 2015. Trial registration number NTR2886 PMID:22747949

Feasibility and Initial Efficacy Evaluation of a Community-Based Cognitive-Behavioral Lifestyle Intervention to Prevent Excessive Weight Gain During Pregnancy in Latina Women.

PubMed

Gesell, Sabina B; Katula, Jeffrey A; Strickland, Carmen; Vitolins, Mara Z

2015-08-01

About 48 % of US women gain more weight during pregnancy than recommended by the Institute of Medicine (IOM). Excessive gestational weight gain is a major risk factor for obesity in both women and offspring over their lifetimes, and should be avoided. This study was designed to test the feasibility and initial efficacy of a prenatal behavioral intervention in a sample of low-income, predominantly Latina women. The intervention was delivered in groups of 8-10 women in a community recreation center, and structured to reduce the proportion of women who gained weight in excess of IOM guidelines. Recruitment targets were met in 3 months: 135 pregnant women (>10 and <28 weeks) were randomly assigned to receive a 12-week intervention (n = 68) or usual care (n = 67). Retention rate was 81 %. On average, women attended 4 of 12 group sessions, and each session had 4 of the 8-10 assigned participants in attendance. Initial efficacy analyses were based on 87 women. Compared to usual care, fewer normal-weight women in the intervention exceeded IOM recommendations (47.1 % usual care vs. 6.7 % intervention; absolute difference 40.4 %; p = .036). Recommendations for recruitment, retention, and delivery are discussed. A community-based cognitive-behavioral lifestyle intervention during pregnancy was feasible in a hard-to-reach, high-risk population of low-income Latina women, and showed efficacy in preventing excessive gestational weight gain. Due to frequently changing work schedules, strategies are needed to either increase attendance at group sessions (e.g., within a group prenatal care format) or to build core skills necessary for behavior change through other modalities.

An economic evaluation of colorectal cancer screening in primary care practice.

PubMed

Meenan, Richard T; Anderson, Melissa L; Chubak, Jessica; Vernon, Sally W; Fuller, Sharon; Wang, Ching-Yun; Green, Beverly B

2015-06-01

Recent colorectal cancer screening studies focus on optimizing adherence. This study evaluated the cost effectiveness of interventions using electronic health records (EHRs); automated mailings; and stepped support increases to improve 2-year colorectal cancer screening adherence. Analyses were based on a parallel-design, randomized trial in which three stepped interventions (EHR-linked mailings ["automated"]; automated plus telephone assistance ["assisted"]; or automated and assisted plus nurse navigation to testing completion or refusal [navigated"]) were compared to usual care. Data were from August 2008 to November 2011, with analyses performed during 2012-2013. Implementation resources were micro-costed; research and registry development costs were excluded. Incremental cost-effectiveness ratios (ICERs) were based on number of participants current for screening per guidelines over 2 years. Bootstrapping examined robustness of results. Intervention delivery cost per participant current for screening ranged from $21 (automated) to $27 (navigated). Inclusion of induced testing costs (e.g., screening colonoscopy) lowered expenditures for automated (ICER=-$159) and assisted (ICER=-$36) relative to usual care over 2 years. Savings arose from increased fecal occult blood testing, substituting for more expensive colonoscopies in usual care. Results were broadly consistent across demographic subgroups. More intensive interventions were consistently likely to be cost effective relative to less intensive interventions, with willingness to pay values of $600-$1,200 for an additional person current for screening yielding ≥80% probability of cost effectiveness. Two-year cost effectiveness of a stepped approach to colorectal cancer screening promotion based on EHR data is indicated, but longer-term cost effectiveness requires further study. Copyright © 2015 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

An Evaluation of a Clinical Pharmacy-Directed Intervention on Blood Pressure Control

PubMed Central

Kicklighter, Caroline E.; Nelson, Kent M.; Humphries, Tammy L.; Delate, Thomas

Objective To compare short and long term blood pressure control with clinical pharmacy specialist involvement to traditional physician management. Setting A non-profit health maintenance organization in the United States covering approximately 385,000 lives. Methods This analysis utilized a prospective parallel design. Adult patients with a baseline Blood pressure>140/90 mmHg and receiving at least one antihypertensive medication were eligible for the study. Eligible hypertension management patients at one medical office were referred to the office’s clinical pharmacy specialist (intervention cohort) while at another comparable medical office they received usual physician-directed care (control cohort). The primary outcome measure was achievement of a goal BP (<140/90 mmHg) during a six month follow-up. Medical records were also reviewed approximately 1.5 years post enrollment to assess long-term BP control after clinical pharmacy-managed patients returned to usual care. Multivariate analyses were performed to adjust for baseline cohort differences. Results One hundred-thirteen and 111 subjects in the intervention and control cohorts completed the study, respectively. At the end of the follow-up period, clinical pharmacy-managed subjects were more likely to have achieved goal BP (64.6%) and received a thiazide diuretic (68.1%) compared to control subjects (40.7% and 33.3%, respectively) (adjusted p=0.002 and p<0.001, respectively). The proportion of clinical pharmacy-managed subjects with controlled BP decreased to 22.2% after returning to usual care (p<0.001). Conclusion Clinical pharmacy involvement in hypertension management resulted in increased BP control. Loss of long-term control after discontinuation of clinical pharmacy management supports a change in care processes that prevent patients from being lost to follow-up. PMID:25214896

Reproductive health knowledge among African American women enrolled in a clinic-based randomized controlled trial to reduce psychosocial and behavioral risk, Project DC-HOPE

PubMed Central

Backonja, Uba; Robledo, Candace A.; Wallace, Maeve E.; Flores, Katrina F.; Kiely, Michele

2016-01-01

Background Washington, D.C. has among the highest rates of sexually transmitted infections (STIs) and unintended pregnancy in the United States. Increasing women’s reproductive health knowledge may help address these reproductive health issues. This analysis assessed whether high-risk pregnant African American women in Washington, D.C. who participated in an intervention to reduce behavioral and psychosocial risks had greater reproductive health knowledge than women receiving usual care. Methods Project DC-HOPE was a randomized controlled trial that included pregnant African American women in Washington, D.C., recruited during prenatal care. Women in the intervention group were provided reproductive health education and received tailored counseling sessions to address their psychosocial and behavioral risk(s) (cigarette smoking, environmental tobacco smoke exposure, depression, and intimate partner violence). Women in the control group received usual prenatal care. Participants completed a 10-item reproductive knowledge assessment at baseline (n=1,044) and postpartum (n=830). Differences in total reproductive health knowledge scores at baseline and postpartum between groups were examined via chi-squared tests. Differences in postpartum mean total score by group were assessed via multiple linear regression. Results Women in both groups and at both time points scored approximately 50% on the knowledge assessments. At postpartum, women in the intervention group had higher total scores compared to women receiving usual care (mean 5.40 [SD 1.60] vs. 5.03 [SD 1.53] out of 10, respectively; p<0.001). Conclusions While intervention participants increased reproductive health knowledge, overall scores remained low. Development of interventions designed to impart accurate, individually tailored information to women may promote reproductive health knowledge among high-risk pregnant African American women residing in Washington, D.C. PMID:27094910

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

Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial

PubMed Central

Wolf, Michael S.; Kaiser, Darren; Morrow, Daniel G.

2016-01-01

Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients' knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients' demonstrated medication use, regimen adherence, or glycemic control (HbA1c). Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633. PMID:27699179

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.

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.

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

Enhancing “usual practice” Treatment Foster Care: Findings from a randomized trial on improving youth outcomes

PubMed Central

Farmer, Elizabeth M.Z.; Burns, Barbara J.; Wagner, H. Ryan; Murray, Maureen; Southerland, Dannia G.

2009-01-01

Objectives This article reports the initial findings from a randomized trial to enhance Treatment Foster Care (TFC) in “usual care” agencies. The intervention, Together Facing the Challenge, was built upon a combination of practice-based elements from a prior descriptive study of TFC and selected elements from Chamberlain’s evidence-based model (MTFC) to fill conspicuous gaps in usual practice. The study was designed to examine whether additional training and consultation to staff and treatment parents improved outcomes for youth. Methods The study was conducted with 247 youth in TFC and their treatment parents from 14 TFC agencies in a southeastern state. Half of the agencies were randomized to the intervention condition and received study-provided training and consultation. Control agencies continued to provide training and treatment as usual. Data for the current analyses come from interviews with treatment parents at baseline, 6, and 12 months. Results Youth in the intervention group showed significant improvement (compared to the youth in the control group) on the three focal domains – symptoms, behaviors, and strengths. Effects were larger for behaviors and symptoms than for strengths. Conclusions This study employs a “hybrid” model to improve practice. It builds upon current practices in existing agencies and infuses additional training and consultation to overcome observed deficits. Such an approach has tremendous potential for moving beyond a singular focus on disseminating evidence-based interventions to a broader view of improving practice in a wide range of agencies. PMID:20513677

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

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.

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.

Cost-effectiveness of a transitional pharmaceutical care program for patients discharged from the hospital

PubMed Central

van der Knaap, Ronald; Bouhannouch, Fatiha; Borgsteede, Sander D.; Janssen, Marjo J. A.; Siegert, Carl E. H.; Egberts, Toine C. G.; van den Bemt, Patricia M. L. A.; van Wier, Marieke F.; Bosmans, Judith E.

2017-01-01

Background To improve continuity of care at hospital admission and discharge and to decrease medication errors pharmaceutical care programs are developed. This study aims to determine the cost-effectiveness of the COACH program in comparison with usual care from a societal perspective. Methods A controlled clinical trial was performed at the Internal Medicine department of a general teaching hospital. All admitted patients using at least one prescription drug were included. The COACH program consisted of medication reconciliation, patient counselling at discharge, and communication to healthcare providers in primary care. The primary outcome was the proportion of patients with an unplanned rehospitalisation within three months after discharge. Also, the number of quality-adjusted life-years (QALYs) was assessed. Cost data were collected using cost diaries. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios between the groups was estimated by bootstrapping. Results In the COACH program, 168 patients were included and in usual care 151 patients. There was no significant difference in the proportion of patients with unplanned rehospitalisations (mean difference 0.17%, 95% CI -8.85;8.51), and in QALYs (mean difference -0.0085, 95% CI -0.0170;0.0001). Total costs for the COACH program were non-significantly lower than usual care (-€1160, 95% CI -3168;847). Cost-effectiveness planes showed that the program was not cost-effective compared with usual care for unplanned rehospitalisations and QALYs gained. Conclusion The COACH program was not cost-effective in comparison with usual care. Future studies should focus on high risk patients and include other outcomes (e.g. adverse drug events) as this may increase the chances of a cost-effective intervention. Dutch trial register NTR1519 PMID:28445474

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

PubMed

Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

2018-05-01

 Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol.  RBR-6XTS8Z. The Faculty of Homeopathy.

Coordinating resources for prospective medication risk management of older home care clients in primary care: procedure development and RCT study design for demonstrating its effectiveness.

PubMed

Toivo, Terhi; Dimitrow, Maarit; Puustinen, Juha; Savela, Eeva; Pelkonen, Katariina; Kiuru, Valtteri; Suominen, Tuula; Kinnunen, Sirkka; Uunimäki, Mira; Kivelä, Sirkka-Liisa; Leikola, Saija; Airaksinen, Marja

2018-03-16

The magnitude of safety risks related to medications of the older adults has been evidenced by numerous studies, but less is known of how to manage and prevent these risks in different health care settings. The aim of this study was to coordinate resources for prospective medication risk management of home care clients ≥ 65 years in primary care and to develop a study design for demonstrating effectiveness of the procedure. Health care units involved in the study are from primary care in Lohja, Southern Finland: home care (191 consented clients), the public healthcare center, and a private community pharmacy. System based risk management theory and action research method was applied to construct the collaborative procedure utilizing each profession's existing resources in medication risk management of older home care clients. An inventory of clinical measures in usual clinical practice and systematic review of rigorous study designs was utilized in effectiveness study design. The new coordinated medication management model (CoMM) has the following 5 stages: 1) practical nurses are trained to identify clinically significant drug-related problems (DRPs) during home visits and report those to the clinical pharmacist. Clinical pharmacist prepares the cases for 2) an interprofessional triage meeting (50-70 cases/meeting of 2 h) where decisions are made on further action, e.g., more detailed medication reviews, 3) community pharmacists conduct necessary medication reviews and each patients' physician makes final decisions on medication changes needed. The final stages concern 4) implementation and 5) follow-up of medication changes. Randomized controlled trial (RCT) was developed to demonstrate the effectiveness of the procedure. The developed procedure is feasible for screening and reviewing medications of a high number of older home care clients to identify clients with severe DRPs and provide interventions to solve them utilizing existing primary care resources. The study is registered in the Clinical Trials.gov ( NCT02545257 ). Registration date September 9 2015.

Effect of patient navigation on satisfaction with cancer-related care.

PubMed

Wells, Kristen J; Winters, Paul C; Jean-Pierre, Pascal; Warren-Mears, Victoria; Post, Douglas; Van Duyn, Mary Ann S; Fiscella, Kevin; Darnell, Julie; Freund, Karen M

2016-04-01

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. 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. 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. 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. clinicaltrials.gov identifiers: NCT00613275 , NCT00496678 , NCT00375024 , NCT01569672.

An Educational Intervention to Train Community Pharmacists in Providing Specialized Asthma Care

PubMed Central

Smith, Lorraine; Armour, Carol; Krass, Ines

2006-01-01

Objectives The development, implementation, and evaluation of an educational intervention to facilitate specialized asthma care provision by community pharmacists. Design Formative evaluation and a parallel group repeated measures design were used to test the effect of an educational intervention on pharmacist satisfaction and practice behavior as well as patient outcomes. The educational intervention was based on practitioner needs and principles of adult learning using flexible delivery formats. Assessment In the intervention area, 15 pharmacists were trained with the educational intervention, and they provided specialized asthma care to 52 patients over 6 months, while in the control area, 12 pharmacists provided “usual care” to 50 patients. The intervention pharmacists were highly satisfied with the education received and rated most aspects highly. Improvements in patient clinical, humanistic, and economic outcomes in the intervention area were obtained. Conclusion The positive results of the educational intervention demonstrate the effectiveness of an educational approach grounded in the theory that inducing behavioral changes in pharmacy practitioners results in improved patient outcomes. PMID:17149447

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

Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study.

PubMed

Salazar-Ospina, Andrea; Amariles, Pedro; Hincapié-García, Jaime A; González-Avendaño, Sebastián; Benjumea, Dora M; Faus, Maria José; Rodriguez, Luis F

2017-01-01

Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I. To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up. This study is based on the EMDADER-TAB trial, which was an RCT designed to compare pharmaceutical care with the usual care given to outpatients with BD-I in a psychiatric clinic. The main outcome was the use of health care services, using Kaplan-Meier methods and Cox regression. The trial protocol was registered in ClinicalTrials.gov (Identifier NCT01750255). 92 patients were included in the EMDADER-TAB study: 43 pharmaceutical care patients (intervention group) and 49 usual care patients (control group). At baseline, no significant differences in demographic and clinical characteristics were found across the 2 groups. After 1 year of follow-up, the risk of hospitalizations and emergencies was higher for the control group than for the intervention group (HR = 9.03, P = 0.042; HR = 3.38, P = 0.034, respectively); however, the risk of unscheduled outpatient visits was higher for the intervention group (HR = 4.18, P = 0.028). There was no "placebo" treatment, and patients in the control group might have produced positive outcomes and reduced the magnitude of differences compared with the intervention group. Compared with usual care, pharmaceutical care significantly reduced hospitalizations and emergency service consultations by outpatients with BD-I. This study received funding from the Universidad de Antioquia, Committee for Development Research and Sustainability Program, CODI, (2013-2014 and 2014-2015). Humax Pharmaceutical provided support for the initial development of the EMDADER-TAB trial without commercial interest in the outcomes derived from the trial. Salazar-Ospina reports grants from Credito Beca Francisco José de Caldas Scholarship for Doctoral Programs (528), which also contributed to the support of this study. González-Avendaño is an employee of Humax Pharmaceutical. The other authors have nothing to disclose. Study concept and design were contributed by Benjumea, Faus, and Rodriguez, along with Salazar-Ospina and Amariles. Salazar-Ospina took the lead in data collection, assisted by González-Avendaño, and data interpretation was performed by Salazar-Ospina, Hincapié-García, and González-Avendaño. The manuscript was written primarily by Salazar-Ospina, with assistance from Amariles and González-Avendaño, and revised by all the authors.

Rationale and study design of a patient-centered intervention to improve health status in chronic heart failure: The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) randomized trial.

PubMed

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

2016-11-01

While contemporary heart failure management has led to some improvements in morbidity and mortality, patients continue to report poor health status (i.e., burdensome symptoms, impaired function, and poor quality of life). The Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) trial is a NIH-funded, three-site, randomized clinical trial that examines the effect of the CASA intervention compared to usual care on the primary outcome of patient-reported health status at 6months in patients with heart failure and poor health status. The CASA intervention involves a nurse who works with patients to treat symptoms (e.g., shortness of breath, fatigue, pain) using disease-specific and palliative approaches, and a social worker who provides psychosocial care targeting depression and adjustment to illness. The intervention uses a collaborative care team model of health care delivery and is structured and primarily phone-based to enhance reproducibility and scalability. This article describes the rationale and design of the CASA trial, including several decision points: (1) how to design a patient-centered intervention to improve health status; (2) how to structure the intervention so that it is reproducible and scalable; and (3) how to systematically identify outpatients with heart failure most likely to need and benefit from the intervention. The results should provide valuable information to providers and health systems about the use of team care to manage symptoms and provide psychosocial care in chronic illness. Published by Elsevier Inc.

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

Evaluation of an education and activation programme to prevent chronic shoulder complaints: design of an RCT [ISRCTN71777817

PubMed Central

Bruijn, Camiel De; de Bie, Rob; Geraets, Jacques; Goossens, Marielle; Köke, Albère; van den Heuvel, Wim; van der Heijden, Geert; Dinant, Geert-Jan

2005-01-01

Background About half of all newly presented episodes of shoulder complaints (SC) in general practice are reported to last for at least six months. Early interventions aimed at the psychological and social determinants of SC are not common in general practice, although such interventions might prevent the development of chronic SC. The Education and Activation Programme (EAP) consists of an educational part and a time-contingent activation part. The aim of the EAP is to provide patients with the proper cognitions by means of education, and to stimulate adequate behaviour through advice on activities of daily living. Design The article describes the design of a randomised clinical trial (RCT) to evaluate the effectiveness and cost-effectiveness of an EAP in addition to usual care, compared to usual care only, in the prevention of chronic SC after six months. It also describes the analysis of the cost and effect balance. Patients suffering from SC for less than three months are recruited in general practice and through open recruitment. A trained general practitioner or a trained therapist administers the EAP. Primary outcome measures are patient-perceived recovery, measured by self-assessment on a seven-point scale, and functional limitations in activities of daily living. Questionnaires are used to study baseline measures, prognostic measures, process measures and outcome measures. Discussion The inclusion of patients in the study lasted until December 31st 2003. Data collection is to end in June 2004. PMID:15715914

The modern CIO: forging a new role in the managed care era.

PubMed

Griffin, J

1997-05-01

The advent of managed care has helped forge new roles for healthcare professionals. Competitive pressures, the profile of the member community, and provider network design drive healthcare delivery via the managed care model. Careful analysis and design of the managed care model charts the success or failure of the health care delivery system--usually an integrated delivery system (IDS). Therefore, those healthcare organizations that have chosen to get on the managed care bandwagon must re-invent themselves, both culturally and technologically. The chief information officer (CIO) leads this technological revolution. To work effectively, the technological infrastructure of the IDS must be closely in line with enterprise goals and objectives. In the managed care environment the old information system (IS) approach of supporting the operational needs of individual departments simply will not work. The CIO's new role will be to master the concept of managed care to ensure that enterprise-wide needs for operational, clinical, and financial information are met, and that IS and enterprise goals are aligned. CIOs who have an intuitive grasp of the managed care environment--although their numbers are growing as managed care mushrooms--make up a minority group. They are a special breed with clearly definable qualities such as business savvy and an affinity for big-picture thinking. To an IDS, a CIO with these qualities is a rare gem indeed. This article introduces Don Winschel, the associate administrator and CIO of Johnson City Medical Center (Johnson City, TN) as an example of one such modern CIO.

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 a value-based insurance design for back pain on health plan member satisfaction and its implications for patient outcomes.

PubMed

Maeng, Daniel D; Fisher, Dorothy Y; Graboski, Anthony; Allison, Peiling L; Rodriguez, Jennifer M; Starr, Alison E; Tomcavage, Janet F; Davis, Duane E

2015-06-01

Back pain is one of the most common reasons for seeking care, and physical therapy (PT) can be an effective treatment option. However, PT coverage for back pain varies widely among private health plans, usually requiring high cost sharing, thereby potentially leading to member dissatisfaction and worse outcomes. In this study, a quasi-experimental design was used to estimate the impact of a new value-based insurance design for back pain-related PT on selected Consumer Assessment of Healthcare Providers and Systems survey items. Under this design, eligible members receive a bundle of 5 PT sessions for a 1-time co-payment; if deemed necessary, the bundle is renewable for 1 additional co-payment. The results indicate that the proportion of members reporting the highest satisfaction rating was higher by about 6 to 10 percentage points among those who received the PT bundle. The data also indicate that those PT bundle members who reported the highest satisfaction rating had improvements in their functional status scores that were roughly 3 to 4 times higher than those who reported a lower satisfaction rating. These findings suggest that providing a value-based insurance design for back pain-related PT can potentially improve health plan members' care experiences and their overall satisfaction. Further study is needed to determine its impact on back pain-related medical care utilization and cost of care.

Interventions for preventing and treating low-back and pelvic pain during pregnancy.

PubMed

Liddle, Sarah D; Pennick, Victoria

2015-09-30

More than two-thirds of pregnant women experience low-back pain and almost one-fifth experience pelvic pain. The two conditions may occur separately or together (low-back and pelvic pain) and typically increase with advancing pregnancy, interfering with work, daily activities and sleep. To update the evidence assessing the effects of any intervention used to prevent and treat low-back pain, pelvic pain or both during pregnancy. We searched the Cochrane Pregnancy and Childbirth (to 19 January 2015), and the Cochrane Back Review Groups' (to 19 January 2015) Trials Registers, identified relevant studies and reviews and checked their reference lists. Randomised controlled trials (RCTs) of any treatment, or combination of treatments, to prevent or reduce the incidence or severity of low-back pain, pelvic pain or both, related functional disability, sick leave and adverse effects during pregnancy. Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. We included 34 RCTs examining 5121 pregnant women, aged 16 to 45 years and, when reported, from 12 to 38 weeks' gestation. Fifteen RCTs examined women with low-back pain (participants = 1847); six examined pelvic pain (participants = 889); and 13 examined women with both low-back and pelvic pain (participants = 2385). Two studies also investigated low-back pain prevention and four, low-back and pelvic pain prevention. Diagnoses ranged from self-reported symptoms to clinicians' interpretation of specific tests. All interventions were added to usual prenatal care and, unless noted, were compared with usual prenatal care. The quality of the evidence ranged from moderate to low, raising concerns about the confidence we could put in the estimates of effect. For low-back painResults from meta-analyses provided low-quality evidence (study design limitations, inconsistency) that any land-based exercise significantly reduced pain (standardised mean difference (SMD) -0.64; 95% confidence interval (CI) -1.03 to -0.25; participants = 645; studies = seven) and functional disability (SMD -0.56; 95% CI -0.89 to -0.23; participants = 146; studies = two). Low-quality evidence (study design limitations, imprecision) also suggested no significant differences in the number of women reporting low-back pain between group exercise, added to information about managing pain, versus usual prenatal care (risk ratio (RR) 0.97; 95% CI 0.80 to 1.17; participants = 374; studies = two). For pelvic painResults from a meta-analysis provided low-quality evidence (study design limitations, imprecision) of no significant difference in the number of women reporting pelvic pain between group exercise, added to information about managing pain, and usual prenatal care (RR 0.97; 95% CI 0.77 to 1.23; participants = 374; studies = two). For low-back and pelvic painResults from meta-analyses provided moderate-quality evidence (study design limitations) that: an eight- to 12-week exercise program reduced the number of women who reported low-back and pelvic pain (RR 0.66; 95% CI 0.45 to 0.97; participants = 1176; studies = four); land-based exercise, in a variety of formats, significantly reduced low-back and pelvic pain-related sick leave (RR 0.76; 95% CI 0.62 to 0.94; participants = 1062; studies = two).The results from a number of individual studies, incorporating various other interventions, could not be pooled due to clinical heterogeneity. There was moderate-quality evidence (study design limitations or imprecision) from individual studies suggesting that osteomanipulative therapy significantly reduced low-back pain and functional disability, and acupuncture or craniosacral therapy improved pelvic pain more than usual prenatal care. Evidence from individual studies was largely of low quality (study design limitations, imprecision), and suggested that pain and functional disability, but not sick leave, were significantly reduced following a multi-modal intervention (manual therapy, exercise and education) for low-back and pelvic pain.When reported, adverse effects were minor and transient. There is low-quality evidence that exercise (any exercise on land or in water), may reduce pregnancy-related low-back pain and moderate- to low-quality evidence suggesting that any exercise improves functional disability and reduces sick leave more than usual prenatal care. Evidence from single studies suggests that acupuncture or craniosacral therapy improves pregnancy-related pelvic pain, and osteomanipulative therapy or a multi-modal intervention (manual therapy, exercise and education) may also be of benefit.Clinical heterogeneity precluded pooling of results in many cases. Statistical heterogeneity was substantial in all but three meta-analyses, which did not improve following sensitivity analyses. Publication bias and selective reporting cannot be ruled out.Further evidence is very likely to have an important impact on our confidence in the estimates of effect and change the estimates. Studies would benefit from the introduction of an agreed classification system that can be used to categorise women according to their presenting symptoms, so that treatment can be tailored accordingly.

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

PubMed

Wylde, Vikki; Bertram, Wendy; Beswick, Andrew D; Blom, Ashley W; Bruce, Julie; Burston, Amanda; Dennis, Jane; Garfield, Kirsty; Howells, Nicholas; Lane, Athene; McCabe, Candy; Moore, Andrew J; Noble, Sian; Peters, Tim J; Price, Andrew; Sanderson, Emily; Toms, Andrew D; Walsh, David A; White, Simon; Gooberman-Hill, Rachael

2018-02-21

Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement. ISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.

Effects of Nurse-Led Telephone-Based Supportive Interventions for Patients With Cancer: A Meta-Analysis.

PubMed

Suh, Soon-Rim; Lee, Myung Kyung

2017-07-01

To evaluate the effects of nurse-led telephone-based supportive interventions (NTSIs) for patients with cancer.
. Electronic databases, including EMBASE®, MEDLINE, Google Scholar, 
Cochrane Library CENTRAL, ProQuest Medical Library, and CINAHL®, were searched through February 2016.
. 239 studies were identified; 16 were suitable for meta-analysis. Cochrane's risk of bias tool and the Comprehensive Meta-Analysis software were used.
. The authors performed a meta-analysis of 16 trials that met eligibility criteria. Thirteen randomized, controlled trials (RCTs) and three non-RCTs examined a total of 2,912 patients with cancer. Patients who received NTSIs were compared with those who received attentional control or usual care (no intervention).
. Telephone interventions delivered by a nurse in an oncology care setting reduced cancer symptoms with a moderate effect size (ES) (-0.33) and emotional distress with a small ES (-0.12), and improved self-care with a large ES (0.64) and health-related quality of life (HRQOL) with a small ES (0.3). Subgroup analyses indicated that the significant effects of NTSIs on cancer symptoms, emotional distress, and HRQOL were larger for studies that combined an application of a theoretical framework, had a control group given usual care, and used an RTC design.
. The findings suggest that an additional tiered evaluation that has a theoretical underpinning and high-quality methodology is required to confirm the efficacy of NTSI for adoption of specific care models.

Examination of the Effects of an Intervention Aiming to Link Patients Receiving Addiction Treatment With Health Care: The LINKAGE Clinical Trial.

PubMed

Weisner, Constance M; Chi, Felicia W; Lu, Yun; Ross, Thekla B; Wood, Sabrina B; Hinman, Agatha; Pating, David; Satre, Derek; Sterling, Stacy A

2016-08-01

Research has shown that higher activation and engagement with health care is associated with better self-management. To our knowledge, the linkage intervention (LINKAGE) is the first to engage patients receiving addiction treatment with health care using the electronic health record and a patient activation approach. To examine the effects of an intervention aiming to link patients receiving addiction treatment with health care. A nonrandomized clinical trial evaluating the LINKAGE intervention vs usual care by applying an alternating 3-month off-and-on design over 30 months. Participants were recruited from an outpatient addiction treatment clinic in a large health system between April 7, 2011, and October 2, 2013. Six group-based, manual-guided sessions on patient engagement in health care and the use of health information technology resources in the electronic health record, as well as facilitated communication with physicians, vs usual care. Primary outcomes, measured at 6 months after enrollment, were patient activation (by interview using the Patient Activation Measure), patient engagement in health care (by interview and electronic health record), and alcohol, drug, and depression outcomes (by interview using the Addiction Severity Index for alcohol and drug outcomes and Patient Health Questionnaire (PHQ) for depression). A total of 503 patients were recruited and assigned to the LINKAGE (n = 252) or usual care (n = 251) conditions, with no differences in baseline characteristics between conditions. The mean (SD) age of the patients was 42.5 (11.8) years, 31.0% (n = 156) were female, and 455 (90.5%) completed the 6-month interview. Compared with usual care participants, LINKAGE participants showed an increase in the mean number of log-in days (incidence rate ratio, 1.53; 95% CI, 1.19-1.97; P = .001). Similar results were found across types of patient portal use (communicating by email, viewing laboratory test results and information, and obtaining medical advice). LINKAGE participants were more likely to talk with their physicians about addiction problems (odds ratio, 2.30; 95% CI, 1.52-3.49; P < .001). Although 6-month abstinence rates were high for both conditions (≥70.0% for both) and depression symptoms improved (the proportion with scores ≥15 on the 9-item PHQ dropped from 15.1% [38 of 252] to 8.0% [18 of 225] among LINKAGE participants), there were no differences between conditions. Those who received all intervention components had significantly better alcohol and other drug outcomes than those who received fewer intervention components. Findings support the feasibility and effectiveness of the LINKAGE intervention in helping patients receiving addiction treatment engage in health care and increase communication with their physicians. The intervention did not affect short-term abstinence or depression outcomes. Understanding if the LINKAGE intervention helps prevent relapse and manage long-term recovery will be important. clinicaltrials.gov Identifier: NCT01621711.

COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study.

PubMed

Potter, Julie E; Herkes, Robert G; Perry, Lin; Elliott, Rosalind M; Aneman, Anders; Brieva, Jorge L; Cavazzoni, Elena; Cheng, Andrew T H; O'Leary, Michael J; Seppelt, Ian M; Gebski, Val

2017-01-17

Discussing deceased organ donation can be difficult not only for families but for health professionals who initiate and manage the conversations. It is well recognised that the methods of communication and communication skills of health professionals are key influences on decisions made by families regarding organ donation. This multicentre study is being performed in nine intensive care units with follow-up conducted by the Organ and Tissue Donation Service in New South Wales (NSW) Australia. The control condition is pre-intervention usual practice for at least six months before each site implements the intervention. The COMFORT intervention consists of six elements: family conversations regarding offers for organ donation to be led by a "designated requester"; family offers for donation are deferred to the designated requester; the offer of donation is separated from the end-of-life discussion that death is inevitable; it takes place within a structured family donation conversation using a "balanced" approach. Designated requesters may be intensivists, critical care nurses or social workers prepared by attending the three-day national "Family Donation Conversation" workshops, and the half-day NSW Simulation Program. The design is pre-post intervention to compare rates of family consent for organ donation six months before and under the intervention. Each ICU crosses from using the control to intervention condition after the site initiation visit. The primary endpoint is the consent rate for deceased organ donation calculated from 140 eligible next of kin families. Secondary endpoints are health professionals' adherence rates to core elements of the intervention; identification of predictors of family donation decision; and the proportion of families who regret their final donation decision at 90 days. The pragmatic design of this study may identify 'what works' in usual clinical settings when requesting organ donation in critical care areas, both in terms of changes in practice healthcare professionals are willing and able to adopt, and the effect this may have on desired outcomes. The findings of this study will be indicative of the potential benefits of the intervention and be relevant and transferrable to clinical settings in other states and countries. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000815763 (24 July 2013). ClinicalTrials.gov: NCT01922310 (14 August 2013) (retrospectively registered).

Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE): A Cluster-Randomized Pragmatic Trial of a Multifactorial Fall Injury Prevention Strategy: Design and Methods.

PubMed

Bhasin, Shalender; Gill, Thomas M; Reuben, David B; Latham, Nancy K; Gurwitz, Jerry H; Dykes, Patricia; McMahon, Siobhan; Storer, Thomas W; Duncan, Pamela W; Ganz, David A; Basaria, Shehzad; Miller, Michael E; Travison, Thomas G; Greene, Erich J; Dziura, James; Esserman, Denise; Allore, Heather; Carnie, Martha B; Fagan, Maureen; Hanson, Catherine; Baker, Dorothy; Greenspan, Susan L; Alexander, Neil; Ko, Fred; Siu, Albert L; Volpi, Elena; Wu, Albert W; Rich, Jeremy; Waring, Stephen C; Wallace, Robert; Casteel, Carri; Magaziner, Jay; Charpentier, Peter; Lu, Charles; Araujo, Katy; Rajeevan, Haseena; Margolis, Scott; Eder, Richard; McGloin, Joanne M; Skokos, Eleni; Wiggins, Jocelyn; Garber, Lawrence; Clauser, Steven B; Correa-De-Araujo, Rosaly; Peduzzi, Peter

2017-10-14

Fall injuries are a major cause of morbidity and mortality among older adults. We describe the design of a pragmatic trial to compare the effectiveness of an evidence-based, patient-centered multifactorial fall injury prevention strategy to an enhanced usual care. Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) is a 40-month cluster-randomized, parallel-group, superiority, pragmatic trial being conducted at 86 primary care practices in 10 healthcare systems across USA. The 86 practices were randomized to intervention or control group using covariate-based constrained randomization, stratified by healthcare system. Participants are community-living persons, ≥70 years, at increased risk for serious fall injuries. The intervention is a co-management model in which a nurse Falls Care Manager performs multifactorial risk assessments, develops individualized care plans, which include surveillance, follow-up evaluation, and intervention strategies. Control group receives enhanced usual care, with clinicians and patients receiving evidence-based information on falls prevention. Primary outcome is serious fall injuries, operationalized as those leading to medical attention (non-vertebral fractures, joint dislocation, head injury, lacerations, and other major sequelae). Secondary outcomes include all fall injuries, all falls, and well-being (concern for falling; anxiety and depressive symptoms; physical function and disability). Target sample size was 5,322 participants to provide 90% power to detect 20% reduction in primary outcome rate relative to control. Trial enrolled 5451 subjects in 20 months. Intervention and follow-up are ongoing. The findings of the STRIDE study will have important clinical and policy implications for the prevention of fall injuries in older adults. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

PubMed Central

Siriwardena, A Niroshan; Apekey, Tanefa; Tilling, Michelle; Harrison, Andrew; Dyas, Jane V; Middleton, Hugh C; Ørner, Roderick; Sach, Tracey; Dewey, Michael; Qureshi, Zubair M

2009-01-01

Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity) and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs). Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours) to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults have shown that psychological treatments for insomnia administered by specialist nurses to groups of patients can be effective within a primary care setting. This will be a pilot study to determine whether an educational intervention aimed at primary care teams to deliver problem focused therapy for insomnia can improve sleep management and outcomes for individual adult patients presenting to general practice. The study will also test procedures and collect information in preparation for a larger definitive cluster-randomised trial. The study is funded by The Health Foundation. Trial Registration ClinicalTrials.gov ID ISRCTN55001433 – PMID:19171070

Protocolized treatment is associated with decreased organ dysfunction in pediatric severe sepsis

PubMed Central

Balamuth, Fran; Weiss, Scott L.; Fitzgerald, Julie C.; Hayes, Katie; Centkowski, Sierra; Chilutti, Marianne; Grundmeier, Robert W.; Lavelle, Jane; Alpern, Elizabeth R.

2016-01-01

Objective To determine whether treatment with a protocolized sepsis guideline in the emergency department (ED) was associated with a lower burden of organ dysfunction (OD) by hospital day 2 compared to non-protocolized usual care in pediatric patients with severe sepsis. Design Retrospective cohort study Setting Tertiary care children’s hospital from January 1, 2012–March 31, 2014. Measurements and Main Results Subjects with international consensus defined severe sepsis and pediatric intensive care unit (PICU) admission within 24 hours of ED arrival were included. The exposure was the use of a protocolized ED sepsis guideline. The primary outcome was complete resolution of OD by hospital day 2. One hundred eighty nine subjects were identified during the study period. Of these, 121 (64%) were treated with the protocolized ED guideline and 68 were not. There were no significant differences between the groups in age, sex, race, number of comorbid conditions, ED triage level, or OD on arrival to the ED. Patients treated with protocolized ED care were more likely to be free of OD on hospital day 2 after controlling for sex, comorbid condition, indwelling central venous catheter, PIM-2 score, and timing of antibiotics and intravenous fluids (adjusted OR 4.2, 95% CI 1.7, 10.4). Conclusions Use of a protocolized ED sepsis guideline was independently associated with resolution of OD by hospital day 2 compared to non-protocolized usual care. These data indicate that morbidity outcomes in children can be improved with the use of protocolized care. PMID:27455114

The Effectiveness of a New Model in Managing Pregnant Women with Iron Deficiency Anemia in Indonesia: A Nonrandomized Controlled Intervention Study.

PubMed

Widyawati, Widyawati; Jans, Suze; Bor, Hans H J; van Dillen, Jeroen; Lagro-Janssen, Antoine L M

2015-12-01

Indonesia has a major problem with iron deficiency anemia among pregnant women. A new model named the Four Pillars Approach was designed to improve antenatal care for these women. This study aimed to measure the effectiveness of the model in managing pregnant women with iron deficiency anemia. We used a nonrandomized controlled intervention study. The study, with the Four Pillars Approach as intervention versus usual care as its control, was conducted in two provinces in Java (Indonesia) during the period from March 2012 until May 2013. Main outcome measures were a difference of Hb level ≥ 0.5 g/dL, the number of women who attended five or more antenatal care visits, and birthing with a skilled birth attendant. Three hundred fifty-four participants were enrolled in the study. Participants in the intervention group had an adjusted odds ratio of 25.0 (95% CI 12.03-52.03, p = 0.001) for increased hemoglobin of ≥ 0.5 g/dL at 35-37 weeks of gestation, compared with the control group. In the intervention group, 95.0 percent of women had five or more antenatal care visits, compared with 57.2 percent (p = 0.001) in the control group. All births in both groups were assisted by skilled birth attendants. The Four Pillars Approach is effective in increasing the hemoglobin level and the frequency of antenatal care visits of participants when compared with the usual care for pregnant women with anemia. © 2015 Wiley Periodicals, Inc.

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.

Effect of a multi-level intervention on nurse—patient communication in the intensive care unit: Results of the SPEACS trial

PubMed Central

Happ, Mary Beth; Garrett, Kathryn L.; Tate, Judith A.; DiVirgilio, Dana; Houze, Martin P.; Demirci, Jill R.; George, Elisabeth; Sereika, Susan M.

2014-01-01

Objective To test the impact of two levels of intervention on communication frequency, quality, success, and ease between nurses and intubated intensive care unit (ICU) patients. Design Quasi-experimental, 3-phase sequential cohort study: (1) usual care, (2) basic communication skills training (BCST) for nurses, (3) additional training in augmentative and alternative communication devices and speech language pathologist consultation (AAC + SLP). Trained observers rated four 3-min video-recordings for each nurseepatient dyad for communication frequency, quality and success. Patients self-rated communication ease. Setting Two ICUs in a university-affiliated medical center. Participants 89 intubated patients awake, responsive and unable to speak and 30 ICU nurses. Main results Communication frequency (mean number of communication acts within a communication exchange) and positive nurse communication behaviors increased significantly in one ICU only. Percentage of successful communication exchanges about pain were greater for the two intervention groups than the usual care/control group across both ICUs (p = .03) with more successful sessions about pain and other symptoms in the AAC + SLP group (p = .07). Patients in the AAC SLP intervention group used significantly more AAC methods (p = .002) and rated communication at high difficulty less often (p < .01). Conclusions This study provides support for the feasibility, utility and efficacy of a multi-level communication skills training, materials and SLP consultation intervention in the ICU. PMID:24495519

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.

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

ERIC Educational Resources Information Center

Nyamathi, Adeline; Salem, Benissa E.; Meyer, Visha; Ganguly, Kalyan K.; Sinha, Sanjeev; Ramakrishnan, Padma

2012-01-01

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),…

An Implementation of Integrated Logistic Support for Turkish Armed Forces

DTIC Science & Technology

1990-06-01

of systems available for sale by friendly countries. Usually the procurement decision is based upon procurement costs so the tendency is to buy the...result from various design alternatives. From the author’s personal experience, careful planning before buying a weapon system would have solved various...convincing the government of the long term advantages of buying the system which has the least life-cycle costs, especially when these costs are spread

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

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.

The moderating effects of group cognitive behavioral therapy for depression among substance users

PubMed Central

Hunter, Sarah B.; Witkiewitz, Katie; Watkins, Katherine E.; Paddock, Susan M.; Hepner, Kimberly A.

2012-01-01

This study examined the prospective longitudinal relationship between changes in depressive symptoms on alcohol and/or drug (i.e., substance) use among addiction treatment participants and whether group cognitive behavioral therapy for depression (GCBT-D) moderated the relationship. Using a quasi-experimental intent-to-treat design, 299 residential addiction treatment clients with depressive symptoms (Beck Depression Inventory-II (BDI-II) >17) were assigned to either usual care (n = 159) or usual care plus a 16-session GCBT-D intervention (n = 140). Two follow-up interviews were conducted, one three months after the baseline interview corresponding to the end of the intervention, and three months later. Parallel process growth modeling was used to examine changes in depressive symptoms and the associated changes in abstinence and negative consequences from substance use over time. Treatment group was included as a moderator of the association. Participants in the GCBT-D condition showed a greater increase in abstinence and greater decreases in depressive symptoms and negative consequences over time. There were significant interaction effects such that the associations between depressive symptoms, negative consequences, and abstinence changes were larger in the usual care condition compared to the GCBT-D condition. The results suggest that the intervention may be effective by attenuating the association between depressive symptoms and substance use outcomes. These findings contribute to the emerging literature on the prospective longitudinal associations between depressive symptoms and substance use changes by being the first to examine it among a sample receiving GCBT-D in an addiction treatment setting. PMID:22564202

Treatment of panic in chest pain patients from emergency departments: efficacy of different interventions focusing on panic management.

PubMed

Marchand, André; Belleville, Geneviève; Fleet, Richard; Dupuis, Gilles; Bacon, Simon L; Poitras, Julien; Chauny, Jean-Marc; Vadeboncoeur, Alain; Lavoie, Kim L

2012-01-01

The aim was to assess the efficacy of two brief cognitive-behavioral therapy (CBT)-based interventions (7×1-h sessions and 1×2-h session) and a pharmacological treatment (paroxetine), compared to supportive usual care, initiated in the emergency department (ED) for individuals suffering from panic disorder (PD) with a chief complain of noncardiac chest pain (NCCP). We hypothesized that the interventions would be more efficacious than supportive usual care on all outcomes. A 12-month follow-up study of patients who received a diagnosis of NCCP in the ED and who met diagnostic criteria for PD (n=71) was performed. Assessments included several psychological questionnaires and a structured interview. A series of repeated-measures analyses of variances, using a split-plot design, were conducted, as well as planned comparisons to examine the differences. The seven-session CBT (n=19), one-session panic management (n=24) and pharmacotherapy (n=13) led to greater improvements in PD severity (primary outcome) compared to supportive usual care (n=15) at posttest, and no significant difference was noted between the three active interventions. On the other measures, patients improved in all conditions, and the therapeutic gains were maintained up to 1 year following the visit to the ED. These results suggests that early intervention, in particular seven sessions of CBT, one session of PM or pharmacotherapy (generic paroxetine), should be considered for the treatment of PD patients consulting the ED with a discharge diagnosis of NCCP. Copyright © 2012 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 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

A Leadership Perspective on a Shared Vision for Healthcare.

PubMed

Kitch, Tracy

2017-01-01

Our country's recent negotiations for a new Health Accord have shone light on the importance of more accessible and better home care. The direction being taken on health funding investments has sent a strong message about healthcare system redesign. It is time to design a healthcare system that moves us away from a hospital-focused model to one that is more effective, integrated and sustainable and one that places a greater emphasis on primary care, community care and home care. The authors of the lead paper (Sharkey and Lefebre 2017) provide their vision for people-powered care and explore the opportunity for nursing leaders to draw upon the unique expertise and insights of home care nursing as a strategic lever to bring about real health system transformation across all settings. Understanding what really matters at the beginning of the healthcare journey and honouring the tenants of partnership and empowerment as a universal starting point to optimize health outcomes along the continuum of care present a very important opportunity. However, as nursing leaders in the health system change, it is important that we extend the conversation beyond one setting. It is essential that as leaders, we seek to design models of care delivery that achieve a shared vision, focused on seamless coordinated care across the continuum that is person-centred. Bringing about real system change requires us to think differently and consider the role of nursing across all settings, collaboratively co-designing so that our collective skills and knowledge can work within a complementary framework. Focusing our leadership efforts on enhancing integration across healthcare settings will ensure that nurses can be important leaders and active decision-makers in health system change. A shared vision for healthcare requires all of us to look beyond the usual practices and structures, hospitals and institutional walls.

Pharmaceutical care for elderly patients shared between community pharmacists and general practitioners: a randomised evaluation. RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) [ISRCTN16932128

PubMed Central

Wong, I; Campion, P; Coulton, S; Cross, B; Edmondson, H; Farrin, A; Hill, G; Hilton, A; Philips, Z; Richmond, S; Russell, I

2004-01-01

Background This trial aims to investigate the effectiveness and cost implications of 'pharmaceutical care' provided by community pharmacists to elderly patients in the community. As the UK government has proposed that by 2004 pharmaceutical care services should extend nationwide, this provides an opportunity to evaluate the effect of pharmaceutical care for the elderly. Design The trial design is a randomised multiple interrupted time series. We aim to recruit 700 patients from about 20 general practices, each associated with about three community pharmacies, from each of the five Primary Care Trusts in North and East Yorkshire. We shall randomise the five resulting groups of practices, pharmacies and patients to begin pharmaceutical care in five successive phases. All five will act as controls until they receive the intervention in a random sequence. Until they receive training community pharmacists will provide their usual dispensing services and so act as controls. The community pharmacists and general practitioners will receive training in pharmaceutical care for the elderly. Once trained, community pharmacists will meet recruited patients, either in their pharmacies (in a consultation room or dispensary to preserve confidentiality) or at home. They will identify drug-related issues/problems, and design a pharmaceutical care plan in conjunction with both the GP and the patient. They will implement, monitor, and update this plan monthly. The primary outcome measure is the 'Medication Appropriateness Index'. Secondary measures include adverse events, quality of life, and patient knowledge and compliance. We shall also investigate the cost of pharmaceutical care to the NHS, to patients and to society as a whole. PMID:15182379

Rationale and design of the Investigator-Steered Project on Intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial.

PubMed

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre; Staessen, Jan A

2014-06-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20-69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTN(TM), SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. ClinicalTrials.gov Identifier: NCT 01505010.

Rationale and design of the Investigator-Steered Project on intravascular Renal Denervation for Management of Drug-Resistant Hypertension (INSPiRED) trial

PubMed Central

Jin, Yu; Jacobs, Lotte; Baelen, Marie; Thijs, Lutgarde; Renkin, Jean; Hammer, Frank; Kefer, Joelle; Petit, Thibault; Verhamme, Peter; Janssens, Stefan; Sinnaeve, Peter; Lengelé, Jean-Philippe; Persu, Alexandre

2014-01-01

The SYMPLICITY studies showed that renal denervation (RDN) is feasible as novel treatment for resistant hypertension. However, RDN is a costly and invasive procedure, the long-term efficacy and safety of which has not yet been proven. Therefore, we designed the INSPiRED trial to compare the blood pressure lowering efficacy and safety of RDN vs usual medical therapy. INSPiRED is a randomized controlled trial enrolling 240 treatment-resistant hypertensive patients at 16 expert hypertension centres in Belgium. Eligible patients, aged 20–69 years old, have a 24-h ambulatory blood pressure of 130 mmHg systolic or 80 mmHg diastolic or more, while taking at least three antihypertensive drugs. They are randomized to RDN (EnligHTNTM, SJM system) plus usual care (intervention group) or usual care alone (control group) in a ratio of 1:1. The primary endpoints for efficacy and safety, measured after 6 months, are the baseline-adjusted between-group differences in 24h systolic blood pressure and in glomerular filtration rate as estimated by the Chronic Kidney Disease Epidemiology Collaboration equation. Follow-up will continue up to 36 months after randomization. INSPiRED is powered to demonstrate a 10-mmHg difference in systolic blood pressure between randomized groups with a two-sided p-value of 0.01 and 90% power. It will generate long-term efficacy and safety data, identify the subset of treatment-resistant hypertensive patients responsive to RDN, provide information on cost-effectiveness, and by doing so INSPiRED will inform guideline committees and health policy makers. Trial registration: ClinicalTrials.gov Identifier: NCT 01505010. PMID:24742341

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.

COACH trial: A randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: Rationale and design

PubMed Central

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-01-01

Background Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. Methods The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. Results A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. Conclusions This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. PMID:21241828

Becoming pregnant: exploring the perspectives of women living with diabetes

PubMed Central

Griffiths, Frances; Lowe, Pam; Boardman, Felicity; Ayre, Catherine; Gadsby, Roger

2008-01-01

Background The risk of adverse pregnancy outcome for women with type 1 diabetes is reduced through tight diabetes control. Most women enter pregnancy with inadequate blood glucose control. Interview studies with women suggest the concept of ‘planned’ and ‘unplanned’ pregnancies is unhelpful. Aim To explore women's accounts of their journeys to becoming pregnant while living with type 1 diabetes. Design of study Semi-structured interviews with 15 women living with pre-gestational type 1 diabetes, between 20 and 30 weeks gestation and with a normal pregnancy ultrasound scan. Setting Four UK specialist diabetes antenatal clinics. Method Interviews explored women's journeys to becoming pregnant and the impact of health care. Analysis involved comparison of women's accounts of each pregnancy and a thematic analysis. Results Women's experiences of becoming pregnant were diverse. Of the 40 pregnancies described, at least one positive step towards becoming pregnant was taken by 11 women in 23 pregnancies but not in the remaining 17 pregnancies, with variation between pregnancies. Prior to and in early pregnancy, some women described themselves as experts in their diabetes but most described seeking and/or receiving advice from their usual health professionals. Three women described pre-conception counselling and the anxiety this provoked. Conclusion For women living with type 1 diabetes each pregnancy is different. The concept of planned and unplanned pregnancy is unhelpful for designing health care. Formal preconception counselling can have unintended consequences. Those providing usual care to women are well positioned to provide advice and support to women about becoming pregnant, tailoring it to the changing needs and situation of each woman. PMID:18318971

COACH trial: a randomized controlled trial of nurse practitioner/community health worker cardiovascular disease risk reduction in urban community health centers: rationale and design.

PubMed

Allen, Jerilyn K; Himmelfarb, Cheryl R Dennison; Szanton, Sarah L; Bone, Lee; Hill, Martha N; Levine, David M

2011-05-01

Despite well-publicized guidelines on the appropriate management of cardiovascular disease (CVD) and type 2 diabetes, implementation of risk-reducing practices remains poor. This paper describes the rationale and design of a randomized controlled clinical trial evaluating the effectiveness of a comprehensive program of CVD risk reduction delivered by nurse practitioner (NP)/community health worker (CHW) teams versus enhanced usual care in improving the proportion of patients in urban community health centers who achieve goal levels recommended by national guidelines for lipids, blood pressure, HbA1c and prescription of appropriate medications. The COACH (Community Outreach and Cardiovascular Health) trial is a randomized controlled trial in which patients at federally-qualified community health centers were randomly assigned to one of two groups: comprehensive intensive management of CVD risk factors for one year by a NP/CHW team or an enhanced usual care control group. A total of 3899 patients were assessed for eligibility and 525 were randomized. Groups were comparable at baseline on sociodemographic and clinical characteristics with the exception of statistically significant differences in total cholesterol and hemoglobin A1c. This study is a novel amalgam of multilevel interdisciplinary strategies to translate highly efficacious therapies to low-income federally-funded health centers that care for patients who carry a disproportionate burden of CVD, type 2 diabetes and uncontrolled CVD risk factors. The impact of such a community clinic-based intervention is potentially enormous. Copyright © 2011 Elsevier Inc. All rights reserved.

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.

Caring and Dominance Affect Participants’ Perceptions and Behaviors During a Virtual Medical Visit

PubMed Central

Hall, Judith A.; Roter, Debra L.

2008-01-01

BACKGROUND Physician communication style affects patients’ perceptions and behaviors. Two aspects of physician communication style, caring and dominance, are often related in that a high caring physician is usually not dominant and vice versa. OBJECTIVE This research was aimed at testing the sole or joint impact of physician caring and physician dominance on participant perceptions and behavior during the medical visit. PARTICIPANTS AND DESIGN In an experimental design, analog patients (APs) (167 university students) interacted with a computer-generated virtual physician on a computer screen. Participants were randomly assigned to 1 of 4 experimental conditions (physician communication style: high dominance and low caring, high dominance and high caring, low dominance and low caring, or low dominance and high caring). The APs’ verbal and nonverbal behavior during the visit as well as their perception of the virtual physician were assessed. RESULTS Analog patients were able to distinguish dominance and caring dimensions of the virtual physician’s communication. Moreover, APs provided less medical information, spoke less, and agreed more when interacting with a high-dominant compared to a low-dominant physician. They also talked more about emotions and were quicker in taking their turn to speak when interacting with a high-caring compared to a low-caring physician. CONCLUSIONS Dominant and caring physicians elicit different emotional and behavioral responses from APs. Physician dominance reduces patient engagement in the medical dialog and produces submissiveness, whereas physician caring increases patient emotionality. Electronic supplementary material The online version of this article (doi:10.1007/s11606-008-0512-5) contains supplementary material, which is available to authorized users. PMID:18259824

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.

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.

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.

Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

PubMed

Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

2017-04-21

Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

Effectiveness of the Engagement and Counseling for Latinos (ECLA) Intervention in Low-Income Latinos

PubMed Central

Ludman, Evette; Kafali, Nilay; Lapatin, Sheri; Vila, Doriliz; Shrout, Patrick E.; Keefe, Kristen; Cook, Benjamin; Ault, Andrea; Li, Xinliang; Bauer, Amy; Epelbaum, Claudia; Alcantara, Carmela; Pineda, Tulia Inés Guerra; Tejera, Gloria Gonzalez; Suarez, Gloria; Leon, Karla; Lessios, Anna S.; Ramirez, Rafael R; Canino, Glorisa

2014-01-01

Background Persistent disparities in access and quality of mental health care for Latinos indicate a need for evidence-based, culturally adapted and outside-the-clinic-walls treatments. Objective Evaluate treatment effectiveness of telephone (ECLA –T) or face-to-face (ECLA-F) delivery of a 6–8 session cognitive behavioral therapy and care-management intervention for low-income Latinos, as compared to usual care for depression. Design Multi-site randomized controlled trial. Setting Eight community health clinics in Boston, Massachusetts and San Juan, Puerto Rico. Participants 257 Latino patients recruited from primary care between May 2011 and September 2012. Main Outcome Measures The primary outcome was severity of depression, assessed with the Patient Health Questionnaire-9 (PHQ-9) and the Hopkins Symptom Checklist-20 (HSCL-20). The secondary outcome was functioning over the previous 30 days, measured using the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). Results Both telephone and face-to-face versions of the ECLA were more effective than usual care. The effect sizes of both intervention conditions on PHQ-9 were moderate when combined data from both sites are analyzed (.56 and .64 for face-to-face and telephone, respectively). Similarly, effect sizes of ECLA-F and ECLA-T on the HSCL were quite large in the Boston site (.64 and .73. respectively) but not in Puerto Rico (.10 and .03). Conclusions and Relevance The intervention appears to help Latino patients reduce depressive symptoms and improve functioning. Of particular importance is the higher treatment initiation for the telephone vs. face-to-face intervention (89.7% vs. 78.8%), which suggests that telephone-based care may improve access and quality of care. PMID:25310525

Economic Analysis of Primary Care-Based Physical Activity Counseling in Older Men: The VA-LIFE Trial

PubMed Central

Cowper, Patricia A; Peterson, Matthew J; Pieper, Carl F; Sloane, Richard J; Hall, Katherine S; McConnell, Eleanor S; Bosworth, Hayden B; Ekelund, Carola C; Pearson, Megan P; Morey, Miriam C

2016-01-01

BACKGROUND/OBJECTIVES To perform an economic evaluation of a primary care-based physical activity counseling intervention that improved physical activity levels and rapid gait speed in older veterans. DESIGN Secondary objective of randomized trial that assessed the effect of exercise counseling (relative to usual care) on physical performance, physical activity, function, disability and medical resource use and cost. SETTING Veterans Affairs Medical Center, Durham, North Carolina. PARTICIPANTS Male veterans aged ≥ 70 years (n=398). INTERVENTION An experienced health counselor provided baseline in-person exercise counseling, followed by telephone counseling at 2, 4, and 6 weeks, and monthly thereafter through one year. Each participant’s primary care physician provided initial endorsement of the intervention, followed by monthly automated telephone messages tailored to the patient. Individualized progress reports were mailed quarterly. MEASUREMENTS Intervention costs were assessed. Health care resource use and costs were estimated from enrollment through one year follow-up. The incremental cost of achieving clinically significant changes in major trial endpoints was calculated. RESULTS The total direct cost of the intervention per participant was $459, 85% of which was counselor effort. With overhead, program cost totaled $696 per participant. Medical costs during follow-up reached $10,418 with the intervention, versus $12,052 with usual care (difference = −$1,634 (95% confidence interval=−$4,683 to $1,416; p=0.29)). Expressed in terms of short-term clinical outcomes, the intervention cost $4,971 per additional patient reaching target exercise levels, or $4,640 per patient achieving a clinically significant change in rapid gait speed. CONCLUSION Improvements in physical activity and rapid gait speed in the physical activity counseling group were obtained at a cost that represents a small fraction of patients’ annual health care costs. PMID:28152170

Having a Physician Rather than a Place as a Usual Source of Care Would Be Better - from 2012 Korea Health Panel Data.

PubMed

Kim, Kyeong Min; Jeon, Hyunsoo; Lee, Jae Ho

2017-01-01

A usual source of care (USC) in primary care improves health care quality and can result in improved health. However, current research about the type of USC (place only vs. physician with a place) is insufficient as an evidence to support the value of primary care. We analyzed data from the 2012 Korea Health Panel survey of adults aged 18 years or older (n = 11,873) who reported whether having a USC or not to compare the effects by type of USC on medical care use and out-of-pocket costs. Descriptive analysis showed significant differences in the distributions of sociodemographic and health status factors except frequency of outpatient visit by type of USC. Adjusted odds ratios (ORs) of having a physician with a place compared to not having a USC were 4.05 for age 65 ≥ years (vs. < 35 years), 1.33 for females (vs. males), 0.63 for the fifth (highest) quintile (vs. the first) of household income, 1.62 for medical aid (vs. employee) health insurance, and 4.46 for having a chronic disease (vs. not). For those having a physician with a place (vs. only a place) as a USC, adjusted ORs of hospital admission and emergency room (ER) visit were 0.77 and 0.71 with out-of-pocket costs not significantly high. Those having a physician with a place (vs. only a place) as a USC included more patients with chronic diseases, but they had fewer hospital admissions and ER visits. When designing a plan for health care reform in Korea, promoting having a physician rather than a place as a USC would be a better policy.

Having a Physician Rather than a Place as a Usual Source of Care Would Be Better - from 2012 Korea Health Panel Data

PubMed Central

2017-01-01

A usual source of care (USC) in primary care improves health care quality and can result in improved health. However, current research about the type of USC (place only vs. physician with a place) is insufficient as an evidence to support the value of primary care. We analyzed data from the 2012 Korea Health Panel survey of adults aged 18 years or older (n = 11,873) who reported whether having a USC or not to compare the effects by type of USC on medical care use and out-of-pocket costs. Descriptive analysis showed significant differences in the distributions of sociodemographic and health status factors except frequency of outpatient visit by type of USC. Adjusted odds ratios (ORs) of having a physician with a place compared to not having a USC were 4.05 for age 65 ≥ years (vs. < 35 years), 1.33 for females (vs. males), 0.63 for the fifth (highest) quintile (vs. the first) of household income, 1.62 for medical aid (vs. employee) health insurance, and 4.46 for having a chronic disease (vs. not). For those having a physician with a place (vs. only a place) as a USC, adjusted ORs of hospital admission and emergency room (ER) visit were 0.77 and 0.71 with out-of-pocket costs not significantly high. Those having a physician with a place (vs. only a place) as a USC included more patients with chronic diseases, but they had fewer hospital admissions and ER visits. When designing a plan for health care reform in Korea, promoting having a physician rather than a place as a USC would be a better policy. PMID:27914125

Impact of Computerized Decision Support on Blood Pressure Management and Control: A Randomized Controlled Trial

PubMed Central

Sequist, Thomas D.; Ayanian, John Z.; Shaykevich, Shimon; Fairchild, David G.; Orav, E. John; Bates, David W.

2008-01-01

BACKGROUND We conducted a cluster randomized controlled trial to examine the effectiveness of computerized decision support (CDS) designed to improve hypertension care and outcomes in a racially diverse sample of primary care patients. METHODS We randomized 2,027 adult patients receiving hypertension care in 14 primary care practices to either 18 months of their physicians receiving CDS for each hypertensive patient or to usual care without computerized support for the control group. We assessed prescribing of guideline-recommended drug therapy and levels of blood pressure control for patients in each group and examined if the effects of the intervention differed by patients’ race/ethnicity using interaction terms. MEASUREMENTS AND MAIN RESULTS Rates of blood pressure control were 42% at baseline and 46% at the outcome visit with no significant differences between groups. After adjustment for patients’ demographic and clinical characteristics, number of prior visits, and levels of baseline blood pressure control, there were no differences between intervention groups in the odds of outcome blood pressure control. The use of CDS to providers significantly improved Joint National Committee (JNC) guideline adherent medication prescribing compared to usual care (7% versus 5%, P < 0.001); the effects of the intervention remained after multivariable adjustment (odds ratio [OR] 1.39 [CI, 1.13–1.72]) and the effects of the intervention did not differ by patients’ race and ethnicity. CONCLUSIONS CDS improved appropriate medication prescribing with no improvement in disparities in care and overall blood pressure control. Future work focusing on improvement of these interventions and the study of other practical interventions to reduce disparities in hypertension-related outcomes is needed. PMID:18373141

Integrated care for frail elderly compared to usual care: a study protocol of a quasi-experiment on the effects on the frail elderly, their caregivers, health professionals and health care costs.

PubMed

Fabbricotti, Isabelle Natalina; Janse, Benjamin; Looman, Wilhelmina Mijntje; de Kuijper, Ruben; van Wijngaarden, Jeroen David Hendrikus; Reiffers, Auktje

2013-04-12

Frail elderly persons living at home are at risk for mental, psychological, and physical deterioration. These problems often remain undetected. If care is given, it lacks the quality and continuity required for their multiple and changing problems. The aim of this project is to improve the quality and efficacy of care given to frail elderly living independently by implementing and evaluating a preventive integrated care model for the frail elderly. The design is quasi-experimental. Effects will be measured by conducting a before and after study with control group. The experimental group will consist of 220 elderly of 8 GPs (General Practitioners) who will provide care according to the integrated model (The Walcheren Integrated Care Model). The control group will consist of 220 elderly of 6 GPs who will give care as usual. The study will include an evaluation of process and outcome measures for the frail elderly, their caregivers and health professionals as well as a cost-effectiveness analysis. A concurrent mixed methods design will be used. The study population will consist of elderly 75 years or older who live independently and score a 4 or higher on the Groningen Frailty Indicator, their caregivers and health professionals. Data will be collected prospectively at three points in time: T0, T1 (3 months after inclusion), and T2 (12 months after inclusion). Similarities between the two groups and changes over time will be assessed with t-tests and chi-square tests. For each measure regression analyses will be performed with the T2-score as the dependent variable and the T0-score, the research group and demographic variables as independent variables. A potential obstacle for this study will be the willingness of the elderly and their caregivers to participate. To increase willingness, the request to participate will be sent via the elders' own GP. Interviewers will be from their local region and gifts will be given. A successful implementation of the integrated model is also necessary. The involved parties are members of a steering group and have contractually committed themselves to the project. Current Controlled Trials ISRCTN05748494.

Pragmatic clinical trials embedded in healthcare systems: generalizable lessons from the NIH Collaboratory.

PubMed

Weinfurt, Kevin P; Hernandez, Adrian F; Coronado, Gloria D; DeBar, Lynn L; Dember, Laura M; Green, Beverly B; Heagerty, Patrick J; Huang, Susan S; James, Kathryn T; Jarvik, Jeffrey G; Larson, Eric B; Mor, Vincent; Platt, Richard; Rosenthal, Gary E; Septimus, Edward J; Simon, Gregory E; Staman, Karen L; Sugarman, Jeremy; Vazquez, Miguel; Zatzick, Douglas; Curtis, Lesley H

2017-09-18

The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped. To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design. In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs. A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

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.

Design and development of a mobile exercise application for home care aides and older adult medicaid home and community-based clients.

PubMed

Danilovich, Margaret K; Diaz, Laura; Saberbein, Gustavo; Healey, William E; Huber, Gail; Corcos, Daniel M

2017-01-01

We describe a community-engaged approach with Medicaid home and community-based services (HCBS), home care aide (HCA), client, and physical therapist stakeholders to develop a mobile application (app) exercise intervention through focus groups and interviews. Participants desired a short exercise program with modification capabilities, goal setting, and mechanisms to track progress. Concerns regarding participation were training needs and feasibility within usual care services. Technological preferences were for simple, easy-to-use, and engaging content. The app was piloted with HCA-client dyads (n = 5) to refine the intervention and evaluate content. Engaging stakeholders in intervention development provides valuable user-feedback on both desired exercise program contents and mobile technology preferences for HCBS recipients.

Supporting Patient Care in the Emergency Department with a Computerized Whiteboard System

PubMed Central

Aronsky, Dominik; Jones, Ian; Lanaghan, Kevin; Slovis, Corey M.

2008-01-01

Efficient information management and communication within the emergency department (ED) is essential to providing timely and high-quality patient care. The ED whiteboard (census board) usually serves as an ED’s central access point for operational and patient-related information. This article describes the design, functionality, and experiences with a computerized ED whiteboard, which has the ability to display relevant operational and patient-related information in real time. Embedded functionality, additional whiteboard views, and the integration with ED and institutional information system components, such as the computerized patient record or the provider order entry system, provide rapid access to more detailed information. As an information center, the computerized whiteboard supports our ED environment not only for providing patient care, but also for operational, educational, and research activities. PMID:18096913

Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial.

PubMed

Jafar, Tazeen H; Jehan, Imtiaz; de Silva, H Asita; Naheed, Aliya; Gandhi, Mihir; Assam, Pryseley; Finkelstein, Eric A; Quigley, Helena Legido; Bilger, Marcel; Khan, Aamir Hameed; Clemens, John David; Ebrahim, Shah; Turner, Elizabeth L; Kasturiratne, Anuradhani

2017-06-12

High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering BP among adults with hypertension in rural communities in Bangladesh, Pakistan and Sri Lanka. This study is a stratified, cluster randomized controlled trial with a qualitative component for evaluation of processes and stakeholder feedback. The MCI has five components: (1) home health education by government community health workers (CHWs), (2) BP monitoring and stepped-up referral to a trained general practitioner using a checklist, (3) training public and private providers in management of hypertension and using a checklist, (4) designating hypertension triage counter and hypertension care coordinators in government clinics and (5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. Usual care will comprise existing services in the community without any additional training. The trial will be conducted on 2550 individuals aged ≥40 years with hypertension (with systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, based on the mean of the last two of three measurements from two separate days, or on antihypertensive therapy) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability-adjusted life years averted will be computed. Stakeholders including policy makers, provincial- and district-level coordinators of relevant programmes, physicians, CHWs, key community leaders, hypertensive individuals and family members in the identified clusters will be interviewed. The study will provide evidence of the effectiveness and cost-effectiveness of MCI strategies for BP control compared to usual care in the rural public health infrastructure in South Asian countries. If shown to be successful, MCI may be a long-term sustainable strategy for tackling the rising rates of CVD in low resourced countries. ClinicalTrials.gov, NCT02657746 . Registered on 14 January 2016.

Collaborative care for depression in European countries: a systematic review and meta-analysis.

PubMed

Sighinolfi, Cecilia; Nespeca, Claudia; Menchetti, Marco; Levantesi, Paolo; Belvederi Murri, Martino; Berardi, Domenico

2014-10-01

This is a systematic review and meta-analysis of randomized controlled trials (RCTs) investigating the effectiveness of collaborative care compared to Primary Care Physician's (PCP's) usual care in the treatment of depression, focusing on European countries. A systematic review of English and non-English articles, from inception to March 2014, was performed using database PubMed, British Nursing Index and Archive, Ovid Medline (R), PsychINFO, Books@Ovid, PsycARTICLES Full Text, EMBASE Classic+Embase, DARE (Database of Abstract of Reviews of Effectiveness) and the Cochrane Library electronic database. Search term included depression, collaborative care, physician family and allied health professional. RCTs comparing collaborative care to usual care for depression in primary care were included. Titles and abstracts were independently examined by two reviewers, who extracted from the included trials information on participants' characteristics, type of intervention, features of collaborative care and type of outcome measure. The 17 papers included, regarding 15 RCTs, involved 3240 participants. Primary analyses showed that collaborative care models were associated with greater improvement in depression outcomes in the short term, within 3 months (standardized mean difference (SMD) -0.19, 95% CI=-0.33; -0.05; p=0.006), medium term, between 4 and 11 months (SMD -0.24, 95% CI=-0.39; -0.09; p=0.001) and medium-long term, from 12 months and over (SMD -0.21, 95% CI=-0.37; -0.04; p=0.01), compared to usual care. The present review, specifically focusing on European countries, shows that collaborative care is more effective than treatment as usual in improving depression outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

Developing, implementing and evaluating an end of life care intervention.

PubMed

Cox, Anna; Arber, Anne; Bailey, Fiona; Dargan, Sue; Gannon, Craig; Lisk, Radcliffe; Quinn, Barry; Samarasinghe, Jane; Wrigley, Martha; Gallagher, Ann

2017-01-31

Aim To develop, implement and evaluate a collaborative intervention in care homes seeking to increase the confidence and competence of staff in end of life care and enable more people to receive end of life care in their usual place of residence. Method A two-phase exploratory mixed methods design was used, evaluating the effect of an end of life care toolkit and associated training in care homes, facilitated by a specialist palliative care team. Six care homes in England were recruited to the intervention; 24 staff participated in discussion groups; 54 staff attended at least one training session; and pre- and post-intervention questionnaires were completed by 78 and 103 staff respectively. Results Staff confidence in receiving emotional and clinical support and managing end of life care symptoms increased post-intervention, but confidence in discussing death and dying with residents and relatives decreased. Audit data indicate greater reduction in the number of residents from participating care homes dying in hospital than those from comparison homes. Conclusion Collaborative end of life care interventions support care home staff to manage end of life and may enable residents to have choice about their place of death.

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.

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.

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.

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 a Patient and Clinician Communication-Priming Intervention on Patient-Reported Goals-of-Care Discussions Between Patients With Serious Illness and Clinicians: A Randomized Clinical Trial.

PubMed

Curtis, J Randall; Downey, Lois; Back, Anthony L; Nielsen, Elizabeth L; Paul, Sudiptho; Lahdya, Alexandria Z; Treece, Patsy D; Armstrong, Priscilla; Peck, Ronald; Engelberg, Ruth A

2018-05-26

Clinician communication about goals of care is associated with improved patient outcomes and reduced intensity of end-of-life care, but it is unclear whether interventions can improve this communication. To evaluate the efficacy of a patient-specific preconversation communication-priming intervention (Jumpstart-Tips) targeting both patients and clinicians and designed to increase goals-of-care conversations compared with usual care. Multicenter cluster-randomized trial in outpatient clinics with physicians or nurse practitioners and patients with serious illness. The study was conducted between 2012 and 2016. Clinicians were randomized to the bilateral, preconversation, communication-priming intervention (n = 65) or usual care (n = 67), with 249 patients assigned to the intervention and 288 to usual care. The primary outcome was patient-reported occurrence of a goals-of-care conversation during a target outpatient visit. Secondary outcomes included clinician documentation of a goals-of-care conversation in the medical record and patient-reported quality of communication (Quality of Communication questionnaire [QOC]; 4-indicator latent construct) at 2 weeks, as well as patient assessments of goal-concordant care at 3 months and patient-reported symptoms of depression (8-item Patient Health Questionnaire; PHQ-8) and anxiety (7-item Generalized Anxiety Disorder survey; GAD-7) at 3 and 6 months. Analyses were clustered by clinician and adjusted for confounders. We enrolled 132 of 485 potentially eligible clinicians (27% participation; 71 women [53.8%]; mean [SD] age, 47.1 [9.6] years) and 537 of 917 eligible patients (59% participation; 256 women [47.7%]; mean [SD] age, 73.4 [12.7] years). The intervention was associated with a significant increase in a goals-of-care discussion at the target visit (74% vs 31%; P < .001) and increased medical record documentation (62% vs 17%; P < .001), as well as increased patient-rated quality of communication (4.6 vs 2.1; P = .01). Patient-assessed goal-concordant care did not increase significantly overall (70% vs 57%; P = .08) but did increase for patients with stable goals between 3-month follow-up and last prior assessment (73% vs 57%; P = .03). Symptoms of depression or anxiety were not different between groups at 3 or 6 months. This intervention increased the occurrence, documentation, and quality of goals-of-care communication during routine outpatient visits and increased goal-concordant care at 3 months among patients with stable goals, with no change in symptoms of anxiety or depression. Understanding the effect on subsequent health care delivery will require additional study. ClinicalTrials.gov identifier: NCT01933789.

Caring for Depression in Older Home Health Patients.

PubMed

Bruce, Martha L

2015-11-01

Depression is common in older home health patients and increases their risk of adverse outcomes. Depression screening is required by Medicare's Outcome and Assessment Information Set. The Depression Care for Patients at Home (CAREPATH) was developed as a feasible strategy for home health nurses to manage depression in their patients. The protocol builds on nurses' existing clinical skills and is designed to fit within routine home visits. Major components include ongoing clinical assessment, care coordination, medication management, education, and goal setting. In a randomized trial, Depression CAREPATH patients had greater improvement in depressive symptoms compared to usual care. The difference between groups was significant at 3 months, growing larger and more clinically meaningful over 1 year. The intervention had no impact on patient length of stay, number of home visits, or duration of visits. Thus, nurses can play a pivotal role in the long-term course and outcomes of patients with depression. Copyright 2015, SLACK Incorporated.

[Gender perspective in health care teaching: a pending task].

PubMed

Arcos, Estela; Poblete, Johanna; Molina Vega, Irma; Miranda, Christian; Zúñiga, Yanira; Fecci, Ester; Rodríguez, Laura; Márquez, Myriam; Ramírez, Miguel

2007-06-01

Gender must be considered in the design and implementation of health policies to safeguard equity and accomplish sanitary objectives. To identify gender perspective in the curricula of five health care careers in the Universidad Austral de Chile. To identify the situation of women in the teaching profile of such curricula. An exploratory and descriptive study with a critical reading of the structure of the programs of 217 courses. Revision of official academic registries. Gender is usually not included in the curricula of health care careers. The generic language conceals female academics and students. There was a scarce inclusion of cross sectional issues such as collaborative work, interpersonal and democratic relationship, equity and critical analysis. There were no differences in academic achievements between female and male students. The contractual profile of female academics reproduces the gender inequity of the work market. The inclusion of gender is a pending task in the training of health care professionals.

Intervention to improve social and family support for caregivers of dependent patients: ICIAS study protocol.

PubMed

Rosell-Murphy, Magdalena; Bonet-Simó, Josep M; Baena, Esther; Prieto, Gemma; Bellerino, Eva; Solé, Francesc; Rubio, Montserrat; Krier, Ilona; Torres, Pascuala; Mimoso, Sonia

2014-03-25

Despite the existence of formal professional support services, informal support (mainly family members) continues to be the main source of eldercare, especially for those who are dependent or disabled. Professionals on the primary health care are the ideal choice to educate, provide psychological support, and help to mobilize social resources available to the informal caregiver.Controversy remains concerning the efficiency of multiple interventions, taking a holistic approach to both the patient and caregiver, and optimum utilization of the available community resources. .For this reason our goal is to assess whether an intervention designed to improve the social support for caregivers effectively decreases caregivers burden and improves their quality of life. CONTROLled, multicentre, community intervention trial, with patients and their caregivers randomized to the intervention or control group according to their assigned Primary Health Care Team (PHCT). Primary Health Care network (9 PHCTs). Primary informal caregivers of patients receiving home health care from participating PHCTs. Required sample size is 282 caregivers (141 from PHCTs randomized to the intervention group and 141 from PHCTs randomized to the control group. a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support. Caregivers and dependent patients: usual home health care, consisting of bimonthly scheduled visits, follow-up as needed, and additional attention upon request.Data analysisDependent variables: Caregiver burden (short-form Zarit test), caregivers' social support (Medical Outcomes Study), and caregivers' reported quality of life (SF-12)INDEPENDENT VARIABLES: a) Caregiver: sociodemographic data, Goldberg Scale, Apgar family questionnaire, Holmes and Rahe Psychosocial Stress Scale, number of chronic diseases. b) Dependent patient: sociodemographic data, level of dependency (Barthel Index), cognitive impairment (Pfeiffer test). If the intervention intended to improve social and family support is effective in reducing the burden on primary informal caregivers of dependent patients, this model can be readily applied throughout usual PHCT clinical practice. Clinical trials registrar: NCT02065427.

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.

A Medical Home versus Temporary Housing: The Importance of a Stable Usual Source of Care Among Low-Income Children

PubMed Central

Saultz, John W.; Krois, Lisa

2011-01-01

Introduction Recent health care reform policies focus on finding the best medical home for everyone. Less is known about how the stability of a usual source of care (USC) over time impacts on structural access to care. Objectives To examine the prevalence of USC changes among a low-income population of children, and how these changes were associated with unmet need. Design and Methods Cross-sectional, multivariable analyses of mail-return survey data from Oregon's food stamp program in January 2005. Results from 2,681 completed surveys were weighted back to a population of 84,087 families with adjustments for oversampling and non-response. The independent variable: whether a child had ever been required to change USC for insurance reasons. Dependent variables included: parents report of unmet medical need, unmet prescription need, missed medication doses, delayed urgent care, no ambulatory visits; and problems obtaining dental care, specialty care and counseling. Results Nearly 23% of children had changed their USC due to insurance reasons, and 10% had no current USC. Compared to children who had maintained a stable USC, children who had changed their USC due to insurance reasons had higher rates of unmet medical need (unadjusted odds ratio [OR] 2.69, 95% confidence interval [CI] 1.83, 3.29); unmet prescription need (OR 1.85, 95% CI 1.31, 2.61); delayed care (OR 1.87, 95% CI 1.21, 2.89); and reported more problems obtaining dental care (OR 1.66, 95% CI 1.20, 2.31) and counseling (OR 3.22, 95% CI 1.53, 6.77). Conclusions This study highlights the importance of ensuring stability with a USC. In our zeal to move people into new medical homes, we need to be wary of harming quality by disturbing existing care relationships, thus merely creating “temporary housing.” PMID:19841117

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.

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.

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.

Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. Methods/design Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. Discussion The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an ‘effectiveness trial’ to support broader implementation in the healthcare system if it is successful. Trial registration Unique identifier: NCT00461513 PMID:23837415

Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

PubMed Central

2012-01-01

Background Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. Methods/Design We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old) undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university) hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. Discussion The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Trial registration Netherlands Trial Register (NTR): NTR2087 PMID:22296950

Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure: HF-ACTION Randomized Controlled Trial

PubMed Central

O’Connor, Christopher M.; Whellan, David J.; Lee, Kerry L.; Keteyian, Steven J.; Cooper, Lawton S.; Ellis, Stephen J.; Leifer, Eric S.; Kraus, William E.; Kitzman, Dalane W.; Blumenthal, James A.; Rendall, David S.; Miller, Nancy Houston; Fleg, Jerome L.; Schulman, Kevin A.; McKelvie, Robert S.; Zannad, Faiez; Piña, Ileana L.

2010-01-01

Context Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes. Objective To test the efficacy and safety of exercise training among patients with heart failure. Design, Setting, and Patients Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months. Interventions Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone. Main Outcome Measures Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization. Results The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Etiology was ischemic in 51%. Median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 (65%) patients in the exercise group died or were hospitalized, compared with 796 (68%) in the usual care group (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.84–1.02; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 [16%] in the exercise group vs 198 [17%] in the usual care group; HR, 0.96; 95% CI, 0.79–1.17; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise group vs 677 [58%] in the usual care group; HR, 0.92; 95% CI, 0.83–1.03; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise group vs 393 [34%] in the usual care group; HR, 0.87; 95% CI, 0.75–1.00; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81–0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82–1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74–0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups. Conclusions In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization. Trial Registration clinicaltrials.gov Identifier: NCT00047437 PMID:19351941

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.

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].

The cost-effectiveness of a new disease management model for frail elderly living in homes for the elderly, design of a cluster randomized controlled clinical trial

PubMed Central

Boorsma, Marijke; van Hout, Hein PJ; Frijters, Dinnus H; Ribbe, Miel W; Nijpels, Giel

2008-01-01

Background The objective of this article is to describe the design of a study to evaluate the clinical and economic effects of a Disease Management model on functional health, quality of care and quality of life of persons living in homes for the elderly. Methods This study concerns a cluster randomized controlled clinical trial among five intervention homes and five usual care homes in the North-West of the Netherlands with a total of over 500 residents. All persons who are not terminally ill, are able to be interviewed and sign informed consent are included. For cognitively impaired persons family proxies will be approached to provide outcome information. The Disease Management Model consists of several elements: (1) Trained staff carries out a multidimensional assessment of the patients functional health and care needs with the interRAI Long Term Care Facilities instrument (LTCF). Computerization of the LTCF produces immediate identification of problem areas and thereby guides individualized care planning. (2) The assessment outcomes are discussed in a Multidisciplinary Meeting (MM) with the nurse, primary care physician, nursing home physician and Psychotherapist and if necessary other members of the care team. The MM presents individualized care plans to manage or treat modifiable disabilities and risk factors. (3) Consultation by an nursing home physician and psychotherapist is offered to the frailest residents at risk for nursing home admission (according to the interRAI LTCF). Outcome measures are Quality of Care indicators (LTCF based), Quality Adjusted Life Years (Euroqol), Functional health (SF12, COOP-WONCA), Disability (GARS), Patients care satisfaction (QUOTE), hospital and nursing home days and mortality, health care utilization and costs. Discussion This design is unique because no earlier studies were performed to evaluate the effects and costs of this Disease Management Model for disabled persons in homes for the elderly on functional health and quality of care. Trail registration number ISRCTN11076857 PMID:18606020

The cost-effectiveness of a new disease management model for frail elderly living in homes for the elderly, design of a cluster randomized controlled clinical trial.

PubMed

Boorsma, Marijke; van Hout, Hein P J; Frijters, Dinnus H; Ribbe, Miel W; Nijpels, Giel

2008-07-07

The objective of this article is to describe the design of a study to evaluate the clinical and economic effects of a Disease Management model on functional health, quality of care and quality of life of persons living in homes for the elderly. This study concerns a cluster randomized controlled clinical trial among five intervention homes and five usual care homes in the North-West of the Netherlands with a total of over 500 residents. All persons who are not terminally ill, are able to be interviewed and sign informed consent are included. For cognitively impaired persons family proxies will be approached to provide outcome information. The Disease Management Model consists of several elements: (1) Trained staff carries out a multidimensional assessment of the patients functional health and care needs with the interRAI Long Term Care Facilities instrument (LTCF). Computerization of the LTCF produces immediate identification of problem areas and thereby guides individualized care planning. (2) The assessment outcomes are discussed in a Multidisciplinary Meeting (MM) with the nurse, primary care physician, nursing home physician and Psychotherapist and if necessary other members of the care team. The MM presents individualized care plans to manage or treat modifiable disabilities and risk factors. (3) Consultation by an nursing home physician and psychotherapist is offered to the frailest residents at risk for nursing home admission (according to the interRAI LTCF). Outcome measures are Quality of Care indicators (LTCF based), Quality Adjusted Life Years (Euroqol), Functional health (SF12, COOP-WONCA), Disability (GARS), Patients care satisfaction (QUOTE), hospital and nursing home days and mortality, health care utilization and costs. This design is unique because no earlier studies were performed to evaluate the effects and costs of this Disease Management Model for disabled persons in homes for the elderly on functional health and quality of care. TRAIL REGISTRATION NUMBER: ISRCTN11076857.

Developing and Testing the Health Care Safety Hotline: A Prototype Consumer Reporting System for Patient Safety Events.

PubMed

Schneider, Eric C; Ridgely, M Susan; Quigley, Denise D; Hunter, Lauren E; Leuschner, Kristin J; Weingart, Saul N; Weissman, Joel S; Zimmer, Karen P; Giannini, Robert C

2017-06-01

This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers.

Developing and Testing the Health Care Safety Hotline

PubMed Central

Schneider, Eric C.; Ridgely, M. Susan; Quigley, Denise D.; Hunter, Lauren E.; Leuschner, Kristin J.; Weingart, Saul N.; Weissman, Joel S.; Zimmer, Karen P.; Giannini, Robert C.

2017-01-01

Abstract This article describes the design, development, and testing of the Health Care Safety Hotline, a prototype consumer reporting system for patient safety events. The prototype was designed and developed with ongoing review by a technical expert panel and feedback obtained during a public comment period. Two health care delivery organizations in one metropolitan area collaborated with the researchers to demonstrate and evaluate the system. The prototype was deployed and elicited information from patients, family members, and caregivers through a website or an 800 phone number. The reports were considered useful and had little overlap with information received by the health care organizations through their usual risk management, customer service, and patient safety monitoring systems. However, the frequency of reporting was lower than anticipated, suggesting that further refinements, including efforts to raise awareness by actively soliciting reports from subjects, might be necessary to substantially increase the volume of useful reports. It is possible that a single technology platform could be built to meet a variety of different patient safety objectives, but it may not be possible to achieve several objectives simultaneously through a single consumer reporting system while also establishing trust with patients, caregivers, and providers. PMID:28845353

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

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

PubMed

Batch, Bryan C; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P

2014-03-01

The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to 3) a usual care, advice-only control condition. A total of 365 community-dwelling overweight/obese adults aged 18-35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

PubMed Central

Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

2014-01-01

Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

Chart Card: feasibility of a tool for improving emergency department care in sickle cell disease.

PubMed

Neumayr, Lynne; Pringle, Steven; Giles, Stephen; Quirolo, Keith C; Paulukonis, Susan; Vichinsky, Elliott P; Treadwell, Marsha J

2010-11-01

Patients with sickle cell disease (SCD) are concerned with emergency department care, including time to treatment and staff attitudes and knowledge. Providers are concerned about rapid access to patient information and SCD treatment protocols. A software application that stores and retrieves encrypted personal medical information on a plastic credit card-sized Chart Card was designed. To determine the applicability and feasibility of the Chart Card on patient satisfaction with emergency department care and provider accessibility to patient information and care protocols. One-half of 44 adults (aged -18 years) and 50 children with SCD were randomized to either the Chart Card or usual care. Patient satisfaction was surveyed pre and post implementation of the Chart Card program, and emergency department staff was surveyed about familiarity with SCD treatment protocols. Patient satisfaction with emergency department care and efficacy in health care increased post Chart Card implementation. Providers valued immediate access to patient information and SCD treatment guidelines. The technology has potential for application in the treatment of other illnesses in other settings.

An economic evaluation of an integrated care pathway in geriatric rehabilitation for older patients with complex health problems

PubMed Central

van Haastregt, Jolanda C. M.; Evers, Silvia M. A. A.; Kempen, Gertrudis I. J. M.; Schols, Jos M. G. A.

2018-01-01

Background Integrated care pathways which cover multiple care settings are increasingly used as a tool to structure care, enhance coordination and improve transitions between care settings. However, little is known about their economic impact. The objective of this study is to determine the cost-effectiveness and cost-utility of an integrated care pathway designed for patients with complex health problems transferring from the hospital, a geriatric rehabilitation facility and primary care. Methods This economic evaluation was performed from a societal perspective alongside a prospective cohort study with two cohorts of patients. The care as usual cohort was included before implementation of the pathway and the care pathway cohort after implementation of the pathway. Both cohorts were measured over nine months, during which intervention costs, healthcare costs, patient and family costs were identified. The outcome measures were dependence in activities of daily living (measured with the KATZ-15) and quality adjusted life years (EQ-5D-3L). Costs and effects were bootstrapped and various sensitivity analyses were performed to assess robustness of the results. Results After nine months, the average societal costs were significantly lower for patients in the care pathway cohort (€50,791) versus patients in the care as usual cohort (€62,170; CI = -22,090, -988). Patients in the care pathway cohort had better scores on the KATZ-15 (1.04), indicating cost-effectiveness. No significant differences were found between the two groups on QALY scores (0.01). Conclusions The results of this study indicate that the integrated care pathway is a cost-effective intervention. Therefore, dissemination of the integrated care pathway on a wider scale could be considered. This would provide us the opportunity to confirm the findings of our study in larger economic evaluations. When looking at QALYs, no effects were found. Therefore, it is also recommended to explore if therapy in geriatric rehabilitation could also pay attention to other quality of life-related domains, such as mood and social participation. PMID:29489820

Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial.

PubMed

Schull, Michael J; Banda, Hastings; Kathyola, Damson; Fairall, Lara; Martiniuk, Alexandra; Burciul, Barry; Zwarenstein, Merrick; Sodhi, Sumeet; Thompson, Sandy; Joshua, Martias; Mondiwa, Martha; Bateman, Eric

2010-12-03

In low-income countries, only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) patients eligible for anti-retroviral treatment currently receive it. Providing decentralized treatment close to where patients live is crucial to a faster scale up, however, a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services (e.g. tuberculosis, malaria, respiratory conditions). This study will test an adapted primary care health care worker training and guideline intervention, Practical Approach to Lung Health and HIV/AIDS Malawi (PALM PLUS), on staff retention and satisfaction, and quality of patient care. A cluster-randomized trial design is being used to compare usual care with a standardized clinical guideline and training intervention, PALM PLUS. The intervention targets middle-cadre health care workers (nurses, clinical officers, medical assistants) in 30 rural primary care health centres in a single district in Malawi. PALM PLUS is an integrated, symptom-based and user-friendly guideline consistent with Malawian national treatment protocols. Training is standardized and based on an educational outreach approach. Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1-2 hours), intermittent, interactive sessions on-site in health centers. Primary outcomes are health care worker retention and satisfaction. Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS, tuberculosis, prevention-of-mother-to-child-transmission of HIV and other primary care conditions. Effect sizes and 95% confidence intervals for outcomes will be presented. Assessment of outcomes will occur at 1 year post- implementation. The PALM PLUS trial aims to address a key problem: strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care. The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention, as well as the quality of patient care, when compared to usual practice. Controlled Clinical Trials ISRCTN47805230.

Developing an active implementation model for a chronic disease management program.

PubMed

Smidth, Margrethe; Christensen, Morten Bondo; Olesen, Frede; Vedsted, Peter

2013-04-01

Introduction and diffusion of new disease management programs in healthcare is usually slow, but active theory-driven implementation seems to outperform other implementation strategies. However, we have only scarce evidence on the feasibility and real effect of such strategies in complex primary care settings where municipalities, general practitioners and hospitals should work together. The Central Denmark Region recently implemented a disease management program for chronic obstructive pulmonary disease (COPD) which presented an opportunity to test an active implementation model against the usual implementation model. The aim of the present paper is to describe the development of an active implementation model using the Medical Research Council's model for complex interventions and the Chronic Care Model. We used the Medical Research Council's five-stage model for developing complex interventions to design an implementation model for a disease management program for COPD. First, literature on implementing change in general practice was scrutinised and empirical knowledge was assessed for suitability. In phase I, the intervention was developed; and in phases II and III, it was tested in a block- and cluster-randomised study. In phase IV, we evaluated the feasibility for others to use our active implementation model. The Chronic Care Model was identified as a model for designing efficient implementation elements. These elements were combined into a multifaceted intervention, and a timeline for the trial in a randomised study was decided upon in accordance with the five stages in the Medical Research Council's model; this was captured in a PaTPlot, which allowed us to focus on the structure and the timing of the intervention. The implementation strategies identified as efficient were use of the Breakthrough Series, academic detailing, provision of patient material and meetings between providers. The active implementation model was tested in a randomised trial (results reported elsewhere). The combination of the theoretical model for complex interventions and the Chronic Care Model and the chosen specific implementation strategies proved feasible for a practice-based active implementation model for a chronic-disease-management-program for COPD. Using the Medical Research Council's model added transparency to the design phase which further facilitated the process of implementing the program. http://www.clinicaltrials.gov/(NCT01228708).

Randomised controlled trial evaluating the effectiveness and cost-effectiveness of 'Families for Health', a family-based childhood obesity treatment intervention delivered in a community setting for ages 6 to 11 years.

PubMed

Robertson, Wendy; Fleming, Joanna; Kamal, Atiya; Hamborg, Thomas; Khan, Kamran A; Griffiths, Frances; Stewart-Brown, Sarah; Stallard, Nigel; Petrou, Stavros; Simkiss, Douglas; Harrison, Elizabeth; Kim, Sung Wook; Thorogood, Margaret

2017-01-01

Effective programmes to help children manage their weight are required. 'Families for Health' focuses on a parenting approach, designed to help parents develop their parenting skills to support lifestyle change within the family. Families for Health version 1 showed sustained reductions in mean body mass index (BMI) z-score after 2 years in a pilot project. The aim was to evaluate its effectiveness and cost-effectiveness in a randomised controlled trial (RCT). The trial was a multicentre, investigator-blind RCT, with a parallel economic and process evaluation, with follow-up at 3 and 12 months. Randomisation was by family unit, using a 1 : 1 allocation by telephone registration, stratified by three sites, with a target of 120 families. Three sites in the West Midlands, England, UK. Children aged 6-11 years who were overweight (≥ 91st centile BMI) or obese (≥ 98th centile BMI), and their parents/carers. Recruitment was via referral or self-referral. Families for Health version 2 is a 10-week, family-based community programme with parallel groups for parents and children, addressing parenting, lifestyle, social and emotional development. Usual care was the treatment for childhood obesity provided within each locality. Joint primary outcome measures were change in children's BMI z-score and incremental cost per quality-adjusted life-year (QALY) gained at 12 months' follow-up (QALYs were calculated using the European Quality of Life-5 Dimensions Youth version). Secondary outcome measures included changes in children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. Parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style were also assessed. The process evaluation documented recruitment, reach, dose delivered, dose received and fidelity, using mixed methods. The study recruited 115 families (128 children; 63 boys and 65 girls), with 56 families randomised to the Families for Health arm and 59 to the 'usual-care' control arm. There was 80% retention of families at 3 months (Families for Health, 46 families; usual care, 46 families) and 72% retention at 12 months (Families for Health, 44 families; usual care, 39 families). The change in BMI z-score at 12 months was not significantly different in the Families for Health arm and the usual-care arm [0.114, 95% confidence interval (CI) -0.001 to 0.229; p  = 0.053]. However, within-group analysis showed that the BMI z-score was significantly reduced in the usual-care arm (-0.118, 95% CI -0.203 to -0.034; p  = 0.007), but not in the Families for Health arm (-0.005, 95% CI -0.085 to 0.078; p  = 0.907). There was only one significant difference between groups for secondary outcomes. The economic evaluation, taking a NHS and Personal Social Services perspective, showed that mean costs 12 months post randomisation were significantly higher for Families for Health than for usual care (£998 vs. £548; p  < 0.001). The mean incremental cost-effectiveness of Families for Health was estimated at £552,175 per QALY gained. The probability that the Families for Health programme is cost-effective did not exceed 40% across a range of thresholds. The process evaluation demonstrated that the programme was implemented, as planned, to the intended population and any adjustments did not deviate widely from the handbook. Many families waited more than 3 months to receive the intervention. Facilitators', parents' and children's experiences of Families for Health were largely positive and there were no adverse events. Further analysis could explore why some children show a clinically significant benefit while others have a worse outcome. Families for Health was neither effective nor cost-effective for the management of obesity in children aged 6-11 years, in comparison with usual care. Further exploration of the wide range of responses in BMI z-score in children following the Families for Health and usual-care interventions is warranted, focusing on children who had a clinically significant benefit and those who showed a worse outcome with treatment. Further research could focus on the role of parents in the prevention of obesity, rather than treatment. Current Controlled Trials ISRCTN45032201. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 21, No. 1. See the NIHR Journals Library website for further project information.

Collaborative care for patients with bipolar disorder: a randomised controlled trial

PubMed Central

2011-01-01

Background Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands. Methods/design The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC) in comparison with Care as usual (CAU) in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver outcomes are burden and satisfaction with care. Discussion Several ways to enhance the quality of this study are described, as well as some limitations caused by the complexities of naturalistic treatment settings where not all influencing factors on an intervention and the outcomes can be controlled. Trial Registration The Netherlands Trial Registry, NTR2600. PMID:21849078

Impact of the Oregon Health Plan on Access and Satisfaction of Adults with Low-income

PubMed Central

Mitchell, Janet B; Haber, Susan G; Khatutsky, Galina; Donoghue, Suzanne

2002-01-01

Objective To evaluate the effects of the Oregon Health Plan (OHP) on beneficiary access and satisfaction. Data Sources Telephone survey of nondisabled adults in 1998. Study Design Two groups of adults were surveyed: OHP enrollees and Food Stamp recipients not enrolled in OHP. The Food Stamp sample included both privately insured and uninsured recipients. This allowed us to disentangle the insurance effects of OHP from other effects such as its reliance on managed care and the priority list. OHP and Food Stamp adults were compared along the following measures: usual source of care, utilization of health care services, unmet need, and satisfaction with care. Data Collection The survey was conducted by telephone, using computer-assisted telephone interviewing techniques. Principal Findings Much of OHP's impact has been realized by its extension of health insurance coverage to Oregon's low-income residents. The availability of health insurance significantly increased the utilization of many health care services and reduced unmet need for care. OHP was associated within a higher percentage of enrollees having a usual source of care and higher rates of Pap test screening among women compared with Food Stamp recipients. OHP enrollees also reported significantly higher use of dental care and prescription drugs; use we attribute to the expanded benefit package under the priority list. At the same time, OHP enrollees reported a greater unmet need for prescription drugs. Drug treatment for below-the-line conditions was one reason for this unmet need, but often the specific drug simply was not in the plan's formulary. OHP enrollees were as satisfied with their health care as those Food Stamp recipients with private health insurance. Conclusions Despite the negative publicity prior to its implementation, there is no evidence that “rationing” under OHP's priority list has substantially restricted access to needed services. OHP adults appear to enjoy access equal to or better than that of low-income persons with private health insurance and have far greater access than the uninsured.

A quasi-experimental outcomes analysis of a psychoeducation intervention for pregnant women with abuse-related posttraumatic stress

PubMed Central

Rowe, Heather; Sperlich, Mickey; Seng, Julia S.

2015-01-01

Objective To test the effectiveness of a trauma-specific psycho-educational intervention for pregnant women with a history of childhood maltreatment on six intrapartum and postpartum psychological outcomes. Design Quasi-experimental study comparing women from a single-group pretest-posttest pilot intervention study with women matched from a prospective observational study. Setting Rural and university-based prenatal clinics. Participants Pregnant women entered the study by responding to an advertisement or by referral from a maternity care provider. Women could take part whether or not they met posttraumatic stress disorder diagnostic criteria. Outcomes data exist for 17 pilot intervention study participants and 43 matched observational study participants. Interventions Participants in the observational study received usual care. Participants in the pilot intervention study received usual care plus the intervention, a fully manualized self-study program supported by weekly phone tutoring sessions with a health professional. Main Outcome Measures The National Women’s Study PTSD Module; The Peritraumatic Dissociation Experience Questionnaire); The Perception of Care Questionnaire; The Postpartum Depression Screening Scale; The Postpartum Bonding Questionnaire; and a semantic differential appraisal of the labor experience. Results Participants in the intervention study had better scores on all measures. Differences in means between participants in the intervention study and participants in the observational study equated to medium effect sized for dissociation during labor, rating of labor experience, and perception of care in labor, and small effect sizes for postpartum PTSD symptoms, postpartum depression symptoms, and mother-infant bonding. Conclusion This trauma-specific intervention reaches and benefits pregnant women with a history of childhood maltreatment. PMID:24754455

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.

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

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.

Are brief interventions to increase physical activity cost-effective? A systematic review

PubMed Central

GC, Vijay; Suhrcke, Marc; Hardeman, Wendy; Sutton, Stephen

2016-01-01

Objective To determine whether brief interventions promoting physical activity are cost-effective in primary care or community settings. Design Systematic review of economic evaluations. Methods and data sources We searched MEDLINE, EMBASE, PsycINFO, CINAHL, EconLit, SPORTDiscus, PEDro, the Cochrane library, National Health Service Economic Evaluation Database and the Cost-Effectiveness Analysis Registry up to 20 August 2014. Web of Knowledge was used for cross-reference search. We included studies investigating the cost-effectiveness of brief interventions, as defined by National Institute for Health and Care Excellence, promoting physical activity in primary care or the community. Methodological quality was assessed using Drummond's checklist for economic evaluations. Data were extracted from individual studies fulfilling selection criteria using a standardised pro forma. Comparisons of cost-effectiveness and cost-utility ratios were made between studies. Results Of 1840 identified publications, 13 studies fulfilled the inclusion criteria describing 14 brief interventions. Studies varied widely in the methods used, such as the perspective of economic analysis, intervention effects and outcome measures. The incremental cost of moving an inactive person to an active state, estimated for eight studies, ranged from £96 to £986. The cost-utility was estimated in nine studies compared with usual care and varied from £57 to £14 002 per quality-adjusted life year; dominant to £6500 per disability-adjusted life year; and £15 873 per life years gained. Conclusions Brief interventions promoting physical activity in primary care and the community are likely to be inexpensive compared with usual care. Given the commonly accepted thresholds, they appear to be cost-effective on the whole, although there is notable variation between studies. PMID:26438429

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

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.

Coaching in self-efficacy improves care responses, health and well-being in dementia carers: a pre/post-test/follow-up study.

PubMed

Chenoweth, Lynn; Stein-Parbury, Jane; White, Danielle; McNeill, Georgene; Jeon, Yun-Hee; Zaratan, Beverley

2016-05-04

Maintaining the health and well-being of family carers of people with dementia is vital, given their potential for experiencing burden associated with the role. The study aimed to help dementia carers develop self-efficacy, be less hassled by the caring role and improve their health and well-being with goal-directed behaviour, by participating in an eight module carer coaching program. The study used mixed methods in a pre/post-test/follow-up design over 24 months, with assignment of consented dementia carers to either individualised (n = 16) or group coaching (n = 32), or usual carer support services (n = 43), depending on preference. Care-giving self-efficacy and hassles, carer health, well-being and goal-directed behaviours were assessed over time. Analysis of Variance (ANOVA) was used to compare changes over time and the effects of coaching on carer self-efficacy, hassles and health, using the Univariate General Linear Model (GLM). All carers were hassled by many aspects of caring at baseline. Participants receiving coaching reported non-significant improvements in most areas of self-efficacy for caring, hassles associated with caring and self-reported health at post-test and follow-up, than did carers receiving usual carer support. Group coaching had greater success in helping carers to achieve their goals and to seek help from informal and formal support networks and services. The study outcomes were generally positive, but need to be interpreted cautiously, given some methodological limitations. It has been shown, however, that health staff can assist dementia carers to develop self-efficacy in better managing their family member's limitations and behaviour, seek help from others and attend to their health. Teaching carers to use goal-directed behaviour may help them achieve these outcomes.

Rationale and design of the HOME trial: A pragmatic randomized controlled trial of home-based human papillomavirus (HPV) self-sampling for increasing cervical cancer screening uptake and effectiveness in a U.S. healthcare system.

PubMed

Winer, Rachel L; Tiro, Jasmin A; Miglioretti, Diana L; Thayer, Chris; Beatty, Tara; Lin, John; Gao, Hongyuan; Kimbel, Kilian; Buist, Diana S M

2018-01-01

Women who delay or do not attend Papanicolaou (Pap) screening are at increased risk for cervical cancer. Trials in countries with organized screening programs have demonstrated that mailing high-risk (hr) human papillomavirus (HPV) self-sampling kits to under-screened women increases participation, but U.S. data are lacking. HOME is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system to compare two programmatic approaches for increasing cervical cancer screening uptake and effectiveness in under-screened women (≥3.4years since last Pap) aged 30-64years: 1) usual care (annual patient reminders and ad hoc outreach by clinics) and 2) usual care plus mailed hrHPV self-screening kits. Over 2.5years, eligible women were identified through electronic medical record (EMR) data and randomized 1:1 to the intervention or control arm. Women in the intervention arm were mailed kits with pre-paid envelopes to return samples to the central clinical laboratory for hrHPV testing. Results were documented in the EMR to notify women's primary care providers of appropriate follow-up. Primary outcomes are detection and treatment of cervical neoplasia. Secondary outcomes are cervical cancer screening uptake, abnormal screening results, and women's experiences and attitudes towards hrHPV self-sampling and follow-up of hrHPV-positive results (measured through surveys and interviews). The trial was designed to evaluate whether a programmatic strategy incorporating hrHPV self-sampling is effective in promoting adherence to the complete screening process (including follow-up of abnormal screening results and treatment). The objective of this report is to describe the rationale and design of this pragmatic trial. Copyright © 2017 Elsevier Inc. All rights reserved.

Synchronized personalized music audio-playlists to improve adherence to physical activity among patients participating in a structured exercise program: a proof-of-principle feasibility study.

PubMed

Alter, David A; O'Sullivan, Mary; Oh, Paul I; Redelmeier, Donald A; Marzolini, Susan; Liu, Richard; Forhan, Mary; Silver, Michael; Goodman, Jack M; Bartel, Lee R

2015-01-01

Preference-based tempo-pace synchronized music has been shown to reduce perceived physical activity exertion and improve exercise performance. The extent to which such strategies can improve adherence to physical activity remains unknown. The objective of the study is to explore the feasibility and efficacy of tempo-pace synchronized preference-based music audio-playlists on adherence to physical activity among cardiovascular disease patients participating in a cardiac rehabilitation. Thirty-four cardiac rehabilitation patients were randomly allocated to one of two strategies: (1) no music usual-care control and (2) tempo-pace synchronized audio-devices with personalized music playlists + usual-care. All songs uploaded onto audio-playlist devices took into account patient personal music genre and artist preferences. However, actual song selection was restricted to music whose tempos approximated patients' prescribed exercise walking/running pace (steps per minute) to achieve tempo-pace synchrony. Patients allocated to audio-music playlists underwent further randomization in which half of the patients received songs that were sonically enhanced with rhythmic auditory stimulation (RAS) to accentuate tempo-pace synchrony, whereas the other half did not. RAS was achieved through blinded rhythmic sonic-enhancements undertaken manually to songs within individuals' music playlists. The primary outcome consisted of the weekly volume of physical activity undertaken over 3 months as determined by tri-axial accelerometers. Statistical methods employed an intention to treat and repeated-measures design. Patients randomized to personalized audio-playlists with tempo-pace synchrony achieved higher weekly volumes of physical activity than did their non-music usual-care comparators (475.6 min vs. 370.2 min, P  < 0.001). Improvements in weekly physical activity volumes among audio-playlist recipients were driven by those randomized to the RAS group which attained weekly exercise volumes that were nearly twofold greater than either of the two other groups (average weekly minutes of physical activity of 631.3 min vs. 320 min vs. 370.2 min, personalized audio-playlists with RAS vs. personalized audio-playlists without RAS vs. non-music usual-care controls, respectively, P  < 0.001). Patients randomized to music with RAS utilized their audio-playlist devices more frequently than did non-RAS music counterparts ( P  < 0.001). The use of tempo-pace synchronized preference-based audio-playlists was feasibly implemented into a structured exercise program and efficacious in improving adherence to physical activity beyond the evidence-based non-music usual standard of care. Larger clinical trials are required to validate these findings. ClinicalTrials.gov ID (NCT01752595).

Protocol for the evaluation of a decision aid for women with a breech-presenting baby [ISRCTN14570598

PubMed Central

Roberts, Christine L; Nassar, Natasha; Barratt, Alexandra; Raynes-Greenow, Camille H; Peat, Brian; Henderson-Smart, David

2004-01-01

Background There is now good evidence about the management options for pregnant women with a breech presentation (buttocks or feet rather than head-first) at term; external cephalic version (ECV) – the turning of a breech baby to a head-down position and/or planned caesarean section (CS). Each of these options has benefits and risks and the relative importance of these vary for each woman, subject to her personal values and preferences, a situation where a decision aid may be helpful. Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values. The ECV decision aid was developed using the Ottawa Decision Support Framework, including a systematic review of the evidence about the benefits and risks of the options for breech pregnancy. It comprises an audiotape with a supplementary booklet and worksheet, a format that can be taken home and discussed with a partner. This project aims to evaluate the ECV decision aid for women with a breech presenting baby in late pregnancy. Study design We aim to evaluate the effectiveness of the decision aid compared with usual care in a randomised controlled trial in maternity hospitals that offer ECV. The study group will receive the decision aid in addition to usual care and the control group will receive standard information on management options for breech presentation from their usual pregnancy care provider. Approximately 184 women with a single breech-presenting baby at greater than 34 weeks gestation and who are clinically eligible for ECV will be recruited for the trial. The primary outcomes of the study are knowledge, decisional conflict, anxiety and satisfaction with decision-making that will be assessed using self-administered questionnaires. The decision aid is not intended to influence either the uptake of either ECV or planned CS, however we will monitor health service utilisation rates and maternal and perinatal outcomes. PMID:15606926

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.

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.

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.).

Technology-facilitated depression care management among predominantly Latino diabetes patients within a public safety net care system: comparative effectiveness trial design.

PubMed

Wu, Shinyi; Ell, Kathleen; Gross-Schulman, Sandra G; Sklaroff, Laura Myerchin; Katon, Wayne J; Nezu, Art M; Lee, Pey-Jiuan; Vidyanti, Irene; Chou, Chih-Ping; Guterman, Jeffrey J

2014-03-01

Health disparities in minority populations are well recognized. Hispanics and Latinos constitute the largest ethnic minority group in the United States; a significant proportion receives their care via a safety net. The prevalence of diabetes mellitus and comorbid depression is high among this group, but the uptake of evidence-based collaborative depression care management has been suboptimal. The study design and baseline characteristics of the enrolled sample in the Diabetes-Depression Care-management Adoption Trial (DCAT) establishes a quasi-experimental comparative effectiveness research clinical trial aimed at accelerating the adoption of collaborative depression care in safety net clinics. The study was conducted in collaboration with the Los Angeles County Department of Health Services at eight county-operated clinics. DCAT has enrolled 1406 low-income, predominantly Hispanic/Latino patients with diabetes to test a translational model of depression care management. This three-group study compares usual care with a collaborative care team support model and a technology-facilitated depression care model that provides automated telephonic depression screening and monitoring tailored to patient conditions and preferences. Call results are integrated into a diabetes disease management registry that delivers provider notifications, generates tasks, and issues critical alerts. All subjects receive comprehensive assessments at baseline, 6, 12, and 18 months by independent English-Spanish bilingual interviewers. Study outcomes include depression outcomes, treatment adherence, satisfaction, acceptance of assessment and monitoring technology, social and economic stress reduction, diabetes self-care management, health care utilization, and care management model cost and cost-effectiveness comparisons. DCAT's goal is to optimize depression screening, treatment, follow-up, outcomes, and cost savings to reduce health disparities. Copyright © 2013 Elsevier Inc. All rights reserved.

Healthy eating and active living for diabetes in primary care networks (HEALD-PCN): rationale, design, and evaluation of a pragmatic controlled trial for adults with type 2 diabetes

PubMed Central

2012-01-01

Background While strong and consistent evidence supports the role of lifestyle modification in the prevention and management of type 2 diabetes (T2DM), the best strategies for program implementation to support lifestyle modification within primary care remain to be determined. The objective of the study is to evaluate the implementation of an evidence-based self- management program for patients with T2DM within a newly established primary care network (PCN) environment. Method Using a non-randomized design, participants (total N = 110 per group) will be consecutively allocated in bi-monthly blocks to either a 6-month self-management program lead by an Exercise Specialist or to usual care. Our primary outcome is self-reported physical activity and pedometer steps. Discussion The present study will assess whether a diabetes self-management program lead by an Exercise Specialist provided within a newly emerging model of primary care and linked to available community-based resources, can lead to positive changes in self-management behaviours for adults with T2DM. Ultimately, our work will serve as a platform upon which an emerging model of primary care can incorporate effective and efficient chronic disease management practices that are sustainable through partnerships with local community partners. Clinical Trials Registration ClinicalTrials.gov identifier: NCT00991380 PMID:22712881

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.

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

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.

Technology- and Phone-Based Weight Loss Intervention

PubMed Central

Hartman, Sheri J.; Nelson, Sandahl H.; Cadmus-Bertram, Lisa A.; Patterson, Ruth E.; Parker, Barbara A.; Pierce, John P.

2017-01-01

Introduction For women with an increased breast cancer risk, reducing excess weight and increasing physical activity are believed to be important approaches for reducing their risk. This study tested a weight loss intervention that combined commercially available technology-based self-monitoring tools with individualized phone calls. Design Women were randomized to a weight loss intervention arm (n=36) or a usual care arm (n=18). Setting/Participants Participants were women with a BMI ≥ 27.5 kg/m2 and elevated breast cancer risk recruited from the mammography clinic at the Moores Cancer Center at the University of California San Diego. Intervention Intervention participants used the MyFitnessPal website and phone app to monitor diet and a Fitbit to monitor physical activity. Participants received 12 standardized coaching calls with trained counselors over 6 months. Usual care participants received the U.S. Dietary Guidelines for Americans at baseline and two brief calls over the 6 months. Main outcome measures Weight and accelerometer-measured physical activity were assessed at baseline and 6 months. Data were collected in San Diego, CA, from 2012 to 2014 and analyzed in 2015. Results Participants (n=54) had a mean age of 59.5 (SD=5.6) years, BMI of 31.9 (SD=3.5), and a mean Gail Model score of 2.5 (SD=1.4). At 6 months, intervention participants had lost significantly more weight (4.4 kg vs 0.8 kg, p=0.004) and a greater percentage of starting weight (5.3% vs 1.0%, p=0.005) than usual care participants. Across arms, greater increases in moderate-to-vigorous physical activity resulted in greater weight loss (p=0.01). Conclusions Combining technology-based self-monitoring tools with phone counseling supported weight loss over 6 months in women at increased risk for breast cancer. PMID:27593420

Work outcomes and their predictors in the Redesigning Daily Occupations (ReDO) rehabilitation programme for women with stress-related disorders.

PubMed

Eklund, Mona; Wästberg, Birgitta A; Erlandsson, Lena-Karin

2013-04-01

Previous research has shown that the Redesigning Daily Occupations programme reduced the degree of sick leave and increased return to work rates among women on sick leave for stress-related disorders when compared with "care as usual". To further investigate the Redesigning Daily Occupations intervention, this study explored changes in the work situation from baseline to a 12-month follow-up in the Redesigning Daily Occupations group compared with the "care as usual" group and analysed any predictors of change. A matched-control design was used and 84 women were recruited. Objective (return to work and sick leave) and subjective work outcomes (perceptions of the worker role and the work environment) were explored. Potential predictors were clinical and demographic variables and an anxiety-depression factor. In both groups, large positive effect sizes from baseline to follow-up were found regarding the objective outcomes, a moderate positive effect size was found for perceived work environment, whereas perceived worker role remained unaffected. Previous work rehabilitation predicted objective work outcomes in both groups. Higher education and older age were predictors of subjective outcomes in the Redesigning Daily Occupations group, whereas a more severe anxiety-depression rating was negative for work environment ratings in the "care as usual" group. Return to work seemed possible without a change in the women's perceptions of the worker role; rather they renegotiated their view of the work environment. The Redesigning Daily Occupations programme was found to be promising, with a positive effect on return to work and sick leave reduction. It seemed more suitable for the higher educated and older women. © 2012 The Authors Australian Occupational Therapy Journal © 2012 Occupational Therapy Australia.

Effect of Custom-Made Footwear on Foot Ulcer Recurrence in Diabetes

PubMed Central

Bus, Sicco A.; Waaijman, Roelof; Arts, Mark; de Haart, Mirjam; Busch-Westbroek, Tessa; van Baal, Jeff; Nollet, Frans

2013-01-01

OBJECTIVE Custom-made footwear is the treatment of choice to prevent foot ulcer recurrence in diabetes. This footwear primarily aims to offload plantar regions at high ulcer risk. However, ulcer recurrence rates are high. We assessed the effect of offloading-improved custom-made footwear and the role of footwear adherence on plantar foot ulcer recurrence. RESEARCH DESIGN AND METHODS We randomly assigned 171 neuropathic diabetic patients with a recently healed plantar foot ulcer to custom-made footwear with improved and subsequently preserved offloading (∼20% peak pressure relief by modifying the footwear) or to usual care (i.e., nonimproved custom-made footwear). Primary outcome was plantar foot ulcer recurrence in 18 months. Secondary outcome was ulcer recurrence in patients with an objectively measured adherence of ≥80% of steps taken. RESULTS On the basis of intention-to-treat, 33 of 85 patients (38.8%) with improved footwear and 38 of 86 patients (44.2%) with usual care had a recurrent ulcer (relative risk −11%, odds ratio 0.80 [95% CI 0.44–1.47], P = 0.48). Ulcer-free survival curves were not significantly different between groups (P = 0.40). In the 79 patients (46% of total group) with high adherence, 9 of 35 (25.7%) with improved footwear and 21 of 44 (47.8%) with usual care had a recurrent ulcer (relative risk −46%, odds ratio 0.38 [0.15–0.99], P = 0.045). CONCLUSIONS Offloading-improved custom-made footwear does not significantly reduce the incidence of plantar foot ulcer recurrence in diabetes compared with custom-made footwear that does not undergo such improvement, unless it is worn as recommended. PMID:24130357

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.

Impact of Iyengar yoga on quality of life in young women with rheumatoid arthritis

PubMed Central

Evans, Subhadra; Moieni, Mona; Lung, Kirsten; Tsao, Jennie; Sternlieb, Beth; Taylor, Mihaela; Zeltzer, Lonnie

2012-01-01

Objective Rheumatoid arthritis (RA) is a chronic, disabling disease that can greatly compromise health related quality of life (HRQOL). The aim of this study was to assess the impact of a 6-week twice/week Iyengar yoga (IY) program on HRQOL of young adults with RA compared to a usual-care waitlist control group. Method The program was designed to improve the primary outcome of HRQOL including pain, as well as disability and psychological functioning in patients. Assessments were collected pre, post, and at 2-months following treatment. Weekly ratings of anxiety, depression, pain and sleep were also recorded. A total of 26 participants completed the intervention (yoga = 11; usual care waitlist = 15). All participants were female (mean age =28 years). Results Overall attrition was low at 15%. On average, women in the yoga group attended 96% of the yoga classes. No adverse events were reported. Relative to the usual-care waitlist, women assigned to the yoga program showed significantly greater improvement on standardized measures of HRQOL, pain disability, general health, mood, fatigue, acceptance of chronic pain and self-efficacy regarding pain at post treatment. Almost half of the yoga group reported clinically meaningful symptom improvement. Analysis of the uncontrolled effects and maintenance of treatment effects showed improvements in HRQOL general health, pain disability and weekly ratings of pain, anxiety and depression that maintained at follow-up. Conclusion The findings suggest a brief IY intervention is a feasible and safe adjunctive treatment for young people with RA, leading to health related quality of life (HRQOL), pain disability, fatigue, and mood benefits. Moreover, improvements in quality of life, pain disability and mood persisted at the 2-month follow-up. PMID:23370082

Nintendo Wii Fit as an adjunct to physiotherapy following lower limb fractures: preliminary feasibility, safety and sample size considerations.

PubMed

McPhail, S M; O'Hara, M; Gane, E; Tonks, P; Bullock-Saxton, J; Kuys, S S

2016-06-01

The Nintendo Wii Fit integrates virtual gaming with body movement, and may be suitable as an adjunct to conventional physiotherapy following lower limb fractures. This study examined the feasibility and safety of using the Wii Fit as an adjunct to outpatient physiotherapy following lower limb fractures, and reports sample size considerations for an appropriately powered randomised trial. Ambulatory patients receiving physiotherapy following a lower limb fracture participated in this study (n=18). All participants received usual care (individual physiotherapy). The first nine participants also used the Wii Fit under the supervision of their treating clinician as an adjunct to usual care. Adverse events, fracture malunion or exacerbation of symptoms were recorded. Pain, balance and patient-reported function were assessed at baseline and discharge from physiotherapy. No adverse events were attributed to either the usual care physiotherapy or Wii Fit intervention for any patient. Overall, 15 (83%) participants completed both assessments and interventions as scheduled. For 80% power in a clinical trial, the number of complete datasets required in each group to detect a small, medium or large effect of the Wii Fit at a post-intervention assessment was calculated at 175, 63 and 25, respectively. The Nintendo Wii Fit was safe and feasible as an adjunct to ambulatory physiotherapy in this sample. When considering a likely small effect size and the 17% dropout rate observed in this study, 211 participants would be required in each clinical trial group. A larger effect size or multiple repeated measures design would require fewer participants. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

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.

Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. Methods/Design In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. Discussion The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program’s potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an extensive process evaluation will take place which will offer insight in the quality and feasibility of the sampling and intervention process. If it is shown to be effective and feasible, this Self-Management Program could be widely disseminated. Clinical trials registration ClinicalTrials.gov, NCT01217502. PMID:24099315

Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial.

PubMed

Farmer, Andrew; Toms, Christy; Hardinge, Maxine; Williams, Veronika; Rutter, Heather; Tarassenko, Lionel

2014-01-08

The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education. The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months. The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations. Current controlled trials ISRCTN40367841.

Assertive community treatment for elderly people with severe mental illness

PubMed Central

2010-01-01

Background Adults aged 65 and older with severe mental illnesses are a growing segment of the Dutch population. Some of them have a range of serious problems and are also difficult to engage. While assertive community treatment is a common model for treating difficult to engage severe mental illnesses patients, no special form of it is available for the elderly. A special assertive community treatment team for the elderly is developed in Rotterdam, the Netherlands and tested for its effectiveness. Methods We will use a randomized controlled trial design to compare the effects of assertive community treatment for the elderly with those of care as usual. Primary outcome measures will be the number of dropouts, the number of patients engaged in care and patient's psychiatric symptoms, somatic symptoms, and social functioning. Secondary outcome measures are the number of unmet needs, the subjective quality of life and patients' satisfaction. Other secondary outcomes include the number of crisis contacts, rates of voluntary and involuntary admission, and length of stay. Inclusion criteria are aged 65 plus, the presence of a mental disorder, a lack of motivation for treatment and at least four suspected problems with functioning (addiction, somatic problems, daily living activities, housing etc.). If patients meet the inclusion criteria, they will be randomly allocated to either assertive community treatment for the elderly or care as usual. Trained assessors will use mainly observational instruments at the following time points: at baseline, after 9 and 18 months. Discussion This study will help establish whether assertive community treatment for the elderly produces better results than care as usual in elderly people with severe mental illnesses who are difficult to engage. When assertive community treatment for the elderly proves valuable in these respects, it can be tested and implemented more widely, and mechanisms for its effects investigated. Trial Registration The Netherlands National Trial Register NTR1620 PMID:20958958

Assertive community treatment for elderly people with severe mental illness.

PubMed

Stobbe, Jolanda; Mulder, Niels C L; Roosenschoon, Bert-Jan; Depla, Marja; Kroon, Hans

2010-10-19

Adults aged 65 and older with severe mental illnesses are a growing segment of the Dutch population. Some of them have a range of serious problems and are also difficult to engage. While assertive community treatment is a common model for treating difficult to engage severe mental illnesses patients, no special form of it is available for the elderly. A special assertive community treatment team for the elderly is developed in Rotterdam, the Netherlands and tested for its effectiveness. We will use a randomized controlled trial design to compare the effects of assertive community treatment for the elderly with those of care as usual. Primary outcome measures will be the number of dropouts, the number of patients engaged in care and patient's psychiatric symptoms, somatic symptoms, and social functioning. Secondary outcome measures are the number of unmet needs, the subjective quality of life and patients' satisfaction. Other secondary outcomes include the number of crisis contacts, rates of voluntary and involuntary admission, and length of stay. Inclusion criteria are aged 65 plus, the presence of a mental disorder, a lack of motivation for treatment and at least four suspected problems with functioning (addiction, somatic problems, daily living activities, housing etc.). If patients meet the inclusion criteria, they will be randomly allocated to either assertive community treatment for the elderly or care as usual. Trained assessors will use mainly observational instruments at the following time points: at baseline, after 9 and 18 months. This study will help establish whether assertive community treatment for the elderly produces better results than care as usual in elderly people with severe mental illnesses who are difficult to engage. When assertive community treatment for the elderly proves valuable in these respects, it can be tested and implemented more widely, and mechanisms for its effects investigated. The Netherlands National Trial Register NTR1620.

Healthcare Access and Utilization among Korean Americans: The Mediating Role of English Use and Proficiency

PubMed Central

Maxwell, Annette E.; Glenn, Beth A.; Herrmann, Alison K.; Chang, L Cindy; Crespi, Catherine M.; Bastani, Roshan

2017-01-01

The literature suggests that Korean Americans underutilize health services. Cultural factors and language barriers appear to influence this pattern of low utilization but studies on the relationships among length of stay in the US, English use and proficiency, and utilization of health services among Korean Americans have yielded inconsistent results. This study examines whether English language use and proficiency plays a mediating role in the relationships between length of stay in the US and health insurance coverage, access to and use of care. Structural equation modeling was used for mediation analysis with multiple dependent variables among Korean Americans (N = 555) using baseline data from a large trial designed to increase Hepatitis B testing. The results show 36% of the total effect of proportion of lifetime in the US on having health insurance was significantly mediated by English use and proficiency (indirect effect = 0.166, SE = 0.07, p<.05; direct effect = 0.296, SE = 0.13, p<.05). Proportion of lifetime in the US was not associated with usual source of care and health service utilization. Instead, health care utilization was primarily driven by having health insurance and a usual source of care, further underscoring the importance of these factors. A focus on increasing English use and proficiency and insurance coverage among older, female, less educated Korean Americans has the potential to mitigate health disparities associated with reduced access to health services in this population. PMID:29057278

[Depression in adolescence treated at primary care centres: size of a hidden problem of general health].

PubMed

dos Santos Palazzo, L; Humberto Béria, J; Alonso-Fernández, F; Tomasi, E

2001-11-15

To investigate the prevalence of depression and its relationship to the reason for the consultation and to the medical diagnosis. Descriptive, cross-sectional design. Primary care units of a community in Brazil. Individuals between 13 and 19 years old, who attended 10 primary care units to consult with a non-psychiatric doctor between October 1997 and January 1998 (n = 463). The CET-DE (Alonso-Fernández, 1986) was used to measure depression, jointly with a questionnaire for evaluating social and demographic details and data pertinent to the consultation. Prevalence ran at 26.5% (95% CI: 22.6-30.4%). 99.2% cases of depression had not been identified. Complaints were spread over the somatic field (61.1%), or were sex-related (49.5%), mainly pregnancy (31.7%), especially among the cases of depression (p < 0.001). There were few psychiatric-social complaints (1.5%). Diagnoses often coincided with complaints: 59.9% somatic, 38.4% sex-related (pregnancy = 21.6%) and 1.7% psychiatric-social. Adolescent depression is common in primary care, but is not usually identified. The reason for this may be the kind of depression, which is usually light or focused on just one dimension of human vitality; the doctors tendency to centre his/her attention on the complaint without broadening the clinical spectrum; or even because the adolescent expresses his/her emotional problems poorly, which often contributes to the depression not being diagnosed.

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.

Comprehensive care improves physical recovery of hip-fractured elderly Taiwanese patients with poor nutritional status.

PubMed

Liu, Hsin-Yun; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Yang, Ching-Tzu; Chou, Shih-Wei; Chen, Ching-Yen; Shyu, Yea-Ing L

2014-06-01

The effects of nutritional management among other intervention components have not been examined for hip-fractured elderly persons with poor nutritional status. Accordingly, this study explored the intervention effects of an in-home program using a comprehensive care model that included a nutrition-management component on recovery of hip-fractured older persons with poor nutritional status at hospital discharge. A secondary analysis of data from a randomized controlled trial with 24-month follow-up. A 3000-bed medical center in northern Taiwan. Subjects were included only if they had "poor nutritional status" at hospital discharge, including those at risk for malnutrition or malnourished. The subsample included 80 subjects with poor nutritional status in the comprehensive care group, 87 in the interdisciplinary care group, and 85 in the usual care group. The 3 care models were usual care, interdisciplinary care, and comprehensive care. Usual care provided no in-home care, interdisciplinary care provided 4 months of in-home rehabilitation, and comprehensive care included management of depressive symptoms, falls, and nutrition as well as 1 year of in-home rehabilitation. Data were collected on nutritional status and physical functions, including range of motion, muscle power, proprioception, balance and functional independence, and analyzed using a generalized estimating equation approach. We also compared patients' baseline characteristics: demographic characteristics, type of surgery, comorbidities, length of hospital stay, cognitive function, and depression. Patients with poor nutritional status who received comprehensive care were 1.67 times (95% confidence interval 1.06-2.61) more likely to recover their nutritional status than those who received interdisciplinary and usual care. Furthermore, the comprehensive care model improved the functional independence and balance of patients who recovered their nutritional status over the first year following discharge, but not of those who had not yet recovered. An in-home program using the comprehensive care model with a nutritional component effectively improved the nutritional status of hip-fractured patients with poor nutrition. This comprehensive care intervention more effectively improved recovery of functional independence and balance for patients with recovered nutritional status. Copyright © 2014 American Medical Directors Association, Inc. Published by Elsevier Inc. All rights reserved.

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.

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

Just-in-Time Evidence-Based E-mail “Reminders” in Home Health Care: Impact on Nurse Practices

PubMed Central

Murtaugh, Christopher M; Pezzin, Liliana E; McDonald, Margaret V; Feldman, Penny H; Peng, Timothy R

2005-01-01

Objective To test the effectiveness of two interventions designed to improve the adoption of evidence-based practices by home health nurses caring for heart failure (HF) patients. Data Sources/Study Setting Information on nurse practices was abstracted from the clinical records of patients admitted between June 2000 and November 2001 to the care of 354 study nurses at a large, urban, nonprofit home care agency. Study Design The study employed a randomized design with nurses assigned to usual care or one of two intervention groups upon identification of an eligible patient. The basic intervention was a one-time e-mail reminder highlighting six HF-specific clinical recommendations. The augmented intervention consisted of the initial e-mail reminder supplemented by provider prompts, patient education material, and clinical nurse specialist outreach. Data Collection At each home health visit provided by a study nurse to an eligible HF patient during the 45-day follow-up period, a structured chart abstraction tool was used to collect information on whether the nurse provided the care practices highlighted in the e-mail reminder. Principal Findings Both the basic and the augmented interventions greatly increased the practice of evidence-based care, according to patient records, in the areas of patient assessment and instructions about HF disease management. While not all results were statistically significant at conventional levels, intervention effects were positive in virtually all cases and effect magnitudes frequently were large. Conclusions The results of this randomized trial strongly support the efficacy of just-in-time evidence-based reminders as a means of changing clinical practice among home health nurses who are geographically dispersed and spend much of their time in the field. PMID:15960694

Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: rationale, design, and methods.

PubMed

Krupski, Antoinette; Joesch, Jutta M; Dunn, Chris; Donovan, Dennis; Bumgardner, Kristin; Lord, Sarah Peregrine; Ries, Richard; Roy-Byrne, Peter

2012-12-14

A substantial body of research has established the effectiveness of brief interventions for problem alcohol use. Following these studies, national dissemination projects of screening, brief intervention (BI), and referral to treatment (SBIRT) for alcohol and drugs have been implemented on a widespread scale in multiple states despite little existing evidence for the impact of BI on drug use for non-treatment seekers. This article describes the design of a study testing the impact of SBIRT on individuals with drug problems, its contributions to the existing literature, and its potential to inform drug policy. The study is a randomized controlled trial of an SBIRT intervention carried out in a primary care setting within a safety net system of care. Approximately 1,000 individuals presenting for scheduled medical care at one of seven designated primary care clinics who endorse problematic drug use when screened are randomized in a 1:1 ratio to BI versus enhanced care as usual (ECAU). Individuals in both groups are reassessed at 3, 6, 9, and 12 months after baseline. Self-reported drug use and other psychosocial measures collected at each data point are supplemented by urine analysis and public health-related data from administrative databases. This study will contribute to the existing literature by providing evidence for the impact of BI on problem drug use based on a broad range of measures including self-reported drug use, urine analysis, admission to drug abuse treatment, and changes in utilization and costs of health care services, arrests, and death with the intent of informing policy and program planning for problem drug use at the local, state, and national levels. ClinicalTrials.gov NCT00877331.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

PubMed Central

2013-01-01

Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. Discussion This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. Trial registration ISRCTN62019087 PMID:23819476

Treatment of severe fear of childbirth with haptotherapy: design of a multicenter randomized controlled trial.

PubMed

Klabbers, Gert A; Wijma, Klaas; Paarlberg, K Marieke; Emons, Wilco Hm; Vingerhoets, Ad Jjm

2014-10-08

About six percent of pregnant women suffer from severe fear of childbirth. These women are at increased risk of obstetric labour and delivery interventions and pre- and postpartum complications, e.g., preterm delivery, emergency caesarean section, caesarean section at maternal request, severe postpartum fear of childbirth and trauma anxiety. During the last decade, there is increasing clinical evidence suggesting that haptotherapy might be an effective intervention to reduce fear of childbirth in pregnant women. The present study has been designed to evaluate the effects of such intervention. Included are singleton pregnant women with severe fear of childbirth, age ≥ 18 year, randomised into three arms: (1) treatment with haptotherapy, (2) internet psycho-education or (3) care as usual. The main study outcome is fear of childbirth. Measurements are taken at baseline in gestation week 20-24, directly after the intervention is completed in gestation week 36, six weeks postpartum and six months postpartum. Secondary study outcomes are distress, general anxiety, depression, somatization, social support, mother-child bonding, pregnancy and delivery complications, traumatic anxiety symptoms, duration of delivery, birth weight, and care satisfaction. The treatment, a standard haptotherapeutical treatment for pregnant women with severe fear of childbirth, implies teaching a combination of skills in eight one hour sessions. The internet group follows an eight-week internet course containing information about pregnancy and childbirth comparable to childbirth classes. The control group has care as usual according to the standards of the Royal Dutch Organisation of Midwives and the Dutch Organization of Obstetrics and Gynaecology. This trial was entered in the Dutch Trial Register and registered under number NTR3339 on March 4th, 2012.

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.

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.

Computer-Facilitated Substance Use Screening and Brief Advice for Teens in Primary Care: An International Trial

PubMed Central

Csémy, Ladislav; Sherritt, Lon; Starostova, Olga; Van Hook, Shari; Johnson, Julie; Boulter, Suzanne; Brooks, Traci; Carey, Peggy; Kossack, Robert; Kulig, John W.; Van Vranken, Nancy; Knight, John R.

2012-01-01

OBJECTIVE: Primary care providers need effective strategies for substance use screening and brief counseling of adolescents. We examined the effects of a new computer-facilitated screening and provider brief advice (cSBA) system. METHODS: We used a quasi-experimental, asynchronous study design in which each site served as its own control. From 2005 to 2008, 12- to 18-year-olds arriving for routine care at 9 medical offices in New England (n = 2096, 58% females) and 10 in Prague, Czech Republic (n = 589, 47% females) were recruited. Patients completed measurements only during the initial treatment-as-usual study phase. We then conducted 1-hour provider training, and initiated the cSBA phase. Before seeing the provider, all cSBA participants completed a computerized screen, and then viewed screening results, scientific information, and true-life stories illustrating substance use harms. Providers received screening results and “talking points” designed to prompt 2 to 3 minutes of brief advice. We examined alcohol and cannabis use, initiation, and cessation rates over the past 90 days at 3-month follow-up, and over the past 12 months at 12-month follow-up. RESULTS: Compared with treatment as usual, cSBA patients reported less alcohol use at follow-up in New England (3-month rates 15.5% vs 22.9%, adjusted relative risk ratio [aRRR] = 0.54, 95% confidence interval 0.38–0.77; 12-month rates 29.3% vs 37.5%, aRRR = 0.73, 0.57–0.92), and less cannabis use in Prague (3-month rates 5.5% vs 9.8%, aRRR = 0.37, 0.17–0.77; 12-month rates 17.0% vs 28.7%, aRRR = 0.47, 0.32–0.71). CONCLUSIONS: Computer-facilitated screening and provider brief advice appears promising for reducing substance use among adolescent primary care patients. PMID:22566420

Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial

PubMed Central

2011-01-01

Background Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. Methods/design The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP. Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term). Assessment of outcomes will be blinded and will follow the intention-to-treat principle. Discussion We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. Trial registration ISRCTN: ISRCTN58719694 PMID:21859489

Design of the Violence and Stress Assessment (ViStA) study: a randomized controlled trial of care management for PTSD among predominantly Latino patients in safety net health centers.

PubMed

Meredith, Lisa S; Eisenman, David P; Green, Bonnie L; Kaltman, Stacey; Wong, Eunice C; Han, Bing; Cassells, Andrea; Tobin, Jonathan N

2014-07-01

Posttraumatic stress disorder (PTSD) is a common problem in primary care. Although effective treatments are available, little is known about whether such treatments are effective within the context of Federally Qualified Health Centers (FQHCs) that serve as national "safety nets" for providing primary care for low income and underinsured patients. The Violence and Stress Assessment (ViStA) study is the first randomized controlled trial (RCT) to test the impact of a care management intervention for treating PTSD in FQHCs. To develop a PTSD management intervention appropriate for lower resource FQHCs and the predominantly Latino patients they serve, formative work was conducted through a collaborative effort between researchers and an FQHC practice-based research network. This article describes how FQHC stakeholders were convened to review, assess, and prioritize evidence-based strategies for addressing patient, clinician, and system-level barriers to care. This multi-component care management intervention incorporates diagnosis with feedback, patient education and activation; navigation and linkage to community resources; clinician education and medication guidance; and structured cross-disciplinary communication and continuity of care, all facilitated by care managers with FQHC experience. We also describe the evaluation design of this five-year RCT and the characteristics of the 404 English or Spanish speaking patients enrolled in the study and randomized to either the intervention or to usual care. Patients are assessed at baseline, six months, and 12 months to examine intervention effectiveness on PTSD, other mental health symptoms, health-related quality-of-life, health care service use; and perceived barriers to care and satisfaction with care. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

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.

Cost-effectiveness of integrated collaborative care for comorbid major depression in patients with cancer☆

PubMed Central

Duarte, A.; Walker, J.; Walker, S.; Richardson, G.; Holm Hansen, C.; Martin, P.; Murray, G.; Sculpher, M.; Sharpe, M.

2015-01-01

Objectives Comorbid major depression is associated with reduced quality of life and greater use of healthcare resources. A recent randomised trial (SMaRT, Symptom Management Research Trials, Oncology-2) found that a collaborative care treatment programme (Depression Care for People with Cancer, DCPC) was highly effective in treating depression in patients with cancer. This study aims to estimate the cost-effectiveness of DCPC compared with usual care from a health service perspective. Methods Costs were estimated using UK national unit cost estimates and health outcomes measured using quality-adjusted life-years (QALYs). Incremental cost-effectiveness of DCPC compared with usual care was calculated and scenario analyses performed to test alternative assumptions on costs and missing data. Uncertainty was characterised using cost-effectiveness acceptability curves. The probability of DCPC being cost-effective was determined using the UK National Institute for Health and Care Excellence's (NICE) cost-effectiveness threshold range of £20,000 to £30,000 per QALY gained. Results DCPC cost on average £631 more than usual care per patient, and resulted in a mean gain of 0.066 QALYs, yielding an incremental cost-effectiveness ratio of £9549 per QALY. The probability of DCPC being cost-effective was 0.9 or greater at cost-effectiveness thresholds above £20,000 per QALY for the base case and scenario analyses. Conclusions Compared with usual care, DCPC is likely to be cost-effective at the current thresholds used by NICE. This study adds to the weight of evidence that collaborative care treatment models are cost-effective for depression, and provides new evidence regarding their use in specialist medical settings. PMID:26652589

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.

Pharmacist-provided diabetes management and education via a telemonitoring program.

PubMed

Shane-McWhorter, Laura; McAdam-Marx, Carrie; Lenert, Leslie; Petersen, Marta; Woolsey, Sarah; Coursey, Jeffrey M; Whittaker, Thomas C; Hyer, Christian; LaMarche, Deb; Carroll, Patricia; Chuy, Libbey

2015-01-01

To assess clinical outcomes (glycosylated hemoglobin [A1C], blood pressure, and lipids) and other measurements (disease state knowledge, adherence, and self-efficacy) associated with the use of approved telemonitoring devices to expand and improve chronic disease management of patients with diabetes, with or without hypertension. Four community health centers (CHCs) in Utah. Federally qualified safety net clinics that provide medical care to underserved patients. Pharmacist-led diabetes management using telemonitoring was compared with a group of patients receiving usual care (without telemonitoring). Daily blood glucose (BG) and blood pressure (BP) values were reviewed and the pharmacist provided phone follow-up to assess and manage out-of-range BG and BP values. Changes in A1C, BP, and low-density lipoprotein (LDL) at approximately 6 months were compared between the telemonitoring group and the usual care group. Patient activation, diabetes/hypertension knowledge, and medication adherence were measured in the telemonitoring group. Of 150 patients, 75 received pharmacist-provided diabetes management and education via telemonitoring, and 75 received usual medical care. Change in A1C was significantly greater in the telemonitoring group compared with the usual care group (2.07% decrease vs. 0.66% decrease; P <0.001). Although BP and LDL levels also declined, differences between the two groups were not statistically significant. Patient activation measure, diabetes/hypertension knowledge, and medication adherence with antihypertensives (but not diabetes medications) improved in the telemonitoring group. Pharmacist-provided diabetes management via telemonitoring resulted in a significant improvement in A1C in federally qualified CHCs in Utah compared with usual medical care. Telemonitoring may be considered a model for providing clinical pharmacy services to patients with diabetes.

Effects of music videos on sleep quality in middle-aged and older adults with chronic insomnia: a randomized controlled trial.

PubMed

Lai, Hui-Ling; Chang, En-Ting; Li, Yin-Ming; Huang, Chiung-Yu; Lee, Li-Hua; Wang, Hsiu-Mei

2015-05-01

Listening to soothing music has been used as a complementary therapy to improve sleep quality. However, there is no empirical evidence for the effects of music videos (MVs) on sleep quality in adults with insomnia as assessed by polysomnography (PSG). In this randomized crossover controlled trial, we compared the effects of a peaceful Buddhist MV intervention to a usual-care control condition before bedtime on subjective and objective sleep quality in middle-aged and older adults with chronic insomnia. The study was conducted in a hospital's sleep laboratory. We randomly assigned 38 subjects, aged 50-75 years, to an MV/usual-care sequence or a usual-care/MV sequence. After pretest data collection, testing was held on two consecutive nights, with subjects participating in one condition each night according to their assigned sequence. Each intervention lasted 30 min. Sleep was assessed using PSG and self-report questionnaires. After controlling for baseline data, sleep-onset latency was significantly shorter by approximately 2 min in the MV condition than in the usual-care condition (p = .002). The MV intervention had no significant effects relative to the usual care on any other sleep parameters assessed by PSG or self-reported sleep quality. These results suggest that an MV intervention may be effective in promoting sleep. However, the effectiveness of a Buddhist MV on sleep needs further study to develop a culturally specific insomnia intervention. Our findings also suggest that an MV intervention can serve as another option for health care providers to improve sleep onset in people with insomnia. © The Author(s) 2014.

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.

Telemonitoring for chronic obstructive pulmonary disease: a cost and cost-utility analysis of a randomised controlled trial.

PubMed

Stoddart, Andrew; van der Pol, Marjon; Pinnock, Hilary; Hanley, Janet; McCloughan, Lucy; Todd, Allison; Krishan, Ashma; McKinstry, Brian

2015-03-01

We compared the costs and cost-effectiveness of telemonitoring vs usual care for patients with chronic obstructive pulmonary disease (COPD). A total of 256 patients were randomised to either telemonitoring or usual care. In the telemonitoring arm, the touch-screen telemonitoring equipment transmitted data to clinical teams monitoring the patients. Total healthcare costs were estimated over a 12-month period from a National Health Service perspective and quality adjusted life year (QALYs) were estimated by the EQ-5D tool. Telemonitoring was not significantly more costly than usual care (mean difference per patient £2065.90 (P < 0.18). The increased costs were predominantly due to telemonitoring service costs and non-significantly higher secondary care costs. Telemonitoring for COPD was not cost-effective at a base case of £137,277 per QALY with only 15% probability of being cost-effective at the usual threshold of £30,000 per QALY. Although there was some statistical and methodological uncertainty in the measures used, telemonitoring was not cost-effective in the sensitivity analyses performed. It seems unlikely that a telemonitoring service of the kind that was trialled would be cost-effective in providing care for people with COPD. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

End of life care interventions for people with dementia in care homes: addressing uncertainty within a framework for service delivery and evaluation.

PubMed

Goodman, Claire; Froggatt, Katherine; Amador, Sarah; Mathie, Elspeth; Mayrhofer, Andrea

2015-09-17

There has been an increase in research on improving end of life (EoL) care for older people with dementia in care homes. Findings consistently demonstrate improvements in practitioner confidence and knowledge, but comparisons are either with usual care or not made. This paper draws on findings from three studies to develop a framework for understanding the essential dimensions of end of life care delivery in long-term care settings for people with dementia. The data from three studies on EoL care in care homes: (i) EVIDEM EoL, (ii) EPOCH, and (iii) TTT EoL were used to inform the development of the framework. All used mixed method designs and two had an intervention designed to improve how care home staff provided end of life care. The EVIDEM EoL and EPOCH studies tracked the care of older people in care homes over a period of 12 months. The TTT study collected resource use data of care home residents for three months, and surveyed decedents' notes for ten months, Across the three studies, 29 care homes, 528 residents, 205 care home staff, and 44 visiting health care professionals participated. Analysis of showed that end of life interventions for people with dementia were characterised by uncertainty in three key areas; what treatment is the 'right' treatment, who should do what and when, and in which setting EoL care should be delivered and by whom? These uncertainties are conceptualised as Treatment uncertainty, Relational uncertainty and Service uncertainty. This paper proposes an emergent framework to inform the development and evaluation of EoL care interventions in care homes. For people with dementia living and dying in care homes, EoL interventions need to provide strategies that can accommodate or "hold" the inevitable and often unresolvable uncertainties of providing and receiving care in these settings.

Does Cognitive Behavioral Therapy for Youth Anxiety Outperform Usual Care in Community Clinics? An Initial Effectiveness Test

ERIC Educational Resources Information Center

Southam-Gerow, Michael A.; Weisz, John R.; Chu, Brian C.; McLeod, Bryce D.; Gordis, Elana B.; Connor-Smith, Jennifer K.

2010-01-01

Objective: Most tests of cognitive behavioral therapy (CBT) for youth anxiety disorders have shown beneficial effects, but these have been efficacy trials with recruited youths treated by researcher-employed therapists. One previous (nonrandomized) trial in community clinics found that CBT did not outperform usual care (UC). The present study used…

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.

The feasibility of a randomised controlled trial to compare the cost-effectiveness of palliative cardiology or usual care in people with advanced heart failure: Two exploratory prospective cohorts.

PubMed

Johnson, Miriam J; McSkimming, Paula; McConnachie, Alex; Geue, Claudia; Millerick, Yvonne; Briggs, Andrew; Hogg, Karen

2018-06-01

The effectiveness of cardiology-led palliative care is unknown; we have insufficient information to conduct a full trial. To assess the feasibility (recruitment/retention, data quality, variability/sample size estimation, safety) of a clinical trial of palliative cardiology effectiveness. Non-randomised feasibility. Unmatched symptomatic heart failure patients on optimal cardiac treatment from (1) cardiology-led palliative service (caring together group) and (2) heart failure liaison service (usual care group). Outcomes/safety: Symptoms (Edmonton Symptom Assessment Scale), Kansas City Cardiomyopathy Questionnaire, performance, understanding of disease, anticipatory care planning, cost-effectiveness, survival and carer burden. A total of 77 participants (caring together group = 43; usual care group = 34) were enrolled (53% men; mean age 77 years (33-100)). The caring together group scored worse in Edmonton Symptom Assessment Scale (43.5 vs 35.2) and Kansas City Cardiomyopathy Questionnaire (35.4 vs 39.9). The caring together group had a lower consent/screen ratio (1:1.7 vs 1: 2.8) and few died before approach (0.08% vs 16%) or declined invitation (17% vs 37%). Data quality: At 4 months, 74% in the caring together group and 71% in the usual care group provided data. Most attrition was due to death or deterioration. Data quality in self-report measures was otherwise good. There was no difference in survival. Symptoms and quality of life improved in both groups. A future trial requires 141 (202 allowing 30% attrition) to detect a minimal clinical difference (1 point) in Edmonton Symptom Assessment Scale score for breathlessness (80% power). More participants (176; 252 allowing 30% attrition) are needed to detect a 10.5 change in Kansas City Cardiomyopathy Questionnaire score (80% power; minimum clinical difference = 5). A trial to test the clinical effectiveness (improvement in breathlessness) of cardiology-led palliative care is feasible.

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 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).

Design and pilot results of a single blind randomized controlled trial of systematic demand-led home visits by nurses to frail elderly persons in primary care [ISRCTN05358495].

PubMed

van Hout, Hein P J; Nijpels, Giel; van Marwijk, Harm W J; Jansen, Aaltje P D; Van't Veer, Petronella J; Tybout, Willemijn; Stalman, Wim A B

2005-09-08

The objective of this article is to describe the design of an evaluation of the cost-effectiveness of systematic home visits by nurses to frail elderly primary care patients. Pilot objectives were: 1. To determine the feasibility of postal multidimensional frailty screening instruments; 2. to identify the need for home visits to elderly. Main study: The main study concerns a randomized controlled in primary care practices (PCP) with 18 months follow-up and blinded PCPs. Frail persons aged 75 years or older and living at home but neither terminally ill nor demented from 33 PCPs were eligible. Trained community nurses (1) visit patients at home and assess the care needs with the Resident Assessment Instrument-Home Care, a multidimensional computerized geriatric assessment instrument, enabling direct identification of problem areas; (2) determine the care priorities together with the patient; (3) design and execute interventions according to protocols; (4) and visit patients at least five times during a year in order to execute and monitor the care-plan. Controls receive usual care. Outcome measures are Quality of life, and Quality Adjusted Life Years; time to nursing home admission; mortality; hospital admissions; health care utilization. Pilot 1: Three brief postal multidimensional screening measures to identify frail health among elderly persons were tested on percentage complete item response (selected after a literature search): 1) Vulnerable Elders Screen, 2) Strawbridge's frailty screen, and 3) COOP-WONCA charts. Pilot 2: Three nurses visited elderly frail patients as identified by PCPs in a health center of 5400 patients and used an assessment protocol to identify psychosocial and medical problems. The needs and experiences of all participants were gathered by semi-structured interviews. The design holds several unique elements such as early identification of frail persons combined with case-management by nurses. From two pilots we learned that of three potential postal frailty measures, the COOP-WONCA charts were completed best by elderly and that preventive home visits by nurses were positively evaluated to have potential for quality of care improvement.

Providing immediate neonatal care and resuscitation at birth beside the mother: clinicians’ views, a qualitative study

PubMed Central

Yoxall, Charles W; Ayers, Susan; Sawyer, Alexandra; Bertullies, Sophia; Thomas, Margaret; D Weeks, Andrew; Duley, Lelia

2015-01-01

Objectives The aims of this study were to assess clinicians’ views and experiences of providing immediate neonatal care at birth beside the mother, and of using a mobile trolley designed to facilitate this bedside care. Design Qualitative interview study with semistructured interviews. Results The results were analysed using thematic analysis. Setting A large UK maternity unit. Participants Clinicians (n=20) from a range of disciplines who were present when the trolley was used to provide neonatal care at birth at the bedside. Five clinicians provided/observed advanced resuscitation by the bedside. Results Five themes were identified: (1) Parents’ involvement, which included ‘Contact and involvement’, ‘Positive emotions for parents’ and ‘Staff communication’; (2) Reservations about neonatal care at birth beside the mother, which included ‘Impact on clinicians’ and ‘Impact on parents’; (3) Practical challenges in providing neonatal care at the bedside, which included ‘Cord length’ and ‘Caesarean section’; (4) Comparison of the trolley with usual resuscitation equipment and (5) Training and integration of bedside care into clinical routine, which included ‘Teething problems’ and ‘Training’. Conclusions Overall, most clinicians were positive about providing immediate neonatal care at the maternal bedside, particularly in terms of the clinicians’ perceptions of the parents’ experience. Clinicians also perceived that their close proximity to parents improved communication. However, there was some concern about performing more intensive interventions in front of parents. Providing immediate neonatal care and resuscitation at the bedside requires staff training and support. PMID:26423852

Evaluation of a tailored implementation strategy to improve the management of patients with chronic obstructive pulmonary disease in primary care: a study protocol of a cluster randomized trial

PubMed Central

2014-01-01

Background Chronic obstructive pulmonary disease (COPD) remains a major health problem, strongly related to smoking. Despite the publication of practice guidelines on prevention and treatment, not all patients with the disease receive the recommended healthcare, particularly with regard to smoking cessation advice where applicable. We have developed a tailored implementation strategy for enhancing general practitioners’ adherence to the disease management guidelines. The primary aim of the study is to evaluate the effects of this tailored implementation intervention on general practitioners’ adherence to guidelines. Methods/Design A pragmatic two-arm cluster randomized trial has been planned to compare care following the implementation of tailored interventions of four recommendations in COPD patients against usual care. The study will involve 18 general practices (9 in the intervention group and 9 in the control group) in Poland, each with at least 80 identified (at the baseline) patients with diagnosed COPD. The nine control practices will provide usual care without any interventions. Tailored interventions to implement four recommendations will be delivered in the remaining nine practices. At follow-up after nine months, data will be collected for all 18 general practices. The primary outcome measure is physicians’ adherence to all four recommendations: brief anti-smoking advice, dyspnea assessment, care checklist utilization and demonstration to patients of correct inhaler use. This measurement will be based on data extracted from identified patients’ records. Additionally, we will survey and interview patients with chronic obstructive pulmonary disease about the process of care. Discussion The results of this trial will be directly applicable to primary care in Poland and add to the growing body of evidence on interventions to improve chronic illness care. Trial registration This trial has been registered with Clinical Trials Protocol Registration System. Trial number: NCT01893476. PMID:24708623

Motivational Interviewing Tailored Interventions for Heart Failure (MITI-HF): study design and methods.

PubMed

Masterson Creber, Ruth; Patey, Megan; Dickson, Victoria Vaughan; DeCesaris, Marissa; Riegel, Barbara

2015-03-01

Lack of engagement in self-care is common among patients needing to follow a complex treatment regimen, especially patients with heart failure who are affected by comorbidity, disability and side effects of poly-pharmacy. The purpose of Motivational Interviewing Tailored Interventions for Heart Failure (MITI-HF) is to test the feasibility and comparative efficacy of an MI intervention on self-care, acute heart failure physical symptoms and quality of life. We are conducting a brief, nurse-led motivational interviewing randomized controlled trial to address behavioral and motivational issues related to heart failure self-care. Participants in the intervention group receive home and phone-based motivational interviewing sessions over 90-days and those in the control group receive care as usual. Participants in both groups receive patient education materials. The primary study outcome is change in self-care maintenance from baseline to 90-days. This article presents the study design, methods, plans for statistical analysis and descriptive characteristics of the study sample for MITI-HF. Study findings will contribute to the literature on the efficacy of motivational interviewing to promote heart failure self-care. We anticipate that using an MI approach can help patients with heart failure focus on their internal motivation to change in a non-confrontational, patient-centered and collaborative way. It also affirms their ability to practice competent self-care relevant to their personal health goals. Copyright © 2015 Elsevier Inc. All rights reserved.

Critical Care

MedlinePlus

Critical care helps people with life-threatening injuries and illnesses. It might treat problems such as complications from surgery, ... attention by a team of specially-trained health care providers. Critical care usually takes place in an ...

Back Complaints in the Elders (BACE); design of cohort studies in primary care: an international consortium

PubMed Central

2011-01-01

Background Although back complaints are common among older people, limited information is available in the literature about the clinical course of back pain in older people and the identification of older persons at risk for the transition from acute back complaints to chronic back pain. The aim of this study is to assess the course of back complaints and identify prognostic factors for the transition from acute back complaints to chronic back complaints in older people who visit a primary health care physician. Methods/design The design is a prospective cohort study with one-year follow-up. There will be no interference with usual care. Patients older than 55 years who consult a primary health care physician with a new episode of back complaints will be included in this study. Data will be collected using a questionnaire, physical examination and X-ray at baseline, and follow-up questionnaires after 6 weeks and 3, 6, 9 and 12 months. The study 'Back Complaints in the Elders' (BACE) will take place in different countries: starting in the Netherlands, Brazil and Australia. The research groups collaborate in the BACE consortium. The design and basic objectives of the study will be the same across the studies. Discussion This consortium is a collaboration between different research groups, aiming to provide insight into the course of back complaints in older people and to identify prognostic factors for the transition from acute back complaints to chronic back complaints in older persons. The BACE consortium allows to investigate differences between older people with back complaints and the health care systems in the different countries and to increase the statistical power by enabling meta-analyses using the individual patient data. Additional research groups worldwide are invited to join the BACE consortium. PMID:21854620

Outcomes of a disease-management program for patients with recent osteoporotic fracture.

PubMed

Che, M; Ettinger, B; Liang, J; Pressman, A R; Johnston, J

2006-01-01

The purpose of this study was to evaluate outcomes of a disease-management program designed to increase rates of bone-mineral-density (BMD) testing and initiation of osteoporosis medication among patients with a recent osteoporotic fracture. We identified 744 consecutive patients aged>or=55 years who were seen at either of 2 of 14 Kaiser Permanente medical facilities in Northern California (KPNC) after sustaining a fracture of the hip, spine, wrist, or humerus between April 2003 and May 2004. These patients were invited to participate in a study of the Fragile Fracture Management Program, whose protocol used fracture-risk assessment tools to determine treatment recommendations. Postfracture care of study participants was compared with usual postfracture care received by osteoporotic-fracture patients at 12 other KPNC facilities. Of the 744 patients who were invited to participate in the study, 293 (39%) agreed to participate, and 169 (23%) completed the evaluation. Of these 169 patients (127 women, 42 men), 65 (51%) of the women and 7 (17%) of the men qualified for drug treatment; of these 72 patients, 6 (86%) of the men and 41 (63%) of the women accepted the offered treatment. At the two study locations, rates of care (BMD testing or prescribing osteoporosis medication) were about twice as high as rates of usual postfracture care observed at 12 other medical centers in KPNC. Compared with patients who received usual care for osteoporotic fracture, patients participating in a postfracture disease management program had substantially higher rates of medical attention given for osteoporosis; however, the overall yield of the program was low. This low uptake rate was related to factors not previously appreciated: many patients refused participation in the program; a high proportion of younger women-and men of all ages-did not qualify for treatment; and treatment was refused by one in three study-qualified women and by one in seven study-qualified men. Additional efforts are needed to overcome patient barriers to improved osteoporosis evaluation, treatment and participation in postfracture programs.

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

5HTTLPR genotype moderates the longitudinal impact of early caregiving on externalizing behavior

PubMed Central

Smyke, Anna T.; Gleason, Mary Margaret; Nelson, Charles A.; Zeanah, Charles H.; Fox, Nathan A; Drury, Stacy S.

2014-01-01

We examined caregiver report of externalizing behavior from 12 to 54 months of age in 102 children randomized to care as usual in institutions or to newly-created high quality foster care. At baseline no differences by group or genotype in externalizing were found. However, changes in externalizing from baseline to 42 months of age were moderated by 5HTTLPR genotype and intervention group, where the slope for s/s individuals differed as a function of intervention group. The slope for individuals carrying the l allele did not significantly differ between groups. At 54 months of age, s/s children in the foster care group had the lowest levels of externalizing behavior, while children with the s/s genotype in the care as usual group demonstrated the highest rates of externalizing behavior. No intervention group differences were found in externalizing behavior among children who carried the l allele. These findings, within a randomized control trial of foster care compared to continued care as usual, indicate that 5HTTLPR genotype moderates the relation between early caregiving environments to predict externalizing behavior in children exposed to early institutional care in a manner most consistent with differential susceptibility. PMID:25640827

Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol.

PubMed

Ehde, Dawn M; Alschuler, Kevin N; Sullivan, Mark D; Molton, Ivan P; Ciol, Marcia A; Bombardier, Charles H; Curran, Mary C; Gertz, Kevin J; Wundes, Annette; Fann, Jesse R

2018-01-01

Evidence-based pharmacological and behavioral interventions are often underutilized or inaccessible to persons with multiple sclerosis (MS) who have chronic pain and/or depression. Collaborative care is an evidence-based patient-centered, integrated, system-level approach to improving the quality and outcomes of depression care. We describe the development of and randomized controlled trial testing a novel intervention, MS Care, which uses a collaborative care model to improve the care of depression and chronic pain in a MS specialty care setting. We describe a 16-week randomized controlled trial comparing the MS Care collaborative care intervention to usual care in an outpatient MS specialty center. Eligible participants with chronic pain of at least moderate intensity (≥3/10) and/or major depressive disorder are randomly assigned to MS Care or usual care. MS Care utilizes a care manager to implement and coordinate guideline-based medical and behavioral treatments with the patient, clinic providers, and pain/depression treatment experts. We will compare outcomes at post-treatment and 6-month follow up. We hypothesize that participants randomly assigned to MS Care will demonstrate significantly greater control of both pain and depression at post-treatment (primary endpoint) relative to those assigned to usual care. Secondary analyses will examine quality of care, patient satisfaction, adherence to MS care, and quality of life. Study findings will aid patients, clinicians, healthcare system leaders, and policy makers in making decisions about effective care for pain and depression in MS healthcare systems. (PCORI- IH-1304-6379; clinicaltrials.gov: NCT02137044). This trial is registered at ClinicalTrials.gov, protocol NCT02137044. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

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.

Patient satisfaction is biased by renovations to the interior of a primary care office: a pretest-posttest assessment.

PubMed

Tièche, Raphaël; da Costa, Bruno R; Streit, Sven

2016-08-11

Measuring quality of care is essential to improve primary care. Quality of primary care for patients is usually assessed by patient satisfaction questionnaires. However, patients may not be able to judge quality of care without also reflecting their perception of the environment. We determined the effect that redesigning a primary care office had on patient satisfaction. We hypothesized that renovating the interior would make patients more satisfied with the quality of medical care. We performed a Pretest-Posttest analysis in a recently renovated single-practice primary care office in Grenchen, Switzerland. Before and after renovation, we distributed a questionnaire to assess patient satisfaction in four domains. We chose a Likert scale (1 = very poor to 6 = very good), and 12 quality indicators, and included two consecutive samples of patients presenting at the primary care office before (n = 153) and after (n = 153) interior design renovation. Response rate was high (overall 85 %). The sample was similar to the enlisted patient collective, but the sample population was older (60 years) than the collective (52 years). Patient satisfaction was higher for all domains after the office was renovated (p < 0.01-0.001). Results did not change when we included potential confounders in the multivariable model (p < 0.01). Renovating the interior of a primary care office was associated with improved patient satisfaction, including satisfaction in domains otherwise unchanged. Physician skills and patient satisfaction sometimes depend on surrounding factors that may bias the ability of patients to assess the quality of medical care. These biases should be taken into account when quality assessment instruments are designed for patients.

Electronic communications and home blood pressure monitoring (e-BP) study: design, delivery, and evaluation framework.

PubMed

Green, Beverly B; Ralston, James D; Fishman, Paul A; Catz, Sheryl L; Cook, Andrea; Carlson, Jim; Tyll, Lynda; Carrell, David; Thompson, Robert S

2008-05-01

Randomized controlled trials have provided unequivocal evidence that treatment of hypertension decreases mortality and major disability from cardiovascular disease; however, blood pressure remains inadequately treated in most affected individuals. This large gap continues despite the facts that more than 90% of adults with hypertension have health insurance, and hypertension is the leading cause of visits to the doctor. New approaches are needed to improve hypertension care. The Electronic Communications and Home Blood Pressure Monitoring (e-BP) study is a three-arm randomized controlled trial designed to determine whether care based on the Chronic Care Model and delivered over the Internet improves hypertension care. The primary study outcomes are systolic, diastolic, and blood pressure control; secondary outcomes are medication adherence, patient self-efficacy, satisfaction and quality of life, and healthcare utilization and costs. Hypertensive patients receiving care at Group Health medical centers are eligible if they have uncontrolled blood pressure on two screening visits and access to the Web and an e-mail address. Study participants are randomly assigned to three intervention groups: (a) usual care; (b) home blood pressure monitoring receipt and proficiency training on its use and the Group Health secure patient website (with secure e-mail access to their healthcare provider, access to a shared medical record, prescription refill and other services); or (c) this plus pharmacist care management (collaborative care management between the patient, the pharmacist, and the patient's physician via a secure patient website and the electronic medical record). We will determine whether a new model of patient-centered care that leverages Web communications, self-monitoring, and collaborative care management improves hypertension control. If this model proves successful and cost-effective, similar interventions could be used to improve the care of large numbers of patients with uncontrolled hypertension.

Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database.

PubMed

Nørskov, Anders Kehlet

2016-05-01

Difficulties with airway management in relation to general anaesthesia have been a challenge for the anaesthesiologist since the birth of anaesthesia. Massive landmark improvements have been made and general anaesthesia is now regarded as a safe procedure. However, rare, difficult airway management still occurs and it prompts increased risk of morbidity and mortality - especially when not anticipated. Several preoperative risk factors for airway difficulties have been identified, yet none have convincing diagnostic accuracy as stand alone tests. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed. The Simplified Airway Risk Index (SARI) is a predictive model developed for anticipation of a difficult direct laryngoscopy. However, neither the diagnostic accuracy of the SARI nor of any other model has been tested prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial, using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation and mask ventilation. Papers 2 and 3 outline the methodology and the pre-trial calculations and considerations leading to the DIFFICAIR trial described in Paper 4. The trial was designed to randomise anaesthesia department to either thorough education in, and subsequent use of the SARI for preoperative airway assessment or to continue usual care. Registration of the SARI in DAD was made mandatory in SARI departments and impossible in usual care departments. Conditions regarding anticipation of difficulties and actual airway managements were recorded as for Paper 1. DAD data made it possible to estimate an appropriate sample size, considering the between cluster variation, and to construct a stratification variable based on 2011 baseline values of the primary outcome used in the DIFFICAIR trial. Paper 1 revealed that 1.86% of all patients who were intubated, but not planned for advanced intubation techniques (e.g. video laryngoscopy), were unanticipated difficult to intubate. However, 75 to 93% of all difficult intubations were unanticipated. Furthermore, 94% of all difficult mask ventilations were unanticipated. In Paper 4, 59,514 patients were included in the primary analyses. The proportion of unanticipated difficult intubations was 2.38% (696/29,209) in SARI departments and 2.39% (723/30,305) in usual care departments. The adjusted odds ratio was 1.03 (95% CI: 0.77-1.38), p = 0.84. No significant differences were detected in other adjusted outcome measures and neither a 58% increase in patients anticipated to have intubation difficulties nor an 84% increase in patients scheduled for advanced intubation techniques in SARI departments reached statistical significance, p = 0.29 and p = 0.06 respectively. The papers constituting this thesis demonstrate that at high proportion of airway management difficulties are unanticipated. In a cluster randomised trial it was not possible to reduce the proportion of unanticipated difficult intubation in daily clinical practice by implementing a systematic approach for airway assessment compared with usual care. However, implementation of the SARI may increase the anticipation of intubation difficulties and it may change practice towards advanced intubation techniques. This thesis underlines the continued challenge anaesthesiologists face in predicting airway management related difficulties.

The effect of a disease management intervention on quality and outcomes of dementia care: a randomized, controlled trial.

PubMed

Vickrey, Barbara G; Mittman, Brian S; Connor, Karen I; Pearson, Marjorie L; Della Penna, Richard D; Ganiats, Theodore G; Demonte, Robert W; Chodosh, Joshua; Cui, Xinping; Vassar, Stefanie; Duan, Naihua; Lee, Martin

2006-11-21

Adherence to dementia guidelines is poor despite evidence that some guideline recommendations can improve symptoms and delay institutionalization of patients. To test the effectiveness of a dementia guideline-based disease management program on quality of care and outcomes for patients with dementia. Clinic-level, cluster randomized, controlled trial. 3 health care organizations collaborating with 3 community agencies in southern California. 18 primary care clinics and 408 patients with dementia age 65 years or older paired with 408 informal caregivers. Disease management program led by care managers and provided to 238 patient-caregiver pairs at 9 intervention clinics for more than 12 months. Adherence to 23 guideline recommendations (primary outcome) and receipt of community resources and patient and caregiver health and quality-of-care measures (secondary outcomes). The mean percentage of per-patient guideline recommendations to which care was adherent was significantly higher in the intervention group than in the usual care group (63.9% vs. 32.9%, respectively; adjusted difference, 30.1% [95% CI, 25.2% to 34.9%]; P < 0.001). Participants who received the intervention had higher care quality on 21 of 23 guidelines (P < or = 0.013 for all), and higher proportions received community agency assistance (P < or = 0.03) than those who received usual care. Patient health-related quality of life, overall quality of patient care, caregiving quality, social support, and level of unmet caregiving assistance needs were better for participants in the intervention group than for those in the usual care group (P < 0.05 for all). Caregiver health-related quality of life did not differ between the 2 groups. Participants were well-educated, were predominantly white, had a usual source of care, and were not institutionalized. Generalizability to other patients and geographic regions is unknown. Also, costs of a care management program under fee-for-service reimbursement may impede adoption. A dementia guideline-based disease management program led to substantial improvements in quality of care for patients with dementia. Current Controlled Trials identifier: ISRCTN72577751.

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

Camacho, Elizabeth M; Ntais, Dionysios; Coventry, Peter; Bower, Peter; Lovell, Karina; Chew-Graham, Carolyn; Baguley, Clare; Gask, Linda; Dickens, Chris; Davies, Linda M

2016-10-07

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). 36 primary care general practices in North West England. 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. 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. 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). 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). 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. ISRCTN80309252; Post-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/.

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.

Association of Structured Virtual Visits for Hypertension Follow-Up in Primary Care with Blood Pressure Control and Use of Clinical Services.

PubMed

Levine, David Michael; Dixon, Ronald F; Linder, Jeffrey A

2018-04-23

Optimal management of hypertension requires frequent monitoring and follow-up. Novel, pragmatic interventions have the potential to engage patients, maintain blood pressure control, and enhance access to busy primary care practices. "Virtual visits" are structured asynchronous online interactions between a patient and a clinician to extend medical care beyond the initial office visit. To compare blood pressure control and healthcare utilization between patients who received virtual visits compared to usual hypertension care. Propensity score-matched, retrospective cohort study with adjustment by difference-in-differences. Primary care patients with hypertension. Patient participation in at least one virtual visit for hypertension. Usual care patients did not use a virtual visit but were seen in-person for hypertension. Adjusted difference in mean systolic blood pressure, primary care office visits, specialist office visits, emergency department visits, and inpatient admissions in the 180 days before and 180 days after the in-person visit. Of the 1051 virtual visit patients and 24,848 usual care patients, we propensity score-matched 893 patients from each group. Both groups were approximately 61 years old, 44% female, 85% White, had about five chronic conditions, and about 20% had a mean pre-visit systolic blood pressure of 140-160 mmHg. Compared to usual care, virtual visit patients had an adjusted 0.8 (95% CI, 0.3 to 1.2) fewer primary care office visits. There was no significant adjusted difference in systolic blood pressure control (0.6 mmHg [95% CI, - 2.0 to 3.1]), specialist visits (0.0 more visits [95% CI, - 0.3 to 0.3]), emergency department visits (0.0 more visits [95% CI, 0.0 to 0.01]), or inpatient admissions (0.0 more admissions [95% CI, 0.0 to 0.1]). Among patients with reasonably well-controlled hypertension, virtual visit participation was associated with equivalent blood pressure control and reduced in-office primary care utilization.

Effects of structured versus usual care on renal endpoint in type 2 diabetes: the SURE study: a randomized multicenter translational study.

PubMed

Chan, Juliana C; So, Wing-Yee; Yeung, Chun-Yip; Ko, Gary T; Lau, Ip-Tim; Tsang, Man-Wo; Lau, Kam-Piu; Siu, Sing-Chung; Li, June K; Yeung, Vincent T; Leung, Wilson Y; Tong, Peter C

2009-06-01

Multifaceted care has been shown to reduce mortality and complications in type 2 diabetes. We hypothesized that structured care would reduce renal complications in type 2 diabetes. A total of 205 Chinese type 2 diabetic patients from nine public hospitals who had plasma creatinine levels of 150-350 micromol/l were randomly assigned to receive structured care (n = 104) or usual care (n = 101) for 2 years. The structured care group was managed according to a prespecified protocol with the following treatment goals: blood pressure <130/80 mmHg, A1C <7%, LDL cholesterol <2.6 mmol/l, triglyceride <2 mmol/l, and persistent treatment with renin-angiotensin blockers. The primary end point was death and/or renal end point (creatinine >500 micromol/l or dialysis). Of these 205 patients (mean +/- SD age 65 +/- 7.2 years; disease duration 14 +/- 7.9 years), the structured care group achieved better control than the usual care group (diastolic blood pressure 68 +/- 12 vs. 71 +/- 12 mmHg, respectively, P = 0.02; A1C 7.3 +/- 1.3 vs. 8.0 +/- 1.6%, P < 0.01). After adjustment for age, sex, and study sites, the structured care (23.1%, n = 24) and usual care (23.8%, n = 24; NS) groups had similar end points, but more patients in the structured care group attained >or=3 treatment goals (61%, n = 63, vs. 28%, n = 28; P < 0.001). Patients who attained >or=3 treatment targets (n = 91) had reduced risk of the primary end point (14 vs. 34; relative risk 0.43 [95% CI 0.21-0.86] compared with that of those who attained

Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial.

PubMed

van der Aa, Hilde P A; van Rens, Ger H M B; Comijs, Hannie C; Margrain, Tom H; Gallindo-Garre, Francisca; Twisk, Jos W R; van Nispen, Ruth M A

2015-11-23

Is stepped care compared with usual care effective in preventing the onset of major depressive, dysthymic, and anxiety disorders in older people with visual impairment (caused mainly by age related eye disease) and subthreshold depression and/or anxiety? 265 people aged ≥50 were randomly assigned to a stepped care programme plus usual care (n=131) or usual care only (n=134). Supervised occupational therapists, social workers, and psychologists from low vision rehabilitation organisations delivered the stepped care programme, which comprised watchful waiting, guided self help based on cognitive behavioural therapy, problem solving treatment, and referral to a general practitioner. The primary outcome was the 24 month cumulative incidence (seven measurements) of major depressive dysthymic and/or anxiety disorders (panic disorder, agoraphobia, social phobia, and generalised anxiety disorder). Secondary outcomes were change in symptoms of depression and anxiety, vision related quality of life, health related quality of life, and adaptation to vision loss over time up to 24 months' follow-up. 62 participants (46%) in the usual care group and 38 participants (29%) from the stepped care group developed a disorder. The intervention was associated with a significantly reduced incidence (relative risk 0.63, 95% confidence interval 0.45 to 0.87; P=0.01), even if time to the event was taken into account (adjusted hazard ratio 0.57, 0.35 to 0.93; P=0.02). The number needed to treat was 5.8 (3.5 to 17.3). The dropout rate was fairly high (34.3%), but rates were not significantly different for the two groups, indicating that the intervention was as acceptable as usual care. Participants who volunteered and were selected for this study might not be representative of visually impaired older adults in general (responders were significantly younger than non-responders), thereby reducing the generalisability of the outcomes. Stepped care seems to be a promising way to deal with depression and anxiety in visually impaired older adults. This approach could lead to standardised strategies for the screening, monitoring, treatment, and referral of visually impaired older adults with depression and anxiety. Funded by ZonMw InZicht, the Dutch Organisation for Health Research and Development-InSight Society. There are no competing interests. Full dataset and statistical code are available from the corresponding author.Study registration www.trialregister.nl NTR3296. © van der Aa et al 2015.

Exploring the Benefits of Respite Services to Family Caregivers: Methodological Issues and Current Findings

PubMed Central

Zarit, Steven H.; Liu, Yin; Bangerter, Lauren R.; Rovine, Michael J.

2017-01-01

Objectives There is growing emphasis on empirical validation of the efficacy of community-based services for older people and their families, but research on services such as respite care faces methodological challenges that have limited the growth of outcome studies. We identify problems associated with the usual research approaches for studying respite care, with the goal of stimulating use of novel and more appropriate research designs that can lead to improved studies of community-based services. Method Using the concept of research validity, we evaluate the methodological approaches in the current literature on respite services, including adult day services, in-home respite and overnight respite. Results Although randomized control trials (RCTs) are possible in community settings, validity is compromised by practical limitations of randomization and other problems. Quasi-experimental and interrupted time series designs offer comparable validity to RCTs and can be implemented effectively in community settings. Conclusion An emphasis on RCTs by funders and researchers is not supported by scientific evidence. Alternative designs can lead to development of a valid body of research on community services such as respite. PMID:26729467

Exploring the benefits of respite services to family caregivers: methodological issues and current findings.

PubMed

Zarit, Steven H; Bangerter, Lauren R; Liu, Yin; Rovine, Michael J

2017-03-01

There is growing emphasis on empirical validation of the efficacy of community-based services for older people and their families, but research on services such as respite care faces methodological challenges that have limited the growth of outcome studies. We identify problems associated with the usual research approaches for studying respite care, with the goal of stimulating use of novel and more appropriate research designs that can lead to improved studies of community-based services. Using the concept of research validity, we evaluate the methodological approaches in the current literature on respite services, including adult day services, in-home respite and overnight respite. Although randomized control trials (RCTs) are possible in community settings, validity is compromised by practical limitations of randomization and other problems. Quasi-experimental and interrupted time series designs offer comparable validity to RCTs and can be implemented effectively in community settings. An emphasis on RCTs by funders and researchers is not supported by scientific evidence. Alternative designs can lead to development of a valid body of research on community services such as respite.

Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

PubMed

Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

2014-02-24

The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing. Enhanced multi-disciplinary wound care teams were cost effective, with most benefit through cost reduction initiated by APNs, but did not improve the treatment of pressure ulcers in nursing homes. Policy makers should consider the potential yield of strengthening evidence based primary care within LTC facilities, through outreach by APNs. ClinicalTrials.gov identifier NCT01232764.

Effects of Exercise Training on Depressive Symptoms in Patients with Chronic Heart Failure: The HF-ACTION Randomized Trial

PubMed Central

Blumenthal, James A.; Babyak, Michael A.; O'Connor, Christopher; Keteyian, Steven; Landzberg, Joel; Howlett, Jonathan; Kraus, William; Gottlieb, Stephen; Blackburn, Gordon; Swank, Ann; Whellan, David J.

2013-01-01

Context Depression is common in cardiac patients, especially in patients with heart failure (HF), and is associated with increased risk for adverse health outcomes. There also is a growing literature to suggest that aerobic exercise may reduce depressive symptoms, but no previous study has evaluated the effects of exercise on depression in HF patients. Objective To determine if exercise training in HF patients will result in greater improvements in depressive symptoms compared with usual care. Design Multicenter, randomized (1:1) controlled trial Setting Ambulatory in 82 clinical centers in the US, Canada, and France. Participants 2,322 stable patients with a left ventricular ejection fraction (LVEF) ≤35% and NYHA class II to IV HF who completed the Beck Depression Inventory-II (BDI-II) to assess depressive symptoms (range 0-63; clinically significant ≥ 14). Interventions Supervised aerobic exercise (goal of 90 min/wk for months 1-3) followed by home exercise (goal of ≥120 min/wk for months 4-12), versus education and usual, guideline-based HF care conducted between April, 2003 and February, 2007. Main Outcome Measures Scores on the BDI-II at 3- and 12-months and the composite of death or hospitalization from any cause. Results 789 (68%) patients died or were hospitalized in the usual care (UC) arm and 759 (66%) in the aerobic exercise (AE) arm (Hazard Ratio [HR] = 0.89, 95% CI = 0.81, 0.99; p=.03) over a median follow-up period of 30 months. The median BDI-II score at study entry was 8, with 28% of the sample obtaining BDI-II scores ≥14. Compared to UC, AE resulted in lower mean BDI-II scores at 3-months, AE = 8.95 (95% CI =8.61, 9.29) vs. 9.70 (95% CI = 9.34, 10.06) for UC (difference =−0.76,95 % CI= −1.22, −0.29, p = .002), and at 12-months, AE= 8.86 (95%CI= 8.67, 9.24) vs. 9.54 (95% CI = 9.15, 9.92) for UC (difference = −0.68, 95% CI = −1.20, −0.16; p = .01). Conclusions Compared to guideline-based usual care, exercise training resulted in reduced depressive symptoms and better clinical outcomes. PMID:22851113

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

Motivational interviewing for screening and feedback and encouraging lifestyle changes to reduce relative weight in 4-8 year old children: design of the MInT study.

PubMed

Taylor, Rachael W; Brown, Deirdre; Dawson, Anna M; Haszard, Jill; Cox, Adell; Rose, Elaine A; Taylor, Barry J; Meredith-Jones, Kim; Treacy, Lee; Ross, Jim; William, Sheila M

2010-05-24

Because parental recognition of overweight in young children is poor, we need to determine how best to inform parents that their child is overweight in a way that enhances their acceptance and supports motivation for positive change. This study will assess 1) whether weight feedback delivered using motivational interviewing increases parental acceptance of their child's weight status and enhances motivation for behaviour change, and 2) whether a family-based individualised lifestyle intervention, delivered primarily by a MInT mentor with limited support from "expert" consultants in psychology, nutrition and physical activity, can improve weight outcomes after 12 and 24 months in young overweight children, compared with usual care. 1500 children aged 4-8 years will be screened for overweight (height, weight, waist, blood pressure, body composition). Parents will complete questionnaires on feeding practices, physical activity, diet, parenting, motivation for healthy lifestyles, and demographics. Parents of children classified as overweight (BMI > or = CDC 85th) will receive feedback about the results using Motivational interviewing or Usual care. Parental responses to feedback will be assessed two weeks later and participants will be invited into the intervention. Additional baseline measurements (accelerometry, diet, quality of life, child behaviour) will be collected and families will be randomised to Tailored package or Usual care. Parents in the Usual care condition will meet once with an advisor who will offer general advice regarding healthy eating and activity. Parents in the Tailored package condition will attend a single session with an "expert team" (MInT mentor, dietitian, physical activity advisor, clinical psychologist) to identify current challenges for the family, develop tailored goals for change, and plan behavioural strategies that best suit each family. The mentor will continue to provide support to the family via telephone and in-person consultations, decreasing in frequency over the two-year intervention. Outcome measures will be obtained at baseline, 12 and 24 months. This trial offers a unique opportunity to identify effective ways of providing feedback to parents about their child's weight status and to assess the efficacy of a supportive, individualised early intervention to improve weight outcomes in young children. Australian New Zealand Clinical Trials Registry ACTRN12609000749202.

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

Effectiveness of Cognitive-Behavioral Treatment for Panic Disorder versus Treatment as Usual in a Managed Care Setting

ERIC Educational Resources Information Center

Addis, Michael E.; Hatgis, Christina; Krasnow, Aaron D.; Jacob, Karen; Bourne, Leslie; Mansfield, Abigail

2004-01-01

Eighty clients enrolled in a managed care health plan who identified panic disorder as their primary presenting problem were randomly assigned to treatment by a therapist recently trained in a manual-based empirically supported psychotherapy (M. G. Craske, E. Meadows, & D. H. Barlow, 1994) or a therapist conducting treatment as usual (TAU).…

Randomized Controlled Trial of the Focus Parent Training for Toddlers with Autism: 1-Year Outcome

ERIC Educational Resources Information Center

Oosterling, Iris; Visser, Janne; Swinkels, Sophie; Rommelse, Nanda; Donders, Rogier; Woudenberg, Tim; Roos, Sascha; van der Gaag, Rutger Jan; Buitelaar, Jan

2010-01-01

This randomized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone. The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. (Eur Child Adolesc Psychiatr 11:266-272, 2002). Seventy-five…

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 ...

Utility of a Web-based intervention for individuals with type 2 diabetes: the impact on physical activity levels and glycemic control.

PubMed

Kim, Chun-Ja; Kang, Duck-Hee

2006-01-01

Despite the numerous benefits of physical activity for patients with diabetes, most healthcare providers in busy clinical settings rarely find time to counsel their patients about it. A Web-based program for healthcare providers can be used as an effective counseling tool, when strategies are outlined for specific stages of readiness for physical activity. Seventy-three adults with type 2 diabetes were randomly assigned to Web-based intervention, printed-material intervention, or usual care. After 12 weeks, the effects of the interventions on physical activity, fasting blood sugar, and glycosylated hemoglobin were evaluated. Both Web-based and printed material intervention, compared with usual care, were effective in increasing physical activity (P < .001) and decreasing fasting blood sugar (P<.01) and glycosylated hemoglobin (P < .01). Post hoc analysis for change scores indicated significant differences between Web-based intervention and usual care and between printed material intervention and usual care, but not between web-based and printed material intervention. The findings of this study support the value of Web-based and printed material interventions in healthcare counseling. With increasing Web access, the effectiveness of Web-based programs offered directly to patients needs to be tested.

Mail and phone interventions for weight loss in a managed-care setting: Weigh-To-Be one-year outcomes.

PubMed

Jeffery, R W; Sherwood, N E; Brelje, K; Pronk, N P; Boyle, R; Boucher, J L; Hase, K

2003-12-01

To describe methods, recruitment success, and 1-y results of a study evaluating the effectiveness of phone- and mail-based weight-loss interventions in a managed care setting. Randomized clinical trial with three groups, that is, usual care, mail intervention, and phone intervention. In total, 1801 overweight members of a managed-care organization (MCO). Height, weight, medical status, and weight-loss history were measured at baseline. Participation in intervention activities was monitored for 12 months in the two active treatment groups. Self-reported weight was obtained at 6 and 12 months. More individuals assigned to mail treatment started it (88%) than did those assigned to phone treatment (69%). However, program completion rates were higher in the phone (36%) than mail (7%) intervention. The mean weight losses were 1.93, 2.38, and 1.47 kg at 6 months in the mail, phone, and usual care groups, respectively. The differences between the phone and usual care groups were statistically significant. The mean weight losses at 12 months did not differ by treatment group (2.28 kg mail, 2.29 kg phone, and 1.92 kg usual care). Greater weight loss was seen in men, older participants, and those with no prior experience in a weight-loss program. Heavier participants and those who reported current treatment for depression lost less weight. Although mail- and phone-based weight-loss programs can be delivered to large numbers of people in an MCO setting, additional work is needed to enhance their clinical efficacy as well as to assess their costs.

Health IT-assisted population-based preventive cancer screening: a cost analysis.

PubMed

Levy, Douglas E; Munshi, Vidit N; Ashburner, Jeffrey M; Zai, Adrian H; Grant, Richard W; Atlas, Steven J

2015-12-01

Novel health information technology (IT)-based strategies harnessing patient registry data seek to improve care at a population level. We analyzed costs from a randomized trial of 2 health IT strategies to improve cancer screening compared with usual care from the perspective of a primary care network. Monte Carlo simulations were used to compare costs across management strategies. We assessed the cost of the software, materials, and personnel for baseline usual care (BUC) compared with augmented usual care (AUC [ie, automated patient outreach]) and augmented usual care with physician input (AUCPI [ie, outreach mediated by physicians' knowledge of their patient panels]) over 1 year. AUC and AUCPI each reduced the time physicians spent on cancer screening by 6.5 minutes per half-day clinical session compared with BUC without changing cancer screening rates. Assuming the value of this time accrues to the network, total costs of cancer screening efforts over the study year were $3.83 million for AUC, $3.88 million for AUCPI, and $4.10 million for BUC. AUC was cost-saving relative to BUC in 87.1% of simulations. AUCPI was cost-saving relative to BUC in 82.5% of simulations. Ongoing per patient costs were lower for both AUC ($35.63) and AUCPI ($35.58) relative to BUC ($39.51). Over the course of the study year, the value of reduced physician time devoted to preventive cancer screening outweighed the costs of the interventions. Primary care networks considering similar interventions will need to capture adequate physician time savings to offset the costs of expanding IT infrastructure.

Cost-effectiveness of the Decipher Genomic Classifier to Guide Individualized Decisions for Early Radiation Therapy After Prostatectomy for Prostate Cancer.

PubMed

Lobo, Jennifer M; Trifiletti, Daniel M; Sturz, Vanessa N; Dicker, Adam P; Buerki, Christine; Davicioni, Elai; Cooperberg, Matthew R; Karnes, R Jeffrey; Jenkins, Robert B; Den, Robert B; Showalter, Timothy N

2017-06-01

Controversy exists regarding the effectiveness of early adjuvant versus salvage radiation therapy after prostatectomy for prostate cancer. Estimates of prostate cancer progression from the Decipher genomic classifier (GC) could guide informed decision-making and improve the outcomes for patients. We developed a Markov model to compare the costs and quality-adjusted life years (QALYs) associated with GC-based treatment decisions regarding adjuvant therapy after prostatectomy with those of 2 control strategies: usual care (determined from patterns of care studies) and the alternative of 100% adjuvant radiation therapy. Using the bootstrapping method of sampling with replacement, the cases of 10,000 patients were simulated during a 10-year time horizon, with each subject having individual estimates for cancer progression (according to GC findings) and noncancer mortality (according to age). GC-based care was more effective and less costly than 100% adjuvant radiation therapy and resulted in cost savings up to an assay cost of $11,402. Compared with usual care, GC-based care resulted in more QALYs. Assuming a $4000 assay cost, the incremental cost-effectiveness ratio was $90,833 per QALY, assuming a 7% usage rate of adjuvant radiation therapy. GC-based care was also associated with a 16% reduction in the percentage of patients with distant metastasis at 5 years compared with usual care. The Decipher GC could be a cost-effective approach for genomics-driven cancer treatment decisions after prostatectomy, with improvements in estimated clinical outcomes compared with usual care. The individualized decision analytic framework applied in the present study offers a flexible approach to estimate the potential utility of genomic assays for personalized cancer medicine. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

An economic case for a cardiovascular polypill? A cost analysis of the Kanyini GAP trial.

PubMed

Laba, Tracey-Lea; Hayes, Alison; Lo, Serigne; Peiris, David P; Usherwood, Tim; Hillis, Graham S; Rafter, Natasha; Reid, Christopher M; Tonkin, Andrew M; Webster, Ruth; Neal, Bruce C; Cass, Alan; Patel, Anushka; Rodgers, Anthony; Jan, Stephen

2014-12-11

To measure the costs of a polypill strategy and compare them with those of usual care in people with established cardiovascular disease (CVD) or at similarly high cardiovascular risk. A within-trial cost analysis of polypill-based care versus usual care with separate medications, using data from the Kanyini Guidelines Adherence with the Polypill (GAP) trial and linked health service and medication administrative claims data. Kanyini GAP participants who consented to Australian Medicare record access. Mean health service and pharmaceutical expenditure per patient per year, estimated with generalised linear models. Costs during the trial (randomisation January 2010 - May 2012, median follow-up 19 months, maximum follow-up 36 months) were inflated to 2012 costs. Our analysis showed a statistically significantly lower mean pharmaceutical expenditure of $989 (95% CI, $648-$1331) per patient per year in the polypill arm compared with usual care (P < 0.001; adjusted, excluding polypill cost). No significant difference was shown in health service expenditure. This study provides evidence of significant cost savings to the taxpayer and Australian Government through the introduction of a CVD polypill strategy. The savings will be less now than during the trial due to subsequent reductions in the costs of usual care. Nonetheless, given the prevalence of CVD in Australia, the introduction of this polypill could increase considerably the efficiency of health care expenditure in Australia. Australian New Zealand Clinical Trials Registry ACTRN126080005833347.

The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials

PubMed Central

2014-01-01

Background The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India. Methods/design This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat. Discussion These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors. Trial registration Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238). PMID:24690184

Remission in Depressed Geriatric Primary Care Patients: A Report From the PROSPECT Study

PubMed Central

Alexopoulos, George S.; Katz, Ira R.; Bruce, Martha L.; Heo, Moonseong; Have, Thomas Ten; Raue, Patrick; Bogner, Hillary R.; Schulberg, Herbert C.; Mulsant, Benoit H.; Reynolds, Charles F.

2009-01-01

Objective This study compared time to first remission for elderly depressed patients in primary care for practices that implemented a care management model versus those providing usual care. In addition, it sought to identify risk factors for nonremission that could guide treatment planning and referral to care managers or specialists. Method Prevention of Suicide in Primary Care Elderly: Collaborative Trial (PROSPECT) data were analyzed. Participants were older patients (≥60 years) selected following screening of 9,072 randomly identified primary care patients. The present analysis examined patients with major depression and a 24-item Hamilton Depression Rating Scale score of 18 or greater who were followed for at least 4 months (N=215). Primary care practices were randomly assigned to offer the PROSPECT intervention or usual care. The intervention consisted of services of trained care managers, who offered algorithm-based recommendations to physicians and helped patients with treatment adherence over 18 months. Results First remission occurred earlier and was more common among patients receiving the intervention than among those receiving usual care. For all patients, limitations in physical and emotional functions predicted poor remission rate. Patients experiencing hopelessness were more likely to achieve remission if treated in intervention practices. Similarly, the intervention was more effective in patients with low baseline anxiety. Conclusions Longitudinal assessment of depression, hopelessness, anxiety, and physical and emotional functional limitations in depressed older primary care patients is critical. Patients with prominent symptoms or impairment in these areas may be candidates for care management or mental health care, since they are at risk for remaining depressed and disabled. PMID:15800144

Design of a randomized controlled trial for genomic carrier screening in healthy patients seeking preconception genetic testing.

PubMed

Kauffman, Tia L; Wilfond, Benjamin S; Jarvik, Gail P; Leo, Michael C; Lynch, Frances L; Reiss, Jacob A; Richards, C Sue; McMullen, Carmit; Nickerson, Deborah; Dorschner, Michael O; Goddard, Katrina A B

2017-02-01

Population-based carrier screening is limited to well-studied or high-impact genetic conditions for which the benefits may outweigh the associated harms and costs. As the cost of genome sequencing declines and availability increases, the balance of risks and benefits may change for a much larger number of genetic conditions, including medically actionable additional findings. We designed an RCT to evaluate genomic clinical sequencing for women and partners considering a pregnancy. All results are placed into the medical record for use by healthcare providers. Through quantitative and qualitative measures, including baseline and post result disclosure surveys, post result disclosure interviews, 1-2year follow-up interviews, and team journaling, we are obtaining data about the clinical and personal utility of genomic carrier screening in this population. Key outcomes include the number of reportable carrier and additional findings, and the comparative cost, utilization, and psychosocial impacts of usual care vs. genomic carrier screening. As the study progresses, we will compare the costs of genome sequencing and usual care as well as the cost of screening, pattern of use of genetic or mental health counseling services, number of outpatient visits, and total healthcare costs. This project includes novel investigation into human reactions and responses from would-be parents who are learning information that could both affect a future pregnancy and their own health. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

PubMed Central

2010-01-01

Background Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes. Methods An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups. Discussion The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work. Trial Registration number NCT00962468 PMID:21092098

Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial.

PubMed

Bekelman, David B; Plomondon, Mary E; Sullivan, Mark D; Nelson, Karin; Hattler, Brack; McBryde, Connor; Lehmann, Kenneth G; Potfay, Jonathan; Heidenreich, Paul; Rumsfeld, John S

2013-07-09

Chronic heart failure (HF) disease management programs have reported inconsistent results and have not included comorbid depression management or specifically focused on improving patient-reported outcomes. The Patient Centered Disease Management (PCDM) trial was designed to test the effectiveness of collaborative care disease management in improving health status (symptoms, functioning, and quality of life) in patients with HF who reported poor HF-specific health status. Patients with a HF diagnosis at four VA Medical Centers were identified through population-based sampling. Patients with a Kansas City Cardiomyopathy Questionnaire (KCCQ, a measure of HF-specific health status) score of < 60 (heavy symptom burden and impaired quality of life) were invited to enroll in the PCDM trial. Enrolled patients were randomized to receive usual care or the PCDM intervention, which included: (1) collaborative care management by VA clinicians including a nurse, cardiologist, internist, and psychiatrist, who worked with patients and their primary care providers to provide guideline-concordant care management, (2) home telemonitoring and guided patient self-management support, and (3) screening and treatment for comorbid depression. The primary study outcome is change in overall KCCQ score. Secondary outcomes include depression, medication adherence, guideline-based care, hospitalizations, and mortality. The PCDM trial builds on previous studies of HF disease management by prioritizing patient health status, implementing a collaborative care model of health care delivery, and addressing depression, a key barrier to optimal disease management. The study has been designed as an 'effectiveness trial' to support broader implementation in the healthcare system if it is successful. Unique identifier: NCT00461513.

Stepped-care to prevent depression and anxiety in visually impaired older adults – design of a randomised controlled trial

PubMed Central

2013-01-01

Background Subthreshold depression and anxiety are common in the growing population of visually impaired older adults and increase the risk of full-blown depressive or anxiety disorders. Adequate treatment may prevent the development of depression or anxiety in this high risk group. Method/design A stepped-care programme was developed based on other effective interventions and focus groups with professionals and patient representatives of three low vision rehabilitation organisations in the Netherlands and Belgium. The final programme consists of four steps: 1) watchful waiting, 2) guided self-help, 3) problem solving treatment, 4) referral to general practitioner. The (cost-)effectiveness of this programme is evaluated in a randomised controlled trial. Patients (N = 230) are randomly assigned to either a treatment group (stepped-care) or a control group (usual care). The primary outcome is the incidence of depressive and anxiety disorders, measured with the Mini International Neuropsychiatric Interview (MINI). Discussion Preventive interventions for depression and anxiety have received little attention in the field of low vision. A stepped-care programme that focuses on both depression and anxiety has never been investigated in visually impaired older adults before. If the intervention is shown to be effective, this study will result in an evidence based treatment programme to prevent depression or anxiety in patients from low vision rehabilitation organisations. The pragmatic design of the study greatly enhances the generalisability of the results. However, a possible limitation is the difficulty to investigate the contribution of each individual step. Trial registration Identifier: NTR3296 PMID:23937975

Clinic-based nutrition and lifestyle counseling for Hispanic women delivered by community health workers: design of the California WISEWOMAN study.

PubMed

Farrell, Maureen A; Hayashi, Toshi; Loo, Ryan K; Rocha, David A; Sanders, Charlene; Hernandez, Marianne; Will, Julie C

2009-05-01

The Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program in California, named Heart of the Family, implements and evaluates the effectiveness of lifestyle interventions to improve nutrition and physical activity while reducing cardiovascular disease (CVD) risk factors among low-income, uninsured or underinsured Hispanic women aged 40-64 who participate in the Cancer Detection Programs: Every Woman Counts (CDP:EWP). This paper reports the study design and baseline findings of the California WISEWOMAN program. Heart of the Family, a within-site randomized controlled study at four community health centers in Los Angeles and San Diego, featured a unique set of strategies meeting the state population in implementing a California WISEWOMAN program. The program exclusively targeted Hispanic women who are at risk of developing CVD, provided lifestyle intervention using a validated intervention material in Spanish and English to motivate behavioral changes, and used bilingual (English and Spanish) community health workers (CHWs) to provide individually based face-to-face counseling. Women meeting enrollment criteria were randomly assigned either to an enhanced intervention group (EIG), who received lifestyle intervention, or usual care group (UCG), who received the usual care for elevated blood pressure or cholesterol. A total of 1093 women enrolled between January 2006 and August 2006. Demographic and baseline CVD risk profiles are similar in both groups. Some notable characteristics of the California participants are lower smoking rate (5%), higher average body mass index (BMI) (31.9), and a significantly higher percentage with less than high school education (70%). With its unique study design and large number of enrolls, Heart of the Family will enable future public health efforts to better meet the health needs of Hispanic women by addressing education levels, economic considerations, and cultural and linguistic needs.

A worksite prevention program for construction workers: design of a randomized controlled trial.

PubMed

Oude Hengel, Karen M; Joling, Catelijne I; Proper, Karin I; Blatter, Birgitte M; Bongers, Paulien M

2010-06-14

A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1) two individual training sessions of a physical therapist to lower the physical workload, (2) a Rest-Break tool to improve the balance between work and recovery, and (3) two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. NTR1278.

A worksite prevention program for construction workers: design of a randomized controlled trial

PubMed Central

2010-01-01

Background A worksite prevention program was developed to promote the work ability of construction workers and thereby prolong a healthy working life. The objective of this paper is to present the design of a randomized controlled trial evaluating the effectiveness of that intervention program compared with usual care for construction workers. Methods The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are construction workers performing actual construction work. The worksite intervention will be compared with usual care. This intervention was developed by using the Intervention Mapping approach and consists of the following components: (1) two individual training sessions of a physical therapist to lower the physical workload, (2) a Rest-Break tool to improve the balance between work and recovery, and (3) two empowerment training sessions to increase the influence of the construction workers at the worksite. Outcome measures are assessed at baseline, 3, 6, and 12 months. The primary outcome measures of this study are work ability and health-related quality of life. Secondary outcome measures include need for recovery, musculoskeletal complaints, work engagement and self efficacy. Cost-effectiveness will be evaluated from the company perspective. Moreover, a process evaluation will be conducted. Discussion The feasibility of the intervention and the study has been enhanced by creating an intervention program that explicitly appeals to construction workers and will not interfere too much with the ongoing construction. The feasibility and effectiveness of this worksite prevention program will be investigated by means of an effect- and a process evaluation. If proven effective, this worksite prevention program can be implemented on a larger scale within the construction industry. Trial Registration NTR1278 PMID:20546568

SLIMMER: a randomised controlled trial of diabetes prevention in Dutch primary health care: design and methods for process, effect, and economic evaluation

PubMed Central

2014-01-01

Background Implementation of interventions in real-life settings requires a comprehensive evaluation approach. The aim of this article is to describe the evaluation design of the SLIMMER diabetes prevention intervention in a Dutch real-life setting. Methods/Design The SLIMMER study is a randomised, controlled intervention study including subjects aged 40 through 70 years with impaired fasting glucose or high risk of diabetes. The 10-month SLIMMER intervention involves a dietary and physical activity intervention, including case management and a maintenance programme. The control group receives usual health care and written information about a healthy lifestyle. A logic model of change is composed to link intervention activities with intervention outcomes in a logical order. Primary outcome is fasting insulin. Measurements are performed at baseline and after 12 and 18 months and cover quality of life, cardio-metabolic risk factors (e.g. glucose tolerance, serum lipids, body fatness, and blood pressure), eating and physical activity behaviour, and behavioural determinants. A process evaluation gives insight in how the intervention was delivered and received by participants and health care professionals. The economic evaluation consists of a cost-effectiveness analysis and a cost-utility analysis. Costs are assessed from both a societal and health care perspective. Discussion This study is expected to provide insight in the effectiveness, including its cost-effectiveness, and delivery of the SLIMMER diabetes prevention intervention conducted in Dutch primary health care. Results of this study provide valuable information for primary health care professionals, researchers, and policy makers. Trial registration The SLIMMER study is registered with ClinicalTrials.gov (NCT02094911) since March 19, 2014. PMID:24928217