Telephone Outreach to Increase Colon Cancer Screening in Medicaid Managed Care Organizations: A Randomized Controlled Trial

PubMed Central

Dietrich, Allen J.; Tobin, Jonathan N.; Robinson, Christina M.; Cassells, Andrea; Greene, Mary Ann; Dunn, Van H.; Falkenstern, Kimberly M.; De Leon, Rosanna; Beach, Michael L.

2013-01-01

PURPOSE Health Plans are uniquely positioned to deliver outreach to members. We explored whether telephone outreach, delivered by Medicaid managed care organization (MMCO) staff, could increase colorectal cancer (CRC) screening among publicly insured urban women, potentially reducing disparities. METHODS We conducted an 18-month randomized clinical trial in 3 MMCOs in New York City in 2008–2010, randomizing 2,240 MMCO-insured women, aged 50 to 63 years, who received care at a participating practice and were overdue for CRC screening. MMCO outreach staff provided cancer screening telephone support, educating patients and helping overcome barriers. The primary outcome was the number of women screened for CRC during the 18-month intervention, assessed using claims. RESULTS MMCO staff reached 60% of women in the intervention arm by telephone. Although significantly more women in the intervention (36.7%) than in the usual care (30.6%) arm received CRC screening (odds ratio [OR] = 1.32; 95% CI, 1.08–1.62), increases varied from 1.1% to 13.7% across the participating MMCOs, and the overall increase was driven by increases at 1 MMCO. In an as-treated comparison, 41.8% of women in the intervention arm who were reached by telephone received CRC screening compared with 26.8% of women in the usual care arm who were not contacted during the study (OR = 1.84; 95% CI, 1.38, 2.44); 7 women needed to be reached by telephone for 1 to become screened. CONCLUSIONS The telephone outreach intervention delivered by MMCO staff increased CRC screening by 6% more than usual care among randomized women, and by 15.1% more than usual care among previously overdue women reached by the intervention. Our research-based intervention was successfully translated to the health plan arena, with variable effects in the participating MMCOs. PMID:23835819

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

Reporting of interventions and "standard of care" control arms in pediatric clinical trials: a quantitative analysis.

PubMed

Yu, Ashley M; Balasubramanaiam, Bannuya; Offringa, Martin; Kelly, Lauren E

2018-06-13

In pediatric medicine, the usual treatment received by children ("standard of care") varies across centers. Evaluations of new treatments often compare to the existing "standard of care" to determine if a treatment is more effective, has a better safety profile, or costs less. The objective of our study was to evaluate intervention and "standard of care" control arms reported in published pediatric clinical trials. Pediatric clinical trials, published in 2014, reporting the use of a "standard of care" control arm were included. Duplicate assessment of reporting completeness was done using the 12-item TIDieR (Template for Intervention Description and Replication) checklist for both the "standard of care" control arms and intervention arms within the same published study. Following screening, 214 pediatric trials in diverse therapeutic areas were included. Several different terms were used to describe "standard of care." There was a significant difference between the mean reported TIDieR checklist items of "standard of care" control arms (5.81 (SD 2.13) and intervention arms (8.45 (SD 1.39, p < 0.0001). Reporting of intervention and "standard of care" control arms in pediatric clinical trials should be improved as current "standard of care" reporting deficiencies limit reproducibility of research and may ultimately contribute to research waste.

Sustaining mammography screening among the medically underserved: a follow-up evaluation.

PubMed

Davis, Terry C; Arnold, Connie L; Bennett, Charles L; Wolf, Michael S; Liu, Dachao; Rademaker, Alfred

2015-04-01

Our previous three-arm comparative effectiveness intervention in community clinic patients who were not up-to-date with screening resulted in mammography rates over 50% in all arms. Our aim was to evaluate the effectiveness and cost-effectiveness of the three interventions on improving biennial screening rates among eligible patients. A three-arm quasi-experimental evaluation was conducted in eight community clinics from 2008 to 2011. Screening efforts included (1) enhanced care: Participants received an in-person recommendation from a research assistant (RA) in year 1, and clinics followed usual clinic protocol for scheduling screening mammograms; (2) education intervention: Participants received education and in-person recommendation from an RA in year 1, and clinics followed usual clinic protocol for scheduling mammograms; or (3) nurse support: A nurse manager provided in-person education and recommendation, scheduled mammograms, and followed up with phone support. In all arms, mammography was offered at no cost to uninsured patients. Of 624 eligible women, biennial mammography within 24-30 months of their previous test was performed for 11.0% of women in the enhanced-care arm, 7.1% in the education- intervention arm, and 48.0% in the nurse-support arm (p<0.0001). The incremental cost was $1,232 per additional woman undergoing screening with nurse support vs. enhanced care and $1,092 with nurse support vs. education. Biennial mammography screening rates were improved by providing nurse support but not with enhanced care or education. However, this approach was not cost-effective.

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

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

PubMed

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

2013-03-28

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

A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study

PubMed Central

2012-01-01

Background Clinical pathways (CPs) are used to improve the outcomes of acute stroke, but their use in stroke care is questionable, because the evidence on their effectiveness is still inconclusive. The objective of this study was to evaluate whether CPs improve the outcomes and the quality of care provided to patients after acute ischemic stroke. Methods This was a multicentre cluster-randomized trial, in which 14 hospitals were randomized to the CP arm or to the non intervention/usual care (UC) arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The teams in the CP arm developed their CPs over a 6-month period. The primary end point was mortality. Secondary end points were: use of diagnostic and therapeutic procedures, implementation of organized care, length of stay, re-admission and institutionalization rates after discharge, dependency levels, and complication rates. Results Compared with the patients in the UC arm, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95) and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98). There was no significant effect on 30-day mortality. Compared with the UC arm, the hospital diagnostic and therapeutic procedures were performed more appropriately in the CP arm, and the evidence-based key interventions and organized care were more applied in the CP arm. Conclusions CPs can significantly improve the outcomes of patients with ischemic patients with stroke, indicating better application of evidence-based key interventions and of diagnostic and therapeutic procedures. This study tested a new hypothesis and provided evidence on how CPs can work. Trial registration ClinicalTrials.gov ID: [NCT00673491]. PMID:22781160

Combined Cognitive-Strategy and Task-Specific Training Affects Cognition and Upper-Extremity Function in Subacute Stroke: An Exploratory Randomized Controlled Trial

PubMed Central

Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; McEwen, Sara

2016-01-01

The purpose of this study was to estimate the effect of Cognitive Orientation to Daily Occupational Performance (CO–OP) compared with usual occupational therapy on upper-extremity movement, cognitive flexibility, and stroke impact in people less than 3 mo after stroke. An exploratory, single-blind randomized controlled trial was conducted with people referred to outpatient occupational therapy services at two rehabilitation centers. Arm movement was measured with the Action Research Arm Test, cognitive flexibility with the Delis–Kaplan Executive Function System Trail Making subtest, and stroke impact with subscales of the Stroke Impact Scale. A total of 35 participants were randomized, and 26 completed the intervention. CO–OP demonstrated measurable effects over usual care on all measures. These data provide early support for the use of CO–OP to improve performance and remediate cognitive and arm movement impairments after stroke over usual care; however, future study is warranted to confirm the effects observed in this trial. PMID:26943113

Sustaining Mammography Screening Among the Medically Underserved: A Follow-Up Evaluation

PubMed Central

Arnold, Connie L.; Bennett, Charles L.; Wolf, Michael S.; Liu, Dachao; Rademaker, Alfred

2015-01-01

Abstract Background: Our previous three-arm comparative effectiveness intervention in community clinic patients who were not up-to-date with screening resulted in mammography rates over 50% in all arms. Objective: Our aim was to evaluate the effectiveness and cost-effectiveness of the three interventions on improving biennial screening rates among eligible patients. Methods: A three-arm quasi-experimental evaluation was conducted in eight community clinics from 2008 to 2011. Screening efforts included (1) enhanced care: Participants received an in-person recommendation from a research assistant (RA) in year 1, and clinics followed usual clinic protocol for scheduling screening mammograms; (2) education intervention: Participants received education and in-person recommendation from an RA in year 1, and clinics followed usual clinic protocol for scheduling mammograms; or (3) nurse support: A nurse manager provided in-person education and recommendation, scheduled mammograms, and followed up with phone support. In all arms, mammography was offered at no cost to uninsured patients. Results: Of 624 eligible women, biennial mammography within 24–30 months of their previous test was performed for 11.0% of women in the enhanced-care arm, 7.1% in the education- intervention arm, and 48.0% in the nurse-support arm (p<0.0001). The incremental cost was $1,232 per additional woman undergoing screening with nurse support vs. enhanced care and $1,092 with nurse support vs. education. Conclusions: Biennial mammography screening rates were improved by providing nurse support but not with enhanced care or education. However, this approach was not cost-effective. PMID:25692910

Exploring patients' treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets.

PubMed

Turner, Katrina M; Percival, John; Kessler, David; Donovan, Jenny

2017-06-15

The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not only to which treatment participants receive but also how they access and engage with their allocated treatment. Such differences could affect trial results. The aim of this study was to assess whether such differences exist and, if they do, to consider their implications for the design of future trials. Interview transcripts were sampled from data sets gathered during three qualitative studies, all of which had been nested within large, primary care depression trials. Each study had explored trial participants' views and experiences of treatments received following randomisation. Transcripts from 37 participants were purposefully sampled, 20 of which were from interviews held with individuals allocated to receive usual GP care. Data were analysed thematically. There was evidence of differences between trial arms across all three data sets. Intervention participants were willing and able to engage with the treatment to which they had been allocated. Randomisation had led to them embarking upon a clear treatment pathway and receiving care in a context where they felt comfortable discussing their mental health and had sufficient time to do so. Intervention participants also had continuity with and confidence in the practitioners they saw. A few usual-care participants talked about having continuity with and confidence in their GPs. However, most of the usual-care participants reported a reluctance to consult GPs about mental health, difficulties in securing treatment appointments, and little or no changes in care following randomisation. Additionally, most reported a lack of continuity of care and a lack confidence in the treatment available to them. There are important differences between usual-care and intervention arms that go beyond treatment received, and they relate to how participants experience accessing and engaging with their allocated care. As these differences could affect trial results, researchers may want to measure or reduce them in order to fully appreciate or control for the range of factors that might affect treatment outcomes.

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

PubMed

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

2015-12-14

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

A randomized controlled trial of very early rehabilitation in speech after stroke.

PubMed

Godecke, Erin; Armstrong, Elizabeth A; Rai, Tapan; Middleton, Sandy; Ciccone, Natalie; Whitworth, Anne; Rose, Miranda; Holland, Audrey; Ellery, Fiona; Hankey, Graeme J; Cadilhac, Dominique A; Bernhardt, Julie

2016-07-01

The efficacy of rehabilitation therapy for aphasia caused by stroke is uncertain. The Very Early Rehabilitation of Speech (VERSE) trial aims to determine if intensive prescribed aphasia therapy (VERSE) is more effective and cost saving than non-prescribed, intensive (usual care-plus) and non-intensive usual care (UC) therapy when started within 15 days of stroke onset and continued daily over four weeks. We hypothesize that aphasia therapy when started very early after stroke and delivered daily could enhance recovery of communication compared with UC. A total of 246 participants (82 per arm) will provide 80% power to detect a 4.4% improvement on aphasia quotient between VERSE and UC plus at a significance level of α = 0.05. Acute-care hospitals and accompanying rehabilitation services throughout Australia, 2014-2017. Three-arm, prospective, randomized, parallel group, open-label, blinded endpoint assessment (PROBE) trial. Acute stroke in previous 14 days and aphasia diagnosed by aphasia quotient (AQ) of the Western Aphasia Battery (WAB). Computer-generated blocked randomization procedure stratified by aphasia severity according to Western Aphasia Battery, to one of three arms. All participants receive UC-usual ward-based aphasia therapy. Arm 1: UC-no additional therapy; Arm 2: UC-plus usual ward-based therapy; Arm 3: VERSE therapy-a prescribed and structured aphasia therapy program. Arms 2 and 3 receive a total of 20 additional sessions (45-60 min, provided daily) of aphasia therapy. The additional intervention must be provided before day 50 post stroke. The aphasia quotient of Western Aphasia Battery at 12 weeks post stroke. Secondary outcomes include discourse measures, the Stroke and Aphasia Quality of Life Scale-39 and the Aphasia Depression Rating Scale at 12 and 26 weeks. Incremental cost-effectiveness ratios at 26 weeks will be reported. This trial is designed to test whether the intensive and prescribed VERSE intervention is effective in promoting maximum recovery and preventing costly health complications in a vulnerable population of survivors of stroke. It will also provide novel, prospective, aphasia specific cost-effectiveness data to guide future policy development for this population. © 2016 World Stroke Organization.

Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial.

PubMed

Nicolaije, Kim A H; Ezendam, Nicole P M; Vos, M Caroline; Pijnenborg, Johanna M A; Boll, Dorry; Boss, Erik A; Hermans, Ralph H M; Engelhart, Karin C M; Haartsen, Joke E; Pijlman, Brenda M; van Loon-Baelemans, Ingrid E A M; Mertens, Helena J M M; Nolting, Willem E; van Beek, Johannes J; Roukema, Jan A; Zijlstra, Wobbe P; Kruitwagen, Roy F P M; van de Poll-Franse, Lonneke V

2015-11-01

This study was conducted to longitudinally assess the impact of an automatically generated survivorship care plan (SCP) on patient-reported outcomes in routine clinical practice. Primary outcomes were patient satisfaction with information and care. Secondary outcomes included illness perceptions and health care use. Twelve hospitals were randomly assigned to SCP care or usual care in a pragmatic, cluster randomized trial. Newly diagnosed patients with endometrial cancer completed questionnaires after diagnosis (n = 221; 75% response), 6 months (n = 158), and 12 months (n = 147). An SCP application was built in the Web-based ROGY (Registration System Oncological Gynecology). By clicking the SCP button, a patient-tailored SCP was generated. In the SCP care arm, 74% of patients received an SCP. They reported receiving more information about their treatment (mean [M] = 57, standard deviation [SD] = 20 v M = 47, SD = 24; P = .03), other services (M = 35, SD = 22 v M = 25, SD = 22; P = .03), and different places of care (M = 27, SD = 25 v M = 23, SD = 26; P = .04) than the usual care arm (scales, 0 to 100). However, there were no differences regarding satisfaction with information or care. Patients in the SCP care arm experienced more symptoms (M = 3.3, SD = 2.0 v M = 2.6, SD = 1.6; P = .03), were more concerned about their illness (M = 4.4, SD = 2.3 v M = 3.9, SD = 2.1; P = .03), were more affected emotionally (M = 4.0, SD = 2.2 v M = 3.7, SD = 2.2; P = .046), and reported more cancer-related contact with their primary care physician (M = 1.8, SD = 2.0 v M = 1.1, SD = 0.9; P = .003) than those in the usual care arm (scale, 1 to 10). These effects did not differ over time. The present trial showed no evidence of a benefit of SCPs on satisfaction with information and care. Furthermore, SCPs increased patients' concerns, emotional impact, experienced symptoms, and the amount of cancer-related contact with the primary care physician. Whether this may ultimately lead to more empowered patients should be investigated further. © 2015 by American Society of Clinical Oncology.

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

PubMed

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

2018-04-01

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

Effect of two contrasting interventions on upper limb chronic pain and disability: a randomized controlled trial.

PubMed

Sundstrup, Emil; Jakobsen, Markus D; Andersen, Christoffer H; Jay, Kenneth; Persson, Roger; Aagaard, Per; Andersen, Lars L

2014-01-01

Chronic pain and disability of the arm, shoulder, and hand severely affect labor market participation. Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain. An alternative strategy could be to increase physical capacity of the worker by physical conditioning. To investigate the effect of 2 contrasting interventions, conventional ergonomic training (usual care) versus resistance training, on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work. Examiner-blinded, parallel-group randomized controlled trial with allocation concealment. Slaughterhouses located in Denmark, Europe. Sixty-six adults with chronic pain in the shoulder, elbow/forearm, or hand/wrist and work disability were randomly allocated to 10 weeks of specific resistance training for the shoulder, arm, and hand muscles for 3 x 10 minutes per week, or ergonomic training and education (usual care control group). Pain intensity (average of shoulder, arm, and hand, scale 0 - 10) was the primary outcome, and disability (Work module of DASH questionnaire) as well as isometric shoulder and wrist muscle strength were secondary outcomes. Pain intensity, disability, and muscle strength improved more following resistance training than usual care (P < 0.001, P = 0.05, P <0.0001, respectively [corrected]). Pain intensity decreased by 1.5 points (95% confidence interval -2.0 to -0.9) following resistance training compared with usual care, corresponding to an effect size of 0.91 (Cohen's d). Blinding of participants is not possible in behavioral interventions. However, at baseline outcome expectations of the 2 interventions were similar. Resistance training at the workplace results in clinical relevant improvements in pain, disability, and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work. NCT01671267.

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

Postoperative Care Navigation for Total Knee Arthroplasty Patients: A Randomized Controlled Trial.

PubMed

Losina, Elena; Collins, Jamie E; Wright, John; Daigle, Meghan E; Donnell-Fink, Laurel A; Strnad, Doris; Usiskin, Ilana M; Yang, Heidi Y; Lerner, Vladislav; Katz, Jeffrey N

2016-09-01

To establish the efficacy of motivational interviewing-based postoperative care navigation in improving functional status after total knee arthroplasty (TKA) and to identify subgroups likely to benefit from the intervention. We conducted a parallel randomized controlled trial in TKA recipients with 2 arms: postoperative care with frequent followup by a care navigator or usual care. The primary outcome was the difference between the arms in Western Ontario and McMaster Universities Osteoarthritis Index function score change, over 6 months postsurgery. We performed a preplanned subgroup analysis of differential efficacy by obesity and exploratory subgroup analyses on sex and pain catastrophizing. We enrolled 308 subjects undergoing TKA for osteoarthritis. Mean ± SD preoperative function score was 41 ± 17 (0-100 scale, where 100 = worst function). At 6 months, subjects in the navigation arm improved by mean ± SD 30 ± 16 points compared to 27 ± 18 points in the usual-care arm (P = 0.148). Participants with moderate to high levels of pain catastrophizing were unlikely to benefit from navigation compared to those with lower levels of pain catastrophizing (P = 0.013 for interaction). Subjects assigned to the navigation intervention did not demonstrate greater functional improvement compared to those in the control group. The negative overall result could be explained by the large effect on functional improvement of TKA itself compared to the smaller, additional benefit from care navigation, as well as by potential differential effects for subjects with moderate to high degrees of pain catastrophizing. Greater focus on developing programs for reducing pain catastrophizing could lead to better functional outcomes following TKA. © 2016, American College of Rheumatology.

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.

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

Structured Pharmacist Review of Medication in Older Hospitalised Patients: A Cost-Effectiveness Analysis.

PubMed

Gallagher, James; O'Sullivan, David; McCarthy, Suzanne; Gillespie, Paddy; Woods, Noel; O'Mahony, Denis; Byrne, Stephen

2016-04-01

A recent cluster randomised controlled trial (RCT) conducted in an Irish hospital evaluating a structured pharmacist review of medication (SPRM), supported by computerised clinical decision support software (CDSS), demonstrated positive outcomes in terms of reduction of adverse drug reactions (ADR). The aim of this study was to examine the cost effectiveness of pharmacists applying an SPRM in conjunction with CDSS to older hospitalised patients compared with usual pharmaceutical care. Cost-effectiveness analysis alongside a cluster RCT. The trial was conducted in a tertiary hospital in the south of Ireland. Patients in the intervention arm (n = 361) received a multifactorial intervention consisting of medicines reconciliation, deployment of CDSS and generation of a pharmaceutical care plan. Patients in the control arm (n = 376) received usual care from the hospital pharmacy team. Incremental cost effectiveness was examined in terms of costs to the healthcare system and an outcome measure of ADRs during an inpatient hospital stay. Uncertainty in the analysis was explored using a cost-effectiveness acceptability curve (CEAC). On average, the intervention arm was the dominant strategy in terms of cost effectiveness. Compared with usual care (control), the intervention was associated with a decrease of €807 [95% confidence interval (CI) -3443 to 1829; p = 0.548) in mean healthcare cost, and a decrease in the mean number of ADR events per patient of -0.064 (95% CI -0.135 to 0.008; p = 0.081). The probability of the intervention being cost effective at respective threshold values of €0, €250, €500, €750, €1000 and €5000 was 0.707, 0.713, 0.716, 0.718, 0.722 and 0.784, respectively. Based on the evidence presented, SPRM/CDSS is likely to be determined to be cost effective compared with usual pharmaceutical care. However, neither incremental costs nor effects demonstrated a statistically significant difference, therefore the results of this single-site study should be interpreted with caution.

COST-EFFECTIVENESS OF STRUCTURED EDUCATION IN CHILDREN WITH TYPE-1 DIABETES MELLITUS.

PubMed

Basarir, Hasan; Brennan, Alan; Jacques, Richard; Pollard, Daniel; Stevens, Katherine; Freeman, Jennifer; Wales, Jerry; Price, Katherine

2016-01-01

Kids in Control OF Food (KICk-OFF) is a 5-day structured education program for 11- to 16-year-olds with type 1 diabetes mellitus (T1DM) who are using multiple daily insulin injections. This study evaluates the cost-effectiveness of the KICk-OFF education program compared with the usual care using data from the KICk-OFF trial. The short-term within-trial analysis covers the 2-year postintervention period. Data on glycated hemoglobin (HbA1c), severe hypoglycemia, and diabetic ketoacidosis (DKA) were collected over a 2-year follow-up period. Sub-group analyses have been defined on the basis of baseline HbA1c being below 7.5 percent (58.5 mmol/mol) (low group), between 7.5 percent and 9.5 percent (80.3 mmol/mol) (medium group), and over 9.5 percent (high group). The long-term cost-effectiveness evaluation has been conducted by using The Sheffield Type 1 Diabetes Policy Model, which is a patient-level simulation model on T1DM. It includes long-term microvascular (retinopathy, neuropathy, and nephropathy) and macrovascular (myocardial infarction, stroke, revascularization, and angina) diabetes-related complications and acute adverse events (severe hypoglycemia and DKA). The most favorable within-trial scenario for the KICk-OFF arm led to an incremental cost-effectiveness ratio (ICER) of £23,688 (base year 2009) with a cost-effectiveness probability of 41.3 percent. Simulating the long-term complications using the full cohort data, the mean ICER for the base case was £28,813 (base year 2011) and the probability of the KICk-OFF intervention being cost-effective at £20,000/QALY threshold was 42.6 percent, with considerable variation due to treatment effect duration. For the high HbA1c sub-group, the KICk-OFF arm was "dominant" (meaning it provided better health gains at lower costs than usual care) over the usual care arm in each scenario considered. For the whole study population, the cost-effectiveness of KICk-OFF depends on the assumption for treatment effect duration. For the high baseline HbA1c sub-group, KICk-OFF arm was estimated to be dominant over the usual care arm regardless of the assumption on the treatment effect duration.

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].

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

PubMed

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

2016-04-15

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

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.

Effects of a Problem-Solving Intervention (COPE) on Quality of Life for Patients with Advanced Cancer on Clinical Trials and their Caregivers: Simultaneous Care Educational Intervention (SCEI): Linking Palliation and Clinical Trials

PubMed Central

Carducci, Michael; Loscalzo, Matthew J.; Linder, John; Greasby, Tamara; Beckett, Laurel A.

2011-01-01

Abstract Context Patients on investigational clinical trials and their caregivers experience poor quality of life (QOL), which declines as the disease progresses. Objective To examine the effect of a standardized cognitive–behavioral problem-solving educational intervention on the QOL of patients enrolled on investigational clinical trials and their caregivers. Design Prospective, multi-institution, randomized trial. QOL was measured repeatedly over 6 months. Participants Patients were simultaneously enrolled onto phase 1, 2, or 3 Institutional Review Board (IRB)-approved cancer clinical trials. Intervention Intervention arm dyads participated in three conjoint educational sessions during the first month, learning the COPE problem solving model. Nonintervention arm dyads received usual care. Outcome Measures Global QOL was measured by the City of Hope Quality of Life Instruments for Patients or Caregivers; problem solving skills were measured by the Social Problem Solving Inventory-Revised. Results The results are reported using the CONSORT statement. The analytic data set included 476 dyads including 1596 patient data points and 1576 care giver data points. Patient QOL showed no significant difference in the rate of change between the intervention and usual care arms (p = 0.70). Caregiver QOL scores in the intervention arm declined, but at less than half the rate in the control arm (p = 0.02). Conclusions The COPE intervention enabled the average caregiver to come much closer to stable QOL over the 6-month follow-up. Future studies should enroll subjects much earlier in the cancer illness trajectory, a common patient/caregiver theme. The maximum effect was seen in caregivers who completed the 6-month follow-up, suggesting that the impact may increase over time. PMID:21413846

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

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.

Mindfulness-Based Cognitive Therapy in Advanced Prostate Cancer: A Randomized Controlled Trial.

PubMed

Chambers, Suzanne K; Occhipinti, Stefano; Foley, Elizabeth; Clutton, Samantha; Legg, Melissa; Berry, Martin; Stockler, Martin R; Frydenberg, Mark; Gardiner, Robert A; Lepore, Stephen J; Davis, Ian D; Smith, David P

2017-01-20

Purpose Advanced prostate cancer (PC) is associated with substantial psychosocial morbidity. We sought to determine whether mindfulness-based cognitive therapy (MBCT) reduces distress in men with advanced PC. Methods Men with advanced PC (proven metastatic and/or castration-resistant biochemical progression) were randomly assigned to an 8-week, group-based MBCT intervention delivered by telephone (n = 94) or to minimally enhanced usual care (n = 95). Primary intervention outcomes were psychological distress, cancer-specific distress, and prostate-specific antigen anxiety. Mindfulness skills were assessed as potential mediators of effect. Participants were assessed at baseline and were followed up at 3, 6, and 9 months. Main statistical analyses were conducted on the basis of intention to treat. Results Fourteen MBCT groups were conducted in the intervention arm. Facilitator adherence ratings were high (> 93%). Using random-effects mixed-regression models, intention-to-treat analyses indicated no significant changes in intervention outcomes or in engagement with mindfulness for men in MBCT compared with those receiving minimally enhanced usual care. Per-protocol analyses also found no differences between arms in outcomes or engagement, with the exception of the mindfulness skill of observing, which increased over time for men in MBCT compared with usual care ( P = .032). Conclusion MBCT in this format was not more effective than minimally enhanced usual care in reducing distress in men with advanced PC. Future intervention research for these men should consider approaches that map more closely to masculinity.

Development of the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Protocol: A National Cluster-Randomized Trial of Resident Duty Hour Policies.

PubMed

Bilimoria, Karl Y; Chung, Jeanette W; Hedges, Larry V; Dahlke, Allison R; Love, Remi; Cohen, Mark E; Tarpley, John; Mellinger, John; Mahvi, David M; Kelz, Rachel R; Ko, Clifford Y; Hoyt, David B; Lewis, Frank H

2016-03-01

Debate continues regarding whether to further restrict resident duty hour policies, but little high-level evidence is available to guide policy changes. To inform decision making regarding duty hour policies, the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial is being conducted to evaluate whether changing resident duty hour policies to permit greater flexibility in work hours affects patient postoperative outcomes, resident education, and resident well-being. Pragmatic noninferiority cluster-randomized trial of general surgery residency programs with 2 study arms. Participating in the study are Accreditation Council for Graduate Medical Education (ACGME)-approved US general surgery residency programs (n = 118), their affiliated hospitals (n = 154), surgical residents and program directors, and general surgery patients from July 1, 2014, to June 30, 2015, with additional patient safety outcomes collected through June 30, 2016. The data collection platform for patient outcomes is the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP), thus only hospitals participating in the ACS NSQIP were included. In the usual care arm, programs adhered to current ACGME resident duty hour standards. In the intervention arm, programs were allowed to deviate from current standards regarding maximum shift lengths and minimum time off between shifts through an ACGME waiver. Death or serious morbidity within 30 days of surgery measured through ACS NSQIP, as well as resident satisfaction and well-being measured through a survey delivered at the time of the 2015 American Board of Surgery in Training Examination (ABSITE). A total of 118 general surgery residency programs and 154 hospitals were enrolled in the FIRST Trial and randomized. Fifty-nine programs (73 hospitals) were randomized to the usual care arm and 59 programs (81 hospitals) were randomized to the intervention arm. Intent-to-treat analysis will be used to estimate the effectiveness of assignment to the intervention arm on patient outcomes, resident education, and resident well-being compared with the usual care arm. Several sensitivity analyses will be performed to determine whether there were differential effects when examining only inpatients, high-risk patients, and emergent/urgent cases. To our knowledge, the FIRST Trial is the first national randomized clinical trial of duty hour policies. Results of this study may be informative to policymakers and other stakeholders engaged in restructuring graduate medical training to enhance the quality of patient care and resident education. clinicaltrials.org Identifier: NCT02050789.

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.

Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial

PubMed Central

Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise

2017-01-01

Background Many developed countries have high mortality rates for fire-related deaths in children aged 0–14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children’s services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. Methods We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children’s centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children’s centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children’s centre. Results 1112 parents at 36 children’s centres participated. There was no significant effect of the intervention on families’ possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20). However, significantly more families in the intervention arms reported more behaviours for escaping from house fires (AOR IPB only vs. usual care: 2.56, 95%CI 01.38, 4.76; AOR IPB+ vs. usual care 1.78, 95%CI 1.01, 3.15). Conclusion Our study demonstrated that children’s centres can deliver an injury prevention intervention to families in disadvantaged communities and achieve changes in home safety behaviours. PMID:28339460

Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial.

PubMed

Deave, Toity; Hawkins, Adrian; Kumar, Arun; Hayes, Mike; Cooper, Nicola; Watson, Michael; Ablewhite, Joanne; Coupland, Carol; Sutton, Alex; Majsak-Newman, Gosia; McDaid, Lisa; Goodenough, Trudy; Beckett, Kate; McColl, Elaine; Reading, Richard; Kendrick, Denise

2017-01-01

Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB), which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation. We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+), IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre. 1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR) IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20). However, significantly more families in the intervention arms reported more behaviours for escaping from house fires (AOR IPB only vs. usual care: 2.56, 95%CI 01.38, 4.76; AOR IPB+ vs. usual care 1.78, 95%CI 1.01, 3.15). Our study demonstrated that children's centres can deliver an injury prevention intervention to families in disadvantaged communities and achieve changes in home safety behaviours.

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

PubMed

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

2015-03-01

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

Results of a randomized controlled trial to increase cervical cancer screening among rural Latinas.

PubMed

Thompson, Beti; Carosso, Elizabeth A; Jhingan, Esther; Wang, Lei; Holte, Sarah E; Byrd, Theresa L; Benavides, Maria C; Lopez, Cathy; Martinez-Gutierrez, Javiera; Ibarra, Genoveva; Gonzalez, Virginia J; Gonzalez, Nora E; Duggan, Catherine R

2017-02-15

Latinas have the highest rates of cervical cancer in the United States and the second highest rate of cervical cancer mortality. One factor in the disparity is the relatively low rate of screening for cervical cancer in this population. Eligible women who were out of adherence with cervical cancer screening (>3 years since their last Papanicolaou [Pap] test) were identified via medical record review by a federally qualified local health center. The effects of a low-intensity intervention (video delivered to participants' homes; n = 150) and a high-intensity intervention (video plus a home-based educational session; n = 146) on cervical cancer screening uptake in comparison with a control arm (usual care; n = 147) were investigated. A cost-effectiveness analysis of the interventions was conducted: all intervention costs were calculated, and the incremental cost-effectiveness ratio was computed. Finally, women with positive Pap tests were provided navigation by a community health educator to ensure that they received follow-up care. A total of 443 Latinas participated. Seven months after randomization, significantly more women in the high-intensity arm received a Pap test (53.4%) in comparison with the low-intensity arm (38.7%; P < .001) and the usual-care arm (34.0%; P < .01). The incremental cost-effectiveness ratio for high-intensity women versus the control group amounted to $4.24. Twelve women had positive Pap tests, which encompassed diagnoses ranging from atypical squamous cells of unknown significance to invasive cancer; these women received navigation for follow-up care. A culturally appropriate, in-home, promotora-led educational intervention was successful in increasing cervical cancer screening among Latinas. Cancer 2017;123:666-674. © 2016 American Cancer Society. © 2016 American Cancer Society.

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

Improving colon cancer screening in community clinics.

PubMed

Davis, Terry; Arnold, Connie; Rademaker, Alfred; Bennett, Charles; Bailey, Stacy; Platt, Daci; Reynolds, Cristalyn; Liu, Dachao; Carias, Edson; Bass, Pat; Wolf, Michael

2013-11-01

The authors evaluated the effectiveness and cost effectiveness of 2 interventions designed to promote colorectal cancer (CRC) screening in safety-net settings. A 3-arm, quasi-experimental evaluation was conducted among 8 clinics in Louisiana. Screening efforts included: 1) enhanced usual care, 2) literacy-informed education of patients, and 3) education plus nurse support. Overall, 961 average-risk patients ages 50 to 85 years were eligible for routine CRC screening and were recruited. Outcomes included CRC screening completion and incremental cost effectiveness using literacy-informed education of patients and education plus nurse support versus enhanced usual care. The baseline screening rate was <3%. After the interventions, the screening rate was 38.6% with enhanced usual care, 57.1% with education, and 60.6% with education that included additional nurse support. After adjusting for age, race, sex, and literacy, patients who received education alone were not more likely to complete screening than those who received enhanced usual care; and those who received additional nurse support were 1.60-fold more likely to complete screening than those who received enhanced usual care (95% confidence interval, 1.06-2.42; P = .024). The incremental cost per additional individual screened was $1337 for education plus nurse support over enhanced usual care. Fecal occult blood test rates were increased beyond enhanced usual care by providing brief education and nurse support but not by providing education alone. More cost-effective alternatives to nurse support need to be investigated. © 2013 American Cancer Society.

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

[Multicentric prospective randomized and controlled study assessing effectiveness of intravaginal electrostimulation at home compared to usual care in female patients with urinary incontinence and prior perineal reeducation].

PubMed

Lopès, P; Rimbault, F; Scheffler, M; André, C; Cappelletti, M-C; Marès, P

2014-11-01

In order to maintain the benefits of perineal reeducation, patients with stress urinary incontinence need to perform self-retraining exercises of the perineal muscles at home. The aim of this randomized prospective multicentric study is to assess the effectiveness of GYNEFFIK(®), a perineal electrostimulator, during this home-care phase. Two parallel groups of women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI), improved by physiotherapy, have followed a self-reeducation program, either with electrostimulation sessions (GYNEFFIK(®) or home perineal electrostimulation [HPES] arm) or with usual care (UC) only, without electrostimulation. The comparison of the two groups was based on the rate of women in which the benefit of the initial perineal reeducation was maintained (defined as the ICIQ and Ditrovie scales' score not worsening) at 2, 4 and 6 months. A total of 161 patients were analyzed (76 in the HPES arm and 85 in the UC arm). The therapeutic benefit of the initial perineal reeducation at the last available measure (6 months for a wide majority of patients) was maintained in 81.6% in the HPES arm versus 62.4% in the UC arm (P=0.007). This significant difference reflects a significant improvement both in clinical symptomatology and in quality of life. ICIQ score was improved in 44% of patients of HPES arm while it was improved in 14% of patients of UC arm (P<0.001) and daily number of urine leakage decreased of 1.2 leakage in the HPES arm versus 0.1 leakage in UC arm (P<0.05). Likewise, improvement of quality of life was superior in the HPES arm (48% improvement of Ditrovie score versus 19% in the UC group ; P<0.05). Investigator global impression was more favorable in the HPES arm (clinical improvement in 83% of patients versus 68% in the UC arm). At the last measure (i.e. endpoint), the benefit of initial physiotherapy was considered maintained or improved in all patients of the HPES arm while it was reported as worsened in 16.5% of the UC group. Using GYNEFFIK(®) favorably impacts quality of life, particularly physical activity and vitality and decreases emotional consequences of UI (i.e. anxiety and depression score as assessed by HAD scale). Copyright © 2014 Elsevier Masson SAS. All rights reserved.

A self-management program for employees with complaints of the arm, neck, or shoulder (CANS): study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Complaints of the arm, neck, or shoulder (CANS) have a multifactorial origin and cause considerable work problems, including decreased work productivity, sickness absence, and, ultimately, job loss. There is a need for intervention programs for people with CANS. Self-management is an approach used in chronic disease care to improve self-efficacy and wellness behaviors to facilitate participants to make informed choices and carry them out. This study will evaluate the effectiveness of a self-management program (including ehealth) and compare it to usual care among employees with chronic CANS (lasting >3 months). Methods/design This is a randomized controlled trial in which 142 participants will be recruited and randomized (with pre-stratification) to either the intervention group (IG) or control group (CG). The IG will participate in a self-management program consisting of six group sessions and an ehealth module. The CG is allowed to use all usual care available. The primary outcome of the study is the self-reported disability of arm, shoulder, and hand, measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Secondary outcomes include: absenteeism, pain in the previous week, quality of life, catastrophizing pain, self-efficacy, workstyle, presenteeism, fatigue, the use of usual care, and limitations experienced on the job. Data are collected at baseline and at 3, 6, and 12 months follow-up. Discussion Following the process of intervention mapping we developed a self-management program to suit and alleviate the problems and needs of employees with CANS. A strength of the study is that our intervention is specifically tailored to match the needs of employees with CANS. The study also has some potential weaknesses (for example, use of co-interventions, combination of group sessions and ehealth, self-reporting of data and possible contamination, Hawthorne effect, and recall or information bias) which are discussed. Trial registration The trial is registered with the Dutch Trial Register (http://www.trialregister.nlNTR3816): (January 2013). The first participant was randomized in September 2012. PMID:23958154

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

PubMed

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

2017-10-17

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

The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial.

PubMed

Levy, Natalie; Moynihan, Victoria; Nilo, Annielyn; Singer, Karyn; Bernik, Lidia S; Etiebet, Mary-Ann; Fang, Yixin; Cho, James; Natarajan, Sundar

2015-07-17

Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm. MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease. Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3).

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

PubMed

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

2016-02-01

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

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

Applying a Family-Level Economic Strengthening Intervention to Improve Education and Health-Related Outcomes of School-Going AIDS-Orphaned Children: Lessons from a Randomized Experiment in Southern Uganda.

PubMed

Ssewamala, Fred M; Karimli, Leyla; Torsten, Neilands; Wang, Julia Shu-Huah; Han, Chang-Keun; Ilic, Vilma; Nabunya, Proscovia

2016-01-01

Children comprise the largest proportion of the population in sub-Saharan Africa. Of these, millions are orphaned. Orphanhood increases the likelihood of growing up in poverty, dropping out of school, and becoming infected with HIV. Therefore, programs aimed at securing a healthy developmental trajectory for these orphaned children are desperately needed. We conducted a two-arm cluster-randomized controlled trial to evaluate the effectiveness of a family-level economic strengthening intervention with regard to school attendance, school grades, and self-esteem in AIDS-orphaned adolescents aged 12-16 years from 10 public rural primary schools in southern Uganda. Children were randomly assigned to receive usual care (counseling, school uniforms, school lunch, notebooks, and textbooks), "bolstered" with mentorship from a near-peer (control condition, n = 167), or to receive bolstered usual care plus a family-level economic strengthening intervention in the form of a matched Child Savings Account (Suubi-Maka treatment arm, n = 179). The two groups did not differ at baseline, but 24 months later, children in the Suubi-Maka treatment arm reported significantly better educational outcomes, lower levels of hopelessness, and higher levels of self-concept compared to participants in the control condition. Our study contributes to the ongoing debate on how to address the developmental impacts of the increasing numbers of orphaned and vulnerable children and adolescents in sub-Saharan Africa, especially those affected by HIV/AIDS. Our findings indicate that innovative family-level economic strengthening programs, over and above bolstered usual care that includes psychosocial interventions for young people, may have positive developmental impacts related to education, health, and psychosocial functioning.

Applying a Family-Level Economic Strengthening Intervention to Improve Education and Health-Related Outcomes of School-going AIDS-Orphaned Children: Lessons from a Randomized Experiment in Southern Uganda

PubMed Central

Ssewamala, Fred M.; Leyla, Karimli; Neilands, Torsten; Julia Shu-Huah, Wang; Chang-Keun, Han; Vilma, Ilic; Proscovia, Nabunya

2015-01-01

Children comprise the largest proportion of the population in sub-Saharan Africa. Of these, millions are orphaned. Orphanhood increases the likelihood of growing up in poverty, dropping out of school, and becoming infected with HIV. Therefore, programs aimed at securing a healthy developmental trajectory for these orphaned children are desperately needed. We conducted a two-arm cluster-randomized controlled trial to evaluate the effectiveness of a family-level economic strengthening intervention with regard to school-attendance, school grades, and self-esteem in AIDS-orphaned adolescents aged 12–16 years from 10 public rural primary schools in southern Uganda. Children were randomly assigned to receive usual care (counseling, school uniforms, school lunch, notebooks and textbooks), “bolstered” with mentorship from a near-peer (control condition, n=167), or to receive bolstered usual care plus a family-level economic strengthening intervention in the form of a matched Child Savings Account (Suubi-Maka treatment arm, n = 179). The two groups did not differ at baseline, but 24-months later, children in the Suubi-Maka treatment arm reported significantly better educational outcomes, lower levels of hopelessness, and higher levels of self-concept compared to participants in the control condition. Our study contributes to the ongoing debate on how to address the developmental impacts of the increasing numbers of orphaned, and vulnerable children and adolescents in sub-Saharan Africa, especially those affected by HIV/AIDS. Our findings indicate that innovative family-level economic strengthening programs, over and above bolstered usual care that includes psychosocial interventions for young people, may have positive developmental impacts related to education, health, and psychosocial functioning. PMID:26228480

The management of acne vulgaris in primary care: a cohort study of consulting and prescribing patterns using the Clinical Practice Research Datalink.

PubMed

Francis, N A; Entwistle, K; Santer, M; Layton, A M; Eady, E A; Butler, C C

2017-01-01

Effective management of acne vulgaris in primary care involves support (usually provided over a number of consultations) and prescription of effective treatments. However, consulting and prescribing patterns for acne in primary care are not well described. To describe the rate of primary-care consultations and follow-up consultations; prescribing patterns, including overall use of acne-related medications (ARMs); and initial and follow-up prescription for acne vulgaris in the U.K. U.K. primary-care acne consultations and prescriptions for ARMs were identified in the Clinical Practice Research Datalink. Annual consultation rates (between 2004 and 2013) by age and sex, new consultations and consultations in the subsequent year were calculated, along with prescribing trends - during a new consultation and over the subsequent 90 days and year - using the number of registered patients as the denominator. Two-thirds (66·1%) of patients who had a new acne consultation had no further acne consultations in the subsequent year. Overall 26·7%, 24·9%, and 23·6% and 2·8% of patients were prescribed no ARM, an oral antibiotic, a topical antibiotic or an oral plus topical antibiotic, respectively, during a new acne consultation. In total 60·1% and 38·6% of patients prescribed an ARM received no further ARM prescriptions in the following 90 days and 1 year, respectively, despite most prescriptions being for 2 months or less. Prescribing rates for lymecycline and topical combined clindamycin and benzoyl peroxide increased substantially between 2004 and 2013. There were no important changes in consultation rates between 2004 and 2013. These data suggest that patients with acne are receiving a suboptimal initial choice of ARMs, longitudinal care and prescribing. © 2016 British Association of Dermatologists.

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

PubMed

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

2016-08-17

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

The impact of a lay counselor led collaborative care intervention for common mental disorders in public and private primary care: a qualitative evaluation nested in the MANAS trial in Goa, India.

PubMed

Shinde, Sachin; Andrew, Gracy; Bangash, Omer; Cohen, Alex; Kirkwood, Betty; Patel, Vikram

2013-07-01

The MANAS trial evaluated the effectiveness of a lay counselor led collaborative stepped care intervention for Common Mental Disorders (CMD) in public and private sector primary care settings in Goa, India. This paper describes the qualitative findings of the experience of the intervention and its impact on health and psychosocial outcomes. Twenty four primary care facilities (12 public and private each) were randomized to provide either collaborative stepped care (CSC) or enhanced usual care (EUC) to adults who screen positive for CMDs. Participants were sampled purposively based on two criteria: gender and, in the CSC arm, adherence with the intervention. The qualitative study component involved two semi-structured interviews with participants of both arms (N = 115); the first interview within 2 months of recruitment and the second 6-8 months after recruitment. Data were collected between September 2007 and November 2009. More participants in the CSC than EUC arm reported relief from symptoms and an improvement in social functioning and positive impact on work and activities of daily life. The CSC participants attributed their improvement both to medication received from the doctors and the strategies suggested by the lay Health Counselors (HC). However, two key differences were observed in the results for the two types of facilities. First, the CSC participants in the public sector clinics were more likely to consider the HCs to be an important component of providing care who served as a link between patient and the doctor, provided them skills on stress management and helped in adherence to medication. Second, in the private sector, doctors performed roles similar to those of the HCs and participants in both arms placed much faith in the doctor who acted as a confidante and was perceived to understand the participant's health and context intimately. Lay counselors working in a CSC model have a positive effect on symptomatic relief, social functioning and satisfaction with care in patients with CMD attending primary care clinics although the impact, compared with usual care, is greater in the public sector. Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

'Pharyngocise': Randomized Controlled Trial of Preventative Exercises to Maintain Muscle Structure and Swallowing Function During Head-and-Neck Chemoradiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Carnaby-Mann, Giselle, E-mail: gmann@phhp.ufl.edu; Crary, Michael A.; Schmalfuss, Ilona

2012-05-01

Purpose: Dysphagia after chemoradiotherapy is common. The present randomized clinical trial studied the effectiveness of preventative behavioral intervention for dysphagia compared with the 'usual care.' Methods and Materials: A total of 58 head-and-neck cancer patients treated with chemoradiotherapy were randomly assigned to usual care, sham swallowing intervention, or active swallowing exercises (pharyngocise). The intervention arms were treated daily during chemoradiotherapy. The primary outcome measure was muscle size and composition (determined by T{sub 2}-weighted magnetic resonance imaging). The secondary outcomes included functional swallowing ability, dietary intake, chemosensory function, salivation, nutritional status, and the occurrence of dysphagia-related complications. Results: The swallowing musculaturemore » (genioglossus, hyoglossuss, and mylohyoid) demonstrated less structural deterioration in the active treatment arm. The functional swallowing, mouth opening, chemosensory acuity, and salivation rate deteriorated less in the pharyngocise group. Conclusion: Patients completing a program of swallowing exercises during cancer treatment demonstrated superior muscle maintenance and functional swallowing ability.« less

Racial differences in the effect of a telephone-delivered hypertension disease management program.

PubMed

Jackson, George L; Oddone, Eugene Z; Olsen, Maren K; Powers, Benjamin J; Grubber, Janet M; McCant, Felicia; Bosworth, Hayden B

2012-12-01

African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events. The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program. Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial. Study arms included: 1) nurse-administered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values. Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure). Improvement in mean systolic blood pressure post-baseline was greater for African American patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI: -12.5, -0.7; p=0.03) and at 18 months (9.7 mmHg; -16.0, -3.4; p=0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI: -8.5, -1.0; p=0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients. The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.

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.

A randomised controlled trial of a couples-based sexuality intervention for men with localised prostate cancer and their female partners.

PubMed

Chambers, Suzanne K; Occhipinti, Stefano; Schover, Leslie; Nielsen, Lisa; Zajdlewicz, Leah; Clutton, Samantha; Halford, Kim; Gardiner, Robert A; Dunn, Jeff

2015-07-01

The diagnosis and treatment of prostate cancer is followed by substantive sexual morbidity. The optimal approach for intervening remains unclear. A three-arm randomised control trial was undertaken with 189 heterosexual couples where the man had been diagnosed with prostate cancer and treated surgically. The efficacy of peer-delivered telephone support versus nurse-delivered telephone counselling versus usual care in improving both men's and women's sexual adjustment was investigated. Assessments were undertaken at baseline (pre-test) with follow-up at 3, 6 and 12 months. At 12 months, men in the peer (p = 0.016) and nurse intervention (p = 0.008) were more likely to use medical treatments for erectile dysfunction (ED) than men in the usual care arm. Men in the nurse intervention more frequently used oral medication for ED than men in usual care (p = 0.002). No significant effects were found for sexual function, sexuality needs, sexual self-confidence, masculine self-esteem, marital satisfaction or intimacy. Although peer and nurse couples-based interventions can increase use of medical treatments for ED, this may not translate into better sexual or relationship outcomes. More research is needed into the optimal timing of interventions to improve sexual outcomes for men with prostate cancer and to identify the subpopulations that will benefit from them. Copyright © 2014 John Wiley & Sons, Ltd.

Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial.

PubMed

Padwal, Raj; McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

2016-06-24

Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving "optimal BP control" (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring-the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with "enhanced usual care" in community-dwelling seniors with diabetes and hypertension. A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors' residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc).

77 FR 75620 - Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-21

... dental health status of members of the Armed Forces. This form is the means for civilian dentists to... military operation. Reserve component members usually receive their dental care from civilian dentists; therefore it would be civilian dentists who would complete the form. Following a routine dental examination...

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.

Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial.

PubMed

Patel, Sajan; Rajkomar, Alvin; Harrison, James D; Prasad, Priya A; Valencia, Victoria; Ranji, Sumant R; Mourad, Michelle

2018-03-05

Audit and feedback improves clinical care by highlighting the gap between current and ideal practice. We combined best practices of audit and feedback with continuously generated electronic health record data to improve performance on quality metrics in an inpatient setting. We conducted a cluster randomised control trial comparing intensive audit and feedback with usual audit and feedback from February 2016 to June 2016. The study subjects were internal medicine teams on the teaching service at an urban tertiary care hospital. Teams in the intensive feedback arm received access to a daily-updated team-based data dashboard as well as weekly inperson review of performance data ('STAT rounds'). The usual feedback arm received ongoing twice-monthly emails with graphical depictions of team performance on selected quality metrics. The primary outcome was performance on a composite discharge metric (Discharge Mix Index, 'DMI'). A washout period occurred at the end of the trial (from May through June 2016) during which STAT rounds were removed from the intensive feedback arm. A total of 40 medicine teams participated in the trial. During the intervention period, the primary outcome of completion of the DMI was achieved on 79.3% (426/537) of patients in the intervention group compared with 63.2% (326/516) in the control group (P<0.0001). During the washout period, there was no significant difference in performance between the intensive and usual feedback groups. Intensive audit and feedback using timely data and STAT rounds significantly increased performance on a composite discharge metric compared with usual feedback. With the cessation of STAT rounds, performance between the intensive and usual feedback groups did not differ significantly, highlighting the importance of feedback delivery on effecting change. The trial was registered with ClinicalTrials.gov (NCT02593253). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

PubMed

Lee, Seunghoon; Kim, Joo-Hee; Shin, Kyung-Min; Kim, Jung-Eun; Kim, Tae-Hun; Kang, Kyung-Won; Lee, Minhee; Jung, So-Young; Shin, Mi-Suk; Kim, Ae-Ran; Park, Hyo-Ju; Hong, Kwon-Eui; Choi, Sun-Mi

2013-07-18

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. 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. The result of this trial will provide a basis for the effectiveness and safety of electroacupuncture for PDN. Clinical Research information Service. Unique identifier: KCT0000466.

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

Entertainment education for breast cancer surgery decisions: a randomized trial among patients with low health literacy.

PubMed

Jibaja-Weiss, Maria L; Volk, Robert J; Granchi, Thomas S; Neff, Nancy E; Robinson, Emily K; Spann, Stephen J; Aoki, Noriaki; Friedman, Lois C; Beck, J Robert

2011-07-01

To evaluate an entertainment-based patient decision aid for early stage breast cancer surgery in low health literacy patients. Newly diagnosed female patients with early stage breast cancer from two public hospitals were randomized to receive an entertainment-based decision aid for breast cancer treatment along with usual care (intervention arm) or to receive usual care only (control arm). Pre-decision (baseline), pre-surgery, and 1-year follow-up assessments were conducted. Patients assigned to the intervention arm of the study were more likely than the controls to choose mastectomy rather than breast-conserving surgery; however, they appeared better informed and clearer about their surgical options than women assigned to the control group. No differences in satisfaction with the surgical decision or the decision-making process were observed between the patients who viewed the intervention and those assigned to the control group. Entertainment education may be a desirable strategy for informing lower health literate women about breast cancer surgery options. Incorporating patient decision aids, particularly computer-based decision aids, into standard clinical practice remains a challenge; however, patients may be directed to view programs at home or at public locations (e.g., libraries, community centers). Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Control treatments in biologics trials of rheumatoid arthritis were often not deemed acceptable in the context of care.

PubMed

Estellat, Candice; Tubach, Florence; Seror, Raphaèle; Alfaiate, Toni; Hajage, David; De Rycke, Yann; Ravaud, Philippe

2016-01-01

Control treatments in randomized controlled trials (RCTs) should not deliberately disadvantage patients. The objectives of the study were to compare (1) willingness to include vs. (2) willingness to prescribe control treatment among physicians randomized to assess, respectively, either (1) enrollment in a trial or (2) appropriateness of control treatment in a care context for the same fictional patient. Physicians were authors of articles about rheumatoid arthritis (RA), involved in RA patient care, and used to enrolling patients in trials. The outcomes were willingness to give control treatment: trial enrollment or control-treatment appropriateness in care context. We derived three case vignettes of fictional standard eligible patients for each of 30 RCTs assessing biologics in RA. Physicians were randomly allocated to the "trial" or "care" arm. For each of the 90 fictional patients, physicians assigned to the trial arm were asked if they would enroll the patient in the RCT the patient was derived from. For the same 90 fictional patients, physicians assigned to the care arm were asked if the control treatment of the RCT was appropriate in a context of usual care. Of the 1,779 physicians invited to participate, 151 were randomized. Half of the fictional patients {41/90; 45% [95% confidence interval (CI): 37%, 53%]} would be enrolled in the RCT although the control-arm treatment of the RCT was not considered appropriate for them in the context of care. This rate differed by type of comparator [55% for non-head-to-head RCTs vs. 6% for head-to-head RCTs; adjusted odds ratio (aOR), 23.9 (95% CI: 5.5, 92.7)] and duration of trial control treatment [56% for ≤24 weeks and 15% for >24 weeks; aOR, 10.7 (95% CI: 2.8, 63.9)] but not patient RA activity [aOR, 2.5 (95% CI: 1.0, 6.6)]. The limitation of this study was that physicians gave their opinion on fictional patients with only RA. Control treatments in RCTs of biologics in RA are often deemed not acceptable in the context of usual care, especially those for non-head-to-head RCTs. These findings raise ethical concerns and challenge the choice of the comparator in RCTs. Copyright © 2016 Elsevier Inc. All rights reserved.

Advance care planning uptake among patients with severe lung disease: a randomised patient preference trial of a nurse-led, facilitated advance care planning intervention.

PubMed

Sinclair, Craig; Auret, Kirsten Anne; Evans, Sharon Frances; Williamson, Fiona; Dormer, Siobhan; Wilkinson, Anne; Greeve, Kim; Koay, Audrey; Price, Dot; Brims, Fraser

2017-02-24

Advance care planning (ACP) clarifies goals for future care if a patient becomes unable to communicate their own preferences. However, ACP uptake is low, with discussions often occurring late. This study assessed whether a systematic nurse-led ACP intervention increases ACP in patients with advanced respiratory disease. A multicentre open-label randomised controlled trial with preference arm. Metropolitan teaching hospital and a rural healthcare network. 149 participants with respiratory malignancy, chronic obstructive pulmonary disease or interstitial lung disease. Nurse facilitators offered facilitated ACP discussions, prompted further discussions with doctors and loved ones, and assisted participants to appoint a substitute medical decision-maker (SDM) and complete an advance directive (AD). The primary measure was formal (AD or SDM) or informal (discussion with doctor) ACP uptake assessed by self-report (6 months) and medical notes audit. Secondary measures were the factors predicting baseline readiness to undertake ACP, and factors predicting postintervention ACP uptake in the intervention arm. At 6 months, formal ACP uptake was significantly higher (p<0.001) in the intervention arm (54/106, 51%), compared with usual care (6/43, 14%). ACP discussions with doctors were also significantly higher (p<0.005) in the intervention arm (76/106, 72%) compared with usual care (20/43, 47%). Those with a strong preference for the intervention were more likely to complete formal ACP documents than those randomly allocated. Increased symptom burden and preference for the intervention predicted later ACP uptake. Social support was positively associated with ACP discussion with loved ones, but negatively associated with discussion with doctors. Nurse-led facilitated ACP is acceptable to patients with advanced respiratory disease and effective in increasing ACP discussions and completion of formal documents. Awareness of symptom burden, readiness to engage in ACP and relevant psychosocial factors may facilitate effective tailoring of ACP interventions and achieve greater uptake. ACTRN12614000255684. 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/.

Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

DTIC Science & Technology

2010-01-01

to usual care (control). Also, in the pilot study of the 4 individual Noetic therapies, off-site prayer was associated with the lowest absolute...mortality in-hospital and at 6 months [16]. The parallel randomization to 4 different Noetic therapies across 5 study arms limited the assessment of...interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study ,” Lancet, vol. 366, no. 9481, pp. 211–217, 2005. [18

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.

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

PubMed

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

2011-12-01

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

Addressing Parents' Vaccine Concerns: A Randomized Trial of a Social Media Intervention.

PubMed

Daley, Matthew F; Narwaney, Komal J; Shoup, Jo Ann; Wagner, Nicole M; Glanz, Jason M

2018-05-08

Successful strategies are needed to address parental vaccine hesitancy, a significant public health issue. The study objective was to assess whether an Internet-based platform with vaccine information and interactive social media components improved parents' vaccine-related attitudes. A three-arm RCT. The study was conducted in a large Colorado integrated healthcare organization. Parents were enrolled during September 2013 through October 2015 and followed through November 2016; data were analyzed in 2017. Parents, recruited during pregnancy, were given a survey about vaccine-related attitudes at enrollment (i.e., baseline) and when their child was aged 3-5 months and 12-15 months (Timepoints 1 and 2, respectively). Parental vaccine hesitancy was assessed at baseline. Study participants were randomized to the following: a study website with vaccine information and social media components (VSM arm); a website with vaccine information only (VI); or usual care. Change in parental vaccine attitudes over time by baseline degree of vaccine hesitancy. Among 1,093 study participants, 945 (86.5%) completed all three surveys. Comparing baseline with Timepoint 1 among vaccine-hesitant parents, the VSM and VI arms were associated with significant improvements in attitudes regarding vaccination benefits compared to usual care (VSM mean change 0.23 on a 5-point scale, 95% CI=0.05, 0.40, VI mean change 0.22, 95% CI=0.04, 0.40). Comparing baseline with Timepoint 2 among hesitant parents, the VSM and VI arms were also associated with significant reductions in parental concerns about vaccination risks compared to usual care (VSM mean change -0.37, 95% CI= -0.60, -0.14, VI mean change -0.31, 95% CI= -0.55, -0.07). Self-efficacy around vaccine decision making also improved among vaccine-hesitant parents. No intervention effect was observed among parents not vaccine-hesitant at baseline. Among vaccine-hesitant parents, an Internet-based intervention improved parents' attitudes about vaccines. This study was registered at www.clinicaltrials.gov NCT01873040. Copyright © 2018 American Journal of Preventive Medicine. Published by 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.

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.

Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial

PubMed Central

McAlister, Finlay Aleck; Wood, Peter William; Boulanger, Pierre; Fradette, Miriam; Klarenbach, Scott; Edwards, Alun L; Holroyd-Leduc, Jayna M; Alagiakrishnan, Kannayiram; Rabi, Doreen; Majumdar, Sumit Ranjan

2016-01-01

Background Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving “optimal BP control” (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring—the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with “enhanced usual care” in community-dwelling seniors with diabetes and hypertension. Methods A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors’ residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ≥80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. Conclusion The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Trial Registration Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc) PMID:27343147

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.

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

A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: the KASTPain protocol

PubMed Central

2012-01-01

Background Approximately 20% of patients report persistent and disabling pain following total knee arthroplasty (TKA) despite an apparently normally functioning prosthesis. One potential risk factor for unexplained persistent pain is high levels of pain catastrophizing. We designed a three-arm trial to determine if a pain coping skills training program, delivered prior to TKA, effectively reduces function-limiting pain following the procedure in patients with high levels of pain catastrophizing. Methods/design The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Discussion The trial will be conducted at four University-based sites in the US. A sample of 402 patients with high levels of pain catastrophizing will be randomly assigned to either a pain coping skills training arm, an arthritis education control arm or usual care. Pain coping skills will be delivered by physical therapists trained and supervised by clinical psychologist experts. Arthritis education will be delivered by nurses trained in the delivery of arthritis-related content. The primary outcome will be change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain scale score 12 months following surgery. A variety of secondary clinical and economic outcomes also will be evaluated. Trial Registration NCT01620983 PMID:22906061

Paper-Based Survivorship Care Plans May be Less Helpful for Cancer Patients Who Search for Disease-Related Information on the Internet: Results of the Registrationsystem Oncological Gynecology (ROGY) Care Randomized Trial.

PubMed

Nicolaije, Kim Ah; Ezendam, Nicole Pm; Pijnenborg, Johanna Ma; Boll, Dorry; Vos, Maria Caroline; Kruitwagen, Roy Fpm; van de Poll-Franse, Lonneke V

2016-07-08

The Institute of Medicine recommends Survivorship Care Plans (SCPs) for all cancer survivors. However, it is unclear whether certain patient groups may or may not benefit from SCPs. The aim was to assess whether the effects of an automatically generated paper SCP on patients' satisfaction with information provision and care, illness perceptions, and health care utilization were moderated by disease-related Internet use. Twelve hospitals were randomized to either SCP care or usual care in the pragmatic cluster randomized Registrationsystem Oncological GYnecology (ROGY) Care trial. Newly diagnosed endometrial cancer patients completed questionnaires after diagnosis (N=221; response: 74.7%, 221/296), 6 months (n=158), and 12 months (n=147), including patients' satisfaction with information provision and care, illness perceptions, health care utilization (how many times patients visited a medical specialist or primary care physician about their cancer in the past 6 months), and disease-related Internet use (whether patients used the Internet to look for information about cancer). In total, 80 of 221 (36.2%) patients used the Internet to obtain disease-related information. Disease-related Internet use moderated the SCP care effect on the amount of information received about the disease (P=.03) and medical tests (P=.01), helpfulness of the information (P=.01), and how well patients understood their illness (P=.04). All stratified analyses were not statistically significant. However, it appeared that patients who did not seek disease-related information on the Internet in the SCP care arm reported receiving more information about their disease (mean 63.9, SD 20.1 vs mean 58.3, SD 23.7) and medical tests (mean 70.6, SD 23.5 vs mean 64.7, SD 24.9), finding the information more helpful (76.7, SD 22.9 vs mean 67.8, SD 27.2; scale 0-100), and understanding their illness better (mean 6.6, SD 3.0 vs mean 6.1, SD 3.2; scale 1-10) than patients in the usual care arm did. In addition, although all stratified analyses were not significant, patients who did seek disease-related information on the Internet in the SCP care arm appeared to receive less information about their disease (mean 65.7, SD 23.4 vs mean 67.1, SD 20.7) and medical tests (mean 72.4, SD 23.5 vs mean 75.3, SD 21.6), did not find the information more helpful (mean 78.6, SD 21.2 vs mean 76.0, SD 22.0), and reported less understanding of their illness (mean 6.3, SD 2.8 vs mean 7.1, SD 2.7) than patients in the usual care arm did. Paper SCPs appear to improve the amount of information received about the disease and medical tests, the helpfulness of the information, and understanding of the illness for patients who do not search for disease-related information on the Internet. In contrast, paper SCPs do not seem beneficial for patients who do seek disease-related information on the Internet. ClinicalTrials.gov NCT01185626; https://clinicaltrials.gov/ct2/show/NCT01185626 (Archived by WebCite at http://www.webcitation.org/6fpaMXsDn).

Paper-Based Survivorship Care Plans May be Less Helpful for Cancer Patients Who Search for Disease-Related Information on the Internet: Results of the Registrationsystem Oncological Gynecology (ROGY) Care Randomized Trial

PubMed Central

Ezendam, Nicole PM; Pijnenborg, Johanna MA; Boll, Dorry; Vos, Maria Caroline; Kruitwagen, Roy FPM; van de Poll-Franse, Lonneke V

2016-01-01

Background The Institute of Medicine recommends Survivorship Care Plans (SCPs) for all cancer survivors. However, it is unclear whether certain patient groups may or may not benefit from SCPs. Objective The aim was to assess whether the effects of an automatically generated paper SCP on patients’ satisfaction with information provision and care, illness perceptions, and health care utilization were moderated by disease-related Internet use. Methods Twelve hospitals were randomized to either SCP care or usual care in the pragmatic cluster randomized Registrationsystem Oncological GYnecology (ROGY) Care trial. Newly diagnosed endometrial cancer patients completed questionnaires after diagnosis (N=221; response: 74.7%, 221/296), 6 months (n=158), and 12 months (n=147), including patients’ satisfaction with information provision and care, illness perceptions, health care utilization (how many times patients visited a medical specialist or primary care physician about their cancer in the past 6 months), and disease-related Internet use (whether patients used the Internet to look for information about cancer). Results In total, 80 of 221 (36.2%) patients used the Internet to obtain disease-related information. Disease-related Internet use moderated the SCP care effect on the amount of information received about the disease (P=.03) and medical tests (P=.01), helpfulness of the information (P=.01), and how well patients understood their illness (P=.04). All stratified analyses were not statistically significant. However, it appeared that patients who did not seek disease-related information on the Internet in the SCP care arm reported receiving more information about their disease (mean 63.9, SD 20.1 vs mean 58.3, SD 23.7) and medical tests (mean 70.6, SD 23.5 vs mean 64.7, SD 24.9), finding the information more helpful (76.7, SD 22.9 vs mean 67.8, SD 27.2; scale 0-100), and understanding their illness better (mean 6.6, SD 3.0 vs mean 6.1, SD 3.2; scale 1-10) than patients in the usual care arm did. In addition, although all stratified analyses were not significant, patients who did seek disease-related information on the Internet in the SCP care arm appeared to receive less information about their disease (mean 65.7, SD 23.4 vs mean 67.1, SD 20.7) and medical tests (mean 72.4, SD 23.5 vs mean 75.3, SD 21.6), did not find the information more helpful (mean 78.6, SD 21.2 vs mean 76.0, SD 22.0), and reported less understanding of their illness (mean 6.3, SD 2.8 vs mean 7.1, SD 2.7) than patients in the usual care arm did. Conclusions Paper SCPs appear to improve the amount of information received about the disease and medical tests, the helpfulness of the information, and understanding of the illness for patients who do not search for disease-related information on the Internet. In contrast, paper SCPs do not seem beneficial for patients who do seek disease-related information on the Internet. Trial Registration ClinicalTrials.gov NCT01185626; https://clinicaltrials.gov/ct2/show/NCT01185626 (Archived by WebCite at http://www.webcitation.org/6fpaMXsDn) PMID:27392550

Multidimensional Treatment Foster Care for Adolescents in English care: randomised trial and observational cohort evaluation.

PubMed

Green, J M; Biehal, N; Roberts, C; Dixon, J; Kay, C; Parry, E; Rothwell, J; Roby, A; Kapadia, D; Scott, S; Sinclair, I

2014-03-01

Children in care often have poor outcomes. There is a lack of evaluative research into intervention options. To examine the efficacy of Multidimensional Treatment Foster Care for Adolescents (MTFC-A) compared with usual care for young people at risk in foster care in England. A two-arm single (assessor) blinded randomised controlled trial (RCT) embedded within an observational quasi-experimental case-control study involving 219 young people aged 11-16 years (trial registration: ISRCTN 68038570). The primary outcome was the Child Global Assessment Scale (CGAS). Secondary outcomes were ratings of educational attendance, achievement and rate of offending. The MTFC-A group showed a non-significant improvement in CGAS outcome in both the randomised cohort (n = 34, adjusted mean difference 1.3, 95% CI -7.1 to 9.7, P = 0.75) and in the trimmed observational cohort (n = 185, adjusted mean difference 0.95, 95% CI -2.38 to 4.29, P = 0.57). No significant effects were seen in secondary outcomes. There was a possible differential effect of the intervention according to antisocial behaviour. There was no evidence that the use of MTFC-A resulted in better outcomes than usual care. The intervention may be more beneficial for young people with antisocial behaviour but less beneficial than usual treatment for those without.

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.

Efficacy of nurse-led and general practitioner-led comprehensive geriatric assessment in primary care: protocol of a pragmatic three-arm cluster randomised controlled trial (CEpiA study)

PubMed Central

Ferrat, Emilie; Bastuji-Garin, Sylvie; Paillaud, Elena; Caillet, Philippe; Clerc, Pascal; Moscova, Laura; Gouja, Amel; Renard, Vincent; Attali, Claude; Breton, Julien Le; Audureau, Etienne

2018-01-01

Introduction Older patients raise therapeutic challenges, because they constitute a heterogeneous population with multimorbidity. To appraise this complexity, geriatricians have developed a multidimensional comprehensive geriatric assessment (CGA), which may be difficult to apply in primary care settings. Our primary objective was to compare the effect on morbimortality of usual care compared with two complex interventions combining educational seminars about CGA: a dedicated geriatric hotline for general practitioners (GPs) and CGA by trained nurses or GPs. Methods and analysis The Clinical Epidemiology and Ageing study is an open-label, pragmatic, multicentre, three-arm, cluster randomised controlled trial comparing two intervention groups and one control group. Patients must be 70 years or older with a long-term illness or with unscheduled hospitalisation in the past 3 months (750 patients planned). This study involves volunteering GPs practising in French primary care centres, with randomisation at the practice level. The multifaceted interventions for interventional arms comprise an educational interactive multiprofessional seminar for GPs and nurses, a geriatric hotline dedicated to GPs in case of difficulties and the performance of a CGA updated to primary care. The CGA is systematically performed by a nurse in arm 1 but is GP-led on a case-by-case basis in arm 2. The primary endpoint is a composite criterion comprising overall death, unscheduled hospitalisations, emergency admissions and institutionalisation within 12 months after inclusion. Intention-to-treat analysis will be performed using mixed-effects logistic regression models, with adjustment for potential confounders. Ethics and dissemination The protocol was approved by an appropriate ethics committee (CPP Ile-de-France IV, Paris, France, approval April 2015;15 664). This study is conducted according to principles of good clinical practice in the context of current care and will provide useful knowledge on the clinical benefits achievable by CGA in primary care. Trial registration number NCT02664454; Pre-results. PMID:29654038

Patient-oriented education and medication management intervention for people with decompensated cirrhosis: study protocol for a randomized controlled trial.

PubMed

Hayward, Kelly L; Martin, Jennifer H; Cottrell, W Neil; Karmakar, Antara; Horsfall, Leigh U; Patel, Preya J; Smith, David D; Irvine, Katharine M; Powell, Elizabeth E; Valery, Patricia C

2017-07-20

People with decompensated cirrhosis require complex medical care and are often prescribed an intricate and frequently changing medication and lifestyle regimen. However, many patients mismanage their medications or have poor comprehension of their disease and self-management tasks. This can lead to harm, hospitalization, and death. A patient-oriented education and medication management intervention has been developed for implementation at a tertiary hospital hepatology outpatient center in Queensland, Australia. Consenting patients with decompensated cirrhosis will be randomly allocated to education intervention or usual care treatment arms when they attend routine follow-up appointments. In the usual care arm, participants will be reviewed by their hepatologist according to the current model of care in the hepatology clinic. In the intervention arm, participants will be reviewed by a clinical pharmacist to receive the education and medication management intervention at baseline in addition to review by their hepatologist. Intervention participants will also receive three further educational contacts from the clinical pharmacist within the following 6-month period, in addition to routine hepatologist review that is scheduled within this time frame. All participants will be surveyed at baseline and follow-up (approximately 6 months post-enrollment). Validated questionnaire tools will be used to determine participant adherence, medication beliefs, illness perceptions, and quality of life. Patients' knowledge of dietary and lifestyle modifications, their current medications, and other clinical data will be obtained from the survey, patient interview, and medical records. Patient outcome data will be collected at 52 weeks. The intervention described within this protocol is ready to adapt and implement in hepatology ambulatory care centers globally. Investigation of potentially modifiable variables that may impact medication management, in addition to the effect of a clinical pharmacist-driven education and medication management intervention on modifying these variables, will provide valuable information for future management of these patients. Australian and New Zealand Clinical Trial Registry identifier: ACTRN12616000780459 . Registered on 15 June 2016.

A structured tool to improve clinical outcomes of Type 2 diabetes mellitus patients: A randomised controlled trial.

PubMed

Ayadurai, Shamala; Sunderland, V Bruce; Tee, Lisa Bg; Md Said, Siti Norlina; Hattingh, H Laetitia

2018-06-07

A review of pharmacist diabetes intervention studies revealed lack of structured process in providing diabetes care which consequently produced varied results from increased to minimal improvements. This study aimed to determine the effectiveness of a structured clinical guidelines tool, the Simpler™ tool, in the delivery of diabetes care. The primary outcome was significant improvement in HbA1c (glycated haemoglobin). Secondary outcomes were improved lipid profiles and blood pressure (BP). A 6-month, parallel, multi-centre, two arms, randomised controlled trial involving 14 pharmacists at seven primary care clinics was conducted in Johor, Malaysia. Pharmacists without prior specialised diabetes training were trained to use the tool. Patients were randomised within each centre to: 1) Simpler™ care (SC), receiving care from pharmacists who applied the tool (n=55); 2) Usual care (UC), receiving usual care and dispensing services (n=69). SC reduced HbA1c significantly by 1.59% (95%CI: -2.2, -0.9) compared to 0.25% (95%CI: -0.62, 0.11), (P=<0.001) in UC. In addition, SC patients had significantly improved systolic BP: (-6.28 mmHg (95%CI: -10.5, 2.0), p=0.005). The proportion of patients who reached the Malaysian guideline treatment goals were significantly more in the SC arm (14.3% vs 1.5% for HbA1c, p=0.020; 80% vs 42% for systolic BP, p=0.001; 60.5% vs 40.4% for LDL cholesterol, p=0.046). Use of the Simpler™ tool facilitated delivery of comprehensive evidence-based diabetes management and significantly improved clinical outcomes. The Simpler™ tool supported pharmacists in providing enhanced structured diabetes care. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

Feedback GAP: pragmatic, cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care

PubMed Central

2013-01-01

Background Audit and feedback to physicians is a commonly used quality improvement strategy, but its optimal design is unknown. This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning, appended to feedback reports on chronic disease management, compared to feedback reports provided without these worksheets. Methods A two-arm pragmatic cluster randomized trial was conducted, with allocation at the level of primary care clinics. Participants were family physicians who contributed data from their electronic medical records. The ‘usual feedback’ arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease. The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Blood pressure (BP) and low-density lipoprotein cholesterol (LDL) values were compared after two years as the primary outcomes. Process outcomes measured the proportion of guideline-recommended actions (e.g., testing and prescribing) conducted within the appropriate timeframe. Intention-to-treat analysis was performed. Results Outcomes were similar across groups at baseline. Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm (15% loss to follow up) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm (10% loss to follow up). Ten of 20 physicians completed the worksheet at least once during the study. Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm, while LDL was 2.1 and 2.0, respectively. Thus, no significant differences were observed across groups in the primary outcomes, but mean haemoglobin A1c was lower in the feedback plus worksheet arm (7.2% versus 7.4%, p<0.001). Improvements in both arms were noted over time for one-half of the process outcomes. Discussion Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes. The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention. Trial registration ClinicalTrials.gov NCT00996645 PMID:24341511

Feedback GAP: pragmatic, cluster-randomized trial of goal setting and action plans to increase the effectiveness of audit and feedback interventions in primary care.

PubMed

Ivers, Noah M; Tu, Karen; Young, Jacqueline; Francis, Jill J; Barnsley, Jan; Shah, Baiju R; Upshur, Ross E; Moineddin, Rahim; Grimshaw, Jeremy M; Zwarenstein, Merrick

2013-12-17

Audit and feedback to physicians is a commonly used quality improvement strategy, but its optimal design is unknown. This trial tested the effects of a theory-informed worksheet to facilitate goal setting and action planning, appended to feedback reports on chronic disease management, compared to feedback reports provided without these worksheets. A two-arm pragmatic cluster randomized trial was conducted, with allocation at the level of primary care clinics. Participants were family physicians who contributed data from their electronic medical records. The 'usual feedback' arm received feedback every six months for two years regarding the proportion of their patients meeting quality targets for diabetes and/or ischemic heart disease. The intervention arm received these same reports plus a worksheet designed to facilitate goal setting and action plan development in response to the feedback reports. Blood pressure (BP) and low-density lipoprotein cholesterol (LDL) values were compared after two years as the primary outcomes. Process outcomes measured the proportion of guideline-recommended actions (e.g., testing and prescribing) conducted within the appropriate timeframe. Intention-to-treat analysis was performed. Outcomes were similar across groups at baseline. Final analysis included 20 physicians from seven clinics and 1,832 patients in the intervention arm (15% loss to follow up) and 29 physicians from seven clinics and 2,223 patients in the usual feedback arm (10% loss to follow up). Ten of 20 physicians completed the worksheet at least once during the study. Mean BP was 128/72 in the feedback plus worksheet arm and 128/73 in the feedback alone arm, while LDL was 2.1 and 2.0, respectively. Thus, no significant differences were observed across groups in the primary outcomes, but mean haemoglobin A1c was lower in the feedback plus worksheet arm (7.2% versus 7.4%, p<0.001). Improvements in both arms were noted over time for one-half of the process outcomes. Appending a theory-informed goal setting and action planning worksheet to an externally produced audit and feedback intervention did not lead to improvements in patient outcomes. The results may be explained in part by passive dissemination of the worksheet leading to inadequate engagement with the intervention. ClinicalTrials.gov NCT00996645.

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

Evaluating the Efficacy of Lay Health Advisors for Increasing Risk-appropriate Pap Test Screening: A randomized controlled trial among Ohio Appalachian women

PubMed Central

Paskett, Electra D.; McLaughlin, John M.; Lehman, Amy M.; Katz, Mira L.; Tatum, Cathy M.; Oliveri, Jill M.

2011-01-01

Background Cervical cancer is a significant health disparity among women in Ohio Appalachia. The goal of this study was to evaluate the efficacy of a lay health advisor (LHA) intervention for improving Pap testing rates, to reduce cervical cancer, among women in need of screening. Methods Women from 14 Ohio Appalachian clinics in need of a Pap test were randomized to receive either usual care or an LHA intervention over a ten-month period. The intervention consisted of two in-person visits with an LHA, two phone calls, and four post cards. Both self-report and medical record review (MRR) data (primary outcome) were analyzed. Results Of the 286 women, 145 and 141 were randomized to intervention and usual care arms, respectively. According to MRR, more women in the LHA arm had a Pap test by the end of the study compared to those randomized to usual care (51.1% vs. 42.0%; OR=1.44, 95%CI: 0.89, 2.33; p=0.135). Results of self-report were more pronounced (71.3% vs. 54.2%; OR=2.10, 95%CI: 1.22, 3.61; p=0.008). Conclusions An LHA intervention showed some improvement in the receipt of Pap tests among Ohio Appalachian women in need of screening. While biases inherent in using self-reports of screening are well known, this study also identified biases in using MRR data in clinics located in underserved areas. Impact LHA interventions show promise for improving screening behaviors among non-adherent women from underserved populations. PMID:21430302

Case management reduces global vascular risk after stroke: secondary results from the The preventing recurrent vascular events and neurological worsening through intensive organized case-management randomized controlled trial.

PubMed

McAlister, Finlay A; Grover, Steven; Padwal, Raj S; Youngson, Erik; Fradette, Miriam; Thompson, Ann; Buck, Brian; Dean, Naeem; Tsuyuki, Ross T; Shuaib, Ashfaq; Majumdar, Sumit R

2014-12-01

Survivors of ischemic stroke/transient ischemic attack (TIA) are at high risk for other vascular events. We evaluated the impact of 2 types of case management (hard touch with pharmacist or soft touch with nurse) added to usual care on global vascular risk. This is a prespecified secondary analysis of a 6-month trial conducted in outpatients with recent stroke/TIA who received usual care and were randomized to additional monthly visits with either nurse case managers (who counseled patients, monitored risk factors, and communicated results to primary care physicians) or pharmacist case managers (who were also able to independently prescribe according to treatment algorithms). The Framingham Risk Score [FRS]) and the Cardiovascular Disease Life Expectancy Model (CDLEM) were used to estimate 10-year risk of any vascular event at baseline, 6 months (trial conclusion), and 12 months (6 months after last trial visit). Mean age of the 275 evaluable patients was 67.6 years. Both study arms were well balanced at baseline and exhibited reductions in absolute global vascular risk estimates at 6 months: median 4.8% (Interquartile range (IQR) 0.3%-11.3%) for the pharmacist arm versus 5.1% (IQR 1.9%-12.5%) for the nurse arm on the FRS (P = .44 between arms) and median 10.0% (0.1%-31.6%) versus 12.5% (2.1%-30.5%) on the CDLEM (P = .37). These reductions persisted at 12 months: median 6.4% (1.2%-11.6%) versus 5.5% (2.0%-12.0%) for the FRS (P = .83) and median 8.4% (0.1%-28.3%) versus 13.1% (1.6%-31.6%) on the CDLEM (P = .20). Case management by nonphysician providers is associated with improved global vascular risk in patients with recent stroke/TIA. Reductions achieved during the active phase of the trial persisted after trial conclusion. Copyright © 2014 Mosby, Inc. All rights reserved.

Constraint-Induced Movement Therapy for Rehabilitation of Arm Dysfunction After Stroke in Adults

PubMed Central

2011-01-01

Executive Summary Objective The purpose of this evidence-based analysis is to determine the effectiveness and cost of CIMT for persons with arm dysfunction after a stroke. Clinical Need: Condition and Target Population A stroke is a sudden loss of brain function caused by the interruption of blood flow to the brain (ischemic stroke) or the rupture of blood vessels in the brain (hemorrhagic stroke). A stroke can affect any number of areas including the ability to move, see, remember, speak, reason, and read and write. Stroke is the leading cause of adult neurological disability in Canada; 300,000 people or 1% of the population live with its effects. Up to 85% of persons experiencing a complete stroke have residual arm dysfunction which will interfere with their ability to live independently. Rehabilitation interventions are the cornerstone of care and recovery after a stroke. Constraint-Induced Movement Therapy Constraint-Induced Movement (CIMT) is a behavioural approach to neurorehabilitation based on the principle of ‘learned non-use’. The term is derived from studies in nonhuman primates in which somatosensory deafferentation of a single forelimb was performed and after which the animal then failed to use that limb. This failure to use the limb was deemed ‘learned non-use’. The major components of CIMT include: i) intense repetitive task-oriented training of the impaired limb ii) immobilization of the unimpaired arm, and iii) shaping. With regard to the first component, persons may train the affected arm for several hours a day for up to 10-15 consecutive days. With immobilization, the unaffected arm may be restrained for up to 90% of waking hours. And finally, with shaping, the difficulty of the training tasks is progressively increased as performance improves and encouraging feedback is provided immediately when small gains are achieved. Research Question What is the effectiveness and cost of CIMT compared with physiotherapy and/or occupational therapy rehabilitative care for the treatment of arm dysfunction after stroke in persons 18 years of age and older? Research Methods Literature Search Search Strategy A literature search was performed on January 21, 2011 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Cochrane Library, Centre for Reviews and Dissemination. (Appendix 1) A preliminary search completed in August 2010 found a Cochrane Systematic review published in 2009. As a result, the literature search for this evidence-based analysis was designed to include studies published from January 1, 2008 to January 21, 2011. Inclusion Criteria Systematic reviews of randomized controlled trials with or without meta-analysis. Study participants 18 years of age and older with arm dysfunction after stroke. Studies comparing the use of CIMT with occupational therapy and/or physiotherapy rehabilitative care (usual care) to improve arm function. Studies which described CIMT as having the following three components: i) restraining unimpaired arm and/or wrist with a sling, hand splint or cast; ii) intensive training with functional task practice of the affected arm; iii) application of shaping methodology during training. No restriction was placed on intensity or duration of treatment otherwise. Duration and intensity of therapy is equal in treatment and control groups. Therapy beginning a minimum of one month after stroke. Published between 2008 and 2011. Exclusion Criteria Narrative reviews, case series, case reports, controlled clinical trials. Letters to the editor Grey literature. Non-English language publications. Outcomes of Interest Primary Outcome Arm motor function: Action Research Arm Test (ARAT) Secondary Outcome Arm motor impairment: Fugl-Meyer Motor Assessment (FMA) Activities of daily living (ADL): Functional Independence Measure (FIM), Chedoke Arm and Hand Inventory Perceived motor function: Motor Activity Log (MAL) Amount of Use (AOU) and Quality of Movement (QOM) scales Quality of Life: Stroke Impact Scale (SIS) Summary of Findings A significant difference was found in our primary outcome of arm motor function measured with the Action Research Arm Test in favour of CIMT compared with usual care delivered with the same intensity and duration. Significant differences were also found in three of the five secondary outcome measures including Arm Motor Impairment and Perceived Motor Function Amount of Use and Quality of Use. There was a nonsignificant effect found with the FIM score and the quality of life Stroke Impact Scale outcome measure. The nonsignificant effect found with the scale score and the quality of life score may be a factor of a nonresponsive outcome measure (FIM scale) and/or a type II statistical error from an inadequate sample size. The quality of evidence was moderate for arm motor function and low for all other outcome measures except quality of life, which was very low. Table 1: Summary of Results* Outcome Outcome Measure Number of Studies (n) Mean Difference in Change scores CIMT vs. Usual Care [95% C.I.] Results GRADE Quality of Evidence Arm motor function Action Research Arm Test 4(43) 13.6[8.7, 18.6] Significant Moderate Arm motor impairment Fugl-Meyer Motor Assessment 8(169) 6.5[2.3, 10.7] Significant Low Activities of daily living Functional Independence Measure 4(128) 3.6[−0.22, 7.4] Nonsignificant Low Self-reported amount of arm use Perceived Arm Motor Function (Amount of Use) Scale 8(241) 1.1[0.60, 1.7] Significant Low Self-reported quality of arm use Perceived Arm Motor Function (Quality of Use) Scale 8(241) 0.97[0.7, 1.3] Significant Low Quality of life Stroke Impact Scale 2(66) 3.9[−5.6, 13.5] Nonsignificant Very Low * CI, Confidence Intervals; n, Sample Size PMID:23074418

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.

HIV knowledge, stigma, and illness beliefs among pediatric caregivers in Ghana who have not disclosed their child's HIV status.

PubMed

Paintsil, Elijah; Renner, Lorna; Antwi, Sampson; Dame, Joycelyn; Enimil, Anthony; Ofori-Atta, Angela; Alhassan, Amina; Ofori, Irene Pokuaa; Cong, Xiangyu; Kyriakides, Tassos; Reynolds, Nancy R

2015-01-01

The majority of HIV-infected children in sub-Saharan Africa have not been informed of their HIV status. Caregivers are reluctant to disclose HIV status to their children because of concern about the child's ability to understand, parental sense of guilt, and fear of social rejection and isolation. We hypothesized that the low prevalence of pediatric HIV disclosure in Ghana is due to lack of accurate HIV information and high HIV stigma among caregivers. This is a preliminary analysis of baseline data of an HIV pediatric disclosure intervention study in Ghana ("Sankofa"). "Sankofa" - is a two-arm randomized controlled clinical trial comparing disclosure intervention plus usual care (intervention arm) vs usual care (control arm) at Korle-Bu Teaching Hospital (KBTH; control arm) and Komfo-Anokye Teaching Hospital (KATH; intervention arm). We enrolled HIV-infected children, ages 7-18 years who do not know their HIV status, and their caregivers. Baseline data of caregivers included demographic characteristics; Brief HIV Knowledge Questionnaire (HIV-KQ-18); Brief Illness Perception Questionnaire; and HIV Stigma Scale. Simple and multivariable linear regression analyses were used to assess the relationship between caregiver characteristics and HIV knowledge, stigma, and illness perception. Two hundred and ninety-eight caregivers were enrolled between January 2013 and July 2014 at the two study sites; KBTH (n = 167) and KATH (n = 131). The median age of caregivers was 41 years; 80.5% of them were female and about 60% of caregivers were HIV-positive. Seventy-eight percent of caregivers were self-employed with low household income. In both unadjusted and adjusted analyses, HIV negative status and lower level of education were associated with poor scores on HIV-KQ. HIV positive status remained significant for higher level of stigma in the adjusted analyses. None of the caregiver's characteristics predicted caregiver's illness perception. Intensification of HIV education in schools and targeted community campaigns are needed.

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

PubMed

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

2017-05-17

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

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

PubMed Central

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

2017-01-01

Objectives To investigate the cost-effectiveness of a telehealthcare solution in addition to usual care compared with usual care. Design A 12-month cost-utility analysis conducted alongside a cluster-randomised trial. Setting Community-based setting in the geographical area of North Denmark Region in Denmark. Participants 26 municipality districts define randomisation clusters with 13 districts in each arm. 1225 patients with chronic obstructive pulmonary disease were enrolled, of which 578 patients were randomised to telehealthcare and 647 to usual care. Interventions In addition to usual care, patients in the intervention group received a set of telehealthcare equipment and were monitored by a municipality-based healthcare team. Patients in the control group received usual care. Main outcome measure Incremental costs per quality-adjusted life-years gained from baseline up to 12 months follow-up. Results From a healthcare and social sector perspective, the adjusted mean difference in total costs between telehealthcare and usual care was €728 (95% CI −754 to 2211) and the adjusted mean difference in quality-adjusted life-years gained was 0.0132 (95% CI −0.0083 to 0.0346). The incremental cost-effectiveness ratio was €55 327 per quality-adjusted life-year gained. Decision-makers should be willing to pay more than €55 000 to achieve a probability of cost-effectiveness >50%. This conclusion is robust to changes in the definition of hospital contacts and reduced intervention costs. Only in the most optimistic scenario combining the effects of all sensitivity analyses, does the incremental cost-effectiveness ratio fall below the UK thresholds values (€21 068 per quality-adjusted life-year). Conclusions Telehealthcare is unlikely to be a cost-effective addition to usual care, if it is offered to all patients with chronic obstructive pulmonary disease and if the willingness-to-pay threshold values from the National Institute for Health and Care Excellence are applied. Trial registration Clinicaltrials.gov, NCT01984840, 14 November 2013. PMID:28515193

My Team of Care Study: A Pilot Randomized Controlled Trial of a Web-Based Communication Tool for Collaborative Care in Patients With Advanced Cancer.

PubMed

Voruganti, Teja; Grunfeld, Eva; Jamieson, Trevor; Kurahashi, Allison M; Lokuge, Bhadra; Krzyzanowska, Monika K; Mamdani, Muhammad; Moineddin, Rahim; Husain, Amna

2017-07-18

The management of patients with complex care needs requires the expertise of health care providers from multiple settings and specialties. As such, there is a need for cross-setting, cross-disciplinary solutions that address deficits in communication and continuity of care. We have developed a Web-based tool for clinical collaboration, called Loop, which assembles the patient and care team in a virtual space for the purpose of facilitating communication around care management. The objectives of this pilot study were to evaluate the feasibility of integrating a tool like Loop into current care practices and to capture preliminary measures of the effect of Loop on continuity of care, quality of care, symptom distress, and health care utilization. We conducted an open-label pilot cluster randomized controlled trial allocating patients with advanced cancer (defined as stage III or IV disease) with ≥3 months prognosis, their participating health care team and caregivers to receive either the Loop intervention or usual care. Outcome data were collected from patients on a monthly basis for 3 months. Trial feasibility was measured with rate of uptake, as well as recruitment and system usage. The Picker Continuity of Care subscale, Palliative care Outcomes Scale, Edmonton Symptom Assessment Scale, and Ambulatory and Home Care Record were patient self-reported measures of continuity of care, quality of care, symptom distress, and health services utilization, respectively. We conducted a content analysis of messages posted on Loop to understand how the system was used. Nineteen physicians (oncologists or palliative care physicians) were randomized to the intervention or control arms. One hundred twenty-seven of their patients with advanced cancer were approached and 48 patients enrolled. Of 24 patients in the intervention arm, 20 (83.3%) registered onto Loop. In the intervention and control arms, 12 and 11 patients completed three months of follow-up, respectively. A mean of 1.2 (range: 0 to 4) additional healthcare providers with an average total of 3 healthcare providers participated per team. An unadjusted between-arm increase of +11.4 was observed on the Picker scale in favor of the intervention arm. Other measures showed negligible changes. Loop was primarily used for medical care management, symptom reporting, and appointment coordination. The results of this study show that implementation of Loop was feasible. It provides useful information for planning future studies further examining effectiveness and team collaboration. Numerically higher scores were observed for the Loop arm relative to the control arm with respect to continuity of care. Future work is required to understand the incentives and barriers to participation so that the implementation of tools like Loop can be optimized. ClinicalTrials.gov NCT02372994; https://clinicaltrials.gov/ct2/show/NCT02372994 (Archived by WebCite at http://www.webcitation.org/6r00L4Skb). ©Teja Voruganti, Eva Grunfeld, Trevor Jamieson, Allison M Kurahashi, Bhadra Lokuge, Monika K Krzyzanowska, Muhammad Mamdani, Rahim Moineddin, Amna Husain. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 18.07.2017.

Training nurses in a competency framework to support adults with epilepsy and intellectual disability: the EpAID cluster RCT.

PubMed

Ring, Howard; Howlett, James; Pennington, Mark; Smith, Christopher; Redley, Marcus; Murphy, Caroline; Hook, Roxanne; Platt, Adam; Gilbert, Nakita; Jones, Elizabeth; Kelly, Joanna; Pullen, Angela; Mander, Adrian; Donaldson, Cam; Rowe, Simon; Wason, James; Irvine, Fiona

2018-02-01

People with an intellectual (learning) disability (ID) and epilepsy have an increased seizure frequency, higher frequencies of multiple antiepileptic drug (AED) use and side effects, higher treatment costs, higher mortality rates and more behavioural problems than the rest of the population with epilepsy. The introduction of nurse-led care may lead to improvements in outcome for those with an ID and epilepsy; however, this has not been tested in a definitive clinical trial. To determine whether or not ID nurses, using a competency framework developed to optimise nurse management of epilepsy in people with an ID, can cost-effectively improve clinical and quality-of-life outcomes in the management of epilepsy compared with treatment as usual. Cluster-randomised two-arm trial. Community-based secondary care delivered by members of community ID teams. Participants were adults aged 18-65 years with an ID and epilepsy under the care of a community ID team and had had at least one seizure in the 6 months before the trial. The experimental intervention was the Learning Disability Epilepsy Specialist Nurse Competency Framework. This provides guidelines describing a structure and goals to support the delivery of epilepsy care and management by ID-trained nurses. The primary outcome was the seizure severity scale from the Epilepsy and Learning Disabilities Quality of Life questionnaire. Measures of mood, behaviour, AED side effects and carer strain were also collected. A cost-utility analysis was undertaken along with a qualitative examination of carers' views of participants' epilepsy management. In total, 312 individuals were recruited into the study from 17 research clusters. Using an intention-to-treat analysis controlling for baseline individual-level and cluster-level variables there was no significant difference in seizure severity score between the two arms. Altogether, 238 complete cases were included in the non-imputed primary analysis. Analyses of the secondary outcomes revealed no significant differences between arms. A planned subgroup analysis identified a significant interaction between treatment arm and level of ID. There was a suggestion in those with mild to moderate ID that the competency framework may be associated with a small reduction in concerns over seizure severity (standard error 2.005, 95% confidence interval -0.554 to 7.307; p  = 0.092). However, neither subgroup showed a significant intervention effect individually. Family members' perceptions of nurses' management depended on the professional status of the nurses, regardless of trial arm. Economic analysis suggested that the competency framework intervention was likely to be cost-effective, primarily because of a reduction in the costs of supporting participants compared with treatment as usual. The intervention could not be delivered blinded. Treatment as usual varied widely between the research sites. Overall, for adults with an ID and epilepsy, the framework conferred no clinical benefit compared with usual treatment. The economic analysis suggested that there may be a role for the framework in enhancing the cost-effectiveness of support for people with epilepsy and an ID. Future research could explore the specific value of the competency framework for those with a mild to moderate ID and the potential for greater long-term benefits arising from the continuing professional development element of the framework. Current Controlled Trials ISRCTN96895428. This trial was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 10. See the NIHR Journals Library website for further project information.

Improving End-of-Life Care: Palliative Care Embedded in an Oncology Clinic Specializing in Targeted and Immune-Based Therapies.

PubMed

Einstein, David J; DeSanto-Madeya, Susan; Gregas, Matthew; Lynch, Jessica; McDermott, David F; Buss, Mary K

2017-09-01

Patients with advanced cancer benefit from early involvement of palliative care. The ideal method of palliative care integration remains to be determined, as does its effectiveness for patients treated with targeted and immune-based therapies. We studied the impact of an embedded palliative care team that saw patients in an academic oncology clinic specializing in targeted and immune-based therapies. Patients seen on a specific day accessed the embedded model, on the basis of automatic criteria; patients seen other days could be referred to a separate palliative care clinic (usual care). We abstracted data from the medical records of 114 patients who died during the 3 years after this model's implementation. Compared with usual care (n = 88), patients with access to the embedded model (n = 26) encountered palliative care as outpatients more often ( P = .003) and earlier (mean, 231 v 109 days before death; P < .001). Hospice enrollment rates were similar ( P = .303), but duration was doubled (mean, 57 v 25 days; P = .006), and enrollment > 7 days before death-a core Quality Oncology Practice Initiative metric-was higher in the embedded model (odds ratio, 5.60; P = .034). Place of death ( P = .505) and end-of-life chemotherapy (odds ratio, 0.361; P = .204) did not differ between the two arms. A model of embedded and automatically triggered palliative care among patients treated exclusively with targeted and immune-based therapies was associated with significant improvements in use and timing of palliative care and hospice, compared with usual practice.

Study protocol for the SMART2D adaptive implementation trial: a cluster randomised trial comparing facility-only care with integrated facility and community care to improve type 2 diabetes outcomes in Uganda, South Africa and Sweden.

PubMed

Guwatudde, David; Absetz, Pilvikki; Delobelle, Peter; Östenson, Claes-Göran; Olmen Van, Josefien; Alvesson, Helle Molsted; Mayega, Roy William; Ekirapa Kiracho, Elizabeth; Kiguli, Juliet; Sundberg, Carl Johan; Sanders, David; Tomson, Göran; Puoane, Thandi; Peterson, Stefan; Daivadanam, Meena

2018-03-17

Type 2 diabetes (T2D) is increasingly contributing to the global burden of disease. Health systems in most parts of the world are struggling to diagnose and manage T2D, especially in low-income and middle-income countries, and among disadvantaged populations in high-income countries. The aim of this study is to determine the added benefit of community interventions onto health facility interventions, towards glycaemic control among persons with diabetes, and towards reduction in plasma glucose among persons with prediabetes. An adaptive implementation cluster randomised trial is being implemented in two rural districts in Uganda with three clusters per study arm, in an urban township in South Africa with one cluster per study arm, and in socially disadvantaged suburbs in Stockholm, Sweden with one cluster per study arm. Clusters are communities within the catchment areas of participating primary healthcare facilities. There are two study arms comprising a facility plus community interventions arm and a facility-only interventions arm. Uganda has a third arm comprising usual care. Intervention strategies focus on organisation of care, linkage between health facility and the community, and strengthening patient role in self-management, community mobilisation and a supportive environment. Among T2D participants, the primary outcome is controlled plasma glucose; whereas among prediabetes participants the primary outcome is reduction in plasma glucose. The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. ISRCTN11913581; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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.

Effects of diabetes self-management programs on time-to-hospitalization among patients with type 2 diabetes: a survival analysis model.

PubMed

Adepoju, Omolola E; Bolin, Jane N; Phillips, Charles D; Zhao, Hongwei; Ohsfeldt, Robert L; McMaughan, Darcy K; Helduser, Janet W; Forjuoh, Samuel N

2014-04-01

This study compared time-to-hospitalization among subjects enrolled in different diabetes self-management programs (DSMP). We sought to determine whether the interventions delayed the occurrence of any acute event necessitating hospitalization. Electronic medical records (EMR) were obtained for 376 adults enrolled in a randomized controlled trial (RCT) of Type 2 diabetes (T2DM) self-management programs. All study participants had uncontrolled diabetes and were randomized into either: personal digital assistant (PDA), Chronic Disease Self-Management Program (CDSMP), combined PDA and CDSMP (COM), or usual care (UC) groups. Subjects were followed for a maximum of two years. Time-to-hospitalization was measured as the interval between study enrollment and the occurrence of a diabetes-related hospitalization. Subjects enrolled in the CDSMP-only arm had significantly prolonged time-to-hospitalization (Hazard ratio: 0.10; p=0.002) when compared to subjects in the control arm. Subjects in the PDA-only and combined PDA and CDSMP arms showed no improvements in comparison to the control arm. CDSMP can be effective in delaying time-to-hospitalization among patients with T2DM. Reducing unnecessary healthcare utilization, particularly inpatient hospitalization is a key strategy to improving the quality of health care and lowering associated health care costs. The CDSMP offers the potential to reduce time-to-hospitalization among T2DM patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

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

Web-Based Intervention for Transitioning Smokers From Inpatient to Outpatient Care: An RCT.

PubMed

Kathleen F, Harrington; Young-Il, Kim; Meifang, Chen; Rekha, Ramachandran; Maria, Pisu; Rajani S, Sadasivam; Thomas K, Houston; William C, Bailey

2016-10-01

Smoking-cessation follow-up care after hospitalization is known to be effective. Cost-effective and disseminable interventions adoptable by hospitals are needed. RCT. Fourteen hundred eighty-eight current smokers recruited during a tertiary care hospital stay were randomly assigned to Usual Care (UC) or Usual Care plus Web-Based Intervention (WI). Data were collected in 2011-2013 and analyzed in 2014-2015. UC provided brief bedside advice to quit, a quit plan template, and quitline contact information. WI included access to a website with asynchronous e-message communication with a tobacco counselor, use of interactive self-assessments, helpful cessation information, and access to additional web resources, as well as automated e-mail messages tailored for health concern and readiness to quit. Self-reported 30-day abstinence at 6 months was the primary outcome; a subset was verified by saliva cotinine. Six-month follow-up was completed by 83% of participants. No difference was found between study arms for self-reported abstinence rates in intent-to-treat (25.4% WI vs 26.8% UC) and complete case (31.3% WI vs 31.4% UC) analyses. Reduced smoking was reported by 45.5% (WI, n=276) and 47% (UC, n=296) of non-abstinent responders (p=0.59). Using a 10-ng/mL cotinine cut off, abstinence was verified in 52.1% of WI and 62.5% of UC (p=0.11). Significant covariates associated with abstinence at 6 months were being male, not smoking during hospitalization, being very confident in quitting, planning to quit/stay quit, smoking fewer days in the past 30 days, fewer years of smoking, and having cerebrovascular or connective tissue rheumatic disease as primary hospital diagnosis. Lack of difference between treatment arms suggests a strong effect for UC, WI was not effective, or both. Low intervention engagement may be partially responsible. Self-reported abstinence rates were relatively high in both arms, although the biochemically verified rates indicate over-reporting of abstinence. These findings suggest brief bedside counseling for all hospitalized smokers is beneficial. This study is registered at www.clinicaltrials.gov NCT01277250. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Reducing patient delay in Acute Coronary Syndrome (RAPiD): research protocol for a web-based randomized controlled trial examining the effect of a behaviour change intervention.

PubMed

Farquharson, Barbara; Johnston, Marie; Smith, Karen; Williams, Brian; Treweek, Shaun; Dombrowski, Stephan U; Dougall, Nadine; Abhyankar, Purva; Grindle, Mark

2017-05-01

To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text + visual and text-only) with usual care. Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for acute coronary syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions. A three-arm web-based, parallel randomized controlled trial of a theory-based intervention. The intervention comprises 12 behaviour change techniques systematically identified following systematic review and a consensus exercise undertaken with behaviour change experts. We aim to recruit n = 177 participants who have experienced acute coronary syndrome in the previous 6 months from a National Health Service Hospital. Consenting participants will be randomly allocated in equal numbers to one of three study groups: i) usual care, ii) usual care plus text-only behaviour change technique-based intervention or iii) usual care plus text + visual behaviour change technique-based intervention. The primary outcome will be the change in intention to phone an ambulance immediately with symptoms of acute coronary syndrome ≥15-minute duration, assessed using two randomized series of eight scenarios representing varied symptoms before and after delivery of the interventions or control condition (usual care). Funding granted January 2014. Positive results changing intentions would lead to a randomized controlled trial of the behaviour change intervention in clinical practice, assessing patient delay in the event of actual symptoms. Registered at ClinicalTrials.gov: NCT02820103. © 2016 John Wiley & Sons Ltd.

Randomized controlled pilot study of an educational video plus telecare for the early outpatient management of musculoskeletal pain among older emergency department patients.

PubMed

Platts-Mills, Timothy F; Hollowell, Allison G; Burke, Gary F; Zimmerman, Sheryl; Dayaa, Joseph A; Quigley, Benjamin R; Bush, Montika; Weinberger, Morris; Weaver, Mark A

2018-01-05

Musculoskeletal pain is a common reason for emergency department (ED) visits. Following discharge from the ED, patients, particularly older patients, often have difficulty controlling their pain and managing analgesic side effects. We conducted a pilot study of an educational video about pain management with and without follow-up telephone support for older adults presenting to the ED with musculoskeletal pain. ED patients aged 50 years and older with musculoskeletal pain were randomized to: (1) usual care, (2) a brief educational video only, or (3) a brief educational video plus a protocol-guided follow-up telephone call from a physician 48-72 hours after discharge (telecare). The primary outcome was the change from the average pain severity before the ED visit to the average pain severity during the past week assessed one month after the ED visit. Pain was assessed using a 0-10 numerical rating scale. Of 75 patients randomized (mean age 64 years), 57 (76%) completed follow up at one month. Of the 18 patients lost to follow up, 12 (67%) had non-working phone numbers. Among patients randomized to the video (arms 2 and 3), 46/50 viewed the entire video; among the 25 patients randomized to the video plus telecare (arm 3), 23 were reached for telecare. Baseline pain scores for the usual care, video, and video plus telecare groups were 7.3, 7.1, and 7.5. At one month, pain scores were 5.8, 4.9, and 4.5, corresponding to average decreases in pain of -1.5, -2.2, and -3.0, respectively. In the pairwise comparison between intervention groups, the video plus telecare group had a 1.7-point (95% CI 1.2, 2.1) greater decrease in pain compared to usual care, and the video group had a 1.1-point (95% CI 0.6, 1.6) greater decrease in pain compared to usual care after adjustment for baseline pain, age, and gender. At one month, clinically important differences were also observed between the video plus telecare and usual care groups for analgesic side effects, ongoing opioid use, and physical function. Results of this pilot trial suggest the potential value of an educational video plus telecare to improve outcomes for older adults presenting to the ED with musculoskeletal pain. Changes to the protocol are identified to increase retention for assessment of outcomes. ClinicalTrials.gov, NCT02438384 . Registered on 5 May 2015.

The cost-effectiveness of an outreach clinical model in the management and prevention of gonorrhea and chlamydia among Chinese female sex workers in Hong Kong.

PubMed

You, Joyce H S; Wong, William C W; Sin, Chung Wah; Woo, Jean

2006-04-01

Social marginalization and stigmatization in usual medical care setting may refrain female sex workers (FSWs) from seeking usual medical care for sexually transmitted infections in Hong Kong. To evaluate the cost-effectiveness of using an outreach approach for treatment and prevention of gonorrhea and chlamydia among FSWs. A decision tree was designed to simulate the outcomes of 2 alternatives: (1) outreach service providing treatment of gonorrhea and chlamydia and counseling to FSWs (outreach arm) and (2) no outreach service (control arm). Five tiers of outcomes were estimated for each study arm: (1) total direct medical cost, (2) number of FSWs infected with gonorrhea, (3) number of new cases of gonorrhea in clients transmitted by FSWs, (4) number of FSWs infected with chlamydia, and (5) number of new cases of chlamydia in clients transmitted by FSWs. Clinical inputs were estimated from literature, and cost analysis was conducted from the perspective of a public health organization. Compared to the control group, the marginal savings per new case of infection averted (marginal cost divided by marginal cases of infection) of the outreach group were $10,988 (US dollars) per case of gonorrhea averted in FSWs, $685 per case of gonorrhea averted in clients, $9643 per case of chlamydia averted in FSWs, and $220 per case of chlamydia averted in clients ($1=7.8 Hong Kong dollars). An outreach clinic is potentially less costly and more effective in preventing transmission of gonorrhea and chlamydia between FSWs and their clients in Hong Kong.

A low cost virtual reality system for home based rehabilitation of the arm following stroke: a randomised controlled feasibility trial

PubMed Central

Standen, PJ; Threapleton, K; Richardson, A; Connell, L; Brown, DJ; Battersby, S; Platts, F; Burton, A

2016-01-01

Objective: To assess the feasibility of conducting a randomised controlled trial of a home-based virtual reality system for rehabilitation of the arm following stroke. Design: Two group feasibility randomised controlled trial of intervention versus usual care. Setting: Patients’ homes. Participants: Patients aged 18 or over, with residual arm dysfunction following stroke and no longer receiving any other intensive rehabilitation. Interventions: Eight weeks’ use of a low cost home-based virtual reality system employing infra-red capture to translate the position of the hand into game play or usual care. Main measures: The primary objective was to collect information on the feasibility of a trial, including recruitment, collection of outcome measures and staff support required. Patients were assessed at three time points using the Wolf Motor Function Test, Nine-Hole Peg Test, Motor Activity Log and Nottingham Extended Activities of Daily Living. Results: Over 15 months only 47 people were referred to the team. Twenty seven were randomised and 18 (67%) of those completed final outcome measures. Sample size calculation based on data from the Wolf Motor Function Test indicated a requirement for 38 per group. There was a significantly greater change from baseline in the intervention group on midpoint Wolf Grip strength and two subscales of the final Motor Activity Log. Training in the use of the equipment took a median of 230 minutes per patient. Conclusions: To achieve the required sample size, a definitive home-based trial would require additional strategies to boost recruitment rates and adequate resources for patient support. PMID:27029939

A low cost virtual reality system for home based rehabilitation of the arm following stroke: a randomised controlled feasibility trial.

PubMed

Standen, P J; Threapleton, K; Richardson, A; Connell, L; Brown, D J; Battersby, S; Platts, F; Burton, A

2017-03-01

To assess the feasibility of conducting a randomised controlled trial of a home-based virtual reality system for rehabilitation of the arm following stroke. Two group feasibility randomised controlled trial of intervention versus usual care. Patients' homes. Patients aged 18 or over, with residual arm dysfunction following stroke and no longer receiving any other intensive rehabilitation. Eight weeks' use of a low cost home-based virtual reality system employing infra-red capture to translate the position of the hand into game play or usual care. The primary objective was to collect information on the feasibility of a trial, including recruitment, collection of outcome measures and staff support required. Patients were assessed at three time points using the Wolf Motor Function Test, Nine-Hole Peg Test, Motor Activity Log and Nottingham Extended Activities of Daily Living. Over 15 months only 47 people were referred to the team. Twenty seven were randomised and 18 (67%) of those completed final outcome measures. Sample size calculation based on data from the Wolf Motor Function Test indicated a requirement for 38 per group. There was a significantly greater change from baseline in the intervention group on midpoint Wolf Grip strength and two subscales of the final Motor Activity Log. Training in the use of the equipment took a median of 230 minutes per patient. To achieve the required sample size, a definitive home-based trial would require additional strategies to boost recruitment rates and adequate resources for patient support.

A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related ED Visits

PubMed Central

Paulozzi, Leonard J.; Howell, Donelle; McPherson, Sterling; Murphy, Sean M.; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, Jon

2017-01-01

Background Increasing prescription overdose deaths have demonstrated the need for safer ED prescribing practices for patients who are frequent ED users. Objectives We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. Methods We conducted a multi-site randomized controlled trial (RCT) across all EDs in a metropolitan area. 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. Results The intervention arm experienced a 34% decrease (IRR = 0.66, p < 0.001; 95% CI: 0.57 – 0.78) in ED visits and an 80% decrease (OR = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers. Conclusion This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. PMID:27624507

A Randomized Controlled Trial of a Citywide Emergency Department Care Coordination Program to Reduce Prescription Opioid Related Emergency Department Visits.

PubMed

Neven, Darin; Paulozzi, Leonard; Howell, Donelle; McPherson, Sterling; Murphy, Sean M; Grohs, Becky; Marsh, Linda; Lederhos, Crystal; Roll, John

2016-11-01

Increasing prescription overdose deaths have demonstrated the need for safer emergency department (ED) prescribing practices for patients who are frequent ED users. We hypothesized that the care of frequent ED users would improve using a citywide care coordination program combined with an ED care coordination information system, as measured by fewer ED visits by and decreased controlled substance prescribing to these patients. We conducted a multisite randomized controlled trial (RCT) across all EDs in a metropolitan area; 165 patients with the most ED visits for complaints of pain were randomized. For the treatment arm, drivers of ED use were identified by medical record review. Patients and their primary care providers were contacted by phone. Each patient was discussed at a community multidisciplinary meeting where recommendations for ED care were formed. The ED care recommendations were stored in an ED information exchange system that faxed them to the treating ED provider when the patient presented to the ED. The control arm was subjected to treatment as usual. The intervention arm experienced a 34% decrease (incident rate ratios = 0.66, p < 0.001; 95% confidence interval 0.57-0.78) in ED visits and an 80% decrease (odds ratio = 0.21, p = 0.001) in the odds of receiving an opioid prescription from the ED relative to the control group. Declines of 43.7%, 53.1%, 52.9%, and 53.1% were observed in the treatment group for morphine milligram equivalents, controlled substance pills, prescriptions, and prescribers, respectively. This RCT showed the effectiveness of a citywide ED care coordination program in reducing ED visits and controlled substance prescribing. Copyright © 2016 The Author(s). Published by Elsevier Inc. All rights reserved.

A Human Systems Integration Analysis of the Army Suicide Prevention Program

DTIC Science & Technology

2013-06-01

ABBREVIATIONS ACE Ask/Care/Escort ACER Army Suicide Event Report ACS Army Community Services AHLTA Armed Forces Health Longitudinal Technology ...Assess Risk and Resilience in Soldiers T2 The National Center for Telehealth and Technology TAU treatment as usual TFPS Task Force on the... Technology (T2), 2010). Despite increases in BH service usage during this time, suicide numbers still showed evidence of an obvious problem. C

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

PubMed

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

2015-04-01

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

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).

Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial.

PubMed

Panella, M; Marchisio, S; Demarchi, M L; Manzoli, L; Di Stanislao, F

2009-10-01

Hospital treatment of heart failure (HF) frequently does not follow published guidelines, potentially contributing to HF high morbidity, mortality and economic cost. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was undertaken to determine how clinical pathways (CP) for hospital treatment of HF affected care variability, guidelines adherence, in-hospital mortality and outcomes at discharge. Methods/ Two-arm, cluster-randomised trial. Fourteen community hospitals were randomised either to the experimental arm (CP: appropriate therapeutic guidelines use, new organisation and procedures, patient education) or to the control arm (usual care). The main outcome was in-hospital mortality; secondary outcomes were length and appropriateness of the stay, rate of unscheduled readmissions, customer satisfaction, usage of diagnostic and therapeutic procedures during hospital stay and quality indicators at discharge. All outcomes were measured using validated instruments available in literature. In-hospital mortality was 5.6% in the experimental arm (n = 12); 15.4% in controls (n = 33, p = 0.001). In CP and usual care groups, the mean rates of unscheduled readmissions were 7.9% and 13.9%, respectively. Adjusting for age, smoking, New York Heart Association score, hypertension and source of referral, patients in the CP group, as compared to controls, had a significantly lower risk of in-hospital death (OR 0.18; 95% CI 0.07 to 0.46) and unscheduled readmissions (OR 0.42; 95% CI 0.20 to 0.87). No differences were found between CP and control with respect to the appropriateness of the stay, costs and patient's satisfaction. Except for electrocardiography, all recommended diagnostic procedures were used more in the CP group. Similarly, pharmaceuticals use was significantly greater in CP, with the exception of diuretics and anti-platelets agents. The introduction of a specifically tailored CP for the hospital treatment of HF was effective in reducing in-hospital mortality and unscheduled readmissions. This study adds to previous knowledge indicating that CP should be used to improve the quality of hospital treatment of HF. NCT00519038.

Effect of Village Health Team Home Visits and Mobile Phone Consultations on Maternal and Newborn Care Practices in Masindi and Kiryandongo, Uganda: A Community-Intervention Trial

PubMed Central

Mangwi Ayiasi, Richard; Kolsteren, Patrick; Batwala, Vincent; Criel, Bart; Orach, Christopher Garimoi

2016-01-01

Introduction The World Health Organisation recommends home visits conducted by Community Health Workers (in Uganda known as Village Health Teams—VHTs) in order to improve maternal and newborn health. This study measured the effect of home visits combined with mobile phone consultations on maternal and newborn care practices. Method In a community intervention trial design 16 health centres in Masindi and Kiryandongo districts, Uganda were randomly and equally allocated to one of two arms: control and intervention arms. Eight control health centres received the usual maternal and newborn educational messages offered by professional health workers and eight intervention health centres that received an intervention package for maternal care and essential newborn care practices. In the intervention arm VHTs made two prenatal and one postnatal home visit to households. VHTs were provided with mobile phones to enable them make regular telephone consultations with health workers at the health centre serving the catchment area. The primary outcome was health facility delivery. Other outcomes included antenatal attendances, birth preparedness, cord and thermal care and breastfeeding practices. Analysis was by intention-to-treat. Results A total of 1385 pregnant women were analysed: 758 and 627 in the control and intervention arms respectively. Significant post-intervention differences were: delivery place [adjusted Odds Ratio aOR: 17.94(95%CI: 6.26–51.37); p<0.001], cord care [aOR: 3.05(95%CI: 1.81–5.12); p<0.001] thermal care [aOR: 7.58(95%CI: 2.52–22.82); p<0.001], and timely care-seeking for newborn illness [aOR: 4.93(95%CI: 1.59–15.31); p = 0.006]. Conclusion VHTs can have an effect in promoting proper cord and thermal care for the newborn and improve timely care-seeking for health facility delivery and newborn illness, because they could answer questions and refer patients correctly. However, VHTs should be supported by professional health workers through the use of mobile phones. Trial Registration ClinicalTrials.gov NCT02084680 PMID:27101379

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

Outcomes from ovarian cancer screening in the PLCO trial: Histologic heterogeneity impacts detection, overdiagnosis and survival.

PubMed

Temkin, Sarah M; Miller, Eric A; Samimi, Goli; Berg, Christine D; Pinsky, Paul; Minasian, Lori

2017-12-01

A mortality benefit from screening for ovarian cancer has never been demonstrated. The aim of this study was to evaluate the screening outcomes for different histologic subtypes of ovarian cancers. Women in the screening arm of the Prostate, Lung, Colorectal and Ovarian Screening Trial underwent CA-125 and transvaginal ultrasound annually for 3-5 years. We compared screening test characteristics (including overdiagnosis) and outcomes by tumour type (type II versus other) and study arm (screening versus usual care). Of 78,215 women randomised, 496 women were diagnosed with ovarian cancer. Of the tumours that were characterised (n = 413; 83%), 74% (n = 305) were type II versus 26% other (n = 108). Among screened patients, 70% of tumours were type II compared to 78% in usual care (p = 0.09). Within the screening arm, 29% of type II tumours were screen detected compared to 54% of the others (p < 0.01). The sensitivity of screening was 65% for type II tumours versus 86% for other types (p = 0.02). 15% of type II screen-detected tumours were stage I/II, compared to 81% of other tumours (p < 0.01). The overdiagnosis rate was lower for type II compared to other tumours (28.2% versus 72.2%; p < 0.01). Ovarian cancer-specific survival was worse for type II tumours compared to others (p < 0.01). Survival was similar for type II (p = 0.74) or other types (p = 0.32) regardless of study arm. Test characteristics of screening for ovarian cancer differed for type II tumours compared to other ovarian tumours. Type II tumours were less likely to be screen diagnosed, early stage at diagnosis or overdiagnosed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of a TELephone Counselling Intervention by Pharmacist (TelCIP) on medication adherence, patient beliefs and satisfaction with information for patients starting treatment: study protocol for a cluster randomized controlled trial

PubMed Central

2014-01-01

Background Adherence to medication is often low. Pharmacists may improve adherence, but a one-size-fits-all approach will not work: different patients have different needs. Goal of the current study is to assess the effectiveness of a patient-tailored, telephone-based intervention by a pharmacist at the start of pharmacotherapy aimed at improving medication adherence, satisfaction with information and counselling and the beliefs about medicines. Methods/Design A cluster randomized controlled intervention trial in 30 Dutch pharmacies, randomly assigned to 1 of 2 intervention groups. Each group consists of an intervention arm and an usual care arm. The intervention arm in the first group is the usual care arm in the second group and vice versa. One intervention arm focuses on patients starting with antidepressants or bisphosphonates and the other on antilipaemic drugs or renin angiotensin system (RAS)-inhibitors. The intervention consists of a telephone call by a pharmacist 2 or 3 weeks after a new prescription. A random sample of pharmacies will send questionnaires 3 months after the first prescription. This contains socio-demographic questions, a measure of beliefs about medicines (BMQ), satisfaction with information received (SIMS, abbreviated) and frequency of pharmacy counselling (Consumer Quality Index, CQI, abbreviated). The primary outcome measure will be medication adherence calculated from dispensing records retrieved 12 months after the intervention. Patients’ beliefs on medication, perception of the quality of information received and pharmacy counselling are secondary outcomes. Discussion The TelCIP study will determine the effectiveness of telephone counselling to improve adherence in patients initiating a new treatment. By measuring satisfaction with information and counselling and beliefs about medication the study will also give clues for the reason of a potential increase in adherence. Finally the study will provide information on which patients are most likely to benefit from this intervention. Trial registration The trial is registered at http://www.trialregister.nl under the identifier NTR3237. PMID:24885317

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

Randomised controlled trial of exercise to prevent shoulder problems in women undergoing breast cancer treatment: study protocol for the prevention of shoulder problems trial (UK PROSPER)

PubMed Central

Williamson, Esther; Lait, Clare; Richmond, Helen; Betteley, Lauren; Lall, Ranjit; Petrou, Stavros; Rees, Sophie; Withers, Emma J; Lamb, Sarah E; Thompson, Alastair M

2018-01-01

Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. Methods This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions. Discussion The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. Protocol version Version 2.1; dated 11 January 2017 Trial registration number ISRCTN35358984; Pre-results. PMID:29574439

Psychoeducation with problem-solving (PEPS) therapy for adults with personality disorder: a pragmatic randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of a manualised intervention to improve social functioning.

PubMed

McMurran, Mary; Crawford, Mike J; Reilly, Joe; Delport, Juan; McCrone, Paul; Whitham, Diane; Tan, Wei; Duggan, Conor; Montgomery, Alan A; Williams, Hywel C; Adams, Clive E; Jin, Huajie; Lewis, Matthew; Day, Florence

2016-07-01

If effective, less intensive treatments for people with personality disorder have the potential to serve more people. To compare the clinical effectiveness and cost-effectiveness of psychoeducation with problem-solving (PEPS) therapy plus usual treatment against usual treatment alone in improving social problem-solving with adults with personality disorder. Multisite two-arm, parallel-group, pragmatic randomised controlled superiority trial. Community mental health services in three NHS trusts in England and Wales. Community-dwelling adults with any personality disorder recruited from community mental health services. Up to four individual sessions of psychoeducation, a collaborative dialogue about personality disorder, followed by 12 group sessions of problem-solving therapy to help participants learn a process for solving interpersonal problems. The primary outcome was measured by the Social Functioning Questionnaire (SFQ). Secondary outcomes were service use (general practitioner records), mood (measured via the Hospital Anxiety and Depression Scale) and client-specified three main problems rated by severity. We studied the mechanism of change using the Social Problem-Solving Inventory. Costs were identified using the Client Service Receipt Inventory and quality of life was identified by the European Quality of Life-5 Dimensions questionnaire. Research assistants blinded to treatment allocation collected follow-up information. There were 739 people referred for the trial and 444 were eligible. More adverse events in the PEPS arm led to a halt to recruitment after 306 people were randomised (90% of planned sample size); 154 participants received PEPS and 152 received usual treatment. The mean age was 38 years and 67% were women. Follow-up at 72 weeks after randomisation was completed for 62% of participants in the usual-treatment arm and 73% in the PEPS arm. Intention-to-treat analyses compared individuals as randomised, regardless of treatment received or availability of 72-week follow-up SFQ data. Median attendance at psychoeducation sessions was approximately 90% and for problem-solving sessions was approximately 50%. PEPS therapy plus usual treatment was no more effective than usual treatment alone for the primary outcome [adjusted difference in means for SFQ -0.73 points, 95% confidence interval (CI) -1.83 to 0.38 points; p = 0.19], any of the secondary outcomes or social problem-solving. Over the follow-up, PEPS costs were, on average, £182 less than for usual treatment. It also resulted in 0.0148 more quality-adjusted life-years. Neither difference was statistically significant. At the National Institute for Health and Care Excellence thresholds, the intervention had a 64% likelihood of being the more cost-effective option. More adverse events, mainly incidents of self-harm, occurred in the PEPS arm, but the difference was not significant (adjusted incidence rate ratio 1.24, 95% CI 0.93 to 1.64). There was possible bias in adverse event recording because of dependence on self-disclosure or reporting by the clinical team. Non-completion of problem-solving sessions and non-standardisation of usual treatment were limitations. We found no evidence to support the use of PEPS therapy alongside standard care for improving social functioning of adults with personality disorder living in the community. We aim to investigate adverse events by accessing centrally held NHS data on deaths and hospitalisation for all PEPS trial participants. Current Controlled Trials ISRCTN70660936. 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. 20, No. 52. See the NIHR Journals Library website for further project information.

A Remote Medication Monitoring System for Chronic Heart Failure Patients to Reduce Readmissions: A Two-Arm Randomized Pilot Study.

PubMed

Hale, Timothy M; Jethwani, Kamal; Kandola, Manjinder Singh; Saldana, Fidencio; Kvedar, Joseph C

2016-04-17

Heart failure (HF) is a chronic condition affecting nearly 5.7 million Americans and is a leading cause of morbidity and mortality. With an aging population, the cost associated with managing HF is expected to more than double from US $31 billion in 2012 to US $70 billion by 2030. Readmission rates for HF patients are high-25% are readmitted at 30 days and nearly 50% at 6 months. Low medication adherence contributes to poor HF management and higher readmission rates. Remote telehealth monitoring programs aimed at improved medication management and adherence may improve HF management and reduce readmissions. The primary goal of this randomized controlled pilot study is to compare the MedSentry remote medication monitoring system versus usual care in older HF adult patients who recently completed a HF telemonitoring program. We hypothesized that remote medication monitoring would be associated with fewer unplanned hospitalizations and emergency department (ED) visits, increased medication adherence, and improved health-related quality of life (HRQoL) compared to usual care. Participants were randomized to usual care or use of the remote medication monitoring system for 90 days. Twenty-nine participants were enrolled and the final analytic sample consisted of 25 participants. Participants completed questionnaires at enrollment and closeout to gather data on medication adherence, health status, and HRQoL. Electronic medical records were reviewed for data on baseline classification of heart function and the number of unplanned hospitalizations and ED visits during the study period. Use of the medication monitoring system was associated with an 80% reduction in the risk of all-cause hospitalization and a significant decrease in the number of all-cause hospitalization length of stay in the intervention arm compared to usual care. Objective device data indicated high adherence rates (95%-99%) among intervention group participants despite finding no significant difference in self-reported adherence between study arms. The intervention group had poorer heart function and HRQoL at baseline, and HRQoL declined significantly in the intervention group compared to controls. The MedSentry medication monitoring system is a promising technology that merits continued development and evaluation. The MedSentry medication monitoring system may be useful both as a standalone system for patients with complex medication regimens or used to complement existing HF telemonitoring interventions. We found significant reductions in risk of all-cause hospitalization and the number of all-cause length of stay in the intervention group compared to controls. Although HRQoL deteriorated significantly in the intervention group, this may have been due to the poorer HF-functioning at baseline in the intervention group compared to controls. Telehealth medication adherence technologies, such as the MedSentry medication monitoring system, are a promising method to improve patient self-management,the quality of patient care, and reduce health care utilization and expenditure for patients with HF and other chronic diseases that require complex medication regimens. ClinicalTrials.gov NCT01814696; https://clinicaltrials.gov/ct2/show/study/NCT01814696 (Archived by WebCite® at http://www.webcitation.org/6giqAVhno).

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.

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.

Effect of peer support on diabetes distress: a cluster randomized controlled trial.

PubMed

Ju, C; Shi, R; Yao, L; Ye, X; Jia, M; Han, J; Yang, T; Lu, Q; Jin, H; Cai, X; Yuan, S; Xie, B; Yu, X; Coufal, M M; Fisher, E B; Sun, Z

2018-06-01

To investigate whether peer support would reduce diabetes distress and improve glycaemic control when added to usual diabetes education among adults with Type 2 diabetes in China. We conducted a cluster randomized trial involving 400 adults with Type 2 diabetes from eight communities in Nanjing. All participants received usual education for an average of 2 h each month from physicians, certified diabetes educators, dieticians, psychologists and podiatric nurses. Peer support was led by trained peer leaders and included diabetes knowledge- and skills-sharing at least once a month, as well as peer-to-peer communication. The primary outcome was diabetes distress measured using the Diabetes Distress Scale at 12 months. Secondary outcomes included fasting plasma glucose, 2-h postprandial glucose and HbA 1c concentration. Outcome data were collected from all participants at baseline, 6 months and 12 months. From 2012 to 2013, there were 200 participants in each study arm at baseline. Compared with the usual education arm, the peer support with usual education arm had greater reductions in regimen-related distress (1.4 ± 0.6 vs 1.2 ± 0.4; P=0.004) and total distress (1.3 ± 0.4 vs 1.2 ± 0.3; P=0.038) at 6 months. At 12 months, the scores for emotional burden (1.2 ± 0.3 vs 1.4 ± 0.6; P=0.002), physician-related distress (1.1 ± 0.3 vs 1.3 ± 0.4; P=0.001) and total scores (1.2 ± 0.3 vs 1.3 ± 0.4; P=0.002) were significantly lower in the peer support with usual education arm than in the usual education arm. Fasting plasma glucose levels were lower in the peer support with usual education arm than in the usual education arm at 6 months (7.5 ± 1.95 vs 8.0 ± 2.2; P=0.044) and 12 months (7.0 ± 2.3 vs 7.6 ± 1.5; P=0.008). Beyond the benefits of usual education, peer support was effective in reducing diabetes distress for Type 2 diabetes mellitus. (Clinical Trials Registry no: NCT02119572). © 2018 Diabetes UK.

Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

PubMed

Dziedzic, K S; Healey, E L; Porcheret, M; Afolabi, E K; Lewis, M; Morden, A; Jinks, C; McHugh, G A; Ryan, S; Finney, A; Main, C; Edwards, J J; Paskins, Z; Pushpa-Rajah, A; Hay, E M

2018-01-01

To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. ISRCTN06984617. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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

Research Plan of the Department of Systems Engineering and the Operations Research Center for Academic Year 2007

DTIC Science & Technology

2006-10-01

high probability for success. Estimated Time to Complete: 31 May 2007. 4. Support and Upgrade of Armed Forces-CARES to integrate Chaplin ...Excellence (ORCEN) is to provide a small, full- time analytical capability to both the Academy and the United States Army and the Department of...complete significant research projects in this time as they usually require little train-up as they are exposed to many military and academic

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.

Cost-Effectiveness and Cost-Utility of Internet-Based Computer Tailoring for Smoking Cessation

PubMed Central

Evers, Silvia MAA; de Vries, Hein; Hoving, Ciska

2013-01-01

Background Although effective smoking cessation interventions exist, information is limited about their cost-effectiveness and cost-utility. Objective To assess the cost-effectiveness and cost-utility of an Internet-based multiple computer-tailored smoking cessation program and tailored counseling by practice nurses working in Dutch general practices compared with an Internet-based multiple computer-tailored program only and care as usual. Methods The economic evaluation was embedded in a randomized controlled trial, for which 91 practice nurses recruited 414 eligible smokers. Smokers were randomized to receive multiple tailoring and counseling (n=163), multiple tailoring only (n=132), or usual care (n=119). Self-reported cost and quality of life were assessed during a 12-month follow-up period. Prolonged abstinence and 24-hour and 7-day point prevalence abstinence were assessed at 12-month follow-up. The trial-based economic evaluation was conducted from a societal perspective. Uncertainty was accounted for by bootstrapping (1000 times) and sensitivity analyses. Results No significant differences were found between the intervention arms with regard to baseline characteristics or effects on abstinence, quality of life, and addiction level. However, participants in the multiple tailoring and counseling group reported significantly more annual health care–related costs than participants in the usual care group. Cost-effectiveness analysis, using prolonged abstinence as the outcome measure, showed that the mere multiple computer-tailored program had the highest probability of being cost-effective. Compared with usual care, in this group €5100 had to be paid for each additional abstinent participant. With regard to cost-utility analyses, using quality of life as the outcome measure, usual care was probably most efficient. Conclusions To our knowledge, this was the first study to determine the cost-effectiveness and cost-utility of an Internet-based smoking cessation program with and without counseling by a practice nurse. Although the Internet-based multiple computer-tailored program seemed to be the most cost-effective treatment, the cost-utility was probably highest for care as usual. However, to ease the interpretation of cost-effectiveness results, future research should aim at identifying an acceptable cutoff point for the willingness to pay per abstinent participant. PMID:23491820

Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial

PubMed Central

Frias, Juan; Raja, Praveen; Kim, Yoona; Savage, George; Osterberg, Lars

2017-01-01

Background Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. Objective The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. Methods Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. Results Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean –21.8, SE 1.5 mm Hg vs mean –12.7, SE 2.8 mmHg; mean difference –9.1, 95% CI –14.0 to –3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). Conclusions For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. Trial Registration Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF) PMID:28698169

Improving patient knowledge and safe use of opioids: a randomized controlled trial.

PubMed

McCarthy, Danielle M; Wolf, Michael S; McConnell, Ryan; Sears, Jill; Chevrier, Allison; Ahlstrom, Eric; Engel, Kirsten G; Cameron, Kenzie A; Adams, James G; Courtney, D Mark

2015-03-01

The use of opioid analgesics in the United States has significantly increased in recent years. However, there is minimal consensus on what discharge counseling should accompany these high-risk prescriptions and large variations in what is done in practice. The objective of this study was to evaluate the effect of a dual-modality (written and spoken) literacy-appropriate educational strategy on patients' knowledge of and safe use of opioid analgesics. This was a prospective, randomized controlled trial. Consecutive discharged patients at an urban academic ED (>88,000 visits) with new prescriptions for hydrocodone-acetaminophen were enrolled. Patients were randomized to receive either usual care or the educational intervention. The educational intervention was a one-page information sheet about hydrocodone-acetaminophen, which was both given to the patients and read aloud by the research assistant (nonblinded). Follow-up phone calls were conducted 4 to 7 days after the visit to assess patient knowledge about the medication and self-report of activities associated with safety of use (e.g., double-dipping with acetaminophen, storage, use with alcohol or while driving). A total of 274 patients were enrolled; 210 completed follow-up (110 usual care and 100 intervention). No significant differences in baseline characteristics emerged between the study arms; 42% were male, and 51% were white, with a median age of 43 years. Half of patients had non-back pain orthopedic injuries (49.5%). On follow-up, overall knowledge was poor, with only 28% able to name both active ingredients in the medication. The intervention group had better knowledge of precautions related to taking additional acetaminophen (usual care 18.2%, 95% confidence interval [CI] = 10.9% to 25.5% vs. intervention 38%, 95% CI = 28.3% to 47.7%; difference = 27.6, 95% CI of difference = 21.5 to 33.7) and knowledge of side effects (usual care median = 1, interquartile range [IQR] 0 to 2 vs. intervention median = 2, IQR = 1 to 2; p < 0.0001). Additionally, those who received the intervention were less likely to have reported driving within 6 hours after taking hydrocodone (usual care 13.6%, 95% CI = 7.2% to 20% vs. intervention 3%, 95% CI = -0.3% to 6.3%; difference = 10.6, 95% CI of difference = 3.4 to 17.9). There was no difference between groups related to knowledge about drinking alcohol while taking hydrocodone (overall 18.1%) or knowledge that the opioid could be addictive (overall 72.4%). This simple strategy improved several, but not all, aspects of patient knowledge and resulted in fewer patients in the intervention arm driving while taking hydrocodone. Integration of a patient education document into conversations about opioids holds promise for improving patient knowledge about these high-risk medications. © 2015 by the Society for Academic Emergency Medicine.

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

PubMed

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

2018-02-01

To compare the efficacy of novel interactive, motion capture-rehabilitation software to usual care stroke rehabilitation on physical function. Randomized controlled clinical trial. Two subacute hospital rehabilitation units in Australia. In all, 73 people less than six months after stroke with reduced mobility and clinician determined capacity to improve. 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. Primary outcome was standing balance (functional reach). Secondary outcomes were lateral reach, step test, sitting balance, arm function, and walking. 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. 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.

The efficacy of SMART Arm training early after stroke for stroke survivors with severe upper limb disability: a protocol for a randomised controlled trial.

PubMed

Brauer, Sandra G; Hayward, Kathryn S; Carson, Richard G; Cresswell, Andrew G; Barker, Ruth N

2013-07-02

Recovery of upper limb function after stroke is poor. The acute to subacute phase after stroke is the optimal time window to promote the recovery of upper limb function. The dose and content of training provided conventionally during this phase is however, unlikely to be adequate to drive functional recovery, especially in the presence of severe motor disability. The current study concerns an approach to address this shortcoming, through evaluation of the SMART Arm, a non-robotic device that enables intensive and repetitive practice of reaching by stroke survivors with severe upper limb disability, with the aim of improving upper limb function. The outcomes of SMART Arm training with or without outcome-triggered electrical stimulation (OT-stim) to augment movement and usual therapy will be compared to usual therapy alone. A prospective, assessor-blinded parallel, three-group randomised controlled trial is being conducted. Seventy-five participants with a first-ever unilateral stroke less than 4 months previously, who present with severe arm disability (three or fewer out of a possible six points on the Motor Assessment Scale [MAS] Item 6), will be recruited from inpatient rehabilitation facilities. Participants will be randomly allocated to one of three dose-matched groups: SMART Arm training with OT-stim and usual therapy; SMART Arm training without OT-stim and usual therapy; or usual therapy alone. All participants will receive 20 hours of upper limb training over four weeks. Blinded assessors will conduct four assessments: pre intervention (0-weeks), post intervention (4-weeks), 26 weeks and 52 weeks follow-up. The primary outcome measure is MAS item 6. All analyses will be based on an intention-to-treat principle. By enabling intensive and repetitive practice of a functional upper limb task during inpatient rehabilitation, SMART Arm training with or without OT-stim in combination with usual therapy, has the potential to improve recovery of upper limb function in those with severe motor disability. The immediate and long-term effects of SMART Arm training on upper limb impairment, activity and participation will be explored, in addition to the benefit of training with or without OT-stim to augment movement when compared to usual therapy alone. ACTRN12608000457347.

Translational control of a graphically simulated robot arm by kinematic rate equations that overcome elbow joint singularity

NASA Technical Reports Server (NTRS)

Barker, L. K.; Houck, J. A.; Carzoo, S. W.

1984-01-01

An operator commands a robot hand to move in a certain direction relative to its own axis system by specifying a velocity in that direction. This velocity command is then resolved into individual joint rotational velocities in the robot arm to effect the motion. However, the usual resolved-rate equations become singular when the robot arm is straightened. To overcome this elbow joint singularity, equations were developed which allow continued translational control of the robot hand even though the robot arm is (or is nearly) fully extended. A feature of the equations near full arm extension is that an operator simply extends and retracts the robot arm to reverse the direction of the elbow bend (difficult maneuver for the usual resolved-rate equations). Results show successful movement of a graphically simulated robot arm.

Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial.

PubMed

Ong, Michael K; Romano, Patrick S; Edgington, Sarah; Aronow, Harriet U; Auerbach, Andrew D; Black, Jeanne T; De Marco, Teresa; Escarce, Jose J; Evangelista, Lorraine S; Hanna, Barbara; Ganiats, Theodore G; Greenberg, Barry H; Greenfield, Sheldon; Kaplan, Sherrie H; Kimchi, Asher; Liu, Honghu; Lombardo, Dawn; Mangione, Carol M; Sadeghi, Bahman; Sadeghi, Banafsheh; Sarrafzadeh, Majid; Tong, Kathleen; Fonarow, Gregg C

2016-03-01

It remains unclear whether telemonitoring approaches provide benefits for patients with heart failure (HF) after hospitalization. To evaluate the effectiveness of a care transition intervention using remote patient monitoring in reducing 180-day all-cause readmissions among a broad population of older adults hospitalized with HF. We randomized 1437 patients hospitalized for HF between October 12, 2011, and September 30, 2013, to the intervention arm (715 patients) or to the usual care arm (722 patients) of the Better Effectiveness After Transition-Heart Failure (BEAT-HF) study and observed them for 180 days. The dates of our study analysis were March 30, 2014, to October 1, 2015. The setting was 6 academic medical centers in California. Participants were hospitalized individuals 50 years or older who received active treatment for decompensated HF. The intervention combined health coaching telephone calls and telemonitoring. Telemonitoring used electronic equipment that collected daily information about blood pressure, heart rate, symptoms, and weight. Centralized registered nurses conducted telemonitoring reviews, protocolized actions, and telephone calls. The primary outcome was readmission for any cause within 180 days after discharge. Secondary outcomes were all-cause readmission within 30 days, all-cause mortality at 30 and 180 days, and quality of life at 30 and 180 days. Among 1437 participants, the median age was 73 years. Overall, 46.2% (664 of 1437) were female, and 22.0% (316 of 1437) were African American. The intervention and usual care groups did not differ significantly in readmissions for any cause 180 days after discharge, which occurred in 50.8% (363 of 715) and 49.2% (355 of 722) of patients, respectively (adjusted hazard ratio, 1.03; 95% CI, 0.88-1.20; P = .74). In secondary analyses, there were no significant differences in 30-day readmission or 180-day mortality, but there was a significant difference in 180-day quality of life between the intervention and usual care groups. No adverse events were reported. Among patients hospitalized for HF, combined health coaching telephone calls and telemonitoring did not reduce 180-day readmissions. clinicaltrials.gov Identifier: NCT01360203.

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

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

2008-09-01

Dyslipidemia is common in patients with chronic kidney disease. The role of statin therapy in the progression of kidney disease is unclear. Prospective randomized clinical trial, post hoc analyses. 10,060 participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (lipid-lowering component) stratified by baseline estimated glomerular filtration rate (eGFR): less than 60, 60 to 89, and 90 or greater mL/min/1.73 m(2). Mean follow-up was 4.8 years. Randomized; pravastatin, 40 mg/d, or usual care. Total, high-density lipoprotein, and low-density lipoprotein cholesterol; end-stage renal disease (ESRD), eGFR. Through year 6, total cholesterol levels decreased in the pravastatin (-20.7%) and usual-care groups (-11.2%). No significant differences were seen between groups for rates of ESRD (1.36 v 1.45/100 patient-years; P = 0.9), composite end points of ESRD and 50% or 25% decrease in eGFR, or rate of change in eGFR. Findings were consistent across eGFR strata. In patients with eGFR of 90 mL/min/1.73 m(2) or greater, the pravastatin arm tended to have a higher eGFR. 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. In hypertensive patients with moderate dyslipidemia and decreased 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 the degree of the cholesterol level decrease achieved.

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

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

A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options).

PubMed

Tracy, Sally K; Hartz, Donna; Hall, Bev; Allen, Jyai; Forti, Amanda; Lainchbury, Anne; White, Jan; Welsh, Alec; Tracy, Mark; Kildea, Sue

2011-10-26

Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant.Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice.) We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05) to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive care of all neonates from 9.9% to 5.8% (requires 721 in each arm). The study is not powered to detect infant or maternal mortality, however all deaths will be reported. Other significant findings will be reported, including a comprehensive process and economic evaluation. Australian New Zealand Clinical Trials Registry ACTRN12609000349246.

Applied behaviour analysis and standard treatment in intellectual disability: 2-year outcomes.

PubMed

Hassiotis, Angela; Canagasabey, Anton; Robotham, Daniel; Marston, Louise; Romeo, Renee; King, Michael

2011-06-01

Applied behaviour analysis by a specialist team plus standard treatment for adults with intellectual disability displaying challenging behaviour was reported to be clinically and cost-effective after 6 months. In a 2-year follow-up of the same trial cohort, participants receiving the specialist intervention had significantly lower total and subdomain Aberrant Behavior Checklist scores than those receiving usual care alone. After adjustment for baseline covariates there was no significant difference in costs between the trial arms.

Nurse-led motivational interviewing to change the lifestyle of patients with type 2 diabetes (MILD-project): protocol for a cluster, randomized, controlled trial on implementing lifestyle recommendations

PubMed Central

Jansink, Renate; Braspenning, Jozé; van der Weijden, Trudy; Niessen, Louis; Elwyn, Glyn; Grol, Richard

2009-01-01

Background The diabetes of many patients is managed in general practice; healthcare providers aim to promote healthful behaviors, such as healthful diet, adequate physical activity, and smoking cessation. These measures may decrease insulin resistance, improve glycemic control, lipid abnormalities, and hypertension. They may also prevent cardiovascular disease and complications of diabetes. However, professionals do not adhere optimally to guidelines for lifestyle counseling. Motivational interviewing to change the lifestyle of patients with type 2 diabetes is intended to improve diabetes care in accordance with the national guidelines for lifestyle counseling. Primary care nurses will be trained in motivational interviewing embedded in structured care in general practice. The aim of this paper is to describe the design and methods of a study evaluating the effects of the nurses' training on patient outcomes. Methods/Design A cluster, randomized, controlled trial involving 70 general practices (35 practices in the intervention arm and 35 in the control arm) starting in March 2007. A total of 700 patients with type 2 diabetes will be recruited. The patients in the intervention arm will receive care from the primary care nurse, who will receive training in an implementation strategy with motivational interviewing as the core component. Other components of this strategy will be adaptation of the diabetes protocol to local circumstances, introduction of a social map for lifestyle support, and educational and supportive tools for sustaining motivational interviewing. The control arm will be encouraged to maintain usual care. The effect measures will be the care process, metabolic parameters (glycosylated hemoglobin, blood pressure and lipids), lifestyle (diet, physical activity, smoking, and alcohol), health-related quality of life, and patients' willingness to change behaviors. The measurements will take place at baseline and after 14 months. Discussion Applying motivational interviewing for patients with diabetes in primary care has been studied, but to our knowledge, no other study has yet evaluated the implementation and sustainability of motivating and involving patients in day-to-day diabetes care in general practice. If this intervention proves to be effective and cost-effective, large-scale implementation of this nurse-oriented intervention will be considered and anticipated. Trial registration Current Controlled Trials ISRCTN68707773. PMID:19183462

Goal-setting intervention in patients with active asthma: protocol for a pilot cluster-randomised controlled trial

PubMed Central

2013-01-01

Background Supporting self-management behaviours is recommended guidance for people with asthma. Preliminary work suggests that a brief, intensive, patient-centred intervention may be successful in supporting people with asthma to participate in life roles and activities they value. We seek to assess the feasibility of undertaking a cluster-randomised controlled trial (cRCT) of a brief, goal-setting intervention delivered in the context of an asthma review consultation. Methods/design A two armed, single-blinded, multi-centre, cluster-randomised controlled feasibility trial will be conducted in UK primary care. Randomisation will take place at the practice level. We aim to recruit a total of 80 primary care patients with active asthma from at least eight practices across two health boards in Scotland (10 patients per practice resulting in ~40 in each arm). Patients in the intervention arm will be asked to complete a novel goal-setting tool immediately prior to an asthma review consultation. This will be used to underpin a focussed discussion about their goals during the asthma review. A tailored management plan will then be negotiated to facilitate achieving their prioritised goals. Patients in the control arm will receive a usual care guideline-based review of asthma. Data on quality of life, asthma control and patient confidence will be collected from both arms at baseline and 3 and 6 months post-intervention. Data on health services resource use will be collected from all patient records 6 months pre- and post-intervention. Semi-structured interviews will be carried out with healthcare staff and a purposive sample of patients to elicit their views and experiences of the trial. The outcomes of interest in this feasibility trial are the ability to recruit patients and healthcare staff, the optimal method of delivering the intervention within routine clinical practice, and acceptability and perceived utility of the intervention among patients and staff. Trial registration ISRCTN18912042 PMID:24021033

A centralized mailed program with stepped increases of support increases time in compliance with colorectal cancer screening guidelines over 5 years: A randomized trial.

PubMed

Green, Beverly B; Anderson, Melissa L; Cook, Andrea J; Chubak, Jessica; Fuller, Sharon; Meenan, Richard T; Vernon, Sally W

2017-11-15

Screening over many years is required to optimize reductions in colorectal cancer (CRC) mortality. However, no prior trials have compared strategies for obtaining long-term adherence. Systems of Support to Increase Colorectal Cancer Screening and Follow-Up was implemented in an integrated health care organization in Washington State. Between 2008 and 2009, 4675 individuals aged 50 to 74 years were randomized to receive the usual care (UC), which included clinic-based strategies to increase CRC screening (arm 1), or, in years 1 and 2, mailings with a call-in number for colonoscopy and mailed fecal tests (arm 2), mailings plus brief telephone assistance (arm 3), or mailings and assistance plus nurse navigation (arm 4). Active-intervention subjects (those in arms 2, 3, and 4 combined) who were still eligible for CRC screening were randomized to mailings being stopped or continued in years 3 and 5. The time in compliance with CRC screening over 5 years was compared for persons assigned to any intervention and persons assigned to UC. Screening tests contributed time on the basis of national guidelines for screening intervals (fecal tests annually, sigmoidoscopy every 5 years, and colonoscopy every 10 years). All participants contributed data, but they were censored at disenrollment, death, the age of 76 years, or a diagnosis of CRC. Compared with UC participants, intervention participants had 31% more adjusted covered time over 5 years (incidence rate ratio, 1.31; 95% confidence interval, 1.25-1.37; covered time, 47.5% vs 62.1%). Fecal testing accounted for almost all additional covered time. In a health care organization with clinic-based activities to increase CRC screening, a centralized program led to increased CRC screening adherence over 5 years. Longer term data on screening adherence and its impact on CRC outcomes are needed. Cancer 2017;123:4472-80. © 2017 American Cancer Society. © 2017 American Cancer Society.

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

PubMed

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

2016-08-01

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

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

PubMed

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

2013-04-11

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

Pharmacist-led management of chronic pain in primary care: results from a randomised controlled exploratory trial

PubMed Central

Bruhn, Hanne; Bond, Christine M; Elliott, Alison M; Hannaford, Philip C; Lee, Amanda J; McNamee, Paul; Smith, Blair H; Watson, Margaret C; Holland, Richard; Wright, David

2013-01-01

Objectives To compare the effectiveness of pharmacist medication review, with or without pharmacist prescribing, with standard care, for patients with chronic pain. Design An exploratory randomised controlled trial. Setting Six general practices with prescribing pharmacists in Grampian (3) and East Anglia (3). Participants Patients on repeat prescribed pain medication (4815) were screened by general practitioners (GPs), and mailed invitations (1397). 196 were randomised and 180 (92%) completed. Exclusion criteria included: severe mental illness, terminally ill, cancer related pain, history of addiction. Randomisation and intervention Patients were randomised using a remote telephone service to: (1) pharmacist medication review with face-to-face pharmacist prescribing; (2) pharmacist medication review with feedback to GP and no planned patient contact or (3) treatment as usual (TAU). Blinding was not possible. Outcome measures Outcomes were the SF-12v2, the Chronic Pain Grade (CPG), the Health Utilities Index 3 and the Hospital Anxiety and Depression Scale (HADS). Outcomes were collected at 0, 3 and 6 months. Results In the prescribing arm (n=70) two patients were excluded/nine withdrew. In the review arm (n=63) one was excluded/three withdrew. In the TAU arm (n=63) four withdrew. Compared with baseline, patients had an improved CPG in the prescribing arm, 47.7% (21/44; p=0.003) and in the review arm, 38.6% (17/44; p=0.001), but not the TAU group, 31.3% (15/48; ns). The SF-12 Physical Component Score showed no effect in the prescribing or review arms but improvement in TAU (p=0.02). The SF-12 Mental Component Score showed no effect for the prescribing or review arms and deterioration in the TAU arm (p=0.002). HADS scores improved within the prescribing arm for depression (p=0.022) and anxiety (p=0.007), between groups (p=0.022 and p=0.045, respectively). Conclusions This is the first randomised controlled trial of pharmacist prescribing in the UK, and suggests that there may be a benefit for patients with chronic pain. A larger trial is required. Trial registration: www.isrctn.org/ISRCTN06131530. Medical Research Council funding. PMID:23562814

Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records—REDUCE Trial study original protocol

PubMed Central

Juszczyk, Dorota; Charlton, Judith; McDermott, Lisa; Soames, Jamie; Sultana, Kirin; Ashworth, Mark; Fox, Robin; Hay, Alastair D; Little, Paul; Moore, Michael V; Yardley, Lucy; Prevost, A Toby; Gulliford, Martin C

2016-01-01

Introduction Respiratory tract infections (RTIs) account for about 60% of antibiotics prescribed in primary care. This study aims to test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multicomponent interventions to reduce unnecessary antibiotic prescribing when patients consult for RTIs in primary care. The research will specifically evaluate the effectiveness of feeding back electronic health records (EHRs) data to general practices. Methods and analysis 2-arm cluster randomised trial using the EHRs of the Clinical Practice Research Datalink (CPRD). General practices in England, Scotland, Wales and Northern Ireland are being recruited and the general population of all ages represents the target population. Control trial arm practices will continue with usual care. Practices in the intervention arm will receive complex multicomponent interventions, delivered remotely to information systems, including (1) feedback of each practice's antibiotic prescribing through monthly antibiotic prescribing reports estimated from CPRD data; (2) delivery of educational and decision support tools; (3) a webinar to explain and promote effective usage of the intervention. The intervention will continue for 12 months. Outcomes will be evaluated from CPRD EHRs. The primary outcome will be the number of antibiotic prescriptions for RTIs per 1000 patient years. Secondary outcomes will be: the RTI consultation rate; the proportion of consultations for RTI with an antibiotic prescribed; subgroups of age; different categories of RTI and quartiles of intervention usage. There will be more than 80% power to detect an absolute reduction in antibiotic prescription for RTI of 12 per 1000 registered patient years. Total healthcare usage will be estimated from CPRD data and compared between trial arms. Ethics and dissemination Trial protocol was approved by the National Research Ethics Service Committee (14/LO/1730). The pragmatic design of the trial will enable subsequent translation of effective interventions at scale in order to achieve population impact. Trial registration number ISRCTN95232781; Pre-results. PMID:27491663

Impact of a pharmacist-delivered discharge and follow-up intervention for patients with acute coronary syndromes in Qatar: a study protocol for a randomised controlled trial.

PubMed

Zidan, Amani; Awaisu, Ahmed; Kheir, Nadir; Mahfoud, Ziyad; Kaddoura, Rasha; AlYafei, Sumaya; El Hajj, Maguy Saffouh

2016-11-18

Acute coronary syndrome (ACS) is one of the leading causes of morbidity and mortality worldwide. Secondary cardiovascular risk reduction therapy (consisting of an aspirin, a β-blocker, an ACE inhibitor or an angiotensin II receptor blocker and a statin) is needed for all patients with ACS. Less than 80% of patients with ACS in Qatar use this combination after discharge. This study is aimed to evaluate the effectiveness of clinical pharmacist-delivered intervention at discharge and tailored follow-up postdischarge on decreasing hospital readmissions, emergency department (ED) visits and mortality among patients with ACS. A prospective, randomised controlled trial will be conducted at the Heart Hospital in Qatar. Patients are eligible for enrolment if they are at least 18 years of age and are discharged from any non-surgical cardiology service with ACS. Participants will be randomised into 1 of 3 arms: (1) 'control' arm which includes patients discharged during weekends or after hours; (2) 'clinical pharmacist delivered usual care at discharge' arm which includes patients receiving the usual care at discharge by clinical pharmacists; and (3) 'clinical pharmacist-delivered structured intervention at discharge and tailored follow-up postdischarge' arm which includes patients receiving intensive structured discharge interventions in addition to 2 follow-up sessions by intervention clinical pharmacists. Outcomes will be measured by blinded research assistants at 3, 6 and 12 months after discharge and will include: all-cause hospitalisations and cardiac-related hospital readmissions (primary outcome), all-cause mortality including cardiac-related mortality, ED visits including cardiac-related ED visits, adherence to medications and treatment burden. Percentage of readmissions between the 3 arms will be compared on intent-to-treat basis using χ 2 test with Bonferroni's adjusted pairwise comparisons if needed. The study was ethically approved by the Qatar University and the Hamad Medical Corporation Institutional Review Boards. The results shall be disseminated in international conferences and peer-reviewed publications. NCT02648243; pre-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/.

Effect of Information and Telephone-Guided Access to Community Support for People with Chronic Kidney Disease: Randomised Controlled Trial

PubMed Central

Blakeman, Tom; Blickem, Christian; Kennedy, Anne; Reeves, David; Bower, Peter; Gaffney, Hannah; Gardner, Caroline; Lee, Victoria; Jariwala, Praksha; Dawson, Shoba; Mossabir, Rahena; Brooks, Helen; Richardson, Gerry; Spackman, Eldon; Vassilev, Ivaylo; Chew-Graham, Carolyn; Rogers, Anne

2014-01-01

Background Implementation of self-management support in traditional primary care settings has proved difficult, encouraging the development of alternative models which actively link to community resources. Chronic kidney disease (CKD) is a common condition usually diagnosed in the presence of other co-morbidities. This trial aimed to determine the effectiveness of an intervention to provide information and telephone-guided access to community support versus usual care for patients with stage 3 CKD. Methods and Findings In a pragmatic, two-arm, patient level randomised controlled trial 436 patients with a diagnosis of stage 3 CKD were recruited from 24 general practices in Greater Manchester. Patients were randomised to intervention (215) or usual care (221). Primary outcome measures were health related quality of life (EQ-5D health questionnaire), blood pressure control, and positive and active engagement in life (heiQ) at 6 months. At 6 months, mean health related quality of life was significantly higher for the intervention group (adjusted mean difference = 0.05; 95% CI = 0.01, 0.08) and blood pressure was controlled for a significantly greater proportion of patients in the intervention group (adjusted odds-ratio = 1.85; 95% CI = 1.25, 2.72). Patients did not differ significantly in positive and active engagement in life. The intervention group reported a reduction in costs compared with control. Conclusions An intervention to provide tailored information and telephone-guided access to community resources was associated with modest but significant improvements in health related quality of life and better maintenance of blood pressure control for patients with stage 3 CKD compared with usual care. However, further research is required to identify the mechanisms of action of the intervention. Trial Registration Controlled-Trials.com ISRCTN45433299 PMID:25330169

Linking clinic and home: a randomized, controlled clinical effectiveness trial of real-time, wireless blood pressure monitoring for older patients with kidney disease and hypertension.

PubMed

Rifkin, Dena E; Abdelmalek, Joseph A; Miracle, Cynthia M; Low, Chai; Barsotti, Ryan; Rios, Phil; Stepnowsky, Carl; Agha, Zia

2013-02-01

Older adults with chronic kidney disease have a high rate of uncontrolled hypertension. Home monitoring of blood pressure (BP) is an integral part of management, but requires that patients bring records to clinic visits. Telemonitoring interventions, however, have not targeted older, less technologically-skilled populations. Veterans with stage 3 or greater chronic kidney disease and uncontrolled hypertension were randomized to a novel telemonitoring device pairing a Bluetooth-enabled BP cuff with an Internet-enabled hub, which wirelessly transmitted readings (n=28), or usual care (n=15). Home recordings were reviewed weekly and telemonitoring participants were contacted if BP was above goal. The prespecified primary endpoints were improved data exchange and device acceptability. Secondary endpoint was BP change. Forty-three participants (average age 68 years, 75% white) completed the 6-month study. Average start-of-study BP was 147/78 mmHg. Those in the intervention arm had a median of 29 (IQR 22, 53) transmitted BP readings per month, with 78% continuing to use the device regularly, whereas only 20% of those in the usual care group brought readings to in-person visits. The median number of telephone contacts triggered by the wireless monitoring was 2 (IQR 1, 4) per patient. Both groups had a significant improvement in systolic BP (P<0.05, for both changes); systolic BP fell a median of 13 mmHg in monitored participants compared with 8.5 mmHg in usual care participants (P for comparison 0.31). This low-cost wireless monitoring strategy led to greater sharing of data between patients and clinic and produced a trend toward improvements in BP control over usual care at 6 months.

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

PubMed

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

2018-05-01

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

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

PubMed

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

2013-05-01

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

Circuit class therapy and 7-day-week therapy increase physiotherapy time, but not patient activity: early results from the CIRCIT trial.

PubMed

English, Coralie; Bernhardt, Julie; Hillier, Susan

2014-10-01

The optimum model of physiotherapy service delivery for maximizing active task practice during rehabilitation after stroke is unknown. The purpose of the study was to examine the relative effectiveness of 2 alternative models of physiotherapy service delivery against a usual care control with regard to increasing patient activity. Substudy within a large 3-armed randomized controlled trial, which compared 3 different models of physiotherapy service delivery, was provided for 4 weeks during subacute, inpatient rehabilitation (n=283). The duration of all physiotherapy sessions was recorded. In addition, 32 participants were observed at 10-minute intervals for 1 weekday and 1 weekend day between 8:00 am and 4:30 pm. At each observation, we recorded physical activity, location, and people present. Participants receiving 7-day-week and circuit class therapy received an additional 3 hours and 22 hours of physiotherapy time, respectively, when compared with usual care. Participants were standing or walking for a median of 8.2% of observations. On weekdays, circuit class therapy participants spent more time in therapy-related activity (10.2% of observations) when compared with usual care participants (6.1% of observations). On weekends, 7-day therapy participants spent more time in therapy-related activity (4.2% of observations) when compared with both usual care and circuit class therapy participants (0% of observations for both groups). Activity levels outside of therapy sessions did not differ between groups. A greater dosage of physiotherapy time did not translate into meaningful increases in physical activity across the day. http://www.anzctr.org.au/. Unique identifier: ACTRN12610000096055. © 2014 American Heart Association, Inc.

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

Electronic medication complete communication strategy for opioid prescriptions in the emergency department: Rationale and design for a three-arm provider randomized trial.

PubMed

McCarthy, Danielle M; Courtney, D Mark; Lank, Patrick M; Cameron, Kenzie A; Russell, Andrea M; Curtis, Laura M; Kim, Kwang-Youn A; Walton, Surrey M; Montague, Enid; Lyden, Abbie L; Gravenor, Stephanie J; Wolf, Michael S

2017-08-01

Thousands of people die annually from prescription opioid overdoses; however there are few strategies to ensure patients receive medication risk information at the time of prescribing. To compare the effectiveness of the Emergency Department (ED) Electronic Medication Complete Communication (EMC 2 ) Opioid Strategy (with and without text messaging) to promote safe medication use and improved patient knowledge as compared to usual care. The ED EMC 2 Opioid Strategy consists of 5 automated components to promote safe medication use: 1) physician reminder to counsel, 2) inbox message sent on to the patient's primary care physician, 3) pharmacist message on the prescription to counsel, 4) MedSheet supporting prescription information, and 5) patient-centered Take-Wait-Stop wording of prescription instructions. This strategy will be assessed both with and without the addition of text messages via a three-arm randomized trial. The study will take place at an urban academic ED (annual volume>85,000) in Chicago, IL. Patients being discharged with a new prescription for hydrocodone-acetaminophen will be enrolled and randomized (based on their prescribing physician). The primary outcome of the study is medication safe use as measured by a demonstrated dosing task. Additionally actual safe use, patient knowledge and provider counseling will be measured. Implementation fidelity as well as costs will be reported. The ED EMC 2 Opioid Strategy embeds a risk communication strategy into the electronic health record and promotes medication counseling with minimal workflow disruption. This trial will evaluate the strategy's effectiveness and implementation fidelity as compared to usual care. This trial is registered on clinicaltrials.gov with identifier NCT02431793. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

The effects of a home-based arm ergometry exercise programme on physical fitness, fatigue and activity in Polio survivors: a randomised controlled trial.

PubMed

Murray, D; Hardiman, O; Campion, A; Vance, R; Horgan, F; Meldrum, D

2017-07-01

To investigate the effect of an eight-week home-based arm ergometry aerobic exercise programme on physical fitness, fatigue, activity and quality of life in Polio Survivors. An assessor blinded randomised controlled trial. Home-based exercise. Fifty-five Polio survivors randomised to exercise or control groups. Home-based arm ergometry at an intensity of 50%-70% maximum heart rate, compared with usual physiotherapy care. The Six-minute Arm Test, Fatigue Severity Scale, Physical Activity Scale for Individuals with Physical Disabilities and SF-36. Assessments were completed at baseline and at eight weeks. There was no significant difference in the primary outcome, exercising heart rate during the Six-minute Arm Test, between the groups at follow-up [97.6 (SD10.1) compared to 102.4 (SD13.7) beats per minute ( P=0.20)]. Blood pressure was significantly lower in the intervention group at follow-up [systolic blood pressure 132(18.6)mmHg compared to 144.1(14.6)mmHg ( P=0.002)]. There were no between group differences in the Fatigue Severity Scale ( P=0.25) or Physical Activity Scale for Individuals with Physical Disabilities ( P=0.49), with a small difference in SF-36 physical component score ( P=0.04). This home-based arm ergometry programme successfully facilitated aerobic exercise in Polio Survivors, but did not result in a significant change in physical fitness, measured by the Six-minute Arm Test.

Reduction of inappropriate benzodiazepine prescriptions among older adults through direct patient education: the EMPOWER cluster randomized trial.

PubMed

Tannenbaum, Cara; Martin, Philippe; Tamblyn, Robyn; Benedetti, Andrea; Ahmed, Sara

2014-06-01

The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults 65 years and older. The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown. To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults. Cluster randomized trial (EMPOWER [Eliminating Medications Through Patient Ownership of End Results] study [2010-2012, 6-month follow-up]). Community pharmacies were randomly allocated to the intervention or control arm in nonstratified, blocked groups of 4. Participants (303 long-term users of benzodiazepine medication aged 65-95 years, recruited from 30 community pharmacies) were screened and enrolled prior to randomization: 15 pharmacies randomized to the educational intervention included 148 participants and 15 pharmacies randomized to the "wait list" control included 155 participants. Participants, physicians, pharmacists, and evaluators were blinded to outcome assessment. The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol. The control arm received usual care. Benzodiazepine therapy discontinuation at 6 months after randomization, ascertained by pharmacy medication renewal profiles. A total of 261 participants (86%) completed the 6-month follow-up. Of the recipients in the intervention group, 62% initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist. At 6 months, 27% of the intervention group had discontinued benzodiazepine use compared with 5% of the control group (risk difference, 23% [95% CI, 14%-32%]; intracluster correlation, 0.008; number needed to treat, 4). Dose reduction occurred in an additional 11% (95% CI, 6%-16%). In multivariate subanalyses, age greater than 80 years, sex, duration of use, indication for use, dose, previous attempt to taper, and concomitant polypharmacy (10 drugs or more per day) did not have a significant interaction effect with benzodiazepine therapy discontinuation. Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults. clinicaltrials.gov Identifier: NCT01148186.

Randomised controlled trial of exercise to prevent shoulder problems in women undergoing breast cancer treatment: study protocol for the prevention of shoulder problems trial (UK PROSPER).

PubMed

Bruce, Julie; Williamson, Esther; Lait, Clare; Richmond, Helen; Betteley, Lauren; Lall, Ranjit; Petrou, Stavros; Rees, Sophie; Withers, Emma J; Lamb, Sarah E; Thompson, Alastair M

2018-03-23

Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions. The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. Version 2.1; dated 11 January 2017 TRIAL REGISTRATION NUMBER: ISRCTN35358984; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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.

The Children and Parents in Focus project: a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children.

PubMed

Salari, Raziye; Fabian, Helena; Prinz, Ron; Lucas, Steven; Feldman, Inna; Fairchild, Amanda; Sarkadi, Anna

2013-10-16

There is large body of knowledge to support the importance of early interventions to improve child health and development. Nonetheless, it is important to identify cost-effective blends of preventive interventions with adequate coverage and feasible delivery modes. The aim of the Children and Parents in Focus trial is to compare two levels of parenting programme intensity and rate of exposure, with a control condition to address impact and cost-effectiveness of a universally offered evidence-based parenting programme in the Swedish context. The trial has a cluster randomised controlled design comprising three arms: Universal arm (with access to participation in Triple P - Positive Parenting Program, level 2); Universal Plus arm (with access to participation in Triple P - Positive Parenting Program, level 2 as well as level 3, and level 4 group); and Services as Usual arm. The sampling frame is Uppsala municipality in Sweden. Child health centres consecutively recruit parents of children aged 3 to 5 years before their yearly check-ups (during the years 2013-2017). Outcomes will be measured annually. The primary outcome will be children's behavioural and emotional problems as rated by three informants: fathers, mothers and preschool teachers. The other outcomes will be parents' behaviour and parents' general health. Health economic evaluations will analyse cost-effectiveness of the interventions versus care as usual by comparing the costs and consequences in terms of impact on children's mental health, parent's mental health and health-related quality of life. This study addresses the need for comprehensive evaluation of the long-term effects, costs and benefits of early parenting interventions embedded within existing systems. In addition, the study will generate population-based data on the mental health and well-being of preschool aged children in Sweden. ISRCTN16513449.

Comparative Effectiveness of Proactive Tobacco Treatment among Smokers with and without Chronic Lower Respiratory Disease.

PubMed

Melzer, Anne C; Clothier, Barbara A; Japuntich, Sandra J; Noorbaloochi, Siamak; Hammett, Patrick; Burgess, Diana J; Joseph, Anne M; Fu, Steven S

2018-03-01

Adults with chronic lower respiratory disease differ in their barriers to smoking cessation but also suffer from tobacco-related health concerns, which may motivate quit attempts. Few studies have examined differences in tobacco treatment response between smokers with and without chronic lower respiratory disease. We examined the effectiveness of a proactive outreach program for cessation among smokers with and without chronic lower respiratory disease. Subgroup analysis of the Veterans Victory over Tobacco Study, a pragmatic randomized controlled trial that demonstrated the effectiveness of proactive outreach and the choice of tobacco treatments compared with usual care. Smokers identified via the electronic medical record were proactively offered phone-based counseling and care coordination to receive medication from their Veterans Affairs providers or in-person care. We compared the response among those with and without an International Classification of Diseases, 9th Revision diagnosis of a chronic lower respiratory disease (chronic obstructive pulmonary disease, chronic bronchitis, emphysema, asthma). We used stratification by propensity scores to adjust for imbalanced covariates between groups with and without chronic lower respiratory disease within each treatment arm, using complete case analysis accounting for the stratified sampling by site. The study participants were predominantly older, white, male smokers. Overall, 19.6% had chronic lower respiratory disease. A total of 3,307 had outcome data with the following assignments to the intervention: proactive care: n = 1,272 without chronic lower respiratory disease, n = 301 with chronic lower respiratory disease; usual care: n = 1,387 without chronic lower respiratory disease, n = 347 with chronic lower respiratory disease. A total of 1,888 had both complete baseline and outcome data and were included in the primary analysis. In unadjusted analyses (n = 3,307), among individuals with chronic lower respiratory disease, 13.1% in the proactive group reported 6-month prolonged abstinence compared with 8.7% of those in the usual care group (odds ratio, 1.57; 95% confidence interval, 0.93-2.65). Among individuals without chronic lower respiratory disease, 13.1% quit in the proactive group compared with 11.0% in the usual care group (odds ratio, 1.22; 95% confidence interval, 0.95-1.55). In adjusted analyses (n = 1,888), the association between treatment arm and quit rate varied by the presence of chronic lower respiratory disease, with a stronger association between allocation to the proactive group and quit rate among those with chronic lower respiratory disease (odds ratio, 3.45; 95% confidence interval, 1.59-7.47) than those without chronic lower respiratory disease (odds ratio, 1.34; 95% confidence interval, 0.95-1.88; P for interaction with chronic lower respiratory disease = 0.03). Smokers with chronic lower respiratory disease may be more likely to respond to a proactive outreach intervention for tobacco cessation treatment than those without chronic lower respiratory disease. Clinical trial registered with www.clinicaltrials.gov (NCT 00608426).

Cost-effectiveness Analysis of an Aftercare Service vs Treatment-As-Usual for Patients with Severe Mental Disorders.

PubMed

Barfar, Eshagh; Sharifi, Vandad; Amini, Homayoun; Mottaghipour, Yasaman; Yunesian, Masud; Tehranidoost, Mehdi; Sobhebidari, Payam; Rashidian, Arash

2017-09-01

There have been claims that community mental health principles leads to the maintenance of better health and functioning in patients and can be more economical for patients with severe and chronic mental disorders. Economic evaluation studies have been used to assess the cost-effectiveness of national health programs, or to propose efficient strategies for health care delivery. The current study is intended to test the cost-effectiveness of an Aftercare Service when compared with Treatment-As-Usual for patients with severe mental disorders in Iran. This study was a parallel group randomized controlled trial. A total of 160 post-discharge eligible patients were randomized into two equal patient groups, Aftercare Service (that includes either Home Visiting Care, or Telephone Follow-up for outpatient treatment) vs Treatment-As-Usual, using stratified balanced block randomization method. All patients were followed for 12 months after discharge. The perspective of the present study was the societal perspective. The outcome measures were the rate of readmission at the hospitals after discharge, psychotic symptoms, manic symptoms, depressive symptoms, illness severity, global functioning, quality of life, and patients' satisfaction with the services. The costs included the intervention costs and the patient and family costs in the evaluation period. There was no significant difference in effectiveness measures between the two groups. The Aftercare Service arm was about 66,000 US$ cheaper than Treatment-As-Usual arm. The average total cost per patient in the Treatment-As-Usual group was about 4651 USD, while it was reduced to 3823 US$ in the Aftercare Service group; equivalent to a cost reduction of about 800 USD per patient per year. Given that there was no significant difference in effectiveness measures between the two groups (slightly in favor of the intervention), the Aftercare Service was cost-effective. The most important limitation of the study was the relatively small sample size due to limited budget for the implementation of the study. A larger sample size and longer follow-ups are warranted. Considering the limited resources and equity concerns for health systems, the importance of making decisions about healthcare interventions based on cost-effectiveness evidence is increasing. Our results suggest that the aftercare service can be recommended as an efficient service delivery mode, especially when psychiatric bed requirements are insufficient for a population. Further research should continue the work done with a larger sample size and longer follow-ups to further establish the cost-effectiveness analysis of an aftercare service program compared with routine conventional care.

Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV) results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community), participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their best possible outcome and may contribute to a functional decline following discharge from formal rehabilitation. Best practice guidelines recommend a prolonged period of rehabilitation, however this is expensive and therefore not undertaken in most publicly funded centres. An effective, cost-effective, and preference-sensitive therapy using basic technology to assist programme delivery may improve patient autonomy as they leave formal rehabilitation and return home. Trial registration ACTRN12612000464864 PMID:23216861

Overcoming Robot-Arm Joint Singularities

NASA Technical Reports Server (NTRS)

Barker, L. K.; Houck, J. A.

1986-01-01

Kinematic equations allow arm to pass smoothly through singular region. Report discusses mathematical singularities in equations of robotarm control. Operator commands robot arm to move in direction relative to its own axis system by specifying velocity in that direction. Velocity command then resolved into individual-joint rotational velocities in robot arm to effect motion. However, usual resolved-rate equations become singular when robot arm is straightened.

Evaluation of a mobile phone telemonitoring system for glycaemic control in patients with diabetes.

PubMed

Istepanian, Robert S H; Zitouni, Karima; Harry, Diane; Moutosammy, Niva; Sungoor, Ala; Tang, Bee; Earle, Kenneth A

2009-01-01

We conducted a randomized controlled trial using mobile health technology in an ethnically diverse sample of 137 patients with complicated diabetes. Patients in the intervention group (n = 72) were trained to measure their blood glucose with a sensor which transmitted the readings to a mobile phone via a Bluetooth wireless link. Clinicians were then able to examine and respond to the readings which were viewed with a web-based application. Patients in the control arm of the study (n = 65) did not transmit their readings and received care with their usual doctor in the outpatient and/or primary care setting. The mean follow-up period was 9 months in each group. The default rate was higher in the patients in the intervention arm due to technical problems. In an intention-to-treat analysis there were no differences in HbA(1c) between the intervention and control groups. In a sub-group analysis of the patients who completed the study, the telemonitoring group had a lower HbA(1c) than those in the control group: 7.76% and 8.40%, respectively (P = 0.06).

CASINO: surgical or nonsurgical treatment for cervical radiculopathy, a randomised controlled trial.

PubMed

van Geest, Sarita; Kuijper, Barbara; Oterdoom, Marinus; van den Hout, Wilbert; Brand, Ronald; Stijnen, Theo; Assendelft, Pim; Koes, Bart; Jacobs, Wilco; Peul, Wilco; Vleggeert-Lankamp, Carmen

2014-04-14

Cervical radicular syndrome (CRS) due to a herniated disc can be safely treated by surgical decompression of the spinal root. In the vast majority of cases this relieves pain in the arm and restores function. However, conservative treatment also has a high chance on relieving symptoms. The objective of the present study is to evaluate the (cost-) effectiveness of surgery versus prolonged conservative care during one year of follow-up, and to evaluate the timing of surgery. Predisposing factors in favour of one of the two treatments will be evaluated. Patients with disabling radicular arm pain, suffering for at least 2 months, and an MRI-proven herniated cervical disc will be randomised to receive either surgery or prolonged conservative care with surgery if needed. The surgical intervention will be an anterior discectomy or a posterior foraminotomy that is carried out according to usual care. Surgery will take place within 2-4 weeks after randomisation. Conservative care starts immediately after randomisation. The primary outcome measure is the VAS for pain or tingling sensations in the arm one year after randomisation. In addition, timing of surgery will be studied by correlating the primary outcome to the duration of symptoms. Secondary outcome measures encompass quality of life, costs and perceived recovery. Predefined prognostic factors will be evaluated. The total follow-up period will cover two years. A sample size of 400 patients is needed. Statistical analysis will be performed using a linear mixed model which will be based on the 'intention to treat' principle. In addition, a new CRS questionnaire for patients will be developed, the Leiden Cervical Radicular Syndrome Functioning (LCRSF) scale. The outcome will contribute to better decision making for the treatment of cervical radicular syndrome. NTR3504.

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Baseline Findings.

PubMed

Grady, Kathleen L; Hof, Kathleen Van't; Andrei, Adin-Cristian; Shankel, Tamara; Chinnock, Richard; Miyamoto, Shelley; Ambardekar, Amrut V; Anderson, Allen; Addonizio, Linda; Latif, Farhana; Lefkowitz, Debra; Goldberg, Lee; Hollander, Seth A; Pham, Michael; Weissberg-Benchell, Jill; Cool, Nichole; Yancy, Clyde; Pahl, Elfriede

2018-02-01

Young adult solid organ transplant recipients who transfer from pediatric to adult care experience poor outcomes related to decreased adherence to the medical regimen. Our pilot trial for young adults who had heart transplant (HT) who transfer to adult care tests an intervention focused on increasing HT knowledge, self-management and self-advocacy skills, and enhancing support, as compared to usual care. We report baseline findings between groups regarding (1) patient-level outcomes and (2) components of the intervention. From 3/14 to 9/16, 88 subjects enrolled and randomized to intervention (n = 43) or usual care (n = 45) at six pediatric HT centers. Patient self-report questionnaires and medical records data were collected at baseline, and 3 and 6 months after transfer. For this report, baseline findings (at enrollment and prior to transfer to adult care) were analyzed using Chi-square and t-tests. Level of significance was p < 0.05. Baseline demographics were similar in the intervention and usual care arms: age 21.3 ± 3.2 vs 21.5 ± 3.3 years and female 44% vs 49%, respectively. At baseline, there were no differences between intervention and usual care for use of tacrolimus (70 vs 62%); tacrolimus level (mean ± SD = 6.5 ± 2.3 ng/ml vs 5.6 ± 2.3 ng/ml); average of the within patient standard deviation of the baseline mean tacrolimus levels (1.6 vs 1.3); and adherence to the medical regimen [3.6 ± 0.4 vs 3.5 ± 0.5 (1 = hardly ever to 4 = all of the time)], respectively. At baseline, both groups had a modest amount of HT knowledge, were learning self-management and self-advocacy, and perceived they were adequately supported. Baseline findings indicate that transitioning HT recipients lack essential knowledge about HT and have incomplete self-management and self-advocacy skills.

Combined cognitive-strategy and task-specific training improves transfer to untrained activities in sub-acute stroke: An exploratory randomized controlled trial

PubMed Central

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2014-01-01

Purpose The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared to usual outpatient rehabilitation on activity and participation in people less than 3 months post stroke. Methods An exploratory, single blind, randomized controlled trial with a usual care control arm was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either Usual Care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self Efficacy Gauge. Results Thirty-five (35) eligible participants were randomized; 26 completed the intervention. Post-intervention, PQRS change scores demonstrated CO-OP had a medium effect over Usual Care on trained self-selected activities (d=0.5) and a large effect on untrained (d=1.2). At a 3 month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d=1.6) and untrained activities (d=1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and the Self-Efficacy Gauge. Conclusion CO-OP was associated with a large treatment effect on follow up performances of self-selected activities, and demonstrated transfer to untrained activities. A larger trial is warranted. PMID:25416738

Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial.

PubMed

McEwen, Sara; Polatajko, Helene; Baum, Carolyn; Rios, Jorge; Cirone, Dianne; Doherty, Meghan; Wolf, Timothy

2015-07-01

The purpose of this study was to estimate the effect of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach compared with usual outpatient rehabilitation on activity and participation in people <3 months poststroke. An exploratory, single-blind, randomized controlled trial, with a usual-care control arm, was conducted. Participants referred to 2 stroke rehabilitation outpatient programs were randomized to receive either usual care or CO-OP. The primary outcome was actual performance of trained and untrained self-selected activities, measured using the Performance Quality Rating Scale (PQRS). Additional outcomes included the Canadian Occupational Performance Measure (COPM), the Stroke Impact Scale Participation Domain, the Community Participation Index, and the Self-Efficacy Gauge. A total of 35 eligible participants were randomized; 26 completed the intervention. Post intervention, PQRS change scores demonstrated that CO-OP had a medium effect over usual care on trained self-selected activities (d = 0.5) and a large effect on untrained activities (d = 1.2). At a 3-month follow-up, PQRS change scores indicated a large effect of CO-OP on both trained (d = 1.6) and untrained activities (d = 1.1). CO-OP had a small effect on COPM and a medium effect on the Community Participation Index perceived control and on the Self-Efficacy Gauge. CO-OP was associated with a large treatment effect on follow-up performances of self-selected activities and demonstrated transfer to untrained activities. A larger trial is warranted. © The Author(s) 2014.

Housing First Improves Adherence to Antipsychotic Medication Among Formerly Homeless Adults With Schizophrenia: Results of a Randomized Controlled Trial

PubMed Central

Moniruzzaman, Akm; Fazel, Seena; McCandless, Lawrence; Procyshyn, Ric; Somers, Julian M.

2017-01-01

Abstract Adherence to antipsychotic medication is a significant challenge among homeless patients. No experimental trials have investigated the impact of Housing First on adherence among patients with schizophrenia. We investigated whether Housing First in congregate and scattered-site configurations resulted in superior adherence compared to usual care. Adult participants (n = 165) met criteria for homelessness, schizophrenia, and initiation of antipsychotic pharmacotherapy prior to recruitment to an unblinded, 3-arm randomized controlled trial in Vancouver, Canada. Randomization arms were: congregate Housing First (CHF) with on-site supports (including physician and pharmacy services); scattered-site Housing First (SHF) with Assertive Community Treatment; or treatment as usual (TAU) consisting of existing services. Participants were followed for an average of 2.6 years. Adherence to antipsychotic medication was measured using the medication possession ratio (MPR), and 1-way ANOVA was used to compare outcomes between the 3 conditions. Data were drawn from comprehensive pharmacy records. Prior to randomization, mean MPR among participants was very low (0.44–0.48). Mean MPR in the follow-up period was significantly different between study arms (P < .001) and approached the guideline threshold of 0.80 in SHF. Compared to TAU, antipsychotic adherence was significantly higher in SHF but not in CHF. The results demonstrate that further implementation of SHF is indicated among homeless people with schizophrenia, and that urgent action is needed to address very low levels of antipsychotic adherence in this population (trial registration: ISRCTN57595077). PMID:27665002

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial

PubMed Central

Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-01-01

Background Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Objective Here, we present the protocol for a new study (Suivi A Grande Echelle d’une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. Methods TELESAGE is a multicenter, double-randomized, open-label, three parallel–arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist’s task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. Results The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. Conclusions The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. Trial Registration ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd) PMID:29674306

Armed and Aging: Dementia and Firearms Do Not Mix !

PubMed

Cipriani, Gabriele; Danti, Sabrina; Carlesi, Cecilia; Di Fiorino, Mario

2017-01-01

The possibility that persons with dementia possess firearms is cause for concern, but only a limited number of research studies have been conducted on such a topic, usually in the form of case reports. Reducing the occurrence of the firearm-related violence requires effectively identifying dangerous individuals and keeping firearms out of their hands. The health care professionals, i.e. the social workers and the physicians, need to work together and to produce a suitable evaluation of patients with dementia to prevent firearm-related injuries and serious and irreparable damage to persons.

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

A Remote Collaborative Care Program for Patients with Depression Living in Rural Areas: Open-Label Trial

PubMed Central

Rojas, Graciela; Guajardo, Viviana; Castro, Ariel; Fritsch, Rosemarie; Moessner, Markus; Bauer, Stephanie

2018-01-01

Background In the treatment of depression, primary care teams have an essential role, but they are most effective when inserted into a collaborative care model for disease management. In rural areas, the shortage of specialized mental health resources may hamper management of depressed patients. Objective The aim was to test the feasibility, acceptability, and effectiveness of a remote collaborative care program for patients with depression living in rural areas. Methods In a nonrandomized, open-label (blinded outcome assessor), two-arm clinical trial, physicians from 15 rural community hospitals recruited 250 patients aged 18 to 70 years with a major depressive episode (DSM-IV criteria). Patients were assigned to the remote collaborative care program (n=111) or to usual care (n=139). The remote collaborative care program used Web-based shared clinical records between rural primary care teams and a specialized/centralized mental health team, telephone monitoring of patients, and remote supervision by psychiatrists through the Web-based shared clinical records and/or telephone. Depressive symptoms, health-related quality of life, service use, and patient satisfaction were measured 3 and 6 months after baseline assessment. Results Six-month follow-up assessments were completed by 84.4% (221/250) of patients. The remote collaborative care program achieved higher user satisfaction (odds ratio [OR] 1.94, 95% CI 1.25-3.00) and better treatment adherence rates (OR 1.81, 95% CI 1.02-3.19) at 6 months compared to usual care. There were no statically significant differences in depressive symptoms between the remote collaborative care program and usual care. Significant differences between groups in favor of remote collaborative care program were observed at 3 months for mental health-related quality of life (beta 3.11, 95% CI 0.19-6.02). Conclusions Higher rates of treatment adherence in the remote collaborative care program suggest that technology-assisted interventions may help rural primary care teams in the management of depressive patients. Future cost-effectiveness studies are needed. Trial Registration Clinicaltrials.gov NCT02200367; https://clinicaltrials.gov/ct2/show/NCT02200367 (Archived by WebCite at http://www.webcitation.org/6xtZ7OijZ) PMID:29712627

Health behaviour change interventions for couples: A systematic review.

PubMed

Arden-Close, Emily; McGrath, Nuala

2017-05-01

Partners are a significant influence on individuals' health, and concordance in health behaviours increases over time in couples. Several theories suggest that couple-focused interventions for health behaviour change may therefore be more effective than individual interventions. A systematic review of health behaviour change interventions for couples was conducted. Systematic search methods identified randomized controlled trials (RCTs) and non-randomized interventions of health behaviour change for couples with at least one member at risk of a chronic physical illness, published from 1990-2014. We identified 14 studies, targeting the following health behaviours: cancer prevention (6), obesity (1), diet (2), smoking in pregnancy (2), physical activity (1) and multiple health behaviours (2). In four out of seven trials couple-focused interventions were more effective than usual care. Of four RCTs comparing a couple-focused intervention to an individual intervention, two found that the couple-focused intervention was more effective. The studies were heterogeneous, and included participants at risk of a variety of illnesses. In many cases the intervention was compared to usual care for an individual or an individual-focused intervention, which meant the impact of the couplebased content could not be isolated. Three arm studies could determine whether any added benefits of couple-focused interventions are due to adding the partner or specific content of couple-focused interventions. Statement of contribution What is already known on this subject? Health behaviours and health behaviour change are more often concordant across couples than between individuals in the general population. Couple-focused interventions for chronic conditions are more effective than individual interventions or usual care (Martire, Schulz, Helgeson, Small, & Saghafi, ). What does this study add? Identified studies targeted a variety of health behaviours, with few studies in any one area. Further assessment of the effectiveness of couple-focused versus individual interventions for those at risk is needed. Three-arm study designs are needed to determine benefits of targeting couples versus couple-focused intervention content. © 2017 The Authors. British Journal of Health Psychology published by John Wiley & Sons Ltd on behalf of the British Psychological Society.

Osteoporosis improvement: a large-scale randomized controlled trial of patient and primary care physician education.

PubMed

Solomon, Daniel H; Katz, Jeffrey N; Finkelstein, Joel S; Polinski, Jennifer M; Stedman, Margaret; Brookhart, M Alan; Arnold, Marilyn; Gauthier, Suzanne; Avorn, Jerry

2007-11-01

We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. There was no difference in the probability of the primary composite endpoint (BMD test or osteoporosis medication) or in either of its components comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). Fractures from osteoporosis are associated with substantial morbidity, mortality, and cost. However, only a minority of at-risk older adults receives screening and/or treatment for this condition. We evaluated the effect of educational interventions for osteoporosis targeting at-risk patients, primary care physicians, or both. We conducted a randomized controlled trial within the setting of a large drug benefit plan for Medicare beneficiaries. Primary care physicians and their patients were randomized to usual care, patient intervention only, physician intervention only, or both interventions. The at-risk patients were women >or=65 yr of age, men and women >or=65 yr of age with a prior fracture, and men and women >or=65 yr of age who used oral glucocorticoids. The primary outcome studied was a composite of either undergoing a BMD test or initiating a medication used for osteoporosis. The secondary outcome was a hip, humerus, spine, or wrist fracture. We randomized 828 primary care physicians and their 13,455 eligible at-risk patients into four study arms. Physician and patient characteristics were very similar across all four groups. Across all four groups, the rate of the composite outcome was 10.3 per 100 person-years and did not differ between the usual care and the combined intervention groups (p = 0.5). In adjusted Cox proportional hazards models, there was no difference in the probability of the primary composite endpoint comparing the combined intervention group with usual care (risk ratio = 1.04; 95% CI, 0.85-1.26). There was also no difference in either of the components of the composite endpoint. The probability of fracture during follow-up was 4.2 per 100 person-years and did not differ by treatment assignment (p = 0.9). In this trial, a relatively brief program of patient and/or physician education did not work to improve the management of osteoporosis. More intensive efforts should be considered for future quality improvement programs for osteoporosis.

National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers

PubMed Central

Achey, Meredith A.; Beck, Christopher A.; Beran, Denise B.; Biglan, Kevin M.; Boyd, Cynthia M.; Schmidt, Peter N.; Simone, Richard; Willis, Allison W.; Galifianakis, Nicholas B.; Katz, Maya; Tanner, Caroline M.; Dodenhoff, Kristen; Ziman, Nathan; Aldred, Jason; Carter, Julie; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Mari, Zoltan; Morgan, John C.; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Bull, Michael T.; Mejia, Nicte I.; Bwala, Grace; Nance, Martha; Shih, Ludy; Anderson, Lauren; Singer, Carlos; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Cooper, Jessica; Webb, Sydney; Dhall, Rohit; Hassan, Anhar; Weis, Delana; DeMello, Steven; Riggare, Sara S.; Wicks, Paul; Smith, Joseph; Keenan, H. Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E. Anna; Zhu, William

2016-01-01

Abstract Background: Delivering specialty care remotely directly into people's homes can enhance access for and improve the healthcare of individuals with chronic conditions. However, evidence supporting this approach is limited. Materials and Methods: Connect.Parkinson is a randomized comparative effectiveness study that compares usual care of individuals with Parkinson's disease in the community with usual care augmented by virtual house calls with a Parkinson's disease specialist from 1 of 18 centers nationally. Individuals in the intervention arm receive four virtual visits from a Parkinson's disease specialist over 1 year via secure, Web-based videoconferencing directly into their homes. All study activities, including recruitment, enrollment, and assessments, are conducted remotely. Here we report on interest, feasibility, and barriers to enrollment in this ongoing study. Results: During recruitment, 11,734 individuals visited the study's Web site, and 927 unique individuals submitted electronic interest forms. Two hundred ten individuals from 18 states enrolled in the study from March 2014 to June 2015, and 195 were randomized. Most participants were white (96%) and college educated (73%). Of the randomized participants, 73% had seen a Parkinson's disease specialist within the previous year. Conclusions: Among individuals with Parkinson's disease, national interest in receiving remote specialty care directly into the home is high. Remote enrollment in this care model is feasible but is likely affected by differential access to the Internet. PMID:26886406

Cost-effectiveness analysis of early point-of-care lactate testing in the emergency department.

PubMed

Ward, Michael J; Self, Wesley H; Singer, Adam; Lazar, Danielle; Pines, Jesse M

2016-12-01

To determine the cost-effectiveness of implementing a point-of-care (POC) Lactate Program in the emergency department (ED) for patients with suspected sepsis to identify patients who can benefit from early resuscitation. We constructed a cost-effectiveness model to examine an ED with 30 000 patients annually. We evaluated a POC lactate program screening patients with suspected sepsis for an elevated lactate ≥4 mmol/L. Those with elevated lactate levels are resuscitated and their lactate clearance is evaluated by serial POC lactate measurements. The POC Lactate Program was compared with a Usual Care Strategy in which all patients with sepsis and an elevated lactate are admitted to the intensive care unit. Costs were estimated from the 2014 Medicare Inpatient and National Physician Fee schedules, and hospital and industry estimates. In the base-case, the POC Lactate Program cost $39.53/patient whereas the Usual Care Strategy cost $33.20/patient. The screened patients in the POC arm resulted in 1.07 quality-adjusted life years for an incremental cost-effectiveness ratio of $31 590 per quality-adjusted life year gained, well below accepted willingness-to-pay-thresholds. Implementing a POC Lactate Program for screening ED patients with suspected sepsis is a cost-effective intervention to identify patients responsive to early resuscitation. Copyright © 2016 Elsevier Inc. All rights reserved.

Managing facility risk: external threats and health care organizations.

PubMed

Reid, Daniel J; Reid, William H

2014-01-01

Clinicians and clinical administrators should have a basic understanding of physical and financial risk to mental health facilities related to external physical threat, including actions usually viewed as "terrorism" and much more common sources of violence. This article refers to threats from mentally ill persons and those acting out of bizarre or misguided "revenge," extortionists and other outright criminals, and perpetrators usually identified as domestic or international terrorists. The principles apply both to relatively small and contained acts (such as a patient or ex-patient attacking a staff member) and to much larger events (such as bombings and armed attack), and are relevant to facilities both within and outside the U.S. Patient care and accessibility to mental health services rest not only on clinical skills, but also on a place to practice them and an organized system supported by staff, physical facilities, and funding. Clinicians who have some familiarity with the non-clinical requirements for care are in a position to support non-clinical staff in preventing care from being interrupted by external threats or events such as terrorist activity, and/or to serve at the interface of facility operations and direct clinical care. Readers should note that this article is an introduction to the topic and cannot address all local, state and national standards for hospital safety, or insurance providers' individual facility requirements. Copyright © 2014 John Wiley & Sons, Ltd.

SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis.

PubMed

Everard, Mark L; Hind, Daniel; Ugonna, Kelechi; Freeman, Jennifer; Bradburn, Mike; Cooper, Cindy L; Cross, Elizabeth; Maguire, Chin; Cantrill, Hannah; Alexander, John; McNamara, Paul S

2014-12-01

Acute bronchiolitis is the commonest cause for hospitalisation in infancy. Supportive care remains the cornerstone of current management and no other therapy has been shown to influence the course of the disease. It has been suggested that adding nebulised hypertonic saline to usual care may shorten the duration of hospitalisation. To determine whether hypertonic saline does have beneficial effects we undertook an open, multi-centre parallel-group, pragmatic RCT in ten UK hospitals. Infants admitted to hospital with a clinical diagnosis of acute bronchiolitis and requiring oxygen therapy were randomised to receive usual care alone or nebulised 3% hypertonic saline (HS) administered 6-hourly. Randomisation was within 4 h of admission. The primary outcome was time to being assessed as 'fit' for discharge with secondary outcomes including time to discharge, incidence of adverse events together with follow up to 28 days assessing patient centred health related outcomes. A total of 317 infants were recruited to the study. 158 infants were randomised to HS (141 analysed) and 159 to standard care (149 analysed). There was no difference between the two arms in time to being declared fit for discharge (hazard ratio: 0-95, 95% CI: 0.75-1.20) nor to actual discharge (hazard ratio: 0.97, 95% CI: 0.76-1.23). There was no difference in adverse events. One infant in the HS group developed bradycardia with desaturation. This study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings. NCT01469845. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

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

Slimming World in Stop Smoking Services (SWISSS): study protocol for a randomized controlled trial.

PubMed

Lycett, Deborah; Aveyard, Paul; Farmer, Andrew; Lewis, Amanda; Munafò, Marcus

2013-06-19

Quitting smokers gain weight. This deters some from trying to stop smoking and may explain the increased incidence of type 2 diabetes after cessation. Dieting when stopping smoking may be counterproductive. Hunger increases cravings for smoking and tackling two behaviours together may undermine quitting success. A meta-analysis of randomized controlled trials (RCTs) showed individualized dietary support may prevent weight gain, although there is insufficient evidence whether it undermines smoking cessation. Commercial weight management providers (CWMPs), such as Slimming World, provide individualized dietary support for National Health Service (NHS) patients; however, there is no evidence that they can prevent cessation-related weight gain.Our objective is to determine whether attending Slimming World from quit date, through referral from NHS Stop Smoking Services, is more effective than usual care at preventing cessation-related weight gain. This RCT will examine the effectiveness of usual cessation support plus referral to Slimming World compared to usual cessation support alone. Healthy weight, overweight and obese adult smokers attending Stop Smoking Services will be included. The primary outcome is weight change in quitters 12 weeks post-randomization. Multivariable linear regression analysis will compare weight change between trial arms and adjust for known predictors of cessation-related weight gain.We will recruit 320 participants, with 160 participants in each arm. An alpha error rate of 5% and 90% power will detect a 2 kg (SD = 2.5) difference in weight gain at 12 weeks, assuming 20% remain abstinent by then. This trial will establish whether referral to the 12-week Slimming World programme plus usual care is an effective intervention to prevent cessation-related weight gain. If so, we will seek to establish whether weight control comes at the expense of a successful quit attempt in a further non-inferiority trial.Positive results from both these trials would provide a potential solution to cessation-related weight gain, which could be rolled out across England within Stop Smoking Services to better meet the needs of 0.75 million smokers stopping with NHS support every year. Current Controlled Trials ISRCTN65705512.

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

PubMed Central

2014-01-01

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

Web-based Social Media Intervention to Increase Vaccine Acceptance: A Randomized Controlled Trial.

PubMed

Glanz, Jason M; Wagner, Nicole M; Narwaney, Komal J; Kraus, Courtney R; Shoup, Jo Ann; Xu, Stanley; O'Leary, Sean T; Omer, Saad B; Gleason, Kathy S; Daley, Matthew F

2017-12-01

Interventions to address vaccine hesitancy and increase vaccine acceptance are needed. This study sought to determine if a Web-based, social media intervention increases early childhood immunization. A 3-arm, randomized controlled trial was conducted in Colorado from September 2013 to July 2016. Participants were pregnant women, randomly assigned (3:2:1) to a Web site with vaccine information and interactive social media components (VSM), a Web site with vaccine information (VI), or usual care (UC). Vaccination was assessed in infants of participants from birth to age 200 days. The primary outcome was days undervaccinated, measured as a continuous and dichotomous variable. Infants of 888 participants were managed for 200 days. By using a nonparametric rank-based analysis, mean ranks for days undervaccinated were significantly lower in the VSM arm versus UC ( P = .02) but not statistically different between the VI and UC ( P = .08) or between VSM and VI arms ( P = .63). The proportions of infants up-to-date at age 200 days were 92.5, 91.3, and 86.6 in the VSM, VI, and UC arms, respectively. Infants in the VSM arm were more likely to be up-to-date than infants in the UC arm (odds ratio [OR] = 1.92; 95% confidence interval [CI], 1.07-3.47). Up-to-date status was not statistically different between VI and UC arms (OR = 1.62; 95% CI, 0.87-3.00) or between the VSM and VI arms (OR = 1.19, 95% CI, 0.70-2.03). Providing Web-based vaccine information with social media applications during pregnancy can positively influence parental vaccine behaviors. Copyright © 2017 by the American Academy of Pediatrics.

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.

PubMed

Johnson, Liam; Bird, Marie-Louise; Muthalib, Makii; Teo, Wei-Peng

2018-01-09

The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors. In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention. The study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings. ACTRN12617000745347; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol

PubMed Central

Bird, Marie-Louise; Muthalib, Makii

2018-01-01

Introduction The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors. Methods and analysis In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3–5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention. Ethics and dissemination The study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017–087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings. Trial registration number ACTRN12617000745347; Pre-results. PMID:29317414

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

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.

Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study.

PubMed

McConnell, Tracey; Graham-Wisener, Lisa; Regan, Joan; McKeown, Miriam; Kirkwood, Jenny; Hughes, Naomi; Clarke, Mike; Leitch, Janet; McGrillen, Kerry; Porter, Sam

2016-01-01

Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients. A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers. This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for improving quality of life in palliative care patients. By undertaking the pilot and feasibility trial under normal clinical conditions in a hospice setting, the trial will result in reliable procedures to overcome some of the difficulties in designing music therapy RCTs for palliative care settings. Clinicaltrials.gov Identifier: NCT02791048.

Increased Survival Among HIV-Infected PWID Receiving a Multi-Level HIV Risk and Stigma Reduction Intervention: Results From a Randomized Controlled Trial.

PubMed

Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Ha, Tran Viet; Latkin, Carl A; Sripaipan, Teerada; Zelaya, Carla E; Davis, Wendy W; Celentano, David D; Quan, Vu Minh

2017-02-01

In Vietnam, where 58% of prevalent HIV cases are attributed to people who inject drugs, we evaluated whether a multi-level intervention could improve care outcomes and increase survival. We enrolled 455 HIV-infected males who inject drugs from 32 communes in Thai Nguyen Province. Communes were randomized to a community stigma reduction intervention or standard of care and then within each commune, to an individual enhanced counseling intervention or standard of care, resulting into 4 arms: Arm 1 (standard of care); Arm 2 (community intervention alone); Arm 3 (individual intervention alone); and Arm 4 (community + individual interventions). Follow-up was conducted at 6, 12, 18, and 24 months to assess survival. Overall mortality was 23% (n = 103/455) more than 2 years. There were no losses to follow-up for the mortality endpoint. Survival at 24 months was different across arms: Arm 4 (87%) vs Arm 1 (82%) vs Arm 2 (68%) vs Arm 3 (73%); log-rank test for comparison among arms: P = 0.001. Among those with CD4 cell count <200 cells/mm and not on antiretroviral therapy at baseline (n = 162), survival at 24 months was higher in Arm 4 (84%) compared with other arms (Arm 1: 61%; Arm 2: 50%; Arm 3: 53%; P-value = 0.002). Overall, Arm 4 (community + individual interventions) had increased uptake of antiretroviral therapy compared with Arms 1, 2, and 3. This multi-level behavioral intervention seemed to increase survival of HIV-infected participants more than a 2-year period. Relative to the standard of care, the greatest intervention effect was among those with lower CD4 cell counts.

Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records-REDUCE Trial study original protocol.

PubMed

Juszczyk, Dorota; Charlton, Judith; McDermott, Lisa; Soames, Jamie; Sultana, Kirin; Ashworth, Mark; Fox, Robin; Hay, Alastair D; Little, Paul; Moore, Michael V; Yardley, Lucy; Prevost, A Toby; Gulliford, Martin C

2016-08-04

Respiratory tract infections (RTIs) account for about 60% of antibiotics prescribed in primary care. This study aims to test the effectiveness, in a cluster randomised controlled trial, of electronically delivered, multicomponent interventions to reduce unnecessary antibiotic prescribing when patients consult for RTIs in primary care. The research will specifically evaluate the effectiveness of feeding back electronic health records (EHRs) data to general practices. 2-arm cluster randomised trial using the EHRs of the Clinical Practice Research Datalink (CPRD). General practices in England, Scotland, Wales and Northern Ireland are being recruited and the general population of all ages represents the target population. Control trial arm practices will continue with usual care. Practices in the intervention arm will receive complex multicomponent interventions, delivered remotely to information systems, including (1) feedback of each practice's antibiotic prescribing through monthly antibiotic prescribing reports estimated from CPRD data; (2) delivery of educational and decision support tools; (3) a webinar to explain and promote effective usage of the intervention. The intervention will continue for 12 months. Outcomes will be evaluated from CPRD EHRs. The primary outcome will be the number of antibiotic prescriptions for RTIs per 1000 patient years. Secondary outcomes will be: the RTI consultation rate; the proportion of consultations for RTI with an antibiotic prescribed; subgroups of age; different categories of RTI and quartiles of intervention usage. There will be more than 80% power to detect an absolute reduction in antibiotic prescription for RTI of 12 per 1000 registered patient years. Total healthcare usage will be estimated from CPRD data and compared between trial arms. Trial protocol was approved by the National Research Ethics Service Committee (14/LO/1730). The pragmatic design of the trial will enable subsequent translation of effective interventions at scale in order to achieve population impact. ISRCTN95232781; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Effectiveness of fluticasone furoate plus vilanterol on asthma control in clinical practice: an open-label, parallel group, randomised controlled trial.

PubMed

Woodcock, Ashley; Vestbo, Jørgen; Bakerly, Nawar Diar; New, John; Gibson, J Martin; McCorkindale, Sheila; Jones, Rupert; Collier, Susan; Lay-Flurrie, James; Frith, Lucy; Jacques, Loretta; Fletcher, Joanne L; Harvey, Catherine; Svedsater, Henrik; Leather, David

2017-11-18

Evidence for management of asthma comes from closely monitored efficacy trials done in highly selected patient groups. There is a need for randomised trials that are closer to usual clinical practice. We did an open-label, randomised, controlled, two-arm effectiveness trial at 74 general practice clinics in Salford and South Manchester, UK. Patients aged 18 years or older with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy were randomly assigned to initiate treatment with a once-daily inhaled combination of either 100 μg or 200 μg fluticasone furoate with 25 μg vilanterol or optimised usual care and followed up for 12 months. The primary endpoint was the percentage of patients who achieved an asthma control test (ACT) score of 20 or greater or an increase in ACT score from baseline of 3 or greater at 24 weeks (termed responders), in patients with a baseline ACT score less than 20 (the primary effectiveness analysis population). All effectiveness analyses were done according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT01706198. Between Nov 12, 2012, and Dec 16, 2016, 4725 patients were enrolled and 4233 randomly assigned to initiate treatment with fluticasone furoate and vilanterol (n=2114) or usual care (n=2119). 1207 patients (605 assigned to usual care, 602 to fluticasone furoate and vilanterol) had a baseline ACT score greater than or equal to 20 and were thus excluded from the primary effectiveness analysis population. At week 24, the odds of being a responder were higher for patients who initiated treatment with fluticasone furoate and vilanterol than for those on usual care (977 [71%] of 1373 in the fluticasone furoate and vilanterol group vs 784 [56%] of 1399 in the usual care group; odds ratio [OR] 2·00 [95% CI 1·70-2·34], p<0·0001). At week 24, the adjusted mean ACT score increased by 4·4 points from baseline in patients initiated with fluticasone furoate and vilanterol, compared with 2·8 points in the usual care group (difference 1·6 [95% CI 1·3-2·0], p<0·0001). This result was consistent for the duration of the study. Pneumonia was uncommon, with no differences between groups; there was no difference in other serious adverse events between the groups. In patients with a general practitioner's diagnosis of symptomatic asthma and on maintenance inhaler therapy, initiation of a once-daily treatment regimen of combined fluticasone furoate and vilanterol improved asthma control without increasing the risk of serious adverse events when compared with optimised usual care. GlaxoSmithKline. Copyright © 2017 Elsevier Ltd. All rights reserved.

Tailoring Outreach Efforts to Increase Primary Care Use Among Homeless Veterans: Results of a Randomized Controlled Trial.

PubMed

O'Toole, Thomas P; Johnson, Erin E; Borgia, Matthew L; Rose, Jennifer

2015-07-01

Homeless individuals often have significant unmet health care needs that are critical to helping them leave homelessness. However, engaging them in primary and mental health care services is often elusive and difficult to achieve. We aimed to increase health-seeking behavior and receipt of health care among homeless Veterans. This was a multi-center, prospective, community-based, two-by-two randomized controlled trial of homeless Veterans. Homeless Veterans not receiving primary care participated in the study. An outreach intervention that included a personal health assessment and brief intervention (PHA/BI), and/or a clinic orientation (CO) was implemented. We measured receipt of primary care within 4 weeks of study enrollment. Overall, 185 homeless Veterans were enrolled: the average age was 48.6 years (SD 10.8), 94.6% were male, 43.0% were from a minority population, 12.0% were unsheltered, 25.5% were staying in a dusk-to-dawn emergency shelter, 26.1% were in transitional housing, while 27.7% were in an unstable, doubled-up arrangement. At one month, 77.3% of the PHA/BI plus CO group accessed primary care and by 6 months, 88.7% had been seen in primary care. This was followed by the CO-only group, 50.0% of whom accessed care in the first 4 weeks, the PHI/BI-only arm at 41.0% and the Usual Care arm at 30.6%. Chi-squared tests by group were significant (p < 0.001) at both 4 weeks and 6 months. There was no difference in attitudes about care at baseline and 6 months or in use patterns once enrolled in care. Our findings suggest that treatment-resistant/avoidant homeless Veterans can be effectively engaged in primary and other clinical care services through a relatively low intensity, targeted and tailored outreach effort.

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

Acupuncture for chronic fatigue syndrome and idiopathic chronic fatigue: a multicenter, nonblinded, randomized controlled trial.

PubMed

Kim, Jung-Eun; Seo, Byung-Kwan; Choi, Jin-Bong; Kim, Hyeong-Jun; Kim, Tae-Hun; Lee, Min-Hee; Kang, Kyung-Won; Kim, Joo-Hee; Shin, Kyung-Min; Lee, Seunghoon; Jung, So-Young; Kim, Ae-Ran; Shin, Mi-Suk; Jung, Hee-Jung; Park, Hyo-Ju; Kim, Sung-Phil; Baek, Yong-Hyeon; Hong, Kwon-Eui; Choi, Sun-Mi

2015-07-26

The causes of chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF) are not clearly known, and there are no definitive treatments for them. Therefore, patients with CFS and ICF are interested in Oriental medicine or complementary and alternative medicine. For this reason, the effectiveness of complementary and alternative treatments should be verified. We investigated the effectiveness of two forms of acupuncture added to usual care for CFS and ICF compared to usual care alone. A three-arm parallel, non-blinded, randomized controlled trial was performed in four hospitals. We divided 150 participants into treatment and control groups at the same ratio. The treatment groups (Group A, body acupuncture; Group B, Sa-am acupuncture) received 10 sessions for 4 weeks. The control group (Group C) continued usual care alone. The primary outcome was the Fatigue Severity Scale (FSS) at 5 weeks after randomization. Secondary outcomes were the FSS at 13 weeks and a short form of the Stress Response Inventory (SRI), the Beck Depression Inventory (BDI), the Numeric Rating Scale (NRS), and the EuroQol-5 Dimension (EQ-5D) at 5 and 13 weeks. Group A showed significantly lower FSS scores than Group C at 5 weeks (P = 0.023). SRI scores were significantly lower in the treatment groups than in the control group at 5 (Group A, P = 0.032; B, P <0.001) and 13 weeks (Group A, P = 0.037; B, P <0.001). Group B showed significantly lower BDI scores than Group C at 13 weeks (P = 0.007). NRS scores from the treatment groups were significantly reduced compared to control at 5 (Group A and B, P <0.001) and 13 weeks (Group A, P = 0.011; B, P = 0.002). Body acupuncture for 4 weeks in addition to usual care may help improve fatigue in CFS and ICF patients. Clinical Research Information Service (CRIS) KCT0000508; Registered on 12 August 2012.

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.

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.

Evaluation of the effectiveness and cost-effectiveness of Families for Health V2 for the treatment of childhood obesity: study protocol for a randomized controlled trial.

PubMed

Robertson, Wendy; Stewart-Brown, Sarah; Stallard, Nigel; Petrou, Stavros; Griffiths, Frances; Thorogood, Margaret; Simkiss, Douglas; Lang, Rebecca; Reddington, Kate; Poole, Fran; Rye, Gloria; Khan, Kamran A; Hamborg, Thomas; Kirby, Joanna

2013-03-20

Effective programs 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 V1 showed sustained reductions in overweight after 2 years in a pilot evaluation, but lacks a randomized controlled trial (RCT) evidence base. This is a multi-center, investigator-blind RCT, with parallel economic evaluation, with a 12-month follow-up. The trial will recruit 120 families with at least one child aged 6 to 11 years who is overweight (≥91st centile BMI) or obese (≥98th centile BMI) from three localities and assigned randomly to Families for Health V2 (60 families) or the usual care control (60 families) groups. Randomization will be stratified by locality (Coventry, Warwickshire, Wolverhampton).Families for Health V2 is a family-based intervention run in a community venue. Parents/carers and children attend parallel groups for 2.5 hours weekly for 10 weeks. The usual care arm will be the usual support provided within each NHS locality.A mixed-methods evaluation will be carried out. Child and parent participants will be assessed at home visits at baseline, 3-month (post-treatment) and 12-month follow-up. The primary outcome measure is the change in the children's BMI z-scores at 12 months from the baseline. Secondary outcome measures include changes in the children's waist circumference, percentage body fat, physical activity, fruit/vegetable consumption and quality of life. The parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style will also be assessed.Economic components will encompass the measurement and valuation of service utilization, including the costs of running Families for Health and usual care, and the EuroQol EQ-5D health outcomes. Cost-effectiveness will be expressed in terms of incremental cost per quality-adjusted life year gained. A de novo decision-analytic model will estimate the lifetime cost-effectiveness of the Families for Health program.Process evaluation will document recruitment, attendance and drop-out rates, and the fidelity of Families for Health delivery. Interviews with up to 24 parents and children from each arm will investigate perceptions and changes made. This paper describes our protocol to assess the effectiveness and cost-effectiveness of a parenting approach for managing childhood obesity and presents challenges to implementation. Current Controlled Trials http://ISRCTN45032201.

An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Universal screening using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria has identified a prevalence of gestational diabetes mellitus (GDM) of 12.4% in women living in Ireland. Women with prior GDM are at increased risk of developing type 2 diabetes later in life. A number of risk factors linked to the development of type 2 diabetes are potentially modifiable through lifestyle and behaviour changes, and medical management. No previous Irish studies have adequately investigated the efficacy of lifestyle intervention programmes in reducing these risk factors in women with prior GDM. Through a two-group, parallel randomised controlled trial (RCT), this study aims to assess the clinical impact, cost-effectiveness and psychological experience of the Croí MyAction intensive lifestyle modification programme for women with prior GDM. Methods/Design A total of 54 women with a history of GDM and persistent post-partum glucose dysfunction (impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)), are randomly assigned to a control arm (n = 27) or to the Croí MyAction intervention group (n = 27). The control arm receives usual health care advice - written information on diet and lifestyle changes for reducing diabetes risks and visits with general practitioners as required. The intervention group receives usual health care as per the control group in addition to attending a 12-week intensive lifestyle modification programme known as Croí MyAction. Croí MyAction involves 2.5 hour sessions once per week (for 12 weeks) comprising a group exercise programme, group health promotion or education seminars, and one-to-one meetings with a multidisciplinary health care team to personalise risk factor reductions. Randomisation and allocation to the intervention arms is carried out by an independent researcher, ensuring that the allocation sequence is concealed from study researchers until the interventions are assigned. The primary analysis is based on glucose dysfunction, comparing a mean reduction in fasting plasma glucose (FPG) levels on a 75 gram oral glucose tolerance test (OGTT) in the two groups at a one-year, post-intervention follow-up. The trial is funded by the Irish Health Research Board (HRB). Ethics approval was obtained on 27 March 2012 from the Clinical Research Ethics Committee, Galway University Hospitals, Health Service Executive of Ireland (Ref: C.A.691). Trial registration Current Controlled Trials ISRCTN41202110. PMID:23782471

An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial.

PubMed

Infanti, Jennifer J; Dunne, Fidelma P; O'Dea, Angela; Gillespie, Paddy; Gibson, Irene; Glynn, Liam G; Noctor, Eoin; Newell, John; McGuire, Brian E

2013-05-02

Universal screening using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria has identified a prevalence of gestational diabetes mellitus (GDM) of 12.4% in women living in Ireland. Women with prior GDM are at increased risk of developing type 2 diabetes later in life. A number of risk factors linked to the development of type 2 diabetes are potentially modifiable through lifestyle and behaviour changes, and medical management. No previous Irish studies have adequately investigated the efficacy of lifestyle intervention programmes in reducing these risk factors in women with prior GDM. Through a two-group, parallel randomised controlled trial (RCT), this study aims to assess the clinical impact, cost-effectiveness and psychological experience of the Croí MyAction intensive lifestyle modification programme for women with prior GDM. A total of 54 women with a history of GDM and persistent post-partum glucose dysfunction (impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)), are randomly assigned to a control arm (n=27) or to the Croí MyAction intervention group (n=27). The control arm receives usual health care advice--written information on diet and lifestyle changes for reducing diabetes risks and visits with general practitioners as required. The intervention group receives usual health care as per the control group in addition to attending a 12-week intensive lifestyle modification programme known as Croí MyAction. Croí MyAction involves 2.5 hour sessions once per week (for 12 weeks) comprising a group exercise programme, group health promotion or education seminars, and one-to-one meetings with a multidisciplinary health care team to personalise risk factor reductions. Randomisation and allocation to the intervention arms is carried out by an independent researcher, ensuring that the allocation sequence is concealed from study researchers until the interventions are assigned. The primary analysis is based on glucose dysfunction, comparing a mean reduction in fasting plasma glucose (FPG) levels on a 75 gram oral glucose tolerance test (OGTT) in the two groups at a one-year, post-intervention follow-up. The trial is funded by the Irish Health Research Board (HRB). Ethics approval was obtained on 27 March 2012 from the Clinical Research Ethics Committee, Galway University Hospitals, Health Service Executive of Ireland (Ref: C.A.691). Current Controlled Trials ISRCTN41202110.

A cluster randomised controlled trial evaluating the effectiveness of a structured pulmonary rehabilitation education programme for improving the health status of people with chronic obstructive pulmonary disease (COPD): The PRINCE Study protocol.

PubMed

Murphy, Kathy; Casey, Dympna; Devane, Declan; Cooney, Adeline; McCarthy, Bernard; Mee, Lorraine; Nichulain, Martina; Murphy, Andrew W; Newell, John; O' Shea, Eamon

2011-01-18

A key strategy in improving care for people with chronic obstructive pulmonary disease (COPD) is the provision of pulmonary rehabilitation programmes. Pulmonary rehabilitation programmes have been successful in improving patients' sense of dyspnoea and Health Related Quality of Life. However, the effectiveness of structured education pulmonary rehabilitation programmes delivered at the level of the general practice on the health status of people with COPD remains uncertain and there is a need for a robust and fair assessment of this. The PRINCE study will evaluate the effectiveness of a Structured Education Pulmonary Rehabilitation Programme (SEPRP), delivered at the level of the general practice, on the health status of people with COPD. The PRINCE Trial is a two-armed, single blind cluster randomised trial conducted in the primary care setting in Ireland. Randomisation to control and intervention is at the level of the General Practice. Participants in the intervention arm will receive a SEPRP and those allocated to the control arm will receive usual care. Delivery of the SEPRP will be by a practice nurse and physiotherapist in the General Practice (GP) site. The primary outcome measure of the study will be health status as measured by the Chronic Respiratory Questionnaire (CRQ). Blinded outcome assessment will be undertaken at baseline and at twelve-fourteen weeks after completion of the programme. A comparison of outcomes between the intervention and control sites will be made to examine if differences exist and, if so, to what extent between control and experimental groups. Sample size calculations estimate that 32 practices with a minimum of 10 participants per practice are required, in total, to be randomised to control and intervention arms for power of at least 80% with alpha levels of 0.05, to determine a clinically significant change of 0.5 units in the CRQ. A cost effectiveness analysis will also be conducted. The results of this trial are directly applicable to primary care settings in Ireland. Should a SEPRP delivered by practice nurses and physiotherapists in primary care be found to be effective in improving patients' sense of dyspnoea and HRQoL, then the findings would be applicable to many thousands of individuals in Ireland and beyond.

The Electronic Medication Complete Communication (EMC2) Study: Rationale and Methods for a Randomized Controlled Trial of a Strategy to Promote Medication Safety in Ambulatory Care

PubMed Central

Bailey, Stacy Cooper; Paasche-Orlow, Michael K.; Adams, William G.; Brokenshire, Samantha A.; Hickson, Ryan P.; Oramasionwu, Christine U.; Curtis, Laura M.; Kwasny, Mary J.; Wolf, Michael S.

2016-01-01

Background Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs. Objective To compare the effectiveness of the Electronic Medication Complete Communication (EMC2) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care. Methods The automated EMC2 Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N=1,200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4 weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated. Conclusions The EMC2 Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care. PMID:27777127

The electronic medication complete communication (EMC2) study: Rationale and methods for a randomized controlled trial of a strategy to promote medication safety in ambulatory care.

PubMed

Bailey, Stacy Cooper; Paasche-Orlow, Michael K; Adams, William G; Brokenshire, Samantha A; Hickson, Ryan P; Oramasionwu, Christine U; Curtis, Laura M; Kwasny, Mary J; Wolf, Michael S

2016-11-01

Adverse drug events (ADEs) affect millions of patients annually and place a significant burden on the healthcare system. The Food and Drug Administration (FDA) has developed patient safety information for high-risk medications that pose serious public health concerns. However, there are currently few assurances that patients receive this information or are able to identify or respond correctly to ADEs. To evaluate the effectiveness of the Electronic Medication Complete Communication (EMC 2 ) Strategy to promote safe medication use and reporting of ADEs in comparison to usual care. The automated EMC 2 Strategy consists of: 1) provider alerts to counsel patients on medication risks, 2) the delivery of patient-friendly medication information via the electronic health record, and 3) an automated telephone assessment to identify potential medication concerns or ADEs. The study will take place in two community health centers in Chicago, IL. Adult, English or Spanish-speaking patients (N=1200) who have been prescribed a high-risk medication will be enrolled and randomized to the intervention arm or usual care based upon practice location. The primary outcomes of the study are medication knowledge, proper medication use, and reporting of ADEs; these will be measured at baseline, 4weeks, and three months. Intervention fidelity as well as barriers and costs of implementation will be evaluated. The EMC 2 Strategy automates a patient-friendly risk communication and surveillance process to promote safe medication use while minimizing clinic burden. This trial seeks to evaluate the effectiveness and feasibility of this strategy in comparison to usual care. Copyright © 2016 Elsevier Inc. All rights reserved.

Randomized trial of guiding hypertension management using central aortic blood pressure compared with best-practice care: principal findings of the BP GUIDE study.

PubMed

Sharman, James E; Marwick, Thomas H; Gilroy, Deborah; Otahal, Petr; Abhayaratna, Walter P; Stowasser, Michael

2013-12-01

Arm cuff blood pressure (BP) may overestimate cardiovascular risk. Central aortic BP predicts mortality and could be a better method for patient management. We sought to determine the usefulness of central BP to guide hypertension management. This was a prospective, open-label, blinded-end point study in 286 patients with hypertension randomized to treatment decisions guided by best-practice usual care (n=142; using office, home, and 24-hour ambulatory BP) or, in addition, by central BP intervention (n=144; using SphygmoCor). Therapy was reviewed every 3 months for 12 months, and recommendations were provided to each patient and his/her doctor on antihypertensive medication titration. Outcome measures were as follows: medication quantity (daily defined dose), quality of life, and left ventricular mass (3-dimensional echocardiography). There was 92% compliance with recommendations on medication titration, and quality of life improved in both groups (post hoc P<0.05). For usual care, there was no change in daily defined dose (all P>0.10), but with intervention there was a significant stepwise decrease in daily defined dose from baseline to 3 months (P=0.008) and each subsequent visit (all P<0.001). Intervention was associated with cessation of medication in 23 (16%) patients versus 3 (2%) in usual care (P<0.001). Despite this, there were no differences between groups in left ventricular mass index, 24-hour ambulatory BP, home systolic BP, or aortic stiffness (all P>0.05). We conclude that guidance of hypertension management with central BP results in a significantly different therapeutic pathway than conventional cuff BP, with less use of medication to achieve BP control and no adverse effects on left ventricular mass, aortic stiffness, or quality of life.

A Remote Collaborative Care Program for Patients with Depression Living in Rural Areas: Open-Label Trial.

PubMed

Rojas, Graciela; Guajardo, Viviana; Martínez, Pablo; Castro, Ariel; Fritsch, Rosemarie; Moessner, Markus; Bauer, Stephanie

2018-04-30

In the treatment of depression, primary care teams have an essential role, but they are most effective when inserted into a collaborative care model for disease management. In rural areas, the shortage of specialized mental health resources may hamper management of depressed patients. The aim was to test the feasibility, acceptability, and effectiveness of a remote collaborative care program for patients with depression living in rural areas. In a nonrandomized, open-label (blinded outcome assessor), two-arm clinical trial, physicians from 15 rural community hospitals recruited 250 patients aged 18 to 70 years with a major depressive episode (DSM-IV criteria). Patients were assigned to the remote collaborative care program (n=111) or to usual care (n=139). The remote collaborative care program used Web-based shared clinical records between rural primary care teams and a specialized/centralized mental health team, telephone monitoring of patients, and remote supervision by psychiatrists through the Web-based shared clinical records and/or telephone. Depressive symptoms, health-related quality of life, service use, and patient satisfaction were measured 3 and 6 months after baseline assessment. Six-month follow-up assessments were completed by 84.4% (221/250) of patients. The remote collaborative care program achieved higher user satisfaction (odds ratio [OR] 1.94, 95% CI 1.25-3.00) and better treatment adherence rates (OR 1.81, 95% CI 1.02-3.19) at 6 months compared to usual care. There were no statically significant differences in depressive symptoms between the remote collaborative care program and usual care. Significant differences between groups in favor of remote collaborative care program were observed at 3 months for mental health-related quality of life (beta 3.11, 95% CI 0.19-6.02). Higher rates of treatment adherence in the remote collaborative care program suggest that technology-assisted interventions may help rural primary care teams in the management of depressive patients. Future cost-effectiveness studies are needed. Clinicaltrials.gov NCT02200367; https://clinicaltrials.gov/ct2/show/NCT02200367 (Archived by WebCite at http://www.webcitation.org/6xtZ7OijZ). ©Graciela Rojas, Viviana Guajardo, Pablo Martínez, Ariel Castro, Rosemarie Fritsch, Markus Moessner, Stephanie Bauer. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 30.04.2018.

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.

Guided and unguided internet-based vestibular rehabilitation versus usual care for dizzy adults of 50 years and older: a protocol for a three-armed randomised trial

PubMed Central

van der Wouden, Johannes C; Bosmans, Judith E; Smalbrugge, Martin; van Diest, Willianne; Essery, Rosie; Yardley, Lucy; van der Horst, Henriëtte E; Maarsingh, Otto R

2017-01-01

Introduction Dizziness is a common symptom in general practice with a high prevalence among older adults. The most common cause of dizziness in general practice is peripheral vestibular disease. Vestibular rehabilitation (VR) is a safe and effective treatment for peripheral vestibular disease that entails specific exercises to maximise the central nervous system compensation for the effects of vestibular pathology. An internet-based VR intervention has recently been shown to be safe and effective. Online interventions are low cost and easily accessible, but prone to attrition and non-adherence. A combination of online and face-to-face therapy, known as blended care, may balance these advantages and disadvantages. Methods and analysis A single-blind, three-arm, randomised controlled trial among patients aged 50 years and over presenting with dizziness of vestibular origin in general practice will be performed. In this study, we will compare the clinical and cost-effectiveness of stand-alone internet-based VR and internet-based VR with physiotherapeutic support (‘blended care’) with usual care during 6 months of follow-up. We will use a translated Dutch version of a British online VR intervention. Randomisation will be stratified by dizziness severity. The primary outcome measure is the Vertigo Symptoms Scale—Short Form. Intention-to-treat analysis will be performed, adjusting for confounders. The economic evaluation will be conducted from a societal perspective. We will perform an additional analysis on the data to identify predictors of successful treatment in the same population to develop a clinical decision rule for general practitioners. Ethics and dissemination The ethical committee of the VU University Medical Center approved ethics and dissemination of the study protocol. The insights and results of this study will be widely disseminated through international peer-reviewed journals and conference presentations. Trial registration number Pre-results, NTR5712. PMID:28110290

Protocol for the End-of-Life Social Action Study (ELSA): a randomised wait-list controlled trial and embedded qualitative case study evaluation assessing the causal impact of social action befriending services on end of life experience.

PubMed

Walshe, Catherine; Algorta, Guillermo Perez; Dodd, Steven; Hill, Matthew; Ockenden, Nick; Payne, Sheila; Preston, Nancy

2016-07-13

Compassionate support at the end of life should not be the responsibility of health and social care professionals alone and requires a response from the wider community. Volunteers, as community members, are a critical part of many end-of-life care services. The impact of their services on important outcomes such as quality of life is currently poorly understood. The purpose of this study is to evaluate a series of social action initiatives which use volunteers to deliver befriending services to people anticipated to be in their last year of life. The aim is to determine if receiving care from a social action volunteer befriending service plus usual care significantly improves quality of life in the last year of life. The research questions will be addressed through a wait-list randomised controlled trial (WLRCT) and qualitative case study evaluation across 12 sites in England. Participants will be randomly allocated to either receive the social action volunteer befriending service straight away or receive the intervention after a four week wait (wait-list arm). The impact of the intervention on end-of-life experience (quality of life as primary outcome, loneliness, social support) will be measured. Repeated assessments will be carried out at baseline and weeks 4 and 8 for the intervention arm and weeks 4, 8 and 12 for the wait-list arm. For selected sites case study evaluation will include interviews, observation and documentary analysis to understand the mechanisms underpinning any found impact. This study will address the need to both provide services which use social action models to support end-of-life care in community settings, and to robustly evaluate these models to determine if they influence the experience of end-of-life care. Such services could work to reduce isolation, help meet emotional needs and maintain a sense of connectedness to the community. ISRCTN 12929812 Registered 20.5.15.

Radial nerve dysfunction (image)

MedlinePlus

The radial nerve travels down the arm and supplies movement to the triceps muscle at the back of the upper arm. ... the wrist and hand. The usual causes of nerve dysfunction are direct trauma, prolonged pressure on the ...

The Children and Parents in Focus project: a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children

PubMed Central

2013-01-01

Background There is large body of knowledge to support the importance of early interventions to improve child health and development. Nonetheless, it is important to identify cost-effective blends of preventive interventions with adequate coverage and feasible delivery modes. The aim of the Children and Parents in Focus trial is to compare two levels of parenting programme intensity and rate of exposure, with a control condition to address impact and cost-effectiveness of a universally offered evidence-based parenting programme in the Swedish context. Methods/Design The trial has a cluster randomised controlled design comprising three arms: Universal arm (with access to participation in Triple P - Positive Parenting Program, level 2); Universal Plus arm (with access to participation in Triple P - Positive Parenting Program, level 2 as well as level 3, and level 4 group); and Services as Usual arm. The sampling frame is Uppsala municipality in Sweden. Child health centres consecutively recruit parents of children aged 3 to 5 years before their yearly check-ups (during the years 2013–2017). Outcomes will be measured annually. The primary outcome will be children’s behavioural and emotional problems as rated by three informants: fathers, mothers and preschool teachers. The other outcomes will be parents’ behaviour and parents’ general health. Health economic evaluations will analyse cost-effectiveness of the interventions versus care as usual by comparing the costs and consequences in terms of impact on children’s mental health, parent’s mental health and health-related quality of life. Discussion This study addresses the need for comprehensive evaluation of the long-term effects, costs and benefits of early parenting interventions embedded within existing systems. In addition, the study will generate population-based data on the mental health and well-being of preschool aged children in Sweden. Trial registration ISRCTN: ISRCTN16513449. PMID:24131587

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

Godycki-Cwirko, Maciek; Zakowska, Izabela; Kosiek, Katarzyna; Wensing, Michel; Krawczyk, Jaroslaw; Kowalczyk, Anna

2014-04-04

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. 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. 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. This trial has been registered with Clinical Trials Protocol Registration System. NCT01893476.

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

PubMed

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

2014-01-01

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

AMIGAS: A Multicity, Multicomponent Cervical Cancer Prevention Trial Among Mexican American Women

PubMed Central

Byrd, Theresa L.; Wilson, Katherine M.; Smith, Judith Lee; Coronado, Gloria; Vernon, Sally W.; Fernandez-Esquer, Maria Eugenia; Thompson, Beti; Ortiz, Melchor; Lairson, David; Fernandez, Maria E.

2015-01-01

BACKGROUND Considerable efforts have been undertaken in the United States to reduce cervical cancer incidence and mortality by increasing screening; however, disparities in screening rates continue to exist among certain racial and ethnic minority groups. The objective of the current study was to determine the effectiveness of a lay health worker-delivered intervention—AMIGAS (Ayudando a las Mujeres con Informacion, Guia, y Amor para su Salud [helping women with information, guidance, and love for their health])—to increase Papanicolaou (Pap) test screening among 3 populations of women of Mexican origin. METHODS Six hundred thirteen women of Mexican origin in 3 treatment sites were randomized among 4 study arms: the full AMIGAS program with a video and a flip chart (n = 151), the AMIGAS program without the video (n = 154), the AMIGAS program without the flip chart (n = 155), and a usual care control group (n = 153). Six months after enrollment, women were surveyed and reported whether or not they had been screened. RESULTS Women in any of the intervention arms were statistically significantly more likely to report being screened than those in the usual care group in both an intent-to-treat analysis and a per-protocol analysis. In the intent-to-treat analysis, 25% of women in the control group and 52% in the full AMIGAS program group reported having had Pap tests (P < .001); in the per-protocol analysis, the percentages were 29% and 62%, respectively (P < .001). CONCLUSIONS AMIGAS was effective in increasing Pap test screening among women of Mexican descent when used in a 1-to-1 setting. Future research should compare the 1-on-1 intervention with the group-based intervention. PMID:23280399

A randomized clinical trial of therapeutic hypothermia mode during transport for neonatal encephalopathy.

PubMed

Akula, Vishnu Priya; Joe, Priscilla; Thusu, Kajori; Davis, Alexis S; Tamaresis, John S; Kim, Sunhwa; Shimotake, Thomas K; Butler, Stephen; Honold, Jose; Kuzniewicz, Michael; DeSandre, Glenn; Bennett, Mihoko; Gould, Jeffrey; Wallenstein, Matthew B; Van Meurs, Krisa

2015-04-01

To determine if temperature regulation is improved during neonatal transport using a servo-regulated cooling device when compared with standard practice. We performed a multicenter, randomized, nonmasked clinical trial in newborns with neonatal encephalopathy cooled during transport to 9 neonatal intensive care units in California. Newborns who met institutional criteria for therapeutic hypothermia were randomly assigned to receive cooling according to usual center practices vs device servo-regulated cooling. The primary outcome was the percentage of temperatures in target range (33°-34°C) during transport. Secondary outcomes included percentage of newborns reaching target temperature any time during transport, time to target temperature, and percentage of newborns in target range 1 hour after cooling initiation. One hundred newborns were enrolled: 49 to control arm and 51 to device arm. Baseline demographics did not differ with the exception of cord pH. For each subject, the percentage of temperatures in the target range was calculated. Infants cooled using the device had a higher percentage of temperatures in target range compared with control infants (median 73% [IQR 17-88] vs 0% [IQR 0-52], P < .001). More subjects reached target temperature during transport using the servo-regulated device (80% vs 49%, P <.001), and in a shorter time period (44 ± 31 minutes vs 63 ± 37 minutes, P = .04). Device-cooled infants reached target temperature by 1 hour with greater frequency than control infants (71% vs 20%, P < .001). Cooling using a servo-regulated device provides more predictable temperature management during neonatal transport than does usual care for outborn newborns with neonatal encephalopathy. Copyright © 2015 Elsevier Inc. All rights reserved.

Impact of National Institutes of Health Gastrointestinal PROMIS Measures in Clinical Practice: Results of a Multicenter Controlled Trial.

PubMed

Almario, Christopher V; Chey, William D; Khanna, Dinesh; Mosadeghi, Sasan; Ahmed, Shahzad; Afghani, Elham; Whitman, Cynthia; Fuller, Garth; Reid, Mark; Bolus, Roger; Dennis, Buddy; Encarnacion, Rey; Martinez, Bibiana; Soares, Jennifer; Modi, Rushaba; Agarwal, Nikhil; Lee, Aaron; Kubomoto, Scott; Sharma, Gobind; Bolus, Sally; Spiegel, Brennan M R

2016-11-01

The National Institutes of Health (NIH) created the Patient Reported Outcomes Measurement Information System (PROMIS) to allow efficient, online measurement of patient-reported outcomes (PROs), but it remains untested whether PROMIS improves outcomes. Here, we aimed to compare the impact of gastrointestinal (GI) PROMIS measures vs. usual care on patient outcomes. We performed a pragmatic clinical trial with an off-on study design alternating weekly between intervention (GI PROMIS) and control arms at one Veterans Affairs and three university-affiliated specialty clinics. Adults with GI symptoms were eligible. Intervention patients completed GI PROMIS symptom questionnaires on an e-portal 1 week before their visit; PROs were available for review by patients and their providers before and during the clinic visit. Usual care patients were managed according to customary practices. Our primary outcome was patient satisfaction as determined by the Consumer Assessment of Healthcare Providers and Systems questionnaire. Secondary outcomes included provider interpersonal skills (Doctors' Interpersonal Skills Questionnaire (DISQ)) and shared decision-making (9-item Shared Decision Making Questionnaire (SDM-Q-9)). There were 217 and 154 patients in the GI PROMIS and control arms, respectively. Patient satisfaction was similar between groups (P>0.05). Intervention patients had similar assessments of their providers' interpersonal skills (DISQ 89.4±11.7 vs. 89.8±16.0, P=0.79) and shared decision-making (SDM-Q-9 79.3±12.4 vs. 79.0±22.0, P=0.85) vs. This is the first controlled trial examining the impact of NIH PROMIS in clinical practice. One-time use of GI PROMIS did not improve patient satisfaction or assessment of provider interpersonal skills and shared decision-making. Future studies examining how to optimize PROs in clinical practice are encouraged before widespread adoption.

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

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.

MAHILA: a protocol for evaluating a nurse-delivered mHealth intervention for women with HIV and psychosocial risk factors in India.

PubMed

Reynolds, Nancy R; Satyanarayana, Veena; Duggal, Mona; Varghese, Meiya; Liberti, Lauren; Singh, Pushpendra; Ranganathan, Mohini; Jeon, Sangchoon; Chandra, Prabha S

2016-08-04

Women living with HIV are vulnerable to a variety of psychosocial barriers that limit access and adherence to treatment. There is little evidence supporting interventions for improving access and treatment adherence among vulnerable groups of women in low- and middle-income countries. The M obile Phone-Based A pproach for H ealth I mprovement, L iteracy and A dherence (MAHILA) trial is assessing the feasibility, acceptability and preliminary efficacy of a novel, theory-guided mobile health intervention delivered by nurses for enhancing self-care and treatment adherence among HIV-infected women in India. Women (n = 120) with HIV infection who screen positive for depressive symptoms and/or other psychosocial vulnerabilities are randomly assigned in equal numbers to one of two treatment arms: treatment as usual plus the mobile phone intervention (experimental group) or treatment as usual (control group). In addition to treatment as usual, the experimental group receives nurse-delivered self-care counselling via mobile phone at fixed intervals over 16 weeks. Outcome measures are collected at baseline and at 4, 12, 24 and 36 weeks post-baseline. Outcomes include antiretroviral treatment adherence, HIV-1 RNA, depressive symptoms, illness perceptions, internalized stigma and quality of life. The MAHILA trial will provide information about how a mobile health counselling intervention delivered by non specialist nurses may improve access to care and support the adherence and clinical outcomes of women with HIV infection living in low- and middle-income countries such as India. NCT02319330 (First received: July 30, 2014; Last verified: January 2016).

Comparison of the caries-protective effect of fluoride varnish with treatment as usual in nursery school attendees receiving preventive oral health support through the Childsmile oral health improvement programme - the Protecting Teeth@3 Study: a randomised controlled trial.

PubMed

Wright, William; Turner, Stephen; Anopa, Yulia; McIntosh, Emma; Wu, Olivia; Conway, David I; Macpherson, Lorna M D; McMahon, Alex D

2015-12-18

The Scottish Government set out its policy on addressing the poor oral health of Scottish children in 2005. This led to the establishment of Childsmile, a national programme designed to improve the oral health of children in Scotland. One element of the programme promotes daily tooth brushing in all nurseries in Scotland (Childsmile Core). A second targeted component (Childsmile Nursery) offers twice-yearly application of fluoride varnish to children attending nurseries in deprived areas. Studies suggest that fluoride varnish application can reduce caries in both adult and child populations. This trial aims to explore the effectiveness and cost-effectiveness of additional preventive value fluoride varnish application compared to Childsmile Core. The Protecting Teeth@3 Study is an ongoing 2 year parallel group randomised treatment as usual controlled trial. Three-year-old children attending the ante pre-school year are randomised (1:1) to the intervention arm (fluoride varnish & treatment as usual) or the control arm (treatment as usual). Children in the intervention arm will have Duraphat® fluoride varnish painted on the primary tooth surfaces and will continue to receive treatment as usual: the core Childsmile Nursery intervention. Children in the treatment as usual arm will receive the same series of contacts, without the application of varnish and will also continue with the Childsmile Core intervention. Interventions are undertaken by Childsmile trained extended duty dental nurses at six-monthly intervals. Participants receive a baseline dental inspection in nursery and an endpoint inspection in Primary 1 at the age of 5 years old. We will use primary and secondary outcome measures to compare the effectiveness of Duraphat® fluoride varnish plus treatment as usual with treatment as usual only in preventing any further dental decay. We will also undertake a full economic evaluation of the trial. This study is registered at ClinicalTrials.gov. Number: NCT01674933 (24 August 2012).

Integrated Care in Prostate Cancer (ICARE-P): Nonrandomized Controlled Feasibility Study of Online Holistic Needs Assessment, Linking the Patient and the Health Care Team

PubMed Central

Dale, Jeremy; Roscoe, Julia; Hamborg, Thomas; Ahmedzai, Sam H; Arvanitis, Theodoros N; Badger, Douglas; James, Nicholas; Mendelsohn, Richard; Khan, Omar; Parashar, Deepak; Patel, Prashant

2017-01-01

Background The potential of technology to aid integration of care delivery systems is being explored in a range of contexts across a variety of conditions in the United Kingdom. Prostate cancer is the most common cancer in UK men. With a 10-year survival rate of 84%, there is a need to explore innovative methods of care that are integrated between primary health care providers and specialist teams in order to address long-term consequences of the disease and its treatment as well as to provide continued monitoring for recurrence. Objective Our aim was to test the feasibility of a randomized controlled trial to compare a model of prostate cancer continuing and follow-up care integration, underpinned by digital technology, with usual care in terms of clinical and cost-effectiveness, patient-reported outcomes, and experience. Methods A first phase of the study has included development of an online adaptive prostate specific Holistic Needs Assessment system (HNA), training for primary care-based nurses, training of an IT peer supporter, and interviews with health care professionals and men with prostate cancer to explore views of their care, experience of technology, and views of the proposed intervention. In Phase 2, men in the intervention arm will complete the HNA at home to help identify and articulate concerns and share them with their health care professionals, in both primary and specialist care. Participants in the control arm will receive usual care. Outcomes including quality of life and well-being, prostate-specific concerns, and patient enablement will be measured 3 times over a 9-month period. Results Findings from phase 1 indicated strong support for the intervention among men, including those who had had little experience of digital technology. Men expressed a range of views on ways that the online system might be used within a clinical pathway. Health care professionals gave valuable feedback on how the output of the assessment might be presented to encourage engagement and uptake by clinical teams. Recruitment to the second phase of the study, the feasibility trial, commenced March 2017. Conclusions To our knowledge, this study is the first in the United Kingdom to trial an online holistic needs assessment for men with prostate cancer, with data shared between patients and primary and secondary care providers. This study addresses recommendations in recent policy documents promoting the importance of data sharing and enhanced communication between care providers as a basis for care integration. We anticipate that this model of care will ultimately provide important benefits for both patients and the National Health Service. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN): 31380482; http://www.isrctn.com/ISRCTN31380482 (Archived by WebCite at http://www.webcitation.org/6s8I42u5N) PMID:28754653

How Effective Is Algorithm-Guided Treatment for Depressed Inpatients? Results from the Randomized Controlled Multicenter German Algorithm Project 3 Trial

PubMed Central

Wiethoff, Katja; Baghai, Thomas C; Fisher, Robert; Seemüller, Florian; Laakmann, Gregor; Brieger, Peter; Cordes, Joachim; Malevani, Jaroslav; Laux, Gerd; Hauth, Iris; Möller, Hans-Jürgen; Kronmüller, Klaus-Thomas; Smolka, Michael N; Schlattmann, Peter; Berger, Maximilian; Ricken, Roland; Stamm, Thomas J; Heinz, Andreas; Bauer, Michael

2017-01-01

Abstract Background Treatment algorithms are considered as key to improve outcomes by enhancing the quality of care. This is the first randomized controlled study to evaluate the clinical effect of algorithm-guided treatment in inpatients with major depressive disorder. Methods Inpatients, aged 18 to 70 years with major depressive disorder from 10 German psychiatric departments were randomized to 5 different treatment arms (from 2000 to 2005), 3 of which were standardized stepwise drug treatment algorithms (ALGO). The fourth arm proposed medications and provided less specific recommendations based on a computerized documentation and expert system (CDES), the fifth arm received treatment as usual (TAU). ALGO included 3 different second-step strategies: lithium augmentation (ALGO LA), antidepressant dose-escalation (ALGO DE), and switch to a different antidepressant (ALGO SW). Time to remission (21-item Hamilton Depression Rating Scale ≤9) was the primary outcome. Results Time to remission was significantly shorter for ALGO DE (n=91) compared with both TAU (n=84) (HR=1.67; P=.014) and CDES (n=79) (HR=1.59; P=.031) and ALGO SW (n=89) compared with both TAU (HR=1.64; P=.018) and CDES (HR=1.56; P=.038). For both ALGO LA (n=86) and ALGO DE, fewer antidepressant medications were needed to achieve remission than for CDES or TAU (P<.001). Remission rates at discharge differed across groups; ALGO DE had the highest (89.2%) and TAU the lowest rates (66.2%). Conclusions A highly structured algorithm-guided treatment is associated with shorter times and fewer medication changes to achieve remission with depressed inpatients than treatment as usual or computerized medication choice guidance. PMID:28645191

How Effective Is Algorithm-Guided Treatment for Depressed Inpatients? Results from the Randomized Controlled Multicenter German Algorithm Project 3 Trial.

PubMed

Adli, Mazda; Wiethoff, Katja; Baghai, Thomas C; Fisher, Robert; Seemüller, Florian; Laakmann, Gregor; Brieger, Peter; Cordes, Joachim; Malevani, Jaroslav; Laux, Gerd; Hauth, Iris; Möller, Hans-Jürgen; Kronmüller, Klaus-Thomas; Smolka, Michael N; Schlattmann, Peter; Berger, Maximilian; Ricken, Roland; Stamm, Thomas J; Heinz, Andreas; Bauer, Michael

2017-09-01

Treatment algorithms are considered as key to improve outcomes by enhancing the quality of care. This is the first randomized controlled study to evaluate the clinical effect of algorithm-guided treatment in inpatients with major depressive disorder. Inpatients, aged 18 to 70 years with major depressive disorder from 10 German psychiatric departments were randomized to 5 different treatment arms (from 2000 to 2005), 3 of which were standardized stepwise drug treatment algorithms (ALGO). The fourth arm proposed medications and provided less specific recommendations based on a computerized documentation and expert system (CDES), the fifth arm received treatment as usual (TAU). ALGO included 3 different second-step strategies: lithium augmentation (ALGO LA), antidepressant dose-escalation (ALGO DE), and switch to a different antidepressant (ALGO SW). Time to remission (21-item Hamilton Depression Rating Scale ≤9) was the primary outcome. Time to remission was significantly shorter for ALGO DE (n=91) compared with both TAU (n=84) (HR=1.67; P=.014) and CDES (n=79) (HR=1.59; P=.031) and ALGO SW (n=89) compared with both TAU (HR=1.64; P=.018) and CDES (HR=1.56; P=.038). For both ALGO LA (n=86) and ALGO DE, fewer antidepressant medications were needed to achieve remission than for CDES or TAU (P<.001). Remission rates at discharge differed across groups; ALGO DE had the highest (89.2%) and TAU the lowest rates (66.2%). A highly structured algorithm-guided treatment is associated with shorter times and fewer medication changes to achieve remission with depressed inpatients than treatment as usual or computerized medication choice guidance. © The Author 2017. Published by Oxford University Press on behalf of CINP.

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.

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

PubMed Central

2012-01-01

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

Exercise counseling to enhance smoking cessation outcomes: the Fit2Quit randomized controlled trial.

PubMed

Maddison, Ralph; Roberts, Vaughan; McRobbie, Hayden; Bullen, Christopher; Prapavessis, Harry; Glover, Marewa; Jiang, Yannan; Brown, Paul; Leung, William; Taylor, Sue; Tsai, Midi

2014-10-01

Regular exercise has been proposed as a potential smoking cessation aid. This study aimed to determine the effects of an exercise counseling program on cigarette smoking abstinence at 24 weeks. A parallel, two-arm, randomized controlled trial was conducted. Adult cigarette smokers (n = 906) who were insufficiently active and interested in quitting were randomized to receive the Fit2Quit intervention (10 exercise telephone counseling sessions over 6 months) plus usual care (behavioral counseling and nicotine replacement therapy) or usual care alone. There were no significant group differences in 7-day point-prevalence and continuous abstinence at 6 months. The more intervention calls successfully delivered, the lower the probability of smoking (OR, 0.88; 95 % CI 0.81-0.97, p = 0.01) in the intervention group. A significant difference was observed for leisure time physical activity (difference = 219.11 MET-minutes/week; 95 % CI 52.65-385.58; p = 0.01). Telephone-delivered exercise counseling may not be sufficient to improve smoking abstinence rates over and above existing smoking cessation services. (Australasian Clinical Trials Registry Number: ACTRN12609000637246.).

Dementia Care Management in an Underserved Community: The Comparative Effectiveness of Two Different Approaches.

PubMed

Chodosh, Joshua; Colaiaco, Benjamin A; Connor, Karen Ilene; Cope, Dennis Wesley; Liu, Hangsheng; Ganz, David Avram; Richman, Mark Jason; Cherry, Debra Lynn; Blank, Joseph Moshe; Carbone, Raquel Del Pilar; Wolf, Sheldon Mark; Vickrey, Barbara Grace

2015-08-01

To compare the effectiveness and costs of telephone-only approach to in-person plus telephone for delivering an evidence-based, coordinated care management program for dementia. We randomized 151 patient-caregiver dyads from an underserved predominantly Latino community to two arms that shared a care management protocol but implemented in different formats: in-person visits at home and/or in the community plus telephone and mail, versus telephone and mail only. We compared between-arm caregiver burden and care-recipient problem behaviors (primary outcomes) and patient-caregiver dyad retention, care quality, health care utilization, and costs (secondary outcomes) at 6- and 12-months follow-up. Care quality improved substantially over time in both arms. Caregiver burden, care-recipient problem behaviors, retention, and health care utilization did not differ across arms but the in-person program cost more to deliver. Dementia care quality improved regardless of how care management was delivered; large differences in effectiveness or cost offsets were not detected. © The Author(s) 2015.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lewis, G.N.; Ride, S.K.; Townsend, J.S.

It is widely believed that an arms control limit on nuclear-armed sea-launched cruise missiles would be nearly impossible to verify. Among the reasons usually given are: these weapons are small, built in nondistinctive industrial facilities, deployed on a variety of ships and submarines, and difficult to distinguish from their conventionally armed counterparts. In this article, it is argued that the covert production and deployment of nuclear-armed sea-launched cruise missiles would not be so straightforward. A specific arms control proposed is described, namely a total ban on nuclear-armed sea-launched cruise missiles. This proposal is used to illustrate how an effective verificationmore » scheme might be constructed. 9 refs., 6 figs.« less

Dispelling myths about verification of sea-launched cruise missiles.

PubMed

Lewis, G N; Ride, S K; Townsend, J S

1989-11-10

It is widely believed that an arms control limit on nuclear-armed sea-launched cruise missiles would be nearly impossible to verify. Among the reasons usually given are: these weapons are small, built in nondistinctive industrial facilities, deployed on a variety of ships and submarines, and difficult to distinguish from their conventionally armed counterparts. In this article, it is argued that the covert production and deployment of nuclear-armed sealaunched cruise missiles would not be so straightforward. A specific arms control proposal is described, namely a total ban on nuclear-armed sea-launched cruise missiles. This proposal is used to illustrate how an effective verification scheme might be constructed.

Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes.

PubMed

Riddell, M A; Dunbar, J A; Absetz, P; Wolfe, R; Li, H; Brand, M; Aziz, Z; Oldenburg, B

2016-08-24

The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries. The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services. This study is an evaluation of a "real world" peer support program aimed at improving the control and management of type 2 diabetes (T2DM) in Australia. The trial used a randomised cluster design with a peer support intervention and routine care control arms and 12-month follow up. Participants in both arms received a standardised session of self-management education at baseline. The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community resources and supports related to diabetes. Clinical, behavioural and other measures were collected at baseline, 6 and 12 months. The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospective Diabetes Study (UKPDS) Risk Equation at 12 months. Secondary outcomes included clinical measures, quality of life, measures of support, psychosocial functioning and lifestyle measures. Eleven of 12 planned groups were successfully implemented in the intervention arm. Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months. There were some small positive changes in self-management behaviours. The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk, possibly because approximately half of the study participants already had quite well controlled T2DM at baseline. Future research needs to address how to enhance community based programs so that they reach and benefit those most in need of resources and supports to improve metabolic control and associated clinical outcomes. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469213 . Registered 16 June 2009.

Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial.

PubMed

Reuland, Daniel S; Brenner, Alison T; Hoffman, Richard; McWilliams, Andrew; Rhyne, Robert L; Getrich, Christina; Tapp, Hazel; Weaver, Mark A; Callan, Danelle; Cubillos, Laura; Urquieta de Hernandez, Brisa; Pignone, Michael P

2017-07-01

Colorectal cancer (CRC) screening is underused, especially among vulnerable populations. Decision aids and patient navigation are potentially complementary interventions for improving CRC screening rates, but their combined effect on screening completion is unknown. To determine the combined effect of a CRC screening decision aid and patient navigation compared with usual care on CRC screening completion. In this randomized clinical trial, data were collected from January 2014 to March 2016 at 2 community health center practices, 1 in North Carolina and 1 in New Mexico, serving vulnerable populations. Patients ages 50 to 75 years who had average CRC risk, spoke English or Spanish, were not current with recommended CRC screening, and were attending primary care visits were recruited and randomized 1:1 to intervention or control arms. Intervention participants viewed a CRC screening decision aid in English or Spanish immediately before their clinician encounter. The decision aid promoted screening and presented colonoscopy and fecal occult blood testing as screening options. After the clinician encounter, intervention patients received support for screening completion from a bilingual patient navigator. Control participants viewed a food safety video before the encounter and otherwise received usual care. The primary outcome was CRC screening completion within 6 months of the index study visit assessed by blinded medical record review. Characteristics of the 265 participants were as follows: their mean age was 58 years; 173 (65%) were female, 164 (62%) were Latino; 40 (15%) were white non-Latino; 61 (23%) were black or of mixed race; 191 (78%) had a household income of less than $20 000; 101 (38%) had low literacy; 75 (28%) were on Medicaid; and 91 (34%) were uninsured. Intervention participants were more likely to complete CRC screening within 6 months (68% vs 27%); adjusted-difference, 40 percentage points (95% CI, 29-51 percentage points). The intervention was more effective in women than in men (50 vs 21 percentage point increase, interaction P = .02). No effect modification was observed across other subgroups. A patient decision aid plus patient navigation increased the rate of CRC screening completion in compared with usual care invulnerable primary care patients. clinicaltrials.gov Identifier: NCT02054598.

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

Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) a pragmatic three-arm cluster randomised trial: designing the intervention (ClinicalTrials.gov registration NCT01602705).

PubMed

Barnett, Karen N; Bennie, Marion; Treweek, Shaun; Robertson, Christopher; Petrie, Dennis J; Ritchie, Lewis D; Guthrie, Bruce

2014-10-11

High-risk prescribing in primary care is common and causes considerable harm. Feedback interventions have small/moderate effects on clinical practice, but few trials explicitly compare different forms of feedback. There is growing recognition that intervention development should be theory-informed, and that comprehensive reporting of intervention design is required by potential users of trial findings. The paper describes intervention development for the Effective Feedback to Improve Primary Care Prescribing Safety (EFIPPS) study, a pragmatic three-arm cluster randomised trial in 262 Scottish general practices. The NHS chose to implement a feedback intervention to utilise a new resource, new Prescribing Information System (newPIS). The development phase required selection of high-risk prescribing outcome measures and design of intervention components: (1) educational material (the usual care comparison), (2) feedback of practice rates of high-risk prescribing received by both intervention arms and (3) a theory-informed behaviour change component to be received by one intervention arm. Outcome measures, educational material and feedback design, were developed with a National Health Service Advisory Group. The behaviour change component was informed by the Theory of Planned Behaviour and the Health Action Process Approach. A focus group elicitation study and an email Delphi study with general practitioners (GPs) identified key attitudes and barriers of responding to the prescribing feedback. Behaviour change techniques were mapped to the psychological constructs, and the content was informed by the results of the elicitation and Delphi study. Six high-risk prescribing measures were selected in a consensus process based on importance and feasibility. Educational material and feedback design were based on current NHS Scotland practice and Advisory Group recommendations. The behaviour change component was resource constrained in development, mirroring what is feasible in an NHS context. Four behaviour change interventions were developed and embedded in five quarterly rounds of feedback targeting attitudes, subjective norms, perceived behavioural control and action planning (2×). The paper describes a process which is feasible to use in the resource-constrained environment of NHS-led intervention development and documents the intervention to make its design and implementation explicit to potential users of the trial findings. ClinicalTrials.gov: NCT01602705.

Community Health Worker Home Visits for Medicaid-Enrolled Children With Asthma: Effects on Asthma Outcomes and Costs

PubMed Central

Brooks, Marissa; Hosokawa, Patrick; Robinson, June; Song, Lin; Krieger, James

2015-01-01

Objectives. We sought to estimate the return on investment of a streamlined version of an evidence-based community health worker (CHW) asthma home visit program. Methods. We used a randomized parallel group trial of home visits by CHWs to Medicaid-enrolled children with uncontrolled asthma versus usual care. Results. A total of 373 participants enrolled in the study (182 in the intervention group and 191 in the control group, of whom 154 and 179, respectively, completed the study). The intervention group had greater improvements in asthma symptom–free days (2.10 days more over 2 weeks; 95% CI =  1.17, 3.05; P < .001) and caretakers’ quality of life (0.43 units more; 95% CI = 0.20, 0.66; P < .001) and a larger reduction in urgent health care utilization events (1.31 events fewer over 12 months; 95% CI = −2.10, −0.52; P = .001). The intervention arm compared with the control arm saved $1340.92 for the $707.04 additional costs invested for the average participant. The return on investment was 1.90. Conclusions. A streamlined CHW asthma home visit program for children with uncontrolled asthma improved health outcomes and yielded a return on investment of 1.90. PMID:26270287

Discharge Planning in Chronic Conditions

PubMed Central

McMartin, K

2013-01-01

Background Chronically ill people experience frequent changes in health status accompanied by multiple transitions between care settings and care providers. Discharge planning provides support services, follow-up activities, and other interventions that span pre-hospital discharge to post-hospital settings. Objective To determine if discharge planning is effective at reducing health resource utilization and improving patient outcomes compared with standard care alone. Data Sources A standard systematic literature search was conducted for studies published from January 1, 2004, until December 13, 2011. Review Methods Reports, randomized controlled trials, systematic reviews, and meta-analyses with 1 month or more of follow-up and limited to specified chronic conditions were examined. Outcomes included mortality/survival, readmissions and emergency department (ED) visits, hospital length of stay (LOS), health-related quality of life (HRQOL), and patient satisfaction. Results One meta-analysis compared individualized discharge planning to usual care and found a significant reduction in readmissions favouring individualized discharge planning. A second meta-analysis compared comprehensive discharge planning with postdischarge support to usual care. There was a significant reduction in readmissions favouring discharge planning with postdischarge support. However, there was significant statistical heterogeneity. For both meta-analyses there was a nonsignificant reduction in mortality between the study arms. Limitations There was difficulty in distinguishing the relative contribution of each element within the terms “discharge planning” and “postdischarge support.” For most studies, “usual care” was not explicitly described. Conclusions Compared with usual care, there was moderate quality evidence that individualized discharge planning is more effective at reducing readmissions or hospital LOS but not mortality, and very low quality evidence that it is more effective at improving HRQOL or patient satisfaction. Compared with usual care, there was low quality evidence that the discharge planning plus postdischarge support is more effective at reducing readmissions but not more effective at reducing hospital LOS or mortality. There was very low quality evidence that it is more effective at improving HRQOL or patient satisfaction. Plain Language Summary Chronically ill people experience frequent changes in their health status and multiple transitions between care settings and care providers (e.g., hospital to home). Discharge planning provides support services, follow-up activities and other interventions that span pre-hospital discharge to post-hospital settings. A review of the effects of different discharge plans was conducted. After searching for relevant studies, 11 studies were found that compared discharge planning with routine discharge care. This review indicates that: Individualized discharge planning reduces initial hospital length of stay and subsequent readmission to hospital but does not reduce mortality. The effect on health-related quality of life (HRQOL) or patient satisfaction is uncertain. Discharge planning plus postdischarge support reduces readmissions but does not reduce the initial hospital length of stay or mortality after discharge. The effect on HRQOL or patient satisfaction is uncertain. PMID:24167538

Psychological interventions for diabetes-related distress in adults with type 2 diabetes mellitus.

PubMed

Chew, Boon How; Vos, Rimke C; Metzendorf, Maria-Inti; Scholten, Rob Jpm; Rutten, Guy Ehm

2017-09-27

Many adults with type 2 diabetes mellitus (T2DM) experience a psychosocial burden and mental health problems associated with the disease. Diabetes-related distress (DRD) has distinct effects on self-care behaviours and disease control. Improving DRD in adults with T2DM could enhance psychological well-being, health-related quality of life, self-care abilities and disease control, also reducing depressive symptoms. To assess the effects of psychological interventions for diabetes-related distress in adults with T2DM. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO, CINAHL, BASE, WHO ICTRP Search Portal and ClinicalTrials.gov. The date of the last search was December 2014 for BASE and 21 September 2016 for all other databases. We included randomised controlled trials (RCTs) on the effects of psychological interventions for DRD in adults (18 years and older) with T2DM. We included trials if they compared different psychological interventions or compared a psychological intervention with usual care. Primary outcomes were DRD, health-related quality of life (HRQoL) and adverse events. Secondary outcomes were self-efficacy, glycosylated haemoglobin A1c (HbA1c), blood pressure, diabetes-related complications, all-cause mortality and socioeconomic effects. Two review authors independently identified publications for inclusion and extracted data. We classified interventions according to their focus on emotion, cognition or emotion-cognition. We performed random-effects meta-analyses to compute overall estimates. We identified 30 RCTs with 9177 participants. Sixteen trials were parallel two-arm RCTs, and seven were three-arm parallel trials. There were also seven cluster-randomised trials: two had four arms, and the remaining five had two arms. The median duration of the intervention was six months (range 1 week to 24 months), and the median follow-up period was 12 months (range 0 to 12 months). The trials included a wide spectrum of interventions and were both individual- and group-based.A meta-analysis of all psychological interventions combined versus usual care showed no firm effect on DRD (standardised mean difference (SMD) -0.07; 95% CI -0.16 to 0.03; P = 0.17; 3315 participants; 12 trials; low-quality evidence), HRQoL (SMD 0.01; 95% CI -0.09 to 0.11; P = 0.87; 1932 participants; 5 trials; low-quality evidence), all-cause mortality (11 per 1000 versus 11 per 1000; risk ratio (RR) 1.01; 95% CI 0.17 to 6.03; P = 0.99; 1376 participants; 3 trials; low-quality evidence) or adverse events (17 per 1000 versus 41 per 1000; RR 2.40; 95% CI 0.78 to 7.39; P = 0.13; 438 participants; 3 trials; low-quality evidence). We saw small beneficial effects on self-efficacy and HbA1c at medium-term follow-up (6 to 12 months): on self-efficacy the SMD was 0.15 (95% CI 0.00 to 0.30; P = 0.05; 2675 participants; 6 trials; low-quality evidence) in favour of psychological interventions; on HbA1c there was a mean difference (MD) of -0.14% (95% CI -0.27 to 0.00; P = 0.05; 3165 participants; 11 trials; low-quality evidence) in favour of psychological interventions. Our included trials did not report diabetes-related complications or socioeconomic effects.Many trials were small and were at high risk of bias for incomplete outcome data as well as possible performance and detection biases in the subjective questionnaire-based outcomes assessment, and some appeared to be at risk of selective reporting. There are four trials awaiting further classification. These are parallel RCTs with cognition-focused and emotion-cognition focused interventions. There are another 18 ongoing trials, likely focusing on emotion-cognition or cognition, assessing interventions such as diabetes self-management support, telephone-based cognitive behavioural therapy, stress management and a web application for problem solving in diabetes management. Most of these trials have a community setting and are based in the USA. Low-quality evidence showed that none of the psychological interventions would improve DRD more than usual care. Low-quality evidence is available for improved self-efficacy and HbA1c after psychological interventions. This means that we are uncertain about the effects of psychological interventions on these outcomes. However, psychological interventions probably have no substantial adverse events compared to usual care. More high-quality research with emotion-focused programmes, in non-US and non-European settings and in low- and middle-income countries, is needed.

Protocol for a randomised controlled trial evaluating the effects of providing essential medicines at no charge: the Carefully seLected and Easily Accessible at No Charge Medicines (CLEAN Meds) trial.

PubMed

Persaud, Nav; Lee, Taehoon; Ahmad, Haroon; Li, Winny; Taglione, Michael Sergio; Rajakulasingam, Yathavan; Umali, Norman; Boozary, Andrew; Glazier, Richard H; Gomes, Tara; Hwang, Stephen W; Jüni, Peter; Law, Michael; Mamdani, Muhammad M; Manns, Braden; Martin, Danielle; Morgan, Steve; Oh, Paul; Pinto, Andrew David; Shah, Baiju R; Sullivan, Frank M; Thorpe, Kevin E; Tu, Karen; Laupacis, Andreas

2017-06-12

Cost-related non-adherence to medicines is common in low-income, middle-income and high-income countries such as Canada. Medicine non-adherence is associated with poor health outcomes and increased mortality. This randomised trial will test the impact of a carefully selected list of essential medicines at no charge (compared with usual medicine access) in primary care patients reporting cost-related non-adherence. This is an open-label, parallel two-arm, superiority, individually randomised controlled trial conducted in three primary care sites (one urban, two rural) in Ontario, Canada, that was codesigned by a community guidance panel. Adult patients (≥18 years) who report cost-related non-adherence to medicines are eligible to participate in the study. Participants will be randomised to receive free and convenient access to a carefully selected list of 125 essential medicines (based on the WHO's Model List of Essential Medicines) or usual means of medicine access. Care for patients in both groups will otherwise be unchanged. The primary outcome of this trial is adherence to appropriately prescribed medicines. Secondary outcomes include medicine adherence, appropriate prescribing, blood pressure, haemoglobin A1c, low-density lipoprotein cholesterol, patient-oriented outcomes and healthcare costs. All participants will be followed for at least 12 months. Ethics approval was obtained in all three participating sites. Results of the main trial and secondary outcomes will be submitted for publication in a peer-reviewed journal and discussed with members of the public and decision makers. NCT02744963. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cost 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.

Telemedicine-based collaborative care for posttraumatic stress disorder: a randomized clinical trial.

PubMed

Fortney, John C; Pyne, Jeffrey M; Kimbrell, Timothy A; Hudson, Teresa J; Robinson, Dean E; Schneider, Ronald; Moore, William M; Custer, Paul J; Grubbs, Kathleen M; Schnurr, Paula P

2015-01-01

Posttraumatic stress disorder (PTSD) is prevalent, persistent, and disabling. Although psychotherapy and pharmacotherapy have proven efficacious in randomized clinical trials, geographic barriers impede rural veterans from engaging in these evidence-based treatments. To test a telemedicine-based collaborative care model designed to improve engagement in evidence-based treatment of PTSD. The Telemedicine Outreach for PTSD (TOP) study used a pragmatic randomized effectiveness trial design with intention-to-treat analyses. Outpatients were recruited from 11 Department of Veterans Affairs (VA) community-based outpatient clinics serving predominantly rural veterans. Inclusion required meeting diagnostic criteria for current PTSD according to the Clinician-Administered PTSD Scale. Exclusion criteria included receiving PTSD treatment at a VA medical center or a current diagnosis of schizophrenia, bipolar disorder, or substance dependence. Two hundred sixty-five veterans were enrolled from November 23, 2009, through September 28, 2011, randomized to usual care (UC) or the TOP intervention, and followed up for 12 months. Off-site PTSD care teams located at VA medical centers supported on-site community-based outpatient clinic providers. Off-site PTSD care teams included telephone nurse care managers, telephone pharmacists, telepsychologists, and telepsychiatrists. Nurses conducted care management activities. Pharmacists reviewed medication histories. Psychologists delivered cognitive processing therapy via interactive video. Psychiatrists supervised the team and conducted interactive video psychiatric consultations. The primary outcome was PTSD severity as measured by the Posttraumatic Diagnostic Scale. Process-of-care outcomes included medication prescribing and regimen adherence and initiation of and adherence to cognitive processing therapy. During the 12-month follow-up period, 73 of the 133 patients randomized to TOP (54.9%) received cognitive processing therapy compared with 16 of 132 randomized to UC (12.1%) (odds ratio, 18.08 [95% CI, 7.96-41.06]; P < .001). Patients in the TOP arm had significantly larger decreases in Posttraumatic Diagnostic Scale scores (from 35.0 to 29.1) compared with those in the UC arm (from 33.5 to 32.1) at 6 months (β = -3.81; P = .002). Patients in the TOP arm also had significantly larger decreases in Posttraumatic Diagnostic Scale scores (from 35.0 to 30.1) compared with those in the UC arm (from 33.5 to 31.7) at 12 months (β = -2.49; P=.04). There were no significant group differences in the number of PTSD medications prescribed and adherence to medication regimens were not significant. Attendance at 8 or more sessions of cognitive processing therapy significantly predicted improvement in Posttraumatic Diagnostic Scale scores (β = -3.86 [95% CI, -7.19 to -0.54]; P = .02) and fully mediated the intervention effect at 12 months. Telemedicine-based collaborative care can successfully engage rural veterans in evidence-based psychotherapy to improve PTSD outcomes. clinicaltrials.gov Identifier: NCT00821678.

DIABEO App Software and Telemedicine Versus Usual Follow-Up in the Treatment of Diabetic Patients: Protocol for the TELESAGE Randomized Controlled Trial.

PubMed

Jeandidier, Nathalie; Chaillous, Lucy; Franc, Sylvia; Benhamou, Pierre-Yves; Schaepelynck, Pauline; Hanaire, Hélène; Catargi, Bogdan; Farret, Anne; Fontaine, Pierre; Guerci, Bruno; Reznik, Yves; Penfornis, Alfred; Borot, Sophie; Serusclat, Pierre; Kherbachi, Yacine; D'Orsay, Geneviève; Detournay, Bruno; Simon, Pierre; Charpentier, Guillaume

2018-04-19

Self-management of diabetes minimizes the risk of macrovascular and microvascular complications, but understanding and/or adherence to self-management recommendations is often suboptimal. DIABEO is a smartphone app (downloaded via the internet) used to calculate bolus insulin doses. A previous study (TELEDIAB 1) showed that the use of DIABEO was associated with a significant improvement in glycemic control in patients with poorly controlled type 1 diabetes mellitus, particularly when combined with teleconsultations with physicians. Here, we present the protocol for a new study (Suivi A Grande Echelle d'une cohorte de diabétiques de type 1 et de type 2 sous schéma insulinique basal bolus par la TELEmédecine; abbreviated TELESAGE), conducted in a larger population of diabetic patients with poorly controlled basal-bolus insulin levels. TELESAGE is a multicenter, double-randomized, open-label, three parallel-arms study, conducted in approximately 100 centers in France. The study will compare a control group (arm 1: usual follow-up) with two DIABEO telemedicine systems: (1) physician-assisted telemedicine (arm 2), and (2) nurse-assisted telemonitoring and teleconsultations by a diabetologist's task delegation (arm 3). Initial randomization will allocate the study arms in 12 French regions. A second randomization will assign patients in the groups allocated to each studied region. The primary objective of TELESAGE will be to investigate the effect of the DIABEO telemedicine system versus usual follow-up, with respect to improvements in the glycated hemoglobin levels of approximately 696 diabetic patients with poorly controlled basal-bolus insulin levels. The TELESAGE study is sponsored by Sanofi (Gentilly, France). A primary completion date is expected in June 2018, and publication of results is expected within 6 months of work completion. The TELESAGE study is expected to confirm the previous results of the TELEDIAB 1 study using a larger sample of diabetic patients. It is also expected to evaluate a nurse-assisted telemonitoring system. We will assess the potential of the DIABEO telemedicine service in terms of its utility and explore whether it can become an integral part of diabetes care for patients. ClinicalTrials.gov NCT02287532; https://clinicaltrials.gov/ct2/show/NCT02287532 (Archived by WebCite at http://www.webcitation.org/6ykajhJKd). ©Nathalie Jeandidier, Lucy Chaillous, Sylvia Franc, Pierre-Yves Benhamou, Pauline Schaepelynck, Hélène Hanaire, Bogdan Catargi, Anne Farret, Pierre Fontaine, Bruno Guerci, Yves Reznik, Alfred Penfornis, Sophie Borot, Pierre Serusclat, Yacine Kherbachi, Geneviève D'Orsay, Bruno Detournay, Pierre Simon, Guillaume Charpentier. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.04.2018.

Tele-Pediatric Intensive Care for Critically Ill Children in Syria.

PubMed

Ghbeis, Muhammad Bakr; Steffen, Katherine M; Braunlin, Elizabeth A; Beilman, Gregory J; Dahman, Jay; Ostwani, Waseem; Steiner, Marie E

2017-12-12

Armed conflicts can result in humanitarian crises and have major impacts on civilians, of whom children represent a significant proportion. Usual pediatric medical care is often disrupted and trauma resulting from war-related injuries is often devastating. High pediatric mortality rates are thus experienced in these ravaged medical environments. Using simple communication technology to provide real-time management recommendations from highly trained pediatric personnel can provide substantive clinical support and have a significant impact on pediatric morbidity and mortality. We implemented a "Tele-Pediatric Intensive Care" program (Tele-PICU) to provide real-time management consultation for critically ill and injured pediatric patients in Syria with intensive care needs. Over the course of 7 months, 19 cases were evaluated, ranging in age from 1 day to 11 years. Consultation questions addressed a wide range of critical care needs. Five patients are known to have survived, three were transferred, five died, and six outcomes were unknown. Based on this limited undertaking with its positive impact on survival, further development of Tele-PICU-based efforts with attention to implementation and barriers identified through this program is desirable. Even limited Tele-PICU can provide timely and potentially lifesaving assistance to pediatric care providers. Future efforts are encouraged.

Early intensive hand rehabilitation after spinal cord injury ("Hands On"): a protocol for a randomised controlled trial.

PubMed

Harvey, Lisa A; Dunlop, Sarah A; Churilov, Leonid; Hsueh, Ya-Seng Arthur; Galea, Mary P

2011-01-17

Loss of hand function is one of the most devastating consequences of spinal cord injury. Intensive hand training provided on an instrumented exercise workstation in conjunction with functional electrical stimulation may enhance neural recovery and hand function. The aim of this trial is to compare usual care with an 8-week program of intensive hand training and functional electrical stimulation. A multicentre randomised controlled trial will be undertaken. Seventy-eight participants with recent tetraplegia (C2 to T1 motor complete or incomplete) undergoing inpatient rehabilitation will be recruited from seven spinal cord injury units in Australia and New Zealand and will be randomised to a control or experimental group. Control participants will receive usual care. Experimental participants will receive usual care and an 8-week program of intensive unilateral hand training using an instrumented exercise workstation and functional electrical stimulation. Participants will drive the functional electrical stimulation of their target hands via a behind-the-ear bluetooth device, which is sensitive to tooth clicks. The bluetooth device will enable the use of various manipulanda to practice functional activities embedded within computer-based games and activities. Training will be provided for one hour, 5 days per week, during the 8-week intervention period. The primary outcome is the Action Research Arm Test. Secondary outcomes include measurements of strength, sensation, function, quality of life and cost effectiveness. All outcomes will be taken at baseline, 8 weeks, 6 months and 12 months by assessors blinded to group allocation. Recruitment commenced in December 2009. The results of this trial will determine the effectiveness of an 8-week program of intensive hand training with functional electrical stimulation. NCT01086930 (12th March 2010)ACTRN12609000695202 (12th August 2009).

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

PubMed

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

2018-06-15

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

Study Protocol: effects of acupuncture on hot flushes in perimenopausal and postmenopausal women – a multicenter randomized clinical trial

PubMed Central

Kim, Kun-Hyung; Kang, Kyung-Won; Jung, Hee-Jung; Park, Ji-Eun; Jung, So-Young; Choi, Jun-Yong; Choi, Sun-Mi

2008-01-01

Background Hot flushes are the most frequent climacteric symptom and a major cause of suffering among menopausal women. The condition negatively influences many aspects of women's lives. To date, conventional hormone replacement therapy (HRT) is considered the most effective treatment for hot flushes. However, HRT is associated with a host of negative side effects. Complementary and alternative medical (CAM) approaches have been employed to relieve symptoms and to avoid these side effects. Acupuncture is one of the most strongly preferred CAM treatments for many diseases, causing few serious adverse effects, and is frequently used in Korea. We aim to evaluate the effectiveness of Traditional Korean Acupuncture (TKA) in conjunction with usual care, compared to usual care alone, on hot flushes in perimenopausal and postmenopausal women in Korea. Methods This study consists of a multi-center randomized controlled trial with 2 parallel arms. Participants included in the study will meet the following criteria: 1) a documented daily average hot flush score ≥ 10 for one week prior to the screening visit 2) not taking HRT and other pharmaceutical therapies which might affect hot flushes or other vasomotor symptoms. While maintaining usual care, the treatment group will receive acupuncture 3 times a week, for a total of 12 sessions over 4 weeks. The control group will receive usual care alone during the same period. Post-treatment follow-up will be performed one month after completing 12 sessions of acupuncture. Discussion This trial will provide evidence for the effectiveness of acupuncture as a treatment for hot flushes. The primary endpoint in both groups is a change in hot flush score from baseline to week 4 and/or week 8. As the secondary endpoint, we will employ the Menopause Rating Scale (MRS), a health-related quality of life questionnaire. Further analysis will examine the frequency, severity and difference in symptoms for daytime vs. nighttime hot flushes, sub-domain analysis of MRS, and participants' expectations of acupuncture treatment. Trial registration Current Controlled Trials ISRCTN49335612 PMID:19055763

Brief smoking cessation intervention: a prospective trial in the urology setting.

PubMed

Bjurlin, Marc A; Cohn, Matthew R; Kim, Dae Y; Freeman, Vincent L; Lombardo, Lindsay; Hurley, Stephen D; Hollowell, Courtney M P

2013-05-01

Urologists have an important role in the treatment of tobacco related diseases, such as kidney and bladder cancer. Despite this role, urologists receive little training in promoting tobacco cessation. We prospectively evaluated a brief smoking cessation intervention offered by a urologist at an outpatient clinic. Between 2009 and 2011 adult smokers from a single institution urology clinic were enrolled in a prospective, brief intervention trial or in usual care as controls. All patients were assessed by the validated Fagerström test for nicotine dependence and the readiness to quit questionnaire. Trial patients received a 5-minute brief smoking cessation intervention. The primary outcome was abstinence at 1 year and the secondary outcome was the number of attempts to quit. Multivariate logistic regression was used to identify factors associated with the quit rate and quit attempts. A total of 179 patients were enrolled in the study, including 100 in the brief smoking cessation intervention, 41 in the brief smoking cessation intervention plus nicotine replacement therapy and 38 usual care controls. Of the participants 81.0% were 40 years old or older with a mean ± SD 11.26 ± 7.23 pack-year smoking history. Mean readiness to quit and tobacco dependence scores were similar in the 2 arms (p = 0.25 and 0.92, respectively). The 1-year quit rate in the brief smoking cessation intervention group was 12.1% vs 2.6% in the usual care group (OR 4.44, p = 0.163) Adding nicotine replacement therapy increased the quit rate to 19.5% (vs usual care OR 9.91, p = 0.039). Patients who received the brief smoking cessation intervention were significantly more likely to attempt to quit (OR 2.31, p = 0.038). Increased readiness scores were associated with an increased quit rate and increased quit attempts. Urologists can successfully implement a brief smoking cessation intervention program. Our study highlights the role of the urologist in providing smoking cessation assistance and the significant impact of brief, simple advice about quitting smoking on the smoker quit rate. Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Early effect of intra-arterial treatment in ischemic stroke on aphasia recovery in MR CLEAN.

PubMed

Crijnen, Yvette S; Nouwens, Femke; de Lau, Lonneke M L; Visch-Brink, Evy G; van de Sandt-Koenderman, Mieke W M E; Berkhemer, Olvert A; Fransen, Puck S S; Beumer, Debbie; van den Berg, Lucie A; Lingsma, Hester F; Roos, Yvo B W E M; van der Lugt, Aad; van Oostenbrugge, Robert J; van Zwam, Wim H; Majoie, Charles B L M; Dippel, Diederik W J

2016-05-31

To investigate the effect of intra-arterial treatment (IAT) on early recovery from aphasia in acute ischemic stroke. We hypothesized that the early effect of IAT on aphasia is smaller than the effect on motor deficits. We included patients with aphasia from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN), in which 500 patients with a proximal anterior circulation stroke were randomized to usual care plus IAT (<6 hours after stroke, mainly stent retrievers) or usual care alone. We estimated the effect of IAT on the shift on the NIH Stroke Scale (NIHSS) item language and the NIHSS item motor arm at 24 hours and 1 week after stroke with multivariable ordinal logistic regression as a common odds ratio, adjusted for prognostic variables (acOR). Differences between the effect of IAT on aphasia and on motor deficits were tested in a multilevel model with a multiplicative interaction term. Of the 288 patients with aphasia, 126 were assigned to IAT and 162 to usual care alone. The acOR for improvement of language score at 24 hours was 1.65 (95% confidence interval [CI] 1.05-2.60), and at 1 week 1.86 (95% CI 1.18-2.94). The acOR for improvement of motor deficit at 24 hours was 2.44 (95% CI 1.54-3.88), and at 1 week 2.32 (95% CI 1.43-3.77). The effect of IAT on language deficits was significantly different from the effect on motor deficits at 24 hours and 1 week (p = 0.005 and p = 0.011). IAT results in better early recovery from aphasia than usual care alone. The early effect of IAT on aphasia is smaller than the effect on motor deficits. This study provides Class II evidence that for patients with acute ischemic stroke IAT increases early recovery from aphasia and that the early effect on aphasia, as measured by the NIHSS, is smaller than the effect on motor deficits. © 2016 American Academy of Neurology.

Effectiveness of Nurse-Practitioner-Delivered Brief Motivational Intervention for Young Adult Alcohol and Drug Use in Primary Care in South Africa: A Randomized Clinical Trial

PubMed Central

Mertens, Jennifer R.; Ward, Catherine L.; Bresick, Graham F.; Broder, Tina; Weisner, Constance M.

2014-01-01

Aims: To assess the effectiveness of brief motivational intervention for alcohol and drug use in young adult primary care patients in a low-income population and country. Methods: A randomized controlled trial in a public-sector clinic in Delft, a township in the Western Cape, South Africa recruited 403 patients who were randomized to either single-session, nurse practitioner-delivered Brief Motivational Intervention plus referral list or usual care plus referral list, and followed up at 3 months. Results: Although rates of at-risk alcohol use and drug use did not differ by treatment arm at follow-up, patients assigned to the Brief Motivational Intervention had significantly reduced scores on ASSIST (Alcohol, Smoking and Substance Involvement Screening Test) for alcohol—the most prevalent substance. Conclusion: Brief Motivational Intervention may be effective at reducing at-risk alcohol use in the short term among low-income young adult primary care patients; additional research is needed to examine long-term outcomes. PMID:24899076

Effects of aromatherapy massage on face-down posture-related pain after vitrectomy: a randomized controlled trial.

PubMed

Adachi, Naho; Munesada, Minako; Yamada, Noriko; Suzuki, Haruka; Futohashi, Ayano; Shigeeda, Takashi; Kato, Satoshi; Nishigaki, Masakazu

2014-06-01

Postoperative face-down posturing (FDP) is recommended to optimize the effects of intraocular gas tamponade after vitrectomy. However, patients undergoing FDP usually experience physical and psychological burdens. This 3-armed, randomized, single-center trial investigated the effects of aromatherapy on FDP-related physical pain. Sixty-three patients under FDP were randomly allocated to one of three treatment groups: aromatherapy massage with essential oil (AT), oil massage without essential oil (OT), and a control group. The AT and OT groups received 10 minutes of massage by ward nurses trained by an aromatherapist, while the control group received usual care. Outcomes were assessed as short-term (pre- to post-intervention) and long-term (first to third postoperative day) changes in physical pain in five body regions using face-scale. The AT and OT groups both revealed similar short-term pain reductions after intervention, compared with the control group. Regarding long-term effects, neither group experienced significant effects until the second day. Significantly more pain reduction compared with usual care occurred on the third day, mainly in the AT group, though there were few significant differences between the AT and OT groups. In conclusion, this study suggests that simple oil massage is an effective strategy for immediate pain reduction in patients undergoing FDP, while aromatherapy may have a long-term effect on pain reduction. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

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.

Integrated Care in Prostate Cancer (ICARE-P): Nonrandomized Controlled Feasibility Study of Online Holistic Needs Assessment, Linking the Patient and the Health Care Team.

PubMed

Nanton, Veronica; Appleton, Rebecca; Dale, Jeremy; Roscoe, Julia; Hamborg, Thomas; Ahmedzai, Sam H; Arvanitis, Theodoros N; Badger, Douglas; James, Nicholas; Mendelsohn, Richard; Khan, Omar; Parashar, Deepak; Patel, Prashant

2017-07-28

The potential of technology to aid integration of care delivery systems is being explored in a range of contexts across a variety of conditions in the United Kingdom. Prostate cancer is the most common cancer in UK men. With a 10-year survival rate of 84%, there is a need to explore innovative methods of care that are integrated between primary health care providers and specialist teams in order to address long-term consequences of the disease and its treatment as well as to provide continued monitoring for recurrence. Our aim was to test the feasibility of a randomized controlled trial to compare a model of prostate cancer continuing and follow-up care integration, underpinned by digital technology, with usual care in terms of clinical and cost-effectiveness, patient-reported outcomes, and experience. A first phase of the study has included development of an online adaptive prostate specific Holistic Needs Assessment system (HNA), training for primary care-based nurses, training of an IT peer supporter, and interviews with health care professionals and men with prostate cancer to explore views of their care, experience of technology, and views of the proposed intervention. In Phase 2, men in the intervention arm will complete the HNA at home to help identify and articulate concerns and share them with their health care professionals, in both primary and specialist care. Participants in the control arm will receive usual care. Outcomes including quality of life and well-being, prostate-specific concerns, and patient enablement will be measured 3 times over a 9-month period. Findings from phase 1 indicated strong support for the intervention among men, including those who had had little experience of digital technology. Men expressed a range of views on ways that the online system might be used within a clinical pathway. Health care professionals gave valuable feedback on how the output of the assessment might be presented to encourage engagement and uptake by clinical teams. Recruitment to the second phase of the study, the feasibility trial, commenced March 2017. To our knowledge, this study is the first in the United Kingdom to trial an online holistic needs assessment for men with prostate cancer, with data shared between patients and primary and secondary care providers. This study addresses recommendations in recent policy documents promoting the importance of data sharing and enhanced communication between care providers as a basis for care integration. We anticipate that this model of care will ultimately provide important benefits for both patients and the National Health Service. International Standard Randomized Controlled Trial Number (ISRCTN): 31380482; http://www.isrctn.com/ISRCTN31380482 (Archived by WebCite at http://www.webcitation.org/6s8I42u5N). ©Veronica Nanton, Rebecca Appleton, Jeremy Dale, Julia Roscoe, Thomas Hamborg, Sam H Ahmedzai, Theodoros N Arvanitis, Douglas Badger, Nicholas James, Richard Mendelsohn, Omar Khan, Deepak Parashar, Prashant Patel. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 28.07.2017.

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.

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

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

PubMed

van der Voort, Trijntje Y G; van Meijel, Berno; Goossens, Peter J J; Renes, Janwillem; Beekman, Aartjan T F; Kupka, Ralph W

2011-08-17

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. 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. 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. The Netherlands Trial Registry, NTR2600.

Comparative Effectiveness of a Technology-Facilitated Depression Care Management Model in Safety-Net Primary Care Patients With Type 2 Diabetes: 6-Month Outcomes of a Large Clinical Trial

PubMed Central

Ell, Kathleen; Jin, Haomiao; Vidyanti, Irene; Chou, Chih-Ping; Lee, Pey-Jiuan; Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Belson, David; Nezu, Arthur M; Hay, Joel; Wang, Chien-Ju; Scheib, Geoffrey; Di Capua, Paul; Hawkins, Caitlin; Liu, Pai; Ramirez, Magaly; Wu, Brian W; Richman, Mark; Myers, Caitlin; Agustines, Davin; Dasher, Robert; Kopelowicz, Alex; Allevato, Joseph; Roybal, Mike; Ipp, Eli; Haider, Uzma; Graham, Sharon; Mahabadi, Vahid; Guterman, Jeffrey

2018-01-01

Background Comorbid depression is a significant challenge for safety-net primary care systems. Team-based collaborative depression care is effective, but complex system factors in safety-net organizations impede adoption and result in persistent disparities in outcomes. Diabetes-Depression Care-management Adoption Trial (DCAT) evaluated whether depression care could be significantly improved by harnessing information and communication technologies to automate routine screening and monitoring of patient symptoms and treatment adherence and allow timely communication with providers. Objective The aim of this study was to compare 6-month outcomes of a technology-facilitated care model with a usual care model and a supported care model that involved team-based collaborative depression care for safety-net primary care adult patients with type 2 diabetes. Methods DCAT is a translational study in collaboration with Los Angeles County Department of Health Services, the second largest safety-net care system in the United States. A comparative effectiveness study with quasi-experimental design was conducted in three groups of adult patients with type 2 diabetes to compare three delivery models: usual care, supported care, and technology-facilitated care. Six-month outcomes included depression and diabetes care measures and patient-reported outcomes. Comparative treatment effects were estimated by linear or logistic regression models that used generalized propensity scores to adjust for sampling bias inherent in the nonrandomized design. Results DCAT enrolled 1406 patients (484 in usual care, 480 in supported care, and 442 in technology-facilitated care), most of whom were Hispanic or Latino and female. Compared with usual care, both the supported care and technology-facilitated care groups were associated with significant reduction in depressive symptoms measured by scores on the 9-item Patient Health Questionnaire (least squares estimate, LSE: usual care=6.35, supported care=5.05, technology-facilitated care=5.16; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.02); decreased prevalence of major depression (odds ratio, OR: supported care vs usual care=0.45, technology-facilitated care vs usual care=0.33; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.007); and reduced functional disability as measured by Sheehan Disability Scale scores (LSE: usual care=3.21, supported care=2.61, technology-facilitated care=2.59; P value: supported care vs usual care=.04, technology-facilitated care vs usual care=.03). Technology-facilitated care was significantly associated with depression remission (technology-facilitated care vs usual care: OR=2.98, P=.04); increased satisfaction with care for emotional problems among depressed patients (LSE: usual care=3.20, technology-facilitated care=3.70; P=.05); reduced total cholesterol level (LSE: usual care=176.40, technology-facilitated care=160.46; P=.01); improved satisfaction with diabetes care (LSE: usual care=4.01, technology-facilitated care=4.20; P=.05); and increased odds of taking an glycated hemoglobin test (technology-facilitated care vs usual care: OR=3.40, P<.001). Conclusions Both the technology-facilitated care and supported care delivery models showed potential to improve 6-month depression and functional disability outcomes. The technology-facilitated care model has a greater likelihood to improve depression remission, patient satisfaction, and diabetes care quality. PMID:29685872

Economic evaluation of a task-shifting intervention for common mental disorders in India

PubMed Central

Buttorff, Christine; Hock, Rebecca S; Weiss, Helen A; Naik, Smita; Araya, Ricardo; Kirkwood, Betty R; Chisholm, Daniel

2012-01-01

Abstract Objective To carry out an economic evaluation of a task-shifting intervention for the treatment of depressive and anxiety disorders in primary-care settings in Goa, India. Methods Cost–utility and cost–effectiveness analyses based on generalized linear models were performed within a trial set in 24 public and private primary-care facilities. Subjects were randomly assigned to an intervention or a control arm. Eligible subjects in the intervention arm were given psycho-education, case management, interpersonal psychotherapy and/or antidepressants by lay health workers. Subjects in the control arm were treated by physicians. The use of health-care resources, the disability of each subject and degree of psychiatric morbidity, as measured by the Revised Clinical Interview Schedule, were determined at 2, 6 and 12 months. Findings Complete data, from all three follow-ups, were collected from 1243 (75.4%) and 938 (81.7%) of the subjects enrolled in the study facilities from the public and private sectors, respectively. Within the public facilities, subjects in the intervention arm showed greater improvement in all the health outcomes investigated than those in the control arm. Time costs were also significantly lower in the intervention arm than in the control arm, whereas health system costs in the two arms were similar. Within the private facilities, however, the effectiveness and costs recorded in the two arms were similar. Conclusion Within public primary-care facilities in Goa, the use of lay health workers in the care of subjects with common mental disorders was not only cost–effective but also cost-saving. PMID:23226893

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

Impact of Music Therapy on Hospitalized Patients Post-Elective Orthopaedic Surgery: A Randomized Controlled Trial.

PubMed

Gallagher, Lisa M; Gardner, Vickie; Bates, Debbie; Mason, Shelley; Nemecek, Jeanine; DiFiore, Jacquelyn Baker; Bena, James; Li, Manshi; Bethoux, Francois

Music therapy (MT) research has demonstrated positive effects on fatigue, depressed mood, anxiety, and pain in perioperative care areas. However, there has been limited research on the effects of MT for surgical patients on orthopaedic units. The purpose of this study was to understand the impact of MT sessions on post-elective orthopaedic surgery patients' pain, mood, nausea, anxiety, use of narcotics and antiemetics, and length of stay. This was a randomized controlled study with an experimental arm (MT sessions) and a control arm (standard medical care). Patients received MT within 24 hours of admission to the unit, as well as every day of their stay. Same-day pre- and postdata were collected 30 minutes apart for both arms, including patient self-reported mood, pain, anxiety, and nausea. Use of medications and length of stay were gleaned from the electronic medical record. Data were obtained for 163 patients, age 60.5 ± 11.1 years, 56% of whom were male. Joints targeted by surgeries were hips (54%), knees (42%), and shoulders (4%). There were significantly greater changes favoring the MT group on Day 1 (pain, anxiety, and mood), Day 2 (pain, anxiety, mood, and nausea), and Day 3 (pain, anxiety, and mood). Among participants with a pre-pain score of 2 or more on Day 1, a decrease of at least 2 points was noted in 36% of the MT group and 10% of the control group (P < .001). Overall, 73% of MT patients versus 41% of control patients reported improved pain (P < .001). No significant between-group differences in medications or length of stay were noted. We observed greater same-day improvements of pain, emotional status, and nausea with MT sessions, compared to usual care, in patients hospitalized after elective orthopaedic surgeries. Effects on narcotic and antiemetic usage, as well as length of stay, were not observed. More research needs to be conducted to better understand the benefits of MT pre- and post-elective orthopaedic surgery.

The voices of neurosurgeons: doctors' non-medical writing.

PubMed

Bernstein, Mark

2007-05-01

Biomedical publishing is an integral part of medicine--both to those who produce it and those who consume it to improve the care of their patients. Non-medical writing by surgeons usually takes the form of creative non-fiction, generally reflective essays on moving and emotionally charged situations such as working in the trenches in war-time or in natural disasters, or dealing with individual patients. Such writing is both creative and cathartic for neurosurgeons, and can help educate patients thus improving the doctor-patient relationship. The purpose of this article is to encourage fellow neurosurgeons to pursue this enjoyable and valuable endeavour, to utter a call to arms so to speak.

HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

PubMed

Chanda, Michael M; Ortblad, Katrina F; Mwale, Magdalene; Chongo, Steven; Kanchele, Catherine; Kamungoma, Nyambe; Fullem, Andrew; Dunn, Caitlin; Barresi, Leah G; Harling, Guy; Bärnighausen, Till; Oldenburg, Catherine E

2017-11-01

HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05-1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. ClinicalTrials.gov NCT02827240.

HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial

PubMed Central

Chanda, Michael M.; Mwale, Magdalene; Chongo, Steven; Kanchele, Catherine; Kamungoma, Nyambe; Fullem, Andrew; Dunn, Caitlin; Barresi, Leah G.; Bärnighausen, Till

2017-01-01

Background HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Methods and findings Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator–FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99–1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86–1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04–1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98–1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92–1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94–1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use was higher in the delivery arm compared to the coupon arm (RR = 1.14, 95% CI 1.05–1.23, P = 0.001) at 1 month, but there was no difference at 4 months. Among participants reporting a positive HIV test at 1 (N = 144) and 4 months (N = 235), linkage to care was non-significantly lower in the 2 HIVST arms compared to the standard-of-care arm. There were 4 instances of intimate partner violence related to study participation, 3 of which were related to HIV self-test use. Limitations include the self-reported nature of study outcomes and overall high uptake of HIV testing. Conclusions In this study among FSWs in Zambia, we found that HIVST was acceptable and accessible. However, HIVST may not substantially increase HIV cascade progression in contexts where overall testing and linkage are already high. Trial registration ClinicalTrials.gov NCT02827240 PMID:29161260

Maximizing Use of Robot-Arm No. 3 in Da Vinci–Assisted Thoracic Surgery

PubMed Central

Kajiwara, Naohiro; Maeda, Junichi; Yoshida, Koichi; Kato, Yasufumi; Hagiwara, Masaru; Kakihana, Masatoshi; Ohira, Tatsuo; Kawate, Norihiko; Ikeda, Norihiko

2015-01-01

We have previously reported on the importance of appropriate robot-arm settings and replacement of instrument ports in robot-assisted thoracic surgery, because the thoracic cavity requires a large space to access all lesions in various areas of the thoracic cavity from the apex to the diaphragm and mediastinum and the chest wall.1–3 Moreover, it can be difficult to manipulate the da Vinci Surgical System using only arms No. 1 and No. 2 depending on the tumor location. However, arm No. 3 is usually positioned on the same side as arm No. 2, and sometimes it is only used as an assisting-arm to avoid conflict with other arms (Fig. 1). In this report, we show how robot-arm No. 3 can be used with maximum effectiveness in da Vinci-assisted thoracic surgery. PMID:26011219

Preventing mental health problems in children: the Families in Mind population-based cluster randomised controlled trial

PubMed Central

2012-01-01

Background Externalising and internalising problems affect one in seven school-aged children and are the single strongest predictor of mental health problems into early adolescence. As the burden of mental health problems persists globally, childhood prevention of mental health problems is paramount. Prevention can be offered to all children (universal) or to children at risk of developing mental health problems (targeted). The relative effectiveness and costs of a targeted only versus combined universal and targeted approach are unknown. This study aims to determine the effectiveness, costs and uptake of two approaches to early childhood prevention of mental health problems ie: a Combined universal-targeted approach, versus a Targeted only approach, in comparison to current primary care services (Usual care). Methods/design Three armed, population-level cluster randomised trial (2010–2014) within the universal, well child Maternal Child Health system, attended by more than 80% of families in Victoria, Australia at infant age eight months. Participants were families of eight month old children from nine participating local government areas. Randomised to one of three groups: Combined, Targeted or Usual care. The interventions comprises (a) the Combined universal and targeted program where all families are offered the universal Toddlers Without Tears group parenting program followed by the targeted Family Check-Up one-on-one program or (b) the Targeted Family Check-Up program. The Family Check-Up program is only offered to children at risk of behavioural problems. Participants will be analysed according to the trial arm to which they were randomised, using logistic and linear regression models to compare primary and secondary outcomes. An economic evaluation (cost consequences analysis) will compare incremental costs to all incremental outcomes from a societal perspective. Discussion This trial will inform public health policy by making recommendations about the effectiveness and cost-effectiveness of these early prevention programs. If effective prevention programs can be implemented at the population level, the growing burden of mental health problems could be curbed. Trial registration ISRCTN61137690 PMID:22682229

The cost-effectiveness of a structured education pulmonary rehabilitation programme for chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial.

PubMed

Gillespie, Paddy; O'Shea, Eamon; Casey, Dympna; Murphy, Kathy; Devane, Declan; Cooney, Adeline; Mee, Lorraine; Kirwan, Collette; McCarthy, Bernard; Newell, John

2013-11-25

To assess the cost-effectiveness of a structured education pulmonary rehabilitation programme (SEPRP) for chronic obstructive pulmonary disease (COPD) relative to usual practice in primary care. The programme consisted of group-based sessions delivered jointly by practice nurses and physiotherapists over 8 weeks. Cost-effectiveness and cost-utility analysis alongside a cluster randomised controlled trial. 32 general practices in Ireland. 350 adults with COPD, 69% of whom were moderately affected. Intervention arm (n=178) received a 2 h group-based SEPRP session per week over 8 weeks delivered jointly by a practice nurse and physiotherapist at the practice surgery or nearby venue. The control arm (n=172) received the usual practice in primary care. Incremental costs, Chronic Respiratory Questionnaire (CRQ) scores, quality-adjusted life years (QALYs) gained estimated using the generic EQ5D instrument, and expected cost-effectiveness at 22 weeks trial follow-up. The intervention was associated with an increase of €944 (95% CIs 489 to 1400) in mean healthcare cost and €261 (95% CIs 226 to 296) in mean patient cost. The intervention was associated with a mean improvement of 1.11 (95% CIs 0.35 to 1.87) in CRQ Total score and 0.002 (95% CIs -0.006 to 0.011) in QALYs gained. These translated into incremental cost-effectiveness ratios of €850 per unit increase in CRQ Total score and €472 000 per additional QALY gained. The probability of the intervention being cost-effective at respective threshold values of €5000, €15 000, €25 000, €35 000 and €45 000 was 0.980, 0.992, 0.994, 0.994 and 0.994 in the CRQ Total score analysis compared to 0.000, 0.001, 0.001, 0.003 and 0.007 in the QALYs gained analysis. While analysis suggests that SEPRP was cost-effective if society is willing to pay at least €850 per one-point increase in disease-specific CRQ, no evidence exists when effectiveness was measured in QALYS gained. Current Controlled Trials ISRCTN52 403 063.

Hemodialysis Self-management Intervention Randomized Trial (HED-SMART): A Practical Low-Intensity Intervention to Improve Adherence and Clinical Markers in Patients Receiving Hemodialysis.

PubMed

Griva, Konstadina; Nandakumar, Mooppil; Ng, Jo-An H; Lam, Kevin F Y; McBain, Hayley; Newman, Stanton P

2018-03-01

Poor adherence to treatment is common in hemodialysis patients. However, effective interventions for adherence in this population are lacking. Small studies of behavioral interventions have yielded improvements, but clinical effectiveness and long-term effects are unclear. Multicenter parallel (1:1) design, blinded cluster-randomized controlled trial. Patients undergoing maintenance hemodialysis enrolled in 14 dialysis centers. Dialysis shifts of eligible patients were randomly assigned to either an interactive and targeted self-management training program (HED-SMART; intervention; n=134) or usual care (control; n=101). HED-SMART, developed using the principles of problem solving and social learning theory, was delivered in a group format by health care professionals over 4 sessions. Serum potassium and phosphate concentrations, interdialytic weight gains (IDWGs), self-reported adherence, and self-management skills at 1 week, 3 months, and 9 months postintervention. 235 participants were enrolled in the study (response rate, 44.2%), and 82.1% completed the protocol. IDWG was significantly lowered across all 3 assessments relative to baseline (P<0.001) among patients randomly assigned to HED-SMART. In contrast, IDWG in controls showed no change except at 3 months, when it worsened significantly. Improvements in mineral markers were noted in the HED-SMART arm at 3 months (P<0.001) and in potassium concentrations (P<0.001) at 9 months. Phosphate concentrations improved in HED-SMART at 3 months (P=0.03), but these effects were not maintained at 9 months postintervention. Significant differences between the arms were found for the secondary outcomes of self-reported adherence, self-management skills, and self-efficacy at all time points. Low proportion of patients with diabetes. HED-SMART provides an effective and practical model for improving health in hemodialysis patients. The observed improvements in clinical markers and self-report adherence, if maintained at the longer follow-up, could significantly reduce end-stage renal disease-related complications. Given the feasibility of this kind of program, it has strong potential for supplementing usual care. Registered at ISRCTN with study number ISRCTN31434033. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Classroom based cognitive behavioural therapy in reducing symptoms of depression in high risk adolescents: pragmatic cluster randomised controlled trial

PubMed Central

Sayal, Kapil; Phillips, Rhiannon; Taylor, John A; Spears, Melissa; Anderson, Rob; Araya, Ricardo; Lewis, Glyn; Millings, Abigail; Montgomery, Alan A

2012-01-01

Objective To compare the effectiveness of classroom based cognitive behavioural therapy with attention control and usual school provision for adolescents at high risk of depression. Design Three arm parallel cluster randomised controlled trial. Setting Eight UK secondary schools. Participants Adolescents (n=5030) aged 12-16 years in school year groups 8-11. Year groups were randomly assigned on a 1:1:1 ratio to cognitive behavioural therapy, attention control, or usual school provision. Allocation was balanced by school, year, number of students and classes, frequency of lessons, and timetabling. Participants were not blinded to treatment allocation. Interventions Cognitive behavioural therapy, attention control, and usual school provision provided in classes to all eligible participants. Main outcome measures Outcomes were collected by self completed questionnaire administered by researchers. The primary outcome was symptoms of depression assessed at 12 months by the short mood and feelings questionnaire among those identified at baseline as being at high risk of depression. Secondary outcomes included negative thinking, self worth, and anxiety. Analyses were undertaken on an intention to treat basis and accounted for the clustered nature of the design. Results 1064 (21.2%) adolescents were identified at high risk of depression: 392 in the classroom based cognitive behavioural therapy arm, 374 in the attention control arm, and 298 in the usual school provision arm. At 12 months adjusted mean scores on the short mood and feelings questionnaire did not differ for cognitive behavioural therapy versus attention control (−0.63, 95% confidence interval −1.85 to 0.58, P=0.41) or for cognitive behavioural therapy versus usual school provision (0.97, −0.20 to 2.15, P=0.12). Conclusion In adolescents with depressive symptoms, outcomes were similar for attention control, usual school provision, and cognitive behavioural therapy. Classroom based cognitive behavioural therapy programmes may result in increased self awareness and reporting of depressive symptoms but should not be undertaken without further evaluation and research. Trial registration Current Controlled Trials ISRCTN19083628. PMID:23043090

Parenting Skills and Emotional Availability: An RCT.

PubMed

Yousafzai, Aisha K; Rasheed, Muneera A; Rizvi, Arjumand; Armstrong, Robert; Bhutta, Zulfiqar A

2015-05-01

To investigate whether a responsive stimulation intervention delivered to caregivers of young children either alone or integrated with nutrition interventions would benefit parenting skills and emotional availability to promote children's development and growth compared with either a nutrition intervention alone or the usual standard of care. A cluster randomized factorial effectiveness trial was implemented in an impoverished community in Pakistan. The 4 trial arms were control (usual standard of care), responsive stimulation (responsive care and stimulation), enhanced nutrition (education and multiple micronutrients), and a combination of both enriched interventions. The 4 intervention packages were delivered by community health workers to 1489 mother-infant dyads in the first 2 years of life. Parenting skills and emotional availability indexed by mother-child interaction, caregiving environment, knowledge and practices pertaining to early childhood care and feeding, and maternal depressive symptoms were assessed at multiple intervals. An intention-to-treat factorial analysis was conducted. Intervention groups were comparable at baseline. Responsive stimulation significantly benefitted parenting skills with large effect sizes on mother-child interaction (Cohen's d 0.8), caregiving environment (Cohen's d 0.9-1.0), and knowledge and practices (Cohen's d 0.7-1.1) compared with small-modest significant effects as a result of nutrition intervention on mother-child interaction and caregiving environment only (Cohen's d 0.4 and 0.2, respectively). The combined intervention had a small significant effect on decreasing maternal depressive symptoms over time (Cohen's d 0-0.2). A responsive stimulation intervention can promote positive caregiving behaviors among impoverished families. Additional research is needed on interventions to reduce maternal depressive symptoms. Copyright © 2015 by the American Academy of Pediatrics.

Evaluation of the effectiveness and cost-effectiveness of lightweight fibreglass heel casts in the management of ulcers of the heel in diabetes: a randomised controlled trial.

PubMed Central

Jeffcoate, William; Game, Frances; Turtle-Savage, Vivienne; Musgrove, Alison; Price, Patricia; Tan, Wei; Bradshaw, Lucy; Montgomery, Alan; Fitzsimmons, Deborah; Farr, Angela; Winfield, Thomas; Phillips, Ceri

2017-01-01

BACKGROUND Ulcers of the foot in people with diabetes mellitus are slow to heal and result in considerable cost and patient suffering. The prognosis is worst for ulcers of the heel. OBJECTIVE To assess both the clinical effectiveness and the cost-effectiveness of lightweight fibreglass casts in the management of heel ulcers. DESIGN A pragmatic, multicentre, parallel, observer-blinded randomised controlled trial. A central randomisation centre used a computer-generated random number sequence to allocate participants to groups. SETTING Thirty-five specialist diabetic foot secondary care centres in the UK. Those recruited were aged ≥ 18 years and had diabetes mellitus complicated by ulcers of the heel of grades 2-4 on the National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory Panel scale. PARTICIPANTS In total, 509 participants [68% male, 15% with type 1 diabetes mellitus, mean age 67.5 years (standard deviation 12.4 years)] were randomised 1 : 1 to the intervention (n = 256) or the control (n = 253) arm. The primary outcome data were available for 425 participants (212 from the intervention arm and 213 from the control arm) and exceeded the total required; attrition was 16.5%. The median ulcer area at baseline was 275 mm(2) [interquartile range (IQR) 104-683 mm(2)] in the intervention group and 206 mm(2) (IQR 77-649 mm(2)) in the control group. There were no differences between the two groups at baseline in any parameter, neither in relation to the participant nor in relation to their ulcer. INTERVENTIONS The intervention group received usual care supplemented by the addition of an individually moulded, lightweight, fibreglass heel cast. The control group received usual care alone. The intervention phase continued either until the participant's ulcer had healed (maintained for 28 days) or for 24 weeks, whichever occurred first. During this intervention phase, the participants were reviewed every 2 weeks, and the fibreglass casts were replaced when they were no longer usable. MAIN OUTCOME MEASURES The primary outcome measure was ulcer healing (confirmed by a blinded observer and maintained for 4 weeks) within 24 weeks. Other outcome measures included the time taken for the ulcer to heal, the percentage reduction in the cross-sectional area, the reduction in local pain, amputation, survival and health economic analysis. The study was powered to define a difference in healing of 15% (55% intervention vs. 40% control). RESULTS Forty-four per cent (n = 94) of the intervention group healed within 24 weeks, compared with 37% (n = 80) of the control participants (odds ratio 1.42, 95% confidence interval 0.95 to 2.14; p = 0.088), using an intention-to-treat analysis. No differences were observed between the two groups for any secondary outcome. LIMITATIONS Although the component items of care were standardised, because this was a pragmatic trial, usual care was not uniform. There was some evidence of a small excess of adverse events in the intervention group; however, non-blinded observers documented these events. There was no excess of adverse device effects. CONCLUSIONS There may be a small increase in healing with the use of a heel cast, but the estimate was not sufficiently precise to provide strong evidence of an effect. There was no evidence of any subgroup in which the intervention appeared to be particularly effective. A health economic analysis suggested that it is unlikely that the intervention represents good value for money. The provision of a lightweight heel cast may be of benefit to some individuals, but we have found no evidence to justify the routine adoption of this in clinical practice. FUTURE WORK It is unlikely that further study of this intervention will have an impact on usual clinical care, and so future efforts should be directed towards other interventions designed to improve the healing of ulcers in this population. TRIAL REGISTRATION Current Controlled Trials ISRCTN62524796. FUNDING 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. 34. See the NIHR Journals Library website for further project information. PMID:28644115

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

Brief counselling after home-based HIV counselling and testing strongly increases linkage to care: a cluster-randomized trial in Uganda.

PubMed

Ruzagira, Eugene; Grosskurth, Heiner; Kamali, Anatoli; Baisley, Kathy

2017-10-01

The aim of this study was to determine whether counselling provided subsequent to HIV testing and referral for care increases linkage to care among HIV-positive persons identified through home-based HIV counselling and testing (HBHCT) in Masaka, Uganda. The study was an open-label cluster-randomized trial. 28 rural communities were randomly allocated (1:1) to intervention (HBHCT, referral and counselling at one and two months) or control (HBHCT and referral only). HIV-positive care-naïve adults (≥18 years) were enrolled. To conceal participants' HIV status, one HIV-negative person was recruited for every three HIV-positive participants. Primary outcomes were linkage to care (clinic-verified registration for care) status at six months, and time to linkage. Primary analyses were intention-to-treat using random effects logistic regression or Cox regression with shared frailty, as appropriate. Three hundred and two(intervention, n = 149; control, n = 153) HIV-positive participants were enrolled. Except for travel time to the nearest HIV clinic, baseline participant characteristics were generally balanced between trial arms. Retention was similar across trial arms (92% overall). One hundred and twenty-seven (42.1%) participants linked to care: 76 (51.0%) in the intervention arm versus 51 (33.3%) in the control arm [odds ratio = 2.18, 95% confidence interval (CI) = 1.26-3.78; p = 0.008)]. There was evidence of interaction between trial arm and follow-up time (p = 0.009). The probability of linkage to care, did not differ between arms in the first two months of follow-up, but was subsequently higher in the intervention arm versus the control arm [hazard ratio = 4.87, 95% CI = 1.79-13.27, p = 0.002]. Counselling substantially increases linkage to care among HIV-positive adults identified through HBHCT and may enhance efforts to increase antiretroviral therapy coverage in sub-Saharan Africa. © 2017 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

Effect of the Uganda Newborn Study on care-seeking and care practices: a cluster-randomised controlled trial

PubMed Central

Waiswa, Peter; Pariyo, George; Kallander, Karin; Akuze, Joseph; Namazzi, Gertrude; Ekirapa-Kiracho, Elizabeth; Kerber, Kate; Sengendo, Hanifah; Aliganyira, Patrick; Lawn, Joy E.; Peterson, Stefan

2015-01-01

Background Care for women and babies before, during, and after the time of birth is a sensitive measure of the functionality of any health system. Engaging communities in preventing newborn deaths is a promising strategy to achieve further progress in child survival in sub-Saharan Africa. Objective To assess the effect of a home visit strategy combined with health facility strengthening on uptake of newborn care-seeking, practices and services, and to link the results to national policy and scale-up in Uganda. Design The Uganda Newborn Study (UNEST) was a two-arm cluster-randomised controlled trial in rural eastern Uganda. In intervention villages volunteer community health workers (CHWs) were trained to identify pregnant women and make five home visits (two during pregnancy and three in the first week after birth) to offer preventive and promotive care and counselling, with extra visits for sick and small newborns to assess and refer. Health facility strengthening was done in all facilities to improve quality of care. Primary outcomes were coverage of key essential newborn care behaviours (breastfeeding, thermal care, and cord care). Analyses were by intention to treat. This study is registered as a clinical trial, number ISRCTN50321130. Results The intervention significantly improved essential newborn care practices, although many interventions saw major increases in both arms over the study period. Immediate breastfeeding after birth and exclusive breastfeeding were significantly higher in the intervention arm compared to the control arm (72.6% vs. 66.0%; p=0.016 and 81.8% vs. 75.9%, p=0.042, respectively). Skin-to-skin care immediately after birth and cord cutting with a clean instrument were marginally higher in the intervention arm versus the control arm (80.7% vs. 72.2%; p=0.071 and 88.1% vs. 84.4%; p=0.023, respectively). Half (49.6%) of the mothers in the intervention arm waited more than 24 hours to bathe the baby, compared to 35.5% in the control arm (p<0.001). Dry umbilical cord care was also significantly higher in intervention areas (63.9% vs. 53.1%, p<0.001). There was no difference in care-seeking for newborn illness, which was high (around 95%) in both arms. Skilled attendance at delivery increased in both the intervention (by 21%) and control arms (by 19%) between baseline and endline, but there was no significant difference in coverage across arms at endline (79.6% vs. 78.9%; p=0.717). Home visits were pro-poor, with more women in the poorest quintile visited by a CHW compared to families in the least poor quintile, and more women who delivered at home visited by a CHW after birth (73.6%) compared to those who delivered in a hospital or health facility (59.7%) (p<0.001). CHWs visited 62.8% of women and newborns in the first week after birth, with 40.2% receiving a visit on the critical first day of life. Conclusion Consistent with results from other community newborn care studies, volunteer CHWs can be effective in changing long-standing practices around newborn care. The home visit strategy may provide greater benefit to poorer families. However, CHW strategies require strong linkages with and concurrent improvement of quality through health system strengthening, especially in settings with high and increasing demand for facility-based services. PMID:25843498

The cost-effectiveness of the RSI QuickScan intervention programme for computer workers: Results of an economic evaluation alongside a randomised controlled trial.

PubMed

Speklé, Erwin M; Heinrich, Judith; Hoozemans, Marco J M; Blatter, Birgitte M; van der Beek, Allard J; van Dieën, Jaap H; van Tulder, Maurits W

2010-11-11

The costs of arm, shoulder and neck symptoms are high. In order to decrease these costs employers implement interventions aimed at reducing these symptoms. One frequently used intervention is the RSI QuickScan intervention programme. It establishes a risk profile of the target population and subsequently advises interventions following a decision tree based on that risk profile. The purpose of this study was to perform an economic evaluation, from both the societal and companies' perspective, of the RSI QuickScan intervention programme for computer workers. In this study, effectiveness was defined at three levels: exposure to risk factors, prevalence of arm, shoulder and neck symptoms, and days of sick leave. The economic evaluation was conducted alongside a randomised controlled trial (RCT). Participating computer workers from 7 companies (N = 638) were assigned to either the intervention group (N = 320) or the usual care group (N = 318) by means of cluster randomisation (N = 50). The intervention consisted of a tailor-made programme, based on a previously established risk profile. At baseline, 6 and 12 month follow-up, the participants completed the RSI QuickScan questionnaire. Analyses to estimate the effect of the intervention were done according to the intention-to-treat principle. To compare costs between groups, confidence intervals for cost differences were computed by bias-corrected and accelerated bootstrapping. The mean intervention costs, paid by the employer, were 59 euro per participant in the intervention and 28 euro in the usual care group. Mean total health care and non-health care costs per participant were 108 euro in both groups. As to the cost-effectiveness, improvement in received information on healthy computer use as well as in their work posture and movement was observed at higher costs. With regard to the other risk factors, symptoms and sick leave, only small and non-significant effects were found. In this study, the RSI QuickScan intervention programme did not prove to be cost-effective from the both the societal and companies' perspective and, therefore, this study does not provide a financial reason for implementing this intervention. However, with a relatively small investment, the programme did increase the number of workers who received information on healthy computer use and improved their work posture and movement. NTR1117.

Comparative Effectiveness of a Technology-Facilitated Depression Care Management Model in Safety-Net Primary Care Patients With Type 2 Diabetes: 6-Month Outcomes of a Large Clinical Trial.

PubMed

Wu, Shinyi; Ell, Kathleen; Jin, Haomiao; Vidyanti, Irene; Chou, Chih-Ping; Lee, Pey-Jiuan; Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Belson, David; Nezu, Arthur M; Hay, Joel; Wang, Chien-Ju; Scheib, Geoffrey; Di Capua, Paul; Hawkins, Caitlin; Liu, Pai; Ramirez, Magaly; Wu, Brian W; Richman, Mark; Myers, Caitlin; Agustines, Davin; Dasher, Robert; Kopelowicz, Alex; Allevato, Joseph; Roybal, Mike; Ipp, Eli; Haider, Uzma; Graham, Sharon; Mahabadi, Vahid; Guterman, Jeffrey

2018-04-23

Comorbid depression is a significant challenge for safety-net primary care systems. Team-based collaborative depression care is effective, but complex system factors in safety-net organizations impede adoption and result in persistent disparities in outcomes. Diabetes-Depression Care-management Adoption Trial (DCAT) evaluated whether depression care could be significantly improved by harnessing information and communication technologies to automate routine screening and monitoring of patient symptoms and treatment adherence and allow timely communication with providers. The aim of this study was to compare 6-month outcomes of a technology-facilitated care model with a usual care model and a supported care model that involved team-based collaborative depression care for safety-net primary care adult patients with type 2 diabetes. DCAT is a translational study in collaboration with Los Angeles County Department of Health Services, the second largest safety-net care system in the United States. A comparative effectiveness study with quasi-experimental design was conducted in three groups of adult patients with type 2 diabetes to compare three delivery models: usual care, supported care, and technology-facilitated care. Six-month outcomes included depression and diabetes care measures and patient-reported outcomes. Comparative treatment effects were estimated by linear or logistic regression models that used generalized propensity scores to adjust for sampling bias inherent in the nonrandomized design. DCAT enrolled 1406 patients (484 in usual care, 480 in supported care, and 442 in technology-facilitated care), most of whom were Hispanic or Latino and female. Compared with usual care, both the supported care and technology-facilitated care groups were associated with significant reduction in depressive symptoms measured by scores on the 9-item Patient Health Questionnaire (least squares estimate, LSE: usual care=6.35, supported care=5.05, technology-facilitated care=5.16; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.02); decreased prevalence of major depression (odds ratio, OR: supported care vs usual care=0.45, technology-facilitated care vs usual care=0.33; P value: supported care vs usual care=.02, technology-facilitated care vs usual care=.007); and reduced functional disability as measured by Sheehan Disability Scale scores (LSE: usual care=3.21, supported care=2.61, technology-facilitated care=2.59; P value: supported care vs usual care=.04, technology-facilitated care vs usual care=.03). Technology-facilitated care was significantly associated with depression remission (technology-facilitated care vs usual care: OR=2.98, P=.04); increased satisfaction with care for emotional problems among depressed patients (LSE: usual care=3.20, technology-facilitated care=3.70; P=.05); reduced total cholesterol level (LSE: usual care=176.40, technology-facilitated care=160.46; P=.01); improved satisfaction with diabetes care (LSE: usual care=4.01, technology-facilitated care=4.20; P=.05); and increased odds of taking an glycated hemoglobin test (technology-facilitated care vs usual care: OR=3.40, P<.001). Both the technology-facilitated care and supported care delivery models showed potential to improve 6-month depression and functional disability outcomes. The technology-facilitated care model has a greater likelihood to improve depression remission, patient satisfaction, and diabetes care quality. ©Shinyi Wu, Kathleen Ell, Haomiao Jin, Irene Vidyanti, Chih-Ping Chou, Pey-Jiuan Lee, Sandra Gross-Schulman, Laura Myerchin Sklaroff, David Belson, Arthur M Nezu, Joel Hay, Chien-Ju Wang, Geoffrey Scheib, Paul Di Capua, Caitlin Hawkins, Pai Liu, Magaly Ramirez, Brian W Wu, Mark Richman, Caitlin Myers, Davin Agustines, Robert Dasher, Alex Kopelowicz, Joseph Allevato, Mike Roybal, Eli Ipp, Uzma Haider, Sharon Graham, Vahid Mahabadi, Jeffrey Guterman. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 23.04.2018.

Effect of telehealth on quality of life and psychological outcomes over 12 months (Whole Systems Demonstrator telehealth questionnaire study): nested study of patient reported outcomes in a pragmatic, cluster randomised controlled trial.

PubMed

Cartwright, Martin; Hirani, Shashivadan P; Rixon, Lorna; Beynon, Michelle; Doll, Helen; Bower, Peter; Bardsley, Martin; Steventon, Adam; Knapp, Martin; Henderson, Catherine; Rogers, Anne; Sanders, Caroline; Fitzpatrick, Ray; Barlow, James; Newman, Stanton P

2013-02-26

To assess the effect of second generation, home based telehealth on health related quality of life, anxiety, and depressive symptoms over 12 months in patients with long term conditions. A study of patient reported outcomes (the Whole Systems Demonstrator telehealth questionnaire study; baseline n=1573) was nested in a pragmatic, cluster randomised trial of telehealth (the Whole Systems Demonstrator telehealth trial, n=3230). General practice was the unit of randomisation, and telehealth was compared with usual care. Data were collected at baseline, four months (short term), and 12 months (long term). Primary intention to treat analyses tested treatment effectiveness; multilevel models controlled for clustering by general practice and a range of covariates. Analyses were conducted for 759 participants who completed questionnaire measures at all three time points (complete case cohort) and 1201 who completed the baseline assessment plus at least one other assessment (available case cohort). Secondary per protocol analyses tested treatment efficacy and included 633 and 1108 participants in the complete case and available case cohorts, respectively. Provision of primary and secondary care via general practices, specialist nurses, and hospital clinics in three diverse regions of England (Cornwall, Kent, and Newham), with established integrated health and social care systems. Patients with chronic obstructive pulmonary disease (COPD), diabetes, or heart failure recruited between May 2008 and December 2009. Generic, health related quality of life (assessed by physical and mental health component scores of the SF-12, and the EQ-5D), anxiety (assessed by the six item Brief State-Trait Anxiety Inventory), and depressive symptoms (assessed by the 10 item Centre for Epidemiological Studies Depression Scale). In the intention to treat analyses, differences between treatment groups were small and non-significant for all outcomes in the complete case (0.480 ≤ P ≤ 0.904) or available case (0.181 ≤ P ≤ 0.905) cohorts. The magnitude of differences between trial arms did not reach the trial defined, minimal clinically important difference (0.3 standardised mean difference) for any outcome in either cohort at four or 12 months. Per protocol analyses replicated the primary analyses; the main effect of trial arm (telehealth v usual care) was non-significant for any outcome (complete case cohort 0.273 ≤ P ≤ 0.761; available case cohort 0.145 ≤ P ≤ 0.696). Second generation, home based telehealth as implemented in the Whole Systems Demonstrator Evaluation was not effective or efficacious compared with usual care only. Telehealth did not improve quality of life or psychological outcomes for patients with chronic obstructive pulmonary disease, diabetes, or heart failure over 12 months. The findings suggest that concerns about potentially deleterious effect of telehealth are unfounded for most patients. ISRCTN43002091.

Online geometrical calibration of a mobile C-arm using external sensors

NASA Astrophysics Data System (ADS)

Mitschke, Matthias M.; Navab, Nassir; Schuetz, Oliver

2000-04-01

3D tomographic reconstruction of high contrast objects such as contrast agent enhanced blood vessels or bones from x-ray images acquired by isocentric C-arm systems recently gained interest. For tomographic reconstruction, a sequence of images is captured during the C-arm rotation around the patient and the precise projection geometry has to be determined for each image. This is a difficult task, as C- arms usually do not provide accurate information about their projection geometry. Standard methods propose the use of an x-ray calibration phantom and an offline calibration, when the motion of the C-arm is supposed to be reproducible between calibration and patient run. However, mobile C-arms usually do not have this desirable property. Therefore, an online recovery of projection geometry is necessary. Here, we study the use of external tracking systems such as Polaris or Optotrak from Northern Digital, Inc., for online calibration. In order to use the external tracking system for recovery of x-ray projection geometry two unknown transformations have to be estimated. We describe our attempt to solve this calibration problem. These are the relations between x-ray imaging system and marker plate of the tracking system as well as worked and sensor coordinate system. Experimental result son anatomical data are presented and visually compared with the results of estimating the projection geometry with an x-ray calibration phantom.

Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer.

PubMed

Poort, Hanneke; Verhagen, Constans A H H V M; Peters, Marlies E W J; Goedendorp, Martine M; Donders, A Rogier T; Hopman, Maria T E; Nijhuis-van der Sanden, Maria W G; Berends, Thea; Bleijenberg, Gijs; Knoop, Hans

2017-01-28

Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer. The TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants. To our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients. NTR3812 ; date of registration: 23/01/2013.

Robot Assisted Training for the Upper Limb after Stroke (RATULS): study protocol for a randomised controlled trial.

PubMed

Rodgers, Helen; Shaw, Lisa; Bosomworth, Helen; Aird, Lydia; Alvarado, Natasha; Andole, Sreeman; Cohen, David L; Dawson, Jesse; Eyre, Janet; Finch, Tracy; Ford, Gary A; Hislop, Jennifer; Hogg, Steven; Howel, Denise; Hughes, Niall; Krebs, Hermano Igo; Price, Christopher; Rochester, Lynn; Stamp, Elaine; Ternent, Laura; Turner, Duncan; Vale, Luke; Warburton, Elizabeth; van Wijck, Frederike; Wilkes, Scott

2017-07-20

Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. NHS stroke services. adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation. Randomisation groups: 1. Robot-assisted training using the InMotion robotic gym system for 45 min, three times/week for 12 weeks 2. Enhanced upper limb therapy for 45 min, three times/week for 12 weeks 3. Usual NHS care in accordance with local clinical practice Randomisation: individual participant randomisation stratified by centre, time since stroke, and severity of upper limb impairment. upper limb function measured by the Action Research Arm Test (ARAT) at 3 months post randomisation. upper limb impairment (Fugl-Meyer Test), activities of daily living (Barthel ADL Index), quality of life (Stroke Impact Scale, EQ-5D-5L), resource use, cost per quality-adjusted life year and adverse events, at 3 and 6 months. Blinding: outcomes are undertaken by blinded assessors. Economic analysis: micro-costing and economic evaluation of interventions compared to usual NHS care. A within-trial analysis, with an economic model will be used to extrapolate longer-term costs and outcomes. Process evaluation: semi-structured interviews with participants and professionals to seek their views and experiences of the rehabilitation that they have received or provided, and factors affecting the implementation of the trial. allowing for 10% attrition, 720 participants provide 80% power to detect a 15% difference in successful outcome between each of the treatment pairs. Successful outcome definition: baseline ARAT 0-7 must improve by 3 or more points; baseline ARAT 8-13 improve by 4 or more points; baseline ARAT 14-19 improve by 5 or more points; baseline ARAT 20-39 improve by 6 or more points. The results from this trial will determine whether robot-assisted training improves upper limb function post stroke. ISRCTN, identifier: ISRCTN69371850 . Registered 4 October 2013.

Do stigma and other perceived barriers to mental health care differ across Armed Forces?

PubMed Central

Gould, Matthew; Adler, Amy; Zamorski, Mark; Castro, Carl; Hanily, Natalie; Steele, Nicole; Kearney, Steve; Greenberg, Neil

2010-01-01

Summary Objectives Military organizations are keen to address barriers to mental health care yet stigma and barriers to care remain little understood, especially potential cultural differences between Armed Forces. The aim of this study was to compare data collected by the US, UK, Australian, New Zealand and Canadian militaries using Hoge et al.'s perceived stigma and barriers to care measure (Combat duty in Iraq and Afghanistan, mental health problems and barriers to care. New Engl J Med 2004;351:13–22). Design Each member country identified data sources that had enquired about Hoge et al.'s perceived stigma and perceived barriers to care items in the re-deployment or immediate post-deployment period. Five relevant statements were included in the study. Setting US, UK Australian, New Zealand and Canadian Armed Forces. Results Concerns about stigma and barriers to care tended to be more prominent among personnel who met criteria for a mental health problem. The pattern of reported stigma and barriers to care was similar across the Armed Forces of all five nations. Conclusions Barriers to care continue to be a major issue for service personnel within Western military forces. Although there are policy, procedural and cultural differences between Armed Forces, the nations studied appear to share some similarities in terms of perceived stigma and barriers to psychological care. Further research to understand patterns of reporting and subgroup differences is required. PMID:20382906

Generalist care managers for the treatment of depressed medicaid patients in North Carolina: a pilot study.

PubMed

Landis, Suzanne E; Gaynes, Bradley N; Morrissey, Joseph P; Vinson, Nina; Ellis, Alan R; Domino, Marisa E

2007-03-05

In most states, mental illness costs are an increasing share of Medicaid expenditures. Specialized depression care managers (CM) have consistently demonstrated improvements in patient outcomes relative to usual primary care (UC), but are costly and may not be fully utilized in smaller practices. A generalist care manager (GCM) could manage multiple chronic conditions and be more accepted and cost-effective than the specialist depression CM. We designed a pilot program to demonstrate the feasibility of training/deploying GCMs into primary care settings. We randomized depressed adult Medicaid patients in 2 primary care practices in Western North Carolina to a GCM intervention or to UC. GCMs, already providing services in diabetes and asthma in both study arms, were further trained to provide depression services including self-management, decision support, use of information systems, and care management. The following data were analyzed: baseline, 3- and 6-month Patient Health Questionnaire (PHQ9) scores; baseline and 6-month Short Form (SF) 12 scores; Medicaid claims data; questionnaire on patients' perceptions of treatment; GCM case notes; physician and office staff time study; and physician and office staff focus group discussions. Forty-five patients were enrolled, the majority with preexisting depression. Both groups improved; the GCM group did not demonstrate better clinical and functional outcomes than the UC group. Patients in the GCM group were more likely to have prescriptions of correct dosing by chart data. GCMs most often addressed comorbid conditions (36%), then social issues (27%) and appointment reminders (14%). GCMs recorded an average of 46 interactions per patient in the GCM arm. Focus group data demonstrated that physicians valued using GCMs. A time study documented that staff required no more time interacting with GCMs, whereas physicians spent an average of 4 minutes more per week. GCMs can be trained in care of depression and other chronic illnesses, are acceptable to practices and patients, and result in physicians prescribing guideline concordant care. GCMs appear to be a feasible intervention for community medical practices and to warrant a larger scale trial to test their appropriateness for Medicaid programs nationally.

Simulation of aerodynamic noise and vibration noise in hard disk drives

NASA Astrophysics Data System (ADS)

Zhu, Lei; Shen, Sheng-Nan; Li, Hui; Zhang, Guo-Qing; Cui, Fu-Hao

2018-05-01

Internal flow field characteristics of HDDs are usually influenced by the arm swing during seek operations. This, in turn, can affect aerodynamic noise and airflow-induced noise. In this paper, the dynamic mesh method is used to calculate the flow-induced vibration (FIV) by transient structure analysis and the boundary element method (BEM) is utilized to predict the vibration noise. Two operational states are considered: the arm is fixed and swinging over the disk. Both aerodynamic noise and vibration noise inside drives increase rapidly with increase in disk rotation and arm swing velocities. The largest aerodynamic noise source is always located near the arm and swung with the arm.

Group physical therapy for veterans with knee osteoarthritis: study design and methodology.

PubMed

Allen, Kelli D; Bongiorni, Dennis; Walker, Tessa A; Bartle, John; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Hansen, Gloria; Jennings, Caroline; Lindquist, Jennifer H; Oddone, Eugene Z; Senick, Margaret J; Sizemore, John C; St John, Jamie; Hoenig, Helen

2013-03-01

Physical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this condition. This manuscript describes a randomized clinical trial of a group-based physical therapy program that can potentially extend services to more patients with knee OA, providing a greater number of sessions per patient, at lower staffing costs compared to traditional individual PT. Participants with symptomatic knee OA (n = 376) are randomized to either a 12-week group-based PT program (six 1 h sessions, eight patients per group, led by a physical therapist and physical therapist assistant) or usual PT care (two individual visits with a physical therapist). Participants in both PT arms receive instruction in an exercise program, information on joint care and protection, and individual consultations with a physical therapist to address specific functional and therapeutic needs. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and the secondary outcome is the Short Physical Performance Test Protocol (objective physical function). Outcomes are assessed at baseline and 12-week follow-up, and the primary outcome is also assessed via telephone at 24-week follow-up to examine sustainability of effects. Linear mixed models will be used to compare outcomes for the two study arms. An economic cost analysis of the PT interventions will also be conducted. Published by Elsevier Inc.

Study of Tomography Of Nephrolithiasis Evaluation (STONE): methodology, approach and rationale.

PubMed

Valencia, Victoria; Moghadassi, Michelle; Kriesel, Dana R; Cummings, Steve; Smith-Bindman, Rebecca

2014-05-01

Urolithiasis (kidney stones) is a common reason for Emergency Department (ED) visits, accounting for nearly 1% of all visits in the United States. Computed tomography (CT) has become the most common imaging test for these patients but there are few comparative effectiveness data to support its use in comparison to ultrasound. This paper describes the rationale and methods of STONE (Study of Tomography Of Nephrolithiasis Evaluation), a pragmatic randomized comparative effectiveness trial comparing different imaging strategies for patients with suspected urolithiasis. STONE is a multi-center, non-blinded pragmatic randomized comparative effectiveness trial of patients between ages 18 and 75 with suspected nephrolithiasis seen in an ED setting. Patients were randomized to one of three initial imaging examinations: point-of-care ultrasound, ultrasound performed by a radiologist or CT. Participants then received diagnosis and treatment per usual care. The primary aim is to compare the rate of severe SAEs (Serious Adverse Events) between the three arms. In addition, a broad range of secondary outcomes was assessed at baseline and regularly for six months post-baseline using phone, email and mail questionnaires. Excluding 17 patients who withdrew after randomization, a total of 2759 patients were randomized and completed a baseline questionnaire (n=908, 893 and 958 in the point-of-care ultrasound, radiology ultrasound and radiology CT arms, respectively). Follow-up is complete, and full or partial outcomes were assessed on over 90% of participants. The detailed methodology of STONE will provide a roadmap for comparative effectiveness studies of diagnostic imaging conducted in an ED setting. Published by Elsevier Inc.

Interprofessional, psycho-social intervention to facilitate resilience and reduce supportive care needs for patients with cancer: Results of a noncomparative, randomized phase II trial.

PubMed

Eicher, Manuela; Ribi, Karin; Senn-Dubey, Catherine; Senn, Stefanie; Ballabeni, Pierluigi; Betticher, Daniel

2018-04-14

We developed 2 intensity levels of a complex intervention for interprofessional supportive care in cancer (IPSC-C) to facilitate resilience and reduce unmet supportive care needs. We aimed to test the feasibility, acceptability, and preliminary effectiveness of both intensity levels in routine practice. In a randomized, noncomparative phase II trial, newly diagnosed patients received either low (LI-IPSC-C) or high (HI-IPSC-C) intensity interventions. Low-intensity-interprofessional supportive care in cancer (LI-IPSC-C) consisted of 3 electronic assessments of resilience, unmet supportive care needs, mood, and coping effort over 16 weeks with an immediate feedback to clinicians including tailored intervention recommendations to facilitate resilience and supportive care. High-intensity-interprofessional supportive care in cancer (HI-IPSC-C) added 5 structured consultations (face-to-face and telephone) provided by specialized nurses. Primary outcome was a change ≥5 in resilience score on the Connor-Davidson Resilience Scale (CD-RISC). Secondary outcomes were unmet supportive care needs, mood, and coping effort. We assessed feasibility by clinician-provided tailored interventions as recommended and acceptability through qualitative interviews with clinicians and patients. In the LI-IPSC-C arm, 11 of 41, in the HI-IPSC-C arm 17 of 43, patients increased resilience scores by ≥5. Relatively more patients decreased unmet needs in HI-IPSC-C arm. Mood, in both arms, and coping effort, in HI-IPSC-C arm, improved meaningfully. Feasibility was limited for the LI-IPSC-C arm, mainly due to lack of time; acceptability was high in both arms. Neither LI-IPSC-C nor HI-IPSC-C interventions reached the desired threshold. HI-IPSC-C showed positive effects on secondary outcomes and was feasible. Resilience as measured by the CD-RISC may not be the optimal outcome measure for this intervention. Copyright © 2018 John Wiley & Sons, Ltd.

Tackling obesity in areas of high social deprivation: clinical effectiveness and cost-effectiveness of a task-based weight management group programme - a randomised controlled trial and economic evaluation.

PubMed

McRobbie, Hayden; Hajek, Peter; Peerbux, Sarrah; Kahan, Brennan C; Eldridge, Sandra; Trépel, Dominic; Parrott, Steve; Griffiths, Chris; Snuggs, Sarah; Myers Smith, Katie

2016-10-01

An increasing number of people require help to manage their weight. The NHS recommends weight loss advice by general practitioners and/or a referral to a practice nurse. Although this is helpful for some, more effective approaches that can be disseminated economically on a large scale are needed. To assess whether or not a task-based weight management programme [Weight Action Programme (WAP)] has better long-term effects than a 'best practice' intervention provided in primary care by practice nurses. Randomised controlled trial with cost-effectiveness analysis. General practices in east London, UK. Three hundred and thirty adults with a body mass index (BMI) of ≥ 30 kg/m 2 or a BMI of ≥ 28 kg/m 2 plus comorbidities were recruited from local general practices and via media publicity. Those who had a BMI of > 45 kg/m 2 , had lost > 5% of their body weight in the previous 6 months, were currently pregnant or taking psychiatric medications were excluded. Participants were randomised (2 : 1) to the WAP or nurse arms. The WAP intervention was delivered in eight weekly group sessions that combined dietary and physical activity, advice and self-monitoring in a group-oriented intervention. The initial course was followed by 10 monthly group maintenance sessions open to all participants in this study arm. The practice nurse intervention (best usual care) consisted of four one-to-one sessions delivered over 8 weeks, and included standard advice on diet and physical activity based on NHS 'Change4Life' materials and motivational support. The primary outcome measure was weight change at 12 months. Secondary outcome measures included change in BMI, waist circumference and blood pressure, and proportion of participants losing at least 5% and 10% of baseline body weight. Staff collecting measurements at the 6- and 12-month follow-ups were blinded to treatment allocation. The primary outcome measure was analysed according to the intention-to-treat principle, and included all participants with at least one recorded outcome at either 1, 2, 6 or 12 months. The analysis employed a mixed-effects linear regression model, adjusted for baseline weight, age, sex, ethnicity, smoking status and general practice. The European Quality of Life-5 Dimensions-5 Levels questionnaire was completed and used to estimate quality-adjusted life-years (QALYs) within the cost-effectiveness analysis. There were 330 participants (WAP arm, n  = 221; nurse arm, n  = 109; 72% women). A total of 291 (88%) participants (WAP arm, n  = 194; nurse arm, n  = 97) were included in the main analysis for the primary outcome. Weight loss at 12 months was greater in the WAP arm than in the nurse intervention arm [-4.2 kg vs. -2.3 kg; difference -1.9 kg, 95% confidence interval (CI) -3.7 to -0.1 kg; p  = 0.04]. Participants in the WAP arm were more likely than participants in the nurse arm to have lost at least 5% of their baseline body weight at 12 months (41% vs. 27%; odds ratio 14.61, 95% CI 2.32 to 91.96; p  = 0.004). The incremental cost-effectiveness ratio for WAP over and above the nurse arm is £7742 per QALY. A WAP delivered in general practice better promotes weight loss over 12 months than a best usual practice nurse-led weight loss programme. The trial recruited mostly women. Research is needed into factors that would make weight loss programmes more attractive to men. Current Controlled Trials ISRCTN45820471. 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. 20, No. 79. See the NIHR Journals Library website for further project information.

Testing non-inferiority of a new treatment in three-arm clinical trials with binary endpoints.

PubMed

Tang, Nian-Sheng; Yu, Bin; Tang, Man-Lai

2014-12-18

A two-arm non-inferiority trial without a placebo is usually adopted to demonstrate that an experimental treatment is not worse than a reference treatment by a small pre-specified non-inferiority margin due to ethical concerns. Selection of the non-inferiority margin and establishment of assay sensitivity are two major issues in the design, analysis and interpretation for two-arm non-inferiority trials. Alternatively, a three-arm non-inferiority clinical trial including a placebo is usually conducted to assess the assay sensitivity and internal validity of a trial. Recently, some large-sample approaches have been developed to assess the non-inferiority of a new treatment based on the three-arm trial design. However, these methods behave badly with small sample sizes in the three arms. This manuscript aims to develop some reliable small-sample methods to test three-arm non-inferiority. Saddlepoint approximation, exact and approximate unconditional, and bootstrap-resampling methods are developed to calculate p-values of the Wald-type, score and likelihood ratio tests. Simulation studies are conducted to evaluate their performance in terms of type I error rate and power. Our empirical results show that the saddlepoint approximation method generally behaves better than the asymptotic method based on the Wald-type test statistic. For small sample sizes, approximate unconditional and bootstrap-resampling methods based on the score test statistic perform better in the sense that their corresponding type I error rates are generally closer to the prespecified nominal level than those of other test procedures. Both approximate unconditional and bootstrap-resampling test procedures based on the score test statistic are generally recommended for three-arm non-inferiority trials with binary outcomes.

Comparison of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease with Flat-Panel Detectors on Mobile C-arm versus Fixed Systems.

PubMed

Guillou, Marie; Maurel, Blandine; Necib, Hatem; Vent, Pierre-Alexandre; Costargent, Alain; Chaillou, Philippe; Gouëffic, Yann; Kaladji, Adrien

2018-02-01

Flat-panel detectors on mobile C-arm (MC-arm) systems are currently challenging fixed C-arm (FC-arm) systems used in hybrid operating rooms. MC-arm systems offer an alternative to FC-arm systems in the endovascular treatment of peripheral arterial disease (PAD) but their efficiency has not been evaluated comparatively. Two series of patients undergoing arteriography with intention to treat were included. Each series consisted of 2 nonrandomized groups: an MC-arm group and an FC-arm group. Series 1 evaluated exposure to the patient (MC-arm, n = 113; FC-arm, n = 206) while series 2 evaluated exposure to patients and also health care personnel (MC-arm, n = 24; FC-arm, n = 76). The primary end points for evaluating exposure were air kerma (AK, in mGy) for patients and effective dose for health care personnel (in μSv). After adjustment for the effect of body mass index (analysis of covariance test), AK was found to be lower in the MC-arm group than in the FC-arm group (124.1 ± 142 vs. 173.3 ± 248.7, P = 0.025). There was no difference between the groups with regard to effective dose recorded for senior surgeons or for operating room nurses. However, a higher effective dose was recorded by the MC-arm group external dosimeter for the trainee resident and for nurse anesthetists. In endovascular treatment of lower limb PAD, use of an FC-arm system is associated with more radiation exposure to the patient than an MC-arm system. However, this type of imaging system does not appear to affect exposure to health care personnel. Copyright © 2017 Elsevier Inc. All rights reserved.

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers.

PubMed

Walters, Jodi; Cazzell, Shawn; Pham, Hau; Vayser, Dean; Reyzelman, Alexander

2016-01-01

The purpose of this 16-week, multicenter, randomized, controlled trial was to assess the healed ulcer rate of a human acellular dermal matrix, DermACELL, compared with conventional care and a second acellular dermal matrix, Graftjacket, in the treatment of full-thickness diabetic foot ulcers. One hundred sixty-eight patients were randomized into DermACELL, conventional care, and Graftjacket treatment arms in a 2:2:1 ratio. Patients in the acellular dermal matrix groups received either 1 or 2 applications of the graft at the discretion of the investigator. Weekly follow-up visits were conducted until the ulcer healed or the endpoint was reached. At 16 weeks, the DermACELL arm had a significantly higher proportion of completely healed ulcers than the conventional care arm (67.9% vs 48.1%; P = .0385) and a nonsignificantly higher proportion than the Graftjacket arm (67.9% vs 47.8%; P = .1149). The DermACELL arm also exhibited a greater average percent reduction in wound area than the conventional care arm (91.4% vs 80.3%; P = .0791) and the Graftjacket arm (91.4% vs 73.5%; P = .0762). The proportion of severe adverse events and the proportion of overall early withdrawals were similar among the 3 groups based on relative population size (P ≥ .05). The results presented here indicate that DermACELL is an appropriate clinical option in the treatment of diabetic foot ulcers, with significant increases in healing rates and rate of percentage wound closure as compared with conventional care options.

Health care for children in Indian Armed Forces.

PubMed

Kanitkar, Madhuri

2017-10-01

Children of Armed Forces personnel constitute 33% of the clientele dependant on our healthcare. Various child health indicators and immunization coverage of Indian Armed Forces children is better than the national figures. With improved patient care, it has been observed that the morbidity and mortality pattern of diseases affecting the children of Armed Forces personnel has shown a change from infectious diseases in the past to more of chronic complex disorders at present. Hospital admissions of children in military hospitals due to nutritional and infectious diseases have reduced and constitute only around 21% of all paediatric hospital admissions. Various factors responsible for this shift are preventive health measures (antenatal care, immunization), Active promotion of health (baby friendly hospital concept, Well baby clinic) curative health services (outpatient services, in-patient care, specialty care, supportive Care) and supportive care-reaching beyond like ASHA schools. Presently, we need to handle, life style diseases like obesity, mental stress, teach coping mechanisms for common stressors such as parental separation, family reunification, parental loss, behavioral problems, diseases other than infectious diseases requiring super specialty care. The challenge lies in planning the road ahead for these children and adolescents ensuring a life-course approach.

Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK

PubMed Central

2014-01-01

Background Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment, experience relapse and readmission to hospital, and sometimes attempt suicide. The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged. Methods This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope, reduce loneliness, improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only, with follow-up at one and three-months post-discharge. Results A total of 46 service users were recruited to the study; 23 receiving peer support and 23 in the care-as-usual arm. While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures, there is an indication that hope may be further increased in those in receipt of peer support. The total cost per case for the peer support arm of the study was £2154 compared to £1922 for the control arm. The mean difference between costs was minimal and not statistically significant. However, further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness. Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support. Conclusions The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered; the length and frequency of support provided; and the contact between peer supporters and mental health staff. There is no conclusive evidence to support the cost effectiveness of providing peer support, but neither was it proven a costly intervention to deliver. The findings support an argument for a larger scale trial of peer support as an adjunct to existing services. Trial registration Current Controlled Trials ISRCTN74852771 PMID:24495599

Results of a pilot randomised controlled trial to measure the clinical and cost effectiveness of peer support in increasing hope and quality of life in mental health patients discharged from hospital in the UK.

PubMed

Simpson, Alan; Flood, Chris; Rowe, Julie; Quigley, Jody; Henry, Susan; Hall, Cerdic; Evans, Richard; Sherman, Paul; Bowers, Len

2014-02-05

Mental health patients can feel anxious about losing the support of staff and patients when discharged from hospital and often discontinue treatment, experience relapse and readmission to hospital, and sometimes attempt suicide. The benefits of peer support in mental health services have been identified in a number of studies with some suggesting clinical and economic gains in patients being discharged. This pilot randomised controlled trial with economic evaluation aimed to explore whether peer support in addition to usual aftercare for patients during the transition from hospital to home would increase hope, reduce loneliness, improve quality of life and show cost effectiveness compared with patients receiving usual aftercare only, with follow-up at one and three-months post-discharge. A total of 46 service users were recruited to the study; 23 receiving peer support and 23 in the care-as-usual arm. While this pilot trial found no statistically significant benefits for peer support on the primary or secondary outcome measures, there is an indication that hope may be further increased in those in receipt of peer support. The total cost per case for the peer support arm of the study was £2154 compared to £1922 for the control arm. The mean difference between costs was minimal and not statistically significant. However, further analyses demonstrated that peer support has a reasonably high probability of being more cost effective for a modest positive change in the measure of hopelessness. Challenges faced in recruitment and follow-up are explored alongside limitations in the delivery of peer support. The findings suggest there is merit in conducting further research on peer support in the transition from hospital to home consideration should be applied to the nature of the patient population to whom support is offered; the length and frequency of support provided; and the contact between peer supporters and mental health staff. There is no conclusive evidence to support the cost effectiveness of providing peer support, but neither was it proven a costly intervention to deliver. The findings support an argument for a larger scale trial of peer support as an adjunct to existing services. Current Controlled Trials ISRCTN74852771.

GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING): a pilot cluster randomised controlled trial of a guideline implementation intervention for the management of maternal obesity by midwives.

PubMed

Heslehurst, Nicola; Rankin, Judith; McParlin, Catherine; Sniehotta, Falko F; Howel, Denise; Rice, Stephen; McColl, Elaine

2018-01-01

Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives' guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives' implementation of weight management guidelines. GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. This pilot study has been developed to support community midwives' implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness. ISRCTN46869894; retrospectively registered 25th May 2016.

ARM Carbon Cycle Gases Flasks at SGP Site

DOE Data Explorer

Biraud, Sebastien

2013-03-26

Data from flasks are sampled at the Atmospheric Radiation Measurement Program ARM, Southern Great Plains Site and analyzed by the National Oceanic and Atmospheric Administration NOAA, Earth System Research Laboratory ESRL. The SGP site is included in the NOAA Cooperative Global Air Sampling Network. The surface samples are collected from a 60 m tower at the ARM SGP Central Facility, usually once per week in the afternoon. The aircraft samples are collected approximately weekly from a chartered aircraft, and the collection flight path is centered over the tower where the surface samples are collected. The samples are collected by the ARM and LBNL Carbon Project.

Octopus arm choice is strongly influenced by eye use.

PubMed

Byrne, Ruth A; Kuba, Michael J; Meisel, Daniela V; Griebel, Ulrike; Mather, Jennifer A

2006-09-25

This study aims to investigate the octopus' eye and arm coordination and raises the question if visual guidance determines choice of arm use. Octopuses possess eight seemingly identical arms but have recently been reported to show a preference as to which arm they use to initiate contact with objects. These animals also exhibit lateralized eye use, therefore, a connection between eye and arm preference seems possible. Seven Octopus vulgaris were observed during approach, contact initiation and exploration of plastic objects that were positioned on three different levels in the water column. The subjects most commonly used an arm to initiate contact with an object that was in a direct line between the eye used to look at the object, and the object itself. This indicates that choice of arm use is spatially rather opportunistic when depending on visual guidance. Additionally, first contact with an object was usually established by the central third of the arm and in arm contact sequences neighboring arms were the most likely to follow an arm already touching the object. Although results point towards strong eye/arm coordination, we did not find lateralized behavior in this experiment. Results are discussed from a neuro-anatomical, behavioral and ecological perspective.

Integrating a Nurse-Midwife-Led Oral Health Intervention Into CenteringPregnancy Prenatal Care: Results of a Pilot Study.

PubMed

Adams, Sally H; Gregorich, Steven E; Rising, Sharon S; Hutchison, Margaret; Chung, Lisa H

2017-07-01

National and professional organizations recommend oral health promotion in prenatal care to improve women's oral health. However, few prenatal programs include education about oral health promotion. The objective of this study was to determine if women receiving a brief, low-cost, and sustainable educational intervention entitled CenteringPregnancy Oral Health Promotion had clinically improved oral health compared to women receiving standard CenteringPregnancy care. Women attending CenteringPregnancy, a group prenatal care model, at 4 health centers in the San Francisco Bay Area, participated in this nonrandomized controlled pilot study in 2010 to 2011. The intervention arm received the CenteringPregnancy Oral Health Promotion intervention consisting of two 15-minute skills-based educational modules addressing maternal and infant oral health, each module presented in a separate CenteringPregnancy prenatal care session. The present analysis focused on the maternal module that included facilitated discussions and skills-building activities including proper tooth brushing. The control arm received standard CenteringPregnancy prenatal care. Dental examinations and questionnaires were administered prior to and approximately 9 weeks postintervention. Primary outcomes included the Plaque Index, percent bleeding on probing, and percent of gingival pocket depths 4 mm or greater. Secondary outcomes were self-reported oral health knowledge, attitudes (importance and self-efficacy), and behaviors (tooth brushing and flossing). Regression models tested whether pre to post changes in outcomes differed between the intervention versus the control arms. One hundred and one women participated in the study; 49 were in the intervention arm, and 52 were in the control arm. The control and intervention arms did not vary significantly at baseline. Significant pre to post differences were noted between the arms with significant improvements in the intervention arm for the Plaque Index, bleeding on probing, and pocket depths 4 mm or greater. Providing brief oral health education and skills-building activities within prenatal care may be effective in improving women's oral health during pregnancy. These findings provide support for developing a full-scale randomized clinical trial of the CenteringPregnancy Oral Health Promotion intervention. © 2017 by the American College of Nurse-Midwives.

Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study.

PubMed

Armour, Mike; Smith, Caroline A; Schabrun, Siobhan; Steiner, Genevieve Z; Zhu, Xiaoshu; Lawson, Kenny; Song, Jing

2018-01-01

Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30-50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP. We will include women aged 18-45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0-10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation. This is a two-armed, assessor blind, randomised controlled feasibility trial. Data will be compared at baseline and trial completion 8 weeks later. Outcomes from this feasibility study will inform a larger, fully powered clinical trial should the treatment show trends for potential effectiveness. Australian New Zealand Clinical Trials Registry, ACTRN12617000053325 (http://www.ANZCTR.org.au/ACTRN12617000053325.aspx).

Health coaching by medical assistants to improve control of diabetes, hypertension, and hyperlipidemia in low-income patients: a randomized controlled trial.

PubMed

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

2015-03-01

Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ(2) tests and linear regression models. Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients' clinical conditions, interventions, and the contextual features of implementation. © 2015 Annals of Family Medicine, Inc.

Economic evaluation of occupational therapy in Parkinson's disease: A randomized controlled trial.

PubMed

Sturkenboom, Ingrid H W M; Hendriks, Jan C M; Graff, Maud J L; Adang, Eddy M M; Munneke, Marten; Nijhuis-van der Sanden, Maria W G; Bloem, Bastiaan R

2015-07-01

A large randomized clinical trial (the Occupational Therapy in Parkinson's Disease [OTiP] study) recently demonstrated that home-based occupational therapy improves perceived performance in daily activities of people with Parkinson's disease (PD). The aim of the current study was to evaluate the cost-effectiveness of this intervention. We performed an economic evaluation over a 6-month period for both arms of the OTiP study. Participants were 191 community-dwelling PD patients and 180 primary caregivers. The intervention group (n = 124 patients) received 10 weeks of home-based occupational therapy; the control group (n = 67 patients) received usual care (no occupational therapy). Costs were assessed from a societal perspective including healthcare use, absence from work, informal care, and intervention costs. Health utilities were evaluated using EuroQol-5d. We estimated cost differences and cost utility using linear mixed models and presented the net monetary benefit at different values for willingness to pay per quality-adjusted life-year gained. In our primary analysis, we excluded informal care hours because of substantial missing data for this item. The estimated mean total costs for the intervention group compared with controls were €125 lower for patients, €29 lower for caregivers, and €122 higher for patient-caregiver pairs (differences not significant). At a value of €40,000 per quality-adjusted life-year gained (reported threshold for PD), the net monetary benefit of the intervention per patient was €305 (P = 0.74), per caregiver €866 (P = 0.01) and per patient-caregiver pair €845 (P = 0.24). In conclusion, occupational therapy did not significantly impact on total costs compared with usual care. Positive cost-effectiveness of the intervention was only significant for caregivers. © 2015 International Parkinson and Movement Disorder Society.

Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care.

PubMed

Sabes-Figuera, Ramon; McCrone, Paul; Hurley, Mike; King, Michael; Donaldson, Ana Nora; Ridsdale, Leone

2012-08-20

Fatigue is common and has been shown to result in high economic costs to society. The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET) and counselling (COUN) with usual care plus a self-help booklet (BUC) for people presenting with chronic fatigue. A randomised controlled trial was conducted with participants consulting for fatigue of over three months' duration recruited from 31 general practices in South East England and allocated to one of three arms. Outcomes and use of services were assessed at 6-month follow-up. The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale. Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves. Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54. Those receiving the active therapies (GET and COUN) had more contacts with care professionals and therefore higher costs, these differences being statistically significant. COUN was more expensive and less effective than the other two therapies. The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement. However, there was much uncertainty around this result. This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue. It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC. Clinical Trial Registration number at ISRCTN register: 72136156.

Health Coaching by Medical Assistants to Improve Control of Diabetes, Hypertension, and Hyperlipidemia in Low-Income Patients: A Randomized Controlled Trial

PubMed Central

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

2015-01-01

PURPOSE Health coaching by medical assistants could be a financially viable model for providing self-management support in primary care if its effectiveness were demonstrated. We investigated whether in-clinic health coaching by medical assistants improves control of cardiovascular and metabolic risk factors when compared with usual care. METHODS We conducted a 12-month randomized controlled trial of 441 patients at 2 safety net primary care clinics in San Francisco, California. The primary outcome was a composite measure of being at or below goal at 12 months for at least 1 of 3 uncontrolled conditions at baseline as defined by hemoglobin A1c, systolic blood pressure, and low-density lipoprotein (LDL) cholesterol. Secondary outcomes were meeting all 3 goals and meeting individual goals. Data were analyzed using χ2 tests and linear regression models. RESULTS Participants in the coaching arm were more likely to achieve both the primary composite measure of 1 of the clinical goals (46.4% vs 34.3%, P = .02) and the secondary composite measure of reaching all clinical goals (34.0% vs 24.7%, P = .05). Almost twice as many coached patients achieved the hemoglobin A1c goal (48.6% vs 27.6%, P = .01). At the larger study site, coached patients were more likely to achieve the LDL cholesterol goal (41.8% vs 25.4%, P = .04). The proportion of patients meeting the systolic blood pressure goal did not differ significantly. CONCLUSIONS Medical assistants serving as in-clinic health coaches improved control of hemoglobin A1c and LDL levels, but not blood pressure, compared with usual care. Our results highlight the need to understand the relationship between patients’ clinical conditions, interventions, and the contextual features of implementation. PMID:25755034

Effects of a lifestyle intervention on psychosocial well-being of severe mentally ill residential patients: ELIPS, a cluster randomized controlled pragmatic trial.

PubMed

Stiekema, Annemarie P M; Looijmans, Anne; van der Meer, Lisette; Bruggeman, Richard; Schoevers, Robert A; Corpeleijn, Eva; Jörg, Frederike

2018-03-01

Large studies investigating the psychosocial effects of lifestyle interventions in patients with a severe mental illness (SMI) are scarce, especially in residential patients. This large, randomized controlled, multicentre pragmatic trial assessed the psychosocial effects of a combined diet-and-exercise lifestyle intervention targeting the obesogenic environment of SMI residential patients. Twenty-nine sheltered and clinical care teams were randomized into intervention (n=15) or control (n=14) arm. Team tailored diet-and-exercise lifestyle plans were set up to change the obesogenic environment into a healthier setting, and team members were trained in supporting patients to make healthier choices. The control group received care-as-usual. The Calgary Depression Scale for Schizophrenia (CDSS), Positive and Negative Syndrome Scale (PANSS), Health of the Nation Outcome Scales (HoNOS) and the Manchester Short Assessment of Quality of Life (MANSA) were assessed at baseline and after three and twelve months. Data were available for 384 intervention and 386 control patients (48.6±12.5years old, 62.7% males, 73.7% psychotic disorder). Linear mixed model analysis showed no psychosocial improvements in the intervention group compared to care-as-usual; the intervention group showed a slightly reduced quality of life (overall) and a small increase in depressive symptoms (clinical care facilities) and psychotic symptoms (sheltered facilities). This may be due to difficulties with implementation, the intervention not being specifically designed for improvements in mental well-being, or the small change approach, which may take longer to reach an effect. Further research might elucidate what type of lifestyle intervention under what circumstances positively affects psychosocial outcomes in this population. Copyright © 2018 Elsevier B.V. All rights reserved.

Maximizing post-stroke upper limb rehabilitation using a novel telerehabilitation interactive virtual reality system in the patient's home: study protocol of a randomized clinical trial.

PubMed

Kairy, Dahlia; Veras, Mirella; Archambault, Philippe; Hernandez, Alejandro; Higgins, Johanne; Levin, Mindy F; Poissant, Lise; Raz, Amir; Kaizer, Franceen

2016-03-01

Telerehabilitation (TR), or the provision of rehabilitation services from a distance using telecommunication tools such as the Internet, can contribute to ensure that patients receive the best care at the right time. This study aims to assess the effect of an interactive virtual reality (VR) system that allows ongoing rehabilitation of the upper extremity (UE) following a stroke, while the person is in their own home, with offline monitoring and feedback from a therapist at a distance. A single-blind (evaluator is blind to group assignment) two-arm randomized controlled trial is proposed, with participants who have had a stroke and are no longer receiving rehabilitation services randomly allocated to: (1) 4-week written home exercise program, i.e. usual care discharge home program or (2) a 4-week home-based TR exercise program using VR in addition to usual care i.e. treatment group. Motor recovery of the UE will be assessed using the Fugl-Meyer Assessment-UE and the Box and Block tests. To determine the efficacy of the system in terms of functional recovery, the Motor Activity Log, a self-reported measure of UE use will be used. Impact on quality of life will be determined using the Stroke Impact Scale-16. Lastly, a preliminary cost-effectiveness analysis will be conducted using costs and outcomes for all groups. Findings will contribute to evidence regarding the use of TR and VR to provide stroke rehabilitation services from a distance. This approach can enhance continuity of care once patients are discharged from rehabilitation, in order to maximize their recovery beyond the current available services. Copyright © 2015 Elsevier Inc. All rights reserved.

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

Gensichen, Jochen; Hiller, Thomas S; Breitbart, Jörg; Teismann, Tobias; Brettschneider, Christian; Schumacher, Ulrike; Piwtorak, Alexander; König, Hans-Helmut; Hoyer, Heike; Schneider, Nico; Schelle, Mercedes; Blank, Wolfgang; Thiel, Paul; Wensing, Michel; Margraf, Jürgen

2014-04-06

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. 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. Current Controlled Trials [http://ISCRTN64669297].

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

The effects of mirror therapy on arm and hand function in subacute stroke in patients.

PubMed

Radajewska, Alina; Opara, Józef A; Kucio, Cezary; Błaszczyszyn, Monika; Mehlich, Krzysztof; Szczygiel, Jarosław

2013-09-01

The aim of this study was to evaluate the effect of mirror therapy on arm and hand function in subacute stroke in patients. The study included 60 hemiparetic right-handed patients after ischemic stroke 8-10 weeks after onset. They underwent stationary comprehensive rehabilitation in the rehabilitation centre. They were divided into two randomly assigned groups: mirror (n=30) and control (n=30). For both groups, two subgroups were created: one that included patients with right arm paresis (n=15) and the other that included patients with left arm paresis (n=15). The mirror group received an additional intervention: training with a mirror for 5 days/week, 2 sessions/day, for 21 days. Each single session lasted for 15 min. The control group (n=30) underwent a conventional rehabilitation program without mirror therapy. To evaluate self-care in performing activities of daily living, the Functional Index 'Repty' was used. To evaluate hand and arm function, the Frenchay Arm Test and the Motor Status Score were used. Measurements were performed twice: before and after 21 days of applied rehabilitation. No significant improvement in hand and arm function in both subgroups in Frenchay Arm Test and Motor Status Score scales was observed. However, there was a significant improvement in self-care of activities of daily living in the right arm paresis subgroup in the mirror group measured using the Functional Index 'Repty'. Mirror therapy improves self-care of activities of daily living for patients with right arm paresis after stroke.

Evaluation of a functional hand orthosis combined with electrical stimulation adjunct to arm-hand rehabilitation in subacute stroke patients with a severely to moderately affected hand function.

PubMed

Franck, Johan Anton; Smeets, Rob Johannes Elise Marie; Seelen, Henk Alexander Maria

2018-01-09

To investigate the usability and effectiveness of a functional hand orthosis, combined with electrical stimulation adjunct to therapy-as-usual, on functional use of the moderately/severely impaired hand in sub-acute stroke patients. Single case experiment (A-B-A'-design) involving eight sub-acute stroke patients. The functional hand orthosis and electrical stimulation were used for six weeks, four days/week, 45'/day. Action_Research_Arm_Test, Intrinsic_Motivation_Inventory. At group level, patients improved 19.2 points (median value) (interquartile range: [8.8, 29.5] points) on the Action_Research_Arm_Test (p = 0.001). After correcting for spontaneous recovery and/or therapy-as-usual effects Action_Research_Arm_Test scores still improved significantly (median: 17.2 points; interquartile range: [5.1, 29.2] points) (p = 0.002). At individual level, six patients had improved as to arm-hand skill performance at follow-up (p < = 0.010). In one patient, arm-hand skill performance improvement did not attain statistical significance. In another patient, no arm-hand skill performance improvement was observed. Average Intrinsic_Motivation_Inventory sub-scores were between 4.6 and 6.3 (maximum: 7), except for 'perceived pressure/tension' (3.3). Sub-acute stroke patients who display only little/modest improvement on their capacity to perform daily activities, seem to benefit from training with a dynamic arm orthosis in combination with electrical stimulation. Patients' perceived intrinsic motivation and sense of self-regulation was high. Implications for rehabilitation Arm-hand training featuring the dynamic hand orthosis in combination with electrical stimulation shows a shift from no dexterity to dexterity. As to the users' experience regarding the dynamic hand orthosis, patients perceive a high-intrinsic motivation and sense of self-regulation. Combining the orthosis with electrical stimulation creates opportunities for a nonfunctional hand towards task-oriented training.

On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study.

PubMed

Ducrotte, P; Grimaud, J C; Dapoigny, M; Personnic, S; O'Mahony, V; Andro-Delestrain, M C

2014-02-01

In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients' quality of life (QoL). A randomised, double-blind, placebo-controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments. Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on-demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 0.0008). The IBS-severity symptom score (IBS-SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS-SSS < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment, which was associated with both lower direct and indirect costs. After 6 months, on-demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments. © 2013 The Authors International Journal of Clinical Practice Published by John Wiley & Sons Ltd.

On-demand treatment with alverine citrate/simeticone compared with standard treatments for irritable bowel syndrome: results of a randomised pragmatic study

PubMed Central

Ducrotte, P; Grimaud, J C; Dapoigny, M; Personnic, S; O'Mahony, V; Andro-Delestrain, M C

2014-01-01

Background In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients’ quality of life (QoL). A randomised, double-blind, placebo-controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. Aim As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments. Methods Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on-demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. Results A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 0.0008). The IBS-severity symptom score (IBS-SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS-SSS < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment, which was associated with both lower direct and indirect costs. Conclusions After 6 months, on-demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments. PMID:24147869

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

PubMed Central

2014-01-01

Background 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.’ Discussion 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. Summary 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. PMID:24438584

Meet Marsha William: In Arms Reach Home Day Care

ERIC Educational Resources Information Center

Exchange: The Early Childhood Leaders' Magazine Since 1978, 2006

2006-01-01

Confident in what she knows, excited about what she's learning, eager to share her passion with others--this is Marsha Williams, director of In Arms Reach Home Day Care, Baltimore, Maryland. She enjoys being a family care provider, because with no more than eight children, she manages to give more individualized attention on a daily basis. She…

Behavioral and technological interventions targeting glycemic control in a racially/ethnically diverse population: a randomized controlled trial

PubMed Central

2014-01-01

Background Diabetes self-care by patients has been shown to assist in the reduction of disease severity and associated medical costs. We compared the effectiveness of two different diabetes self-care interventions on glycemic control in a racially/ethnically diverse population. We also explored whether reductions in glycated hemoglobin (HbA1c) will be more marked in minority persons. Methods We conducted an open-label randomized controlled trial of 376 patients with type 2 diabetes aged ≥18 years and whose last measured HbA1c was ≥7.5% (≥58 mmol/mol). Participants were randomized to: 1) a Chronic Disease Self-Management Program (CDSMP; n = 101); 2) a diabetes self-care software on a personal digital assistant (PDA; n = 81); 3) a combination of interventions (CDSMP + PDA; n = 99); or 4) usual care (control; n = 95). Enrollment occurred January 2009-June 2011 at seven regional clinics of a university-affiliated multi-specialty group practice. The primary outcome was change in HbA1c from randomization to 12 months. Data were analyzed using a multilevel statistical model. Results Average baseline HbA1c in the CDSMP, PDA, CDSMP + PDA, and control arms were 9.4%, 9.3%, 9.2%, and 9.2%, respectively. HbA1c reductions at 12 months for the groups averaged 1.1%, 0.7%, 1.1%, and 0.7%, respectively and did not differ significantly from baseline based on the model (P = .771). Besides the participants in the PDA group reporting eating more high-fat foods compared to their counterparts (P < .004), no other significant differences were observed in participants’ diabetes self-care activities. Exploratory sub-analysis did not reveal any marked reductions in HbA1c for minority persons but rather modest reductions for all racial/ethnic groups. Conclusions Although behavioral and technological interventions can result in some modest improvements in glycemic control, these interventions did not fare significantly better than usual care in achieving glycemic control. More research is needed to understand how these interventions can be most effective in clinical practice. The reduction in HbA1c levels found in our control group that received usual care also suggests that good routine care in an integrated healthcare system can lead to better glycemic control. Trial registration Clinicaltrials.gov Identifier: NCT01221090. PMID:24450992

Educational videos to reduce racial disparities in ICD therapy via innovative designs (VIVID): a randomized clinical trial.

PubMed

Thomas, Kevin L; Zimmer, Louise O; Dai, David; Al-Khatib, Sana M; Allen LaPointe, Nancy M; Peterson, Eric D

2013-07-01

Black individuals eligible for an implantable cardioverter/defibrillator (ICD) are considerably less likely than white individuals to receive one. This disparity may, in part, be explained by racial differences in patient preferences. We hypothesized that a targeted patient-centered educational video could improve knowledge of sudden cardiac arrest (SCA) and ICDs and reduce racial differences in ICD preferences. We conducted a pilot study to assess the feasibility of testing this hypothesis in a randomized trial. We created a video that included animation, physician commentary, and patient testimonials on SCA and ICDs. The primary outcome was the decision to have an ICD implanted as a function of race and intervention. Between January 1, 2011, and December 31, 2011, 59 patients (37 white and 22 black) were randomized to the video or health care provider counseling/usual care. Relative to white patients, black patients were younger (median age, 55 vs 68 years) and more likely to have attended college or technical school. Baseline SCA and ICD knowledge was similar and improved significantly in both racial groups after the intervention. Black patients viewing the video were as likely as white patients to want an ICD (60.0% vs 79.2%, P = .20); and among those in the usual care arm, black patients were less likely than white patients to want an ICD (42.9% vs 84.6% P = .05). Among individuals eligible for an ICD, a video decision aid increased patient knowledge and reduced racial differences in patient preference for an ICD. Copyright © 2013 Mosby, Inc. All rights reserved.

Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes. Design The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom. Discussion The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide. Trial registration Current controlled trials ISRCTN62237498 Date registered: 5 September 2013 PMID:25016303

The impact of a multidisciplinary self-care management program on quality of life, self-care, adherence to anti-hypertensive therapy, glycemic control, and renal function in diabetic kidney disease: A Cross-over Study Protocol.

PubMed

Helou, Nancy; Talhouedec, Dominique; Shaha, Maya; Zanchi, Anne

2016-07-19

Diabetic kidney disease, a global health issue, remains associated with high morbidity and mortality. Previous research has shown that multidisciplinary management of chronic disease can improve patient outcomes. The effect of multidisciplinary self-care management on quality of life and renal function of patients with diabetic kidney disease has not yet been well established. The aim of this study is to evaluate the impact of a multidisciplinary self-care management program on quality of life, self-care behavior, adherence to anti-hypertensive treatment, glycemic control, and renal function of adults with diabetic kidney disease. A uniform balanced cross-over design is used, with the objective to recruit 40 adult participants with diabetic kidney disease, from public and private out-patient settings in French speaking Switzerland. Participants are randomized in equal number into four study arms. Each participant receives usual care alternating with the multidisciplinary self- care management program. Each treatment period lasts three months and is repeated twice at different time intervals over 12 months depending on the cross-over arm. The multidisciplinary self-care management program is led by an advanced practice nurse and adds nursing and dietary consultations and follow-ups, to the habitual management provided by the general practitioner, the nephrologist and the diabetologist. Data is collected every three months for 12 months. Quality of life is measured using the Audit of Diabetes-Dependent Quality of Life scale, patient self-care behavior is assessed using the Revised Summary of Diabetes Self-Care Activities, and adherence to anti-hypertensive therapy is evaluated using the Medication Events Monitoring System. Blood glucose control is measured by the glycated hemoglobin levels and renal function by serum creatinine, estimated glomerular filtration rate and urinary albumin/creatinine ratio. Data will be analyzed using STATA version 14. The cross-over design will elucidate the responses of individual participant to each treatment, and will allow us to better evaluate the use of such a design in clinical settings and behavioral studies. This study also explores the impact of a theory-based nursing practice and its implementation into a multidisciplinary context. ClinicalTrials.gov identifier: NCT01967901 , registered on the 18th of October 2013.

Cognitive behavioural anger management intervention for people with intellectual disabilities: costs of intervention and impact on health and social care resource use.

PubMed

Felce, D; Cohen, D; Willner, P; Rose, J; Kroese, B; Rose, N; Shead, J; Jahoda, A; MacMahon, P; Lammie, C; Stimpson, A; Woodgate, C; Gillespie, D; Townson, J; Nuttall, J; Hood, K

2015-01-01

Anger and aggression among adults with intellectual disability (ID) are associated with a range of adverse consequences for their well-being and that of their family or staff carers. The aims were to evaluate the effectiveness of an anger management intervention for adults with mild to moderate ID and to evaluate the costs of the intervention and its impact on health and social care resource use. This paper is concerned with the latter aim. A cluster-randomised controlled trial was conducted involving day services for adults with ID in Scotland, England and Wales. Incremental costs of delivering the intervention and its impact on subsequent total health and social care package costs were calculated. Full data comparing costs between baseline and follow-up 10 months later were collected for 67 participants in the intervention arm and 62 participants in the control arm. Cost differences between the groups at follow-up, adjusted for baseline levels, were calculated using non-parametric bootstrapping controlling for clustering. The mean hourly excess cost of intervention over treatment as usual was £12.34. A mean adjusted cost difference of £22.46 per person per week in favour of the intervention group was found but this was not statistically significant. The baseline-adjusted cost difference at follow-up would result in a fairly immediate compensation for the excess costs of intervention, provided the difference is not a statistical artefact. Further research is needed to clarify the extent to which it might represent a real saving in service support costs. © 2014 MENCAP and International Association of the Scientific Study of Intellectual and Developmental Disabilities and John Wiley & Sons Ltd.

The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD) in primary care

PubMed Central

de Lusignan, Simon; Gallagher, Hugh; Chan, Tom; Thomas, Nicki; van Vlymen, Jeremy; Nation, Michael; Jain, Neerja; Tahir, Aumran; du Bois, Elizabeth; Crinson, Iain; Hague, Nigel; Reid, Fiona; Harris, Kevin

2009-01-01

Background Chronic kidney disease (CKD) is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP) control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression Design Cluster randomised controlled trial (CRT) Methods This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices) powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small group of practices (n = 4) will take part in an in-depth process evaluation. We will use time series data to examine the natural history of CKD in the community. Finally, we will conduct an economic evaluation based on a comparison of the cost effectiveness of each intervention. Clinical Trials Registration ISRCTN56023731. ClinicalTrials.gov identifier. PMID:19602233

The Treatment of cardiovascular Risk in Primary care using Electronic Decision supOrt (TORPEDO) study-intervention development and protocol for a cluster randomised, controlled trial of an electronic decision support and quality improvement intervention in Australian primary healthcare.

PubMed

Peiris, David; Usherwood, Tim; Panaretto, Katie; Harris, Mark; Hunt, Jenny; Patel, Bindu; Zwar, Nicholas; Redfern, Julie; Macmahon, Stephen; Colagiuri, Stephen; Hayman, Noel; Patel, Anushka

2012-01-01

Large gaps exist in the implementation of guideline recommendations for cardiovascular disease (CVD) risk management. Electronic decision support (EDS) systems are promising interventions to close these gaps but few have undergone clinical trial evaluation in Australia. We have developed HealthTracker, a multifaceted EDS and quality improvement intervention to improve the management of CVD risk. It is hypothesised that the use of HealthTracker over a 12-month period will result in: (1) an increased proportion of patients receiving guideline-indicated measurements of CVD risk factors and (2) an increased proportion of patients at high risk will receive guideline-indicated prescriptions for lowering their CVD risk. Sixty health services (40 general practices and 20 Aboriginal Community Controlled Health Services (ACCHSs) will be randomised in a 1:1 allocation to receive either the intervention package or continue with usual care, stratified by service type, size and participation in existing quality improvement initiatives. The intervention consists of point-of-care decision support; a risk communication interface; a clinical audit tool to assess performance on CVD-related indicators; a quality improvement component comprising peer-ranked data feedback and support to develop strategies to improve performance. The control arm will continue with usual care without access to these intervention components. Quantitative data will be derived from cross-sectional samples at baseline and end of study via automated data extraction. Detailed process and economic evaluations will also be conducted. The general practice component of the study is approved by the University of Sydney Human Research Ethics Committee (HREC) and the ACCHS component is approved by the Aboriginal Health and Medical Research Council HREC. Formal agreements with each of the participating sites have been signed. In addition to the usual scientific forums, results will be disseminated via newsletters, study websites, face-to-face feedback forums and workshops. The trial is registered with the Australian Clinical Trials Registry ACTRN 12611000478910.

Protocol for the mWellcare trial: a multicentre, cluster randomised, 12-month, controlled trial to compare the effectiveness of mWellcare, an mHealth system for an integrated management of patients with hypertension and diabetes, versus enhanced usual care in India.

PubMed

Jha, Dilip; Gupta, Priti; Ajay, Vamadevan S; Jindal, Devraj; Perel, Pablo; Prieto-Merino, David; Jacob, Pramod; Nyong, Jonathan; Venugopal, Vidya; Singh, Kavita; Goenka, Shifalika; Roy, Ambuj; Tandon, Nikhil; Patel, Vikram; Prabhakaran, Dorairaj

2017-08-11

Rising burden of cardiovascular disease (CVD) and diabetes is a major challenge to the health system in India. Innovative approaches such as mobile phone technology (mHealth) for electronic decision support in delivering evidence-based and integrated care for hypertension, diabetes and comorbid depression have potential to transform the primary healthcare system. METHODS AND ANALYSIS: mWellcare trial is a multicentre, cluster randomised controlled trial evaluating the clinical and cost-effectiveness of a mHealth system and nurse managed care for people with hypertension and diabetes in rural India. mWellcare system is an Android-based mobile application designed to generate algorithm-based clinical management prompts for treating hypertension and diabetes and also capable of storing health records, sending alerts and reminders for follow-up and adherence to medication. We recruited a total of 3702 participants from 40 Community Health Centres (CHCs), with ≥90 at each of the CHCs in the intervention and control (enhanced care) arms. The primary outcome is the difference in mean change (from baseline to 1 year) in systolic blood pressure and glycated haemoglobin (HbA1c) between the two treatment arms. The secondary outcomes are difference in mean change from baseline to 1 year in fasting plasma glucose, total cholesterol, predicted 10-year risk of CVD, depression, smoking behaviour, body mass index and alcohol use between the two treatment arms and cost-effectiveness. The study has been approved by the institutional Ethics Committees at Public Health Foundation of India and the London School of Hygiene and Tropical Medicine. Findings will be disseminated widely through peer-reviewed publications, conference presentations and other mechanisms. mWellcare trial is registered with Clinicaltrial.gov (Registration number NCT02480062; Pre-results) and Clinical Trial Registry of India (Registration number CTRI/2016/02/006641). The current version of the protocol is Version 2 dated 19 October 2015 and the study sponsor is Public Health Foundation of India, Gurgaon, India (www.phfi.org). © 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.

Lymphedema - self-care

MedlinePlus

... in your body. The buildup can cause an arm, leg, or other area of your body to ... Use your arm that has lymphedema for everyday activities, such as combing your hair, bathing, dressing, and eating. Rest this arm ...

Improvement in neonatal intensive care unit care: a cluster randomised controlled trial of active dissemination of information.

PubMed

Acolet, Dominique; Allen, Elizabeth; Houston, Rosie; Wilkinson, Andrew R; Costeloe, Kate; Elbourne, Diana

2011-11-01

Research findings are not rapidly or fully implemented into policies and practice in care. To assess whether an 'active' strategy was more likely to lead to changes in policy and practice in preterm baby care than traditional information dissemination. Cluster randomised trial. 180 neonatal units (87 active, 93 control) in England; clinicians from active arm units; babies born <27 weeks gestation. CONTROL ARM: Dissemination of research report; slides; information about newborn care position statement. ACTIVE ARM: As above plus offer to become 'regional 'champion' (attend two workshops, support clinicians to implement research evidence regionally), or attend one workshop, promote implementation of research evidence locally. timing of surfactant administration; admission temperature; staffing of resuscitation team present at birth. 48/87 Lead clinicians in the active arm attended one or both workshops. There was no evidence of difference in post-intervention policies between trial arms. Practice outcomes based on babies in the active (169) and control arms (186), in 45 and 49 neonatal units respectively, showed active arm babies were more likely to have been given surfactant on labour ward (RR=1.30; 95% CI 0.99 to 1.70); p=0.06); to have a higher temperature on admission to neonatal intensive care unit (mean difference=0.29(o)C; 95% CI 0.22 to 0.55; p=0.03); and to have had the baby's trunk delivered into a plastic bag (RR=1.27; 95% CI 1.01 to 1.60; p=0.04) than the control group. The effect on having an 'ideal' resuscitation team at birth was in the same direction of benefit for the active arm (RR=1.18; 95% CI 0.97 to 1.43; p=0.09). The costs of the intervention were modest. This is the first trial to evaluate methods for transferring information from neonatal research into local policies and practice in England. An active approach to research dissemination is both feasible and cost-effective. Current controlled trials ISRCTN89683698.

Improving coronary heart disease self-management using mobile technologies (Text4Heart): a randomised controlled trial protocol.

PubMed

Dale, Leila Pfaeffli; Whittaker, Robyn; Jiang, Yannan; Stewart, Ralph; Rolleston, Anna; Maddison, Ralph

2014-03-04

Cardiac rehabilitation (CR) is a secondary prevention program that offers education and support to assist patients with coronary heart disease (CHD) make lifestyle changes. Despite the benefits of CR, attendance at centre-based sessions remains low. Mobile technology (mHealth) has potential to reach more patients by delivering CR directly to mobile phones, thus providing an alternative to centre-based CR. The aim of this trial is to evaluate if a mHealth comprehensive CR program can improve adherence to healthy lifestyle behaviours (for example, physically active, fruit and vegetable intake, not smoking, low alcohol consumption) over and above usual CR services in New Zealand adults diagnosed with CHD. A two-arm, parallel, randomised controlled trial will be conducted at two Auckland hospitals in New Zealand. One hundred twenty participants will be randomised to receive a 24-week evidence- and theory-based personalised text message program and access to a supporting website in addition to usual CR care or usual CR care alone (control). The primary outcome is the proportion of participants adhering to healthy behaviours at 6 months, measured using a composite health behaviour score. Secondary outcomes include overall cardiovascular disease risk, body composition, illness perceptions, self-efficacy, hospital anxiety/depression and medication adherence. This study is one of the first to examine an mHealth-delivered comprehensive CR program. Strengths of the trial include quality research design and in-depth description of the intervention to aid replication. If effective, the trial has potential to augment standard CR practices and to be used as a model for other disease prevention or self-management programs. Australian New Zealand Clinical Trials Registry: ACTRN12613000901707.

Promotion of early pediatric hearing detection through patient navigation: A randomized controlled clinical trial.

PubMed

Bush, Matthew L; Taylor, Zachary R; Noblitt, Bryce; Shackleford, Taylor; Gal, Thomas J; Shinn, Jennifer B; Creel, Liza M; Lester, Cathy; Westgate, Philip M; Jacobs, Julie A; Studts, Christina R

2017-11-01

To assess the efficacy of a patient navigator intervention to decrease nonadherence to obtain audiological testing following failed screening, compared to those receiving the standard of care. Using a randomized controlled design, guardian-infant dyads, in which the infants had abnormal newborn hearing screening, were recruited within the first week after birth. All participants were referred for definitive audiological diagnostic testing. Dyads were randomized into a patient navigator study arm or standard of care arm. The primary outcome was the percentage of patients with follow-up nonadherence to obtain diagnostic testing. Secondary outcomes were parental knowledge of infant hearing testing recommendations and barriers in obtaining follow-up testing. Sixty-one dyads were enrolled in the study (patient navigator arm = 27, standard of care arm = 34). The percentage of participants nonadherent to diagnostic follow-up during the first 6 months after birth was significantly lower in the patient navigator arm compared with the standard of care arm (7.4% vs. 38.2%) (P = .005). The timing of initial follow-up was significantly lower in the navigator arm compared with the standard of care arm (67.9 days after birth vs. 105.9 days, P = .010). Patient navigation increased baseline knowledge regarding infant hearing loss diagnosis recommendations compared with the standard of care (P = .004). Patient navigation decreases nonadherence rates following abnormal infant hearing screening and improves knowledge of follow-up recommendations. This intervention has the potential to improve the timeliness of delivery of infant hearing healthcare; future research is needed to assess the cost and feasibility of larger scale implementation. 1b. Laryngoscope, 127:S1-S13, 2017. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women.

PubMed

Boyle, Rhianon; Hay-Smith, E Jean C; Cody, June D; Mørkved, Siv

2012-10-17

About a third of women have urinary incontinence and up to a 10th have faecal incontinence after childbirth. Pelvic floor muscle training is commonly recommended during pregnancy and after birth both for prevention and the treatment of incontinence. To determine the effect of pelvic floor muscle training compared to usual antenatal and postnatal care on incontinence. We searched the Cochrane Incontinence Group Specialised Register, which includes searches of CENTRAL, MEDLINE, MEDLINE in Process and handsearching (searched 7 February 2012) and the references of relevant articles. Randomised or quasi-randomised trials in pregnant or postnatal women. One arm of the trial needed to include pelvic floor muscle training (PFMT). Another arm was either no PFMT or usual antenatal or postnatal care. Trials were independently assessed for eligibility and methodological quality. Data were extracted then cross checked. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook for Systematic Reviews of Interventions. Three different populations of women were considered separately, women dry at randomisation (prevention); women wet at randomisation (treatment); and a mixed population of women who might be one or the other (prevention or treatment). Trials were further divided into those which started during pregnancy (antenatal); and those started after delivery (postnatal). Twenty-two trials involving 8485 women (4231 PFMT, 4254 controls) met the inclusion criteria and contributed to the analysis.Pregnant women without prior urinary incontinence (prevention) who were randomised to intensive antenatal PFMT were less likely than women randomised to no PFMT or usual antenatal care to report urinary incontinence up to six months after delivery (about 30% less; risk ratio (RR) 0.71, 95% CI 0.54 to 0.95, combined result of 5 trials).Postnatal women with persistent urinary incontinence (treatment) three months after delivery and who received PFMT were less likely than women who did not receive treatment or received usual postnatal care to report urinary incontinence 12 months after delivery (about 40% less; RR 0.60, 95% CI 0.35 to 1.03, combined result of 3 trials). It seemed that the more intensive the programme the greater the treatment effect.The results of seven studies showed a statistically significant result favouring PFMT in a mixed population (women with and without incontinence symptoms) in late pregnancy (RR 0.74, 95% CI 0.58 to 0.94, random-effects model). Based on the trial data to date, the extent to which mixed prevention and treatment approaches to PFMT in the postnatal period are effective is less clear (that is, offering advice on PFMT to all pregnant or postpartum women whether they have incontinence symptoms or not). It is possible that mixed prevention and treatment approaches might be effective when the intervention is intensive enough.There was little evidence about long-term effects for either urinary or faecal incontinence. There is some evidence that for women having their first baby, PFMT can prevent urinary incontinence up to six months after delivery. There is support for the widespread recommendation that PFMT is an appropriate treatment for women with persistent postpartum urinary incontinence. It is possible that the effects of PFMT might be greater with targeted rather than mixed prevention and treatment approaches and in certain groups of women (for example primiparous women; women who had bladder neck hypermobility in early pregnancy, a large baby, or a forceps delivery). These and other uncertainties, particularly long-term effectiveness, require further testing.

Economic evaluation of an extended nutritional intervention in older Australian hospitalized patients: a randomized controlled trial.

PubMed

Sharma, Yogesh; Thompson, Campbell; Miller, Michelle; Shahi, Rashmi; Hakendorf, Paul; Horwood, Chris; Kaambwa, Billingsley

2018-02-05

Prevalence of malnutrition in older hospitalized patients is 30%. Malnutrition is associated with poor clinical outcomes in terms of high morbidity and mortality and is costly for hospitals. Extended nutrition interventions improve clinical outcomes but limited studies have investigated whether these interventions are cost-effective. In this randomized controlled trial, 148 malnourished general medical patients ≥60 years were recruited and randomized to receive either an extended nutritional intervention or usual care. Nutrition intervention was individualized and started with 24 h of admission and was continued for 3 months post-discharge with a monthly telephone call whereas control patients received usual care. Nutrition status was confirmed by Patient generated subjective global assessment (PG-SGA) and health-related quality of life (HRQoL) was measured using EuroQoL 5D (EQ-5D-5 L) questionnaire at admission and at 3-months follow-up. A cost-effectiveness analysis was conducted for the primary outcome (incremental costs per unit improvement in PG-SGA) while a cost-utility analysis (CUA) was undertaken for the secondary outcome (incremental costs per quality adjusted life year (QALY) gained). Nutrition status and HRQoL improved in intervention patients. Mean per included patient Australian Medicare costs were lower in intervention group compared to control arm (by $907) but these differences were not statistically significant (95% CI: -$2956 to $4854). The main drivers of higher costs in the control group were higher inpatient ($13,882 versus $13,134) and drug ($838 versus $601) costs. After adjusting outcomes for baseline differences and repeated measures, the intervention was more effective than the control with patients in this arm reporting QALYs gained that were higher by 0.0050 QALYs gained per patient (95% CI: -0.0079 to 0.0199). The probability of the intervention being cost-effective at willingness to pay values as low as $1000 per unit improvement in PG-SGA was > 98% while it was 78% at a willingness to pay $50,000 per QALY gained. This health economic analysis suggests that the use of extended nutritional intervention in older general medical patients is likely to be cost-effective in the Australian health care setting in terms of both primary and secondary outcomes. ACTRN No. 12614000833662 . Registered 6 August 2014.

Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial.

PubMed

Gunn, Jane; Wachtler, Caroline; Fletcher, Susan; Davidson, Sandra; Mihalopoulos, Cathrine; Palmer, Victoria; Hegarty, Kelsey; Coe, Amy; Murray, Elizabeth; Dowrick, Christopher; Andrews, Gavin; Chondros, Patty

2017-07-20

Depression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to half the patients presenting to general practice report symptoms of depression, but general practitioners have no systematic way of efficiently identifying level of need and allocating treatment accordingly. Therefore, our team developed a new clinical prediction tool (CPT) to assist with this task. The CPT predicts depressive symptom severity in three months' time and based on these scores classifies individuals into three groups (minimal/mild, moderate, severe), then provides a matched treatment recommendation. This study aims to test whether using the CPT reduces depressive symptoms at three months compared with usual care. The Target-D study is an individually randomized controlled trial. Participants will be 1320 general practice patients with depressive symptoms who will be approached in the practice waiting room by a research assistant and invited to complete eligibility screening on an iPad. Eligible patients will provide informed consent and complete the CPT on a purpose-built website. A computer-generated allocation sequence stratified by practice and depressive symptom severity group, will randomly assign participants to intervention (treatment recommendation matched to predicted depressive symptom severity group) or comparison (usual care plus Target-D attention control) arms. Follow-up assessments will be completed online at three and 12 months. The primary outcome is depressive symptom severity at three months. Secondary outcomes include anxiety, mental health self-efficacy, quality of life, and cost-effectiveness. Intention-to-treat analyses will test for differences in outcome means between study arms overall and by depressive symptom severity group. To our knowledge, this is the first depressive symptom stratification tool designed for primary care which takes a prognosis-based approach to provide a tailored treatment recommendation. If shown to be effective, this tool could be used to assist general practitioners to implement stepped mental-healthcare models and contribute to a more efficient and effective mental health system. Australian New Zealand Clinical Trials Registry (ANZCTR 12616000537459 ). Retrospectively registered on 27 April 2016. See Additional file 1 for trial registration data.

Reducing suicidal ideation in depressed older primary care patients.

PubMed

Unützer, Jürgen; Tang, Lingqi; Oishi, Sabine; Katon, Wayne; Williams, John W; Hunkeler, Enid; Hendrie, Hugh; Lin, Elizabeth H B; Levine, Stuart; Grypma, Lydia; Steffens, David C; Fields, Julie; Langston, Christopher

2006-10-01

To determine the effect of a primary care-based collaborative care program for depression on suicidal ideation in older adults. Randomized, controlled trial. Eighteen diverse primary care clinics. One thousand eight hundred one adults aged 60 and older with major depression or dysthymia. Participants randomized to collaborative care had access to a depression care manager who supported antidepressant medication management prescribed by their primary care physician and offered a course of Problem Solving Treatment in Primary Care for 12 months. Participants in the control arm received care as usual. Participants had independent assessments of depression and suicidal ideation at baseline and 3, 6, 12, 18, and 24 months. Depression was assessed using the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (SCID). Suicidal ideation was determined using the SCID and the Hopkins Symptoms Checklist. At baseline, 139 (15.3%) intervention subjects and 119 (13.3%) controls reported thoughts of suicide. Intervention subjects had significantly lower rates of suicidal ideation than controls at 6 months (7.5% vs 12.1%) and 12 months (9.8% vs 15.5%) and even after intervention resources were no longer available at 18 months (8.0% vs 13.3%) and 24 months (10.1% vs 13.9%). There were no completed suicides in either group. Information on suicide attempts or hospitalization for suicidal ideation was not available. Primary care-based collaborative care programs for depression represent one strategy to reduce suicidal ideation and potentially the risk of suicide in older primary care patients.

Risk Factors for Musculoskeletal Symptoms Among Korean Broadcast Actors.

PubMed

Park, Moon-Hee; Kim, Ham-Gyum; Cho, Jae-Hwan

2015-01-01

Musculoskeletal diseases (MSDs) are functional disabilities in the musculoskeletal area that occur when continuous damage to the muscles or tissues is caused by performing a repetitive task. These diseases are usually found in the waist, shoulder, neck, arm, and wrist. MSD is also referred to as cumulative trauma disorder, repetitive strain injury, occupational overuse syndrome, and visual display terminal, depending on the country. The condition is now commonly referred to as work-related musculoskeletal disorder. The aim of this study was to develop a prevention plan against musculoskeletal disease and to provide better health care to broadcast actors by understanding the association between musculoskeletal symptoms and working conditions. The results of the study can be utilized to maintain effective systematic resources to treat such diseases. A survey was conducted in Seoul between January 1 and May 10, 2014 with broadcast actors working in the South Korean entertainment industry. Tests with respect to musculoskeletal symptoms indicated that the study participants were likely to experience having musculoskeletal symptoms in the shoulders, waist, neck, leg/foot, hand/wrist/finger, and arm/elbow. Most of the participants reported pain on both sides of their shoulders and in their legs/feet or on the right side of the arm/elbow and in hand/wrist/finger. Pain lasted between 1 and 7 days, with an incidence of 33.8% in the neck, 36% in the shoulders, 33.3% in the arm/elbow, 47.4% in the hand/wrist/finger, 34.7% in the waist, and 39.3% in the leg/foot. This study should prove useful in determining systematic and effective resources to prevent broadcast actors from developing MSD in the future. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Association of prenatal lipid-based nutritional supplementation with fetal growth in rural Gambia.

PubMed

Johnson, William; Darboe, Momodou K; Sosseh, Fatou; Nshe, Patrick; Prentice, Andrew M; Moore, Sophie E

2017-04-01

Prenatal supplementation with protein-energy (PE) and/or multiple-micronutrients (MMNs) may improve fetal growth, but trials of lipid-based nutritional supplements (LNSs) have reported inconsistent results. We conducted a post-hoc analysis of non-primary outcomes in a trial in Gambia, with the aim to test the associations of LNS with fetal growth and explore how efficacy varies depending on nutritional status. The sample comprised 620 pregnant women in an individually randomized, partially blinded trial with four arms: (a) iron and folic acid (FeFol) tablet (usual care, referent group), (b) MMN tablet, (c) PE LNS, and (d) PE + MMN LNS. Analysis of variance examined unadjusted differences in fetal biometry z-scores at 20 and 30 weeks and neonatal anthropometry z-scores, while regression tested for modification of intervention-outcome associations by season and maternal height, body mass index, and weight gain. Despite evidence of between-arm differences in some fetal biometry, z-scores at birth were not greater in the intervention arms than the FeFol arm (e.g., birth weight z-scores: FeFol -0.71, MMN -0.63, PE -0.64, PE + MMN -0.62; group-wise p = .796). In regression analyses, intervention associations with birth weight and head circumference were modified by maternal weight gain between booking and 30 weeks gestation (e.g., PE + MMN associations with birth weight were +0.462 z-scores (95% CI [0.097, 0.826]) in the highest quartile of weight gain but -0.099 z-scores (-0.459, 0.260) in the lowest). In conclusion, we found no strong evidence that a prenatal LNS intervention was associated with better fetal growth in the whole sample. © 2016 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.

Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study.

PubMed

van Hoeven, Lonneke; Vergouwe, Yvonne; Koes, Bart W; Hazes, Johanna M W; Weel, Angelique E A M

2016-07-12

Axial spondyloarthritis (axSpA) is a disabling inflammatory joint disease with chronic low back pain (CLBP) as leading symptom. Recognizing axSpA in the large amount of CLBP patients is difficult for general practioners (GP). This evaluation aims to assess the effect of a referral strategy for axSpA in young primary care patients with CLBP by comparing the use of the strategy with usual care. The effect is measured at three different levels; by patient reported outcomes (the clinical effect), process and costs evaluation. This study design is a cluster randomized controlled trial with GP as clusters. GPs throughout the Netherlands are invited to participate and randomized to either the intervention or the control group. Patients from participating GPs are invited to participate if they have ever been registered with low back pain, without radiation (ICPC L03) and aged 18-45 years. To be included in the study, patients need to have current low back pain and chronic low back pain (>12 weeks). In the intervention arm a referral strategy for axSpA will be applied in CLBP patients, in the control arm care as usual will be provided for CLBP patients. The referral strategy consists of four easy to use variables. All are questions about the back pain complaints of the patients. Data is prospectively collected in an online database at baseline (T0), 4 months (T1), 12 months (T2) and 24 months (T3). After time point T1 (4 months) patients from the control group will also receive the intervention i.e. the application of a referral strategy for axSpA. The effect of the referral strategy is measured at three different levels, by patient outcomes (e.g. pain scores, quality of life), process measures (e.g. number of axSpA diagnoses by rheumatologists) and by costs (work productivity and health care resources use). Our primary outcome is the Roland Morris Disability Questionnaire after 4 months, secondary outcomes are pain and quality of life. Costs will be assessed before and after the use of the referral strategy, to estimate if the use of the strategy will lead to a reduction in health care costs and improvement in work participation. It is anticipated that using the axSpA referral strategy for primary care CLBP patients will increase the quality of life of CLBP patients, will result in more (correct) diagnoses of axSpA by the rheumatologists, and will be cost-effective. Ultimately, the results of this study may contribute to the startup of a national implementation of the axSpA referral strategy to identify timely CLBP patients with axSpA. NCT01944163 , date of registration; September 6, 2013 (Clinicaltrials.gov).

Household point of care CD4 testing and isoniazid preventive therapy initiation in a household TB contact tracing programme in two districts of South Africa.

PubMed

Page-Shipp, Liesl; Lewis, James J; Velen, Kavindhran; Senoge, Sedikanelo; Zishiri, Elizabeth; Popane, Flora; Chihota, Violet N; Clark, Dave; Churchyard, Gavin J; Charalambous, Salome

2018-01-01

In South Africa, TB household contact tracing provides an opportunity for increased TB and HIV case finding. We aimed to determine the effect of two new potential interventions for TB contact tracing programmes: Point of Care CD4 (PoC CD4) on HIV linkage to care and household Isoniazid Preventive Therapy (IPT) provision on uptake and retention of IPT. A pragmatic, three-arm, cluster-randomized trial was undertaken. TB Household contacts were randomised to 3 arms: 1) Standard of Care TB and HIV testing (SOC); 2) SOC with POC CD4 for those testing HIV positive; 3) SOC with POC CD4 and IPT for eligible household members. Linkage to care within 90 days was assessed either through patient visits (at 10 weeks and 6 months) or via telephonic contact. 2,243 index TB patients and 3,012 contacts (64,3% female, median age 30 years) were enrolled. On self-report, 26(1.2%) were currently receiving TB treatment and 1816 (60.3%) reported a prior HIV test. HIV testing uptake was 34.7% in the SoC arm, 40.2% in the PoC CD4 arm (RR1.16, CI 0.99-1.36, p-value = 0.060) and 39.9% in the PoC CD4 + HH-IPT arm (RR = 1.15, CI 0.99-1.35, p-value = 0.075). Linkage to care within 3 months was 30.8% in the SoC arm and 42.1% in the POC CD4 arms (RR 1.37; CI: 0.68-2.76, p-value = 0.382). 20/21 contacts (95.2%) initiated IPT in the PoC CD4 + HH-IPT arm, compared to 3/20 (15.0%) in the PoC CD4 arm (p = 0.004; p-value from Fisher's exact test < 0.001). Among 3,008 contacts screened for tuberculosis, 15 (3.4%) had bacteriologically confirmed TB with an overall yield of TB of 0.5% (95% CI: 0.3%, 0.8%). Household PoC CD4 testing and IPT initiation is feasible. There was only weak evidence that PoCCD4 led to a small increase in HCT uptake and no evidence for an increase in linkage-to-care. IPT initiation and completion was increased by the household intervention. Although feasible, these interventions had low impact due to the low uptake of HIV testing in households.

How good are GPs at adhering to a pragmatic trial protocol in primary care? Results from the ADDITION-Cambridge cluster-randomised pragmatic trial

PubMed Central

Boothby, Clare E; Griffin, Simon J

2018-01-01

Objective To assess the fidelity of general practitioners’ (GPs) adherence to a long-term pragmatic trial protocol. Design Retrospective analyses of electronic primary care records of participants in the pragmatic cluster-randomised ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment In People with Screen Detected Diabetes in Primary Care)-Cambridge trial, comparing intensive multifactorial treatment (IT) versus routine care (RC). Data were collected from the date of diagnosis until December 2010. Setting Primary care surgeries in the East of England. Study sample/participants A subsample (n=189, RC arm: n=99, IT arm: n=90) of patients from the ADDITION-Cambridge cohort (867 patients), consisting of patients 40–69 years old with screen-detected diabetes mellitus. Interventions In the RC arm treatment was delivered according to concurrent treatment guidelines. Surgeries in the IT arm received funding for additional contacts between GPs/nurses and patients, and GPs were advised to follow more intensive treatment algorithms for the management of glucose, lipids and blood pressure and aspirin therapy than in the RC arm. Outcome measures The number of annual contacts between patients and GPs/nurses, the proportion of patients receiving prescriptions for cardiometabolic medication in years 1–5 after diabetes diagnosis and the adherence to prescription algorithms. Results The difference in the number of annual GP contacts (β=0.65) and nurse contacts (β=−0.15) between the study arms was small and insignificant. Patients in the IT arm were more likely to receive glucose-lowering (OR=3.27), ACE-inhibiting (OR=2.03) and lipid-lowering drugs (OR=2.42, all p values <0.01) than patients in the RC arm. The prescription adherence varied between medication classes, but improved in both trial arms over the 5-year follow-up. Conclusions The adherence of GPs to different aspects of the trial protocol was mixed. Background changes in healthcare policy need to be considered as they have the potential to dilute differences in treatment intensity and hence incremental effects. Trial registration number ISRCTN86769081. PMID:29903781

Claudication

MedlinePlus

... limbs are damaged, usually as a result of atherosclerosis. Atherosclerosis can develop in any of your arteries, especially those in your heart. When atherosclerosis affects your arms and legs, it's called peripheral ...

Costs of Home Versus Inpatient Treatment for Fever and Neutropenia: Analysis of a Multicenter Randomized Trial

PubMed Central

Hendricks, Ann M.; Loggers, Elizabeth Trice; Talcott, James A.

2011-01-01

Purpose For patients with cancer who have febrile neutropenia, relative costs of home versus hospital treatment, including unreimbursed costs borne by patients and families, are poorly characterized. We estimated costs from a randomized trial of patients with low-risk febrile neutropenia for whom outpatient care was feasible, comparing inpatient treatment with discharge to home care after inpatient observation. Methods We collected direct medical and self-reported indirect costs for 57 inpatient and 35 outpatient treatment episodes of patients enrolled in a randomized trial from 1996 through 2000. Charges from hospital bills were converted to costs using Medicare cost-to-charge ratios. Patients kept daily logs of out-of-pocket payments and time spent by informal caregivers providing care. Dollar amounts were standardized to June 2008. Results Mean total charges for the hospital arm were 49% higher than for the home treatment arm ($16,341 v $10,977; P < .01). Mean estimated total costs for the hospital arm were 30% higher ($10,143 v $7,830; P < .01). Inspection of sparse available data suggests that payments made were similar by treatment arm. Inpatients and their caregivers spent more out of pocket than their outpatient counterparts (mean, $201 v $74; P < .01). Informal caregivers for both treatment arms reported similar time caring and lost from work. Conclusion Home intravenous antibiotic treatment was less costly than continued inpatient care for carefully selected patients with cancer having febrile neutropenia without significantly increased indirect costs or caregiver burden. PMID:21931037

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

Effectiveness and cost-effectiveness of transmural collaborative care with consultation letter (TCCCL) and duloxetine for major depressive disorder (MDD) and (sub)chronic pain in collaboration with primary care: design of a randomized placebo-controlled multi-Centre trial: TCC:PAINDIP.

PubMed

de Heer, Eric W; Dekker, Jack; van Eck van der Sluijs, Jonna F; Beekman, Aartjan Tf; van Marwijk, Harm Wj; Holwerda, Tjalling J; Bet, Pierre M; Roth, Joost; Hakkaart-Van Roijen, Leona; Ringoir, Lianne; Kat, Fiona; van der Feltz-Cornelis, Christina M

2013-05-24

The comorbidity of pain and depression is associated with high disease burden for patients in terms of disability, wellbeing, and use of medical care. Patients with major and minor depression often present themselves with pain to a general practitioner and recognition of depression in such cases is low, but evolving. Also, physical symptoms, including pain, in major depressive disorder, predict a poorer response to treatment. A multi-faceted, patient-tailored treatment programme, like collaborative care, is promising. However, treatment of chronic pain conditions in depressive patients has, so far, received limited attention in research. Cost effectiveness of an integrated approach of pain in depressed patients has not been studied. This study is a placebo controlled double blind, three armed randomized multi centre trial. Patients with (sub)chronic pain and a depressive disorder are randomized to either a) collaborative care with duloxetine, b) collaborative care with placebo or c) duloxetine alone. 189 completers are needed to attain sufficient power to show a clinically significant effect of 0.6 SD on the primary outcome measures (PHQ-9 score). Data on depression, anxiety, mental and physical health, medication adherence, medication tolerability, quality of life, patient-doctor relationship, coping, health resource use and productivity will be collected at baseline and after three, six, nine and twelve months. This study enables us to show the value of a closely monitored integrated treatment model above usual pharmacological treatment. Furthermore, a comparison with a placebo arm enables us to evaluate effectiveness of duloxetine in this population in a real life setting. Also, this study will provide evidence-based treatments and tools for their implementation in practice. This will facilitate generalization and implementation of results of this study. Moreover, patients included in this study are screened for pain symptoms, differentiating between nociceptive and neuropathic pain. Therefore, pain relief can be thoroughly evaluated. NTR1089.

Text message-based diabetes self-management support (SMS4BG): study protocol for a randomised controlled trial.

PubMed

Dobson, Rosie; Whittaker, Robyn; Jiang, Yannan; Shepherd, Matthew; Maddison, Ralph; Carter, Karen; Cutfield, Richard; McNamara, Catherine; Khanolkar, Manish; Murphy, Rinki

2016-04-02

Addressing the increasing prevalence, and associated disease burden, of diabetes is a priority of health services internationally. Interventions to support patients to effectively self-manage their condition have the potential to reduce the risk of costly and debilitating complications. The utilisation of mobile phones to deliver self-management support allows for patient-centred care at the frequency and intensity that patients desire from outside the clinic environment. Self-Management Support for Blood Glucose (SMS4BG) is a novel text message-based intervention for supporting people with diabetes to improve self-management behaviours and achieve better glycaemic control and is tailored to individual patient preferences, demographics, clinical characteristics, and culture. This study aims to assess whether SMS4BG can improve glycaemic control in adults with poorly controlled diabetes. This paper outlines the rationale and methods of the trial. A two-arm, parallel, randomised controlled trial will be conducted across New Zealand health districts. One thousand participants will be randomised at a 1:1 ratio to receive SMS4BG, a theoretically based and individually tailored automated text message-based diabetes self-management support programme (intervention) in addition to usual care, or usual care alone (control). The primary outcome is change in glycaemic control (HbA1c) at 9 months. Secondary outcomes include glycaemic control at 3 and 6 months, self-efficacy, self-care behaviours, diabetes distress, health-related quality of life, perceived social support, and illness perceptions. Cost information and healthcare utilisation will also be collected as well as intervention satisfaction and interaction. This study will provide information on the effectiveness of a text message-based self-management support tool for people with diabetes. If found to be effective it has the potential to provide individualised support to people with diabetes across New Zealand (and internationally), thus extending care outside the clinic environment. Australian New Zealand Clinical Trials Registry: ACTRN12614001232628 .

Patient satisfaction with different interpreting methods: a randomized controlled trial.

PubMed

Gany, Francesca; Leng, Jennifer; Shapiro, Ephraim; Abramson, David; Motola, Ivette; Shield, David C; Changrani, Jyotsna

2007-11-01

Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction. 1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants. 541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (beta 0.10, 95% CI 0.02-0.18, scale 0-1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters. While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health care.

Patient Satisfaction with Different Interpreting Methods: A Randomized Controlled Trial

PubMed Central

Leng, Jennifer; Shapiro, Ephraim; Abramson, David; Motola, Ivette; Shield, David C.; Changrani, Jyotsna

2007-01-01

Background Growth of the foreign-born population in the U.S. has led to increasing numbers of limited-English-proficient (LEP) patients. Innovative medical interpreting strategies, including remote simultaneous medical interpreting (RSMI), have arisen to address the language barrier. This study evaluates the impact of interpreting method on patient satisfaction. Methods 1,276 English-, Spanish-, Mandarin-, and Cantonese-speaking patients attending the primary care clinic and emergency department of a large New York City municipal hospital were screened for enrollment in a randomized controlled trial. Language-discordant patients were randomized to RSMI or usual and customary (U&C) interpreting. Patients with language-concordant providers received usual care. Demographic and patient satisfaction questionnaires were administered to all participants. Results 541 patients were language-concordant with their providers and not randomized; 371 were randomized to RSMI, 167 of whom were exposed to RSMI; and 364 were randomized to U&C, 198 of whom were exposed to U&C. Patients randomized to RSMI were more likely than those with U&C to think doctors treated them with respect (RSMI 71%, U&C 64%, p < 0.05), but they did not differ in other measures of physician communication/care. In a linear regression analysis, exposure to RSMI was significantly associated with an increase in overall satisfaction with physician communication/care (β 0.10, 95% CI 0.02–0.18, scale 0–1.0). Patients randomized to RSMI were more likely to think the interpreting method protected their privacy (RSMI 51%, U&C 38%, p < 0.05). Patients randomized to either arm of interpretation reported less comprehension and satisfaction than patients in language-concordant encounters. Conclusions While not a substitute for language-concordant providers, RSMI can improve patient satisfaction and privacy among LEP patients. Implementing RSMI should be considered an important component of a multipronged approach to addressing language barriers in health care. PMID:17957417

Treatment of depression after myocardial infarction and the effects on cardiac prognosis and quality of life: rationale and outline of the Myocardial INfarction and Depression-Intervention Trial (MIND-IT).

PubMed

van den Brink, Rob H S; van Melle, Joost P; Honig, Adriaan; Schene, Aart H; Crijns, Harry J G M; Lambert, Frank P G; Ormel, Johan

2002-08-01

Patients with a depressive disorder after myocardial infarction (MI) have a significantly increased risk of major cardiac events. The Myocardial INfarction and Depression-Intervention Trial (MIND-IT) investigates whether antidepressive treatment can improve the cardiac prognosis for these patients. The rationale and outline of the study are described. In this multicenter randomized clinical trial, 2140 patients admitted for MI are screened for depressive symptoms with a questionnaire 0, 3, 6, 9, and 12 months after MI. Patients with symptoms undergo a standardized psychiatric interview. Those with a post-MI depressive episode are randomized to intervention (ie, antidepressive treatment; n = 190) or care-as-usual (CAU; n = 130). In the intervention arm, the research diagnosis is to be confirmed by a psychiatrist. First-choice treatment consists of placebo-controlled treatment with mirtazapine. In case of refusal or nonresponse, alternative open treatment with citalopram is offered. In the CAU arm, the patient is not informed about the research diagnosis. Psychiatric treatment outside the study is recorded, but no treatment is offered. Both arms are followed for end points (cardiac death or hospital admission for MI, unstable angina, heart failure, or ventricular tachyarrhythmia) during an average period of 27 months. Analysis is on an intention-to-treat basis. The MIND-IT study will show whether treatment of post-MI depression can improve cardiac prognosis.

Comparison of an additional early visit to routine postpartum care on initiation of long-acting reversible contraception: a randomized trial.

PubMed

Bernard, Caitlin; Wan, Leping; Peipert, Jeffrey F; Madden, Tessa

2018-05-17

To investigate whether an early 3-week postpartum visit in addition to the standard 6-week visit increases LARC initiation by 8weeks postpartum compared to the routine 6-week visit alone. We enrolled pregnant and immediate postpartum women into a prospective randomized, non-blinded trial comparing a single 6-week postpartum visit (routine care) to two visits at 3 and 6weeks postpartum (intervention), with initiation of contraception at the 3-week visit, if desired. All participants received structured contraceptive counseling. Participants completed surveys in-person at baseline and at the time of each postpartum visit. A sample size of 200 total participants was needed to detect a 2-fold difference in LARC initiation (20% vs. 40%). Between May 2016 and March 2017, 200 participants enrolled; outcome data are available for 188. The majority of LARC initiation occurred immediately postpartum (25% of the intervention arm and 27% of the routine care arm). By 8weeks postpartum,34% of participants in the intervention arm initiated LARC, compared to 41% in the routine care arm (p=.35). Overall contraceptive initiation by 8weeks was 83% and84% in the intervention and routine care arms, respectively (p=.79). There was no difference between the arms in the proportion of women who attended at least one postpartum visit (70% vs. 74%, p=.56). The addition of a 3-week postpartum visit to routine care does not increase LARC initiation by 8weeks postpartum. The majority of LARC users desired immediate rather than interval postpartum initiation. Clinicaltrials.govNCT02769676 Implications. The addition of a 3-week postpartum visit to routine care does not increase LARC or overall contraceptive initiation by 8weeks post-partum when the option of immediate postpartum placement is available. The majority of LARC users desired immediate rather than interval postpartum initiation. Copyright © 2018. Published by Elsevier Inc.

Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

PubMed

Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

2012-12-24

Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

Association of objectively measured arm inclination with shoulder pain: A 6-month follow-up prospective study of construction and health care workers.

PubMed

Koch, Markus; Lunde, Lars-Kristian; Veiersted, Kaj Bo; Knardahl, Stein

2017-01-01

The aim was to determine the association of occupational arm inclination with shoulder pain in construction and health care workers. Arm inclination relative to the vertical was measured with an accelerometer placed on the dominant upper arm for up to four full days at baseline in 62 construction workers and 63 health care workers. The pain intensity in the shoulder and mechanical and psychosocial work factors were measured by self-reports at baseline and prospectively after 6 months. The associations between exposures and shoulder pain were analyzed with multilevel mixed-effects linear regressions. For the total study population working with the dominant arm at inclinations > 30° and >120° was associated with lower levels of shoulder pain both cross-sectionally and after 6 months. Associations were attenuated when adjusting for individual and social factors, psychological state, and exposure during leisure time, especially for the high inclination levels. Analyses, only including subjects with no pain at baseline revealed no significant associations. While stratified analysis showed negative associations in the construction worker group, there were no significant association in health care workers. Compared to the number of hypotheses tested, the number of significant findings was low. Adjustment by Bonferroni-correction made almost all findings insignificant. All analyses reflected a negative association between arm inclination and shoulder pain, but few analyses showed these associations to be statistically significant. If there is a relationship between arm inclination and shoulder pain, these findings could indicate that pain-avoidance may modify how workers perform their tasks.

Association of objectively measured arm inclination with shoulder pain: A 6-month follow-up prospective study of construction and health care workers

PubMed Central

Koch, Markus; Lunde, Lars-Kristian; Veiersted, Kaj Bo; Knardahl, Stein

2017-01-01

Objectives The aim was to determine the association of occupational arm inclination with shoulder pain in construction and health care workers. Methods Arm inclination relative to the vertical was measured with an accelerometer placed on the dominant upper arm for up to four full days at baseline in 62 construction workers and 63 health care workers. The pain intensity in the shoulder and mechanical and psychosocial work factors were measured by self-reports at baseline and prospectively after 6 months. The associations between exposures and shoulder pain were analyzed with multilevel mixed-effects linear regressions. Results For the total study population working with the dominant arm at inclinations > 30° and >120° was associated with lower levels of shoulder pain both cross-sectionally and after 6 months. Associations were attenuated when adjusting for individual and social factors, psychological state, and exposure during leisure time, especially for the high inclination levels. Analyses, only including subjects with no pain at baseline revealed no significant associations. While stratified analysis showed negative associations in the construction worker group, there were no significant association in health care workers. Compared to the number of hypotheses tested, the number of significant findings was low. Adjustment by Bonferroni-correction made almost all findings insignificant. Conclusions All analyses reflected a negative association between arm inclination and shoulder pain, but few analyses showed these associations to be statistically significant. If there is a relationship between arm inclination and shoulder pain, these findings could indicate that pain-avoidance may modify how workers perform their tasks. PMID:29176761

Principles of Jet Engine Operation

DTIC Science & Technology

1978-05-01

and discharged from the rotor radially (perpendicular-to the axis .,f rotation). In-contrast, the axial flow compressor both admits and dis- charges... TurbofanS for most contemporary turbojet powered aircraft applications, the axial flow compressor is utilized. The remainder of the discussion will...usually installed on several radial arms which are evenly spaced around the compressor face. The spacing of the probes on the arms is such that they are

Health and economic effects from linking bedside and outpatient tobacco cessation services for hospitalized smokers in two large hospitals: study protocol for a randomized controlled trial.

PubMed

Fellows, Jeffrey L; Mularski, Richard; Waiwaiole, Lisa; Funkhouser, Kim; Mitchell, Julie; Arnold, Kathleen; Luke, Sabrina

2012-08-01

Extended smoking cessation follow-up after hospital discharge significantly increases abstinence. Hospital smoke-free policies create a period of 'forced abstinence' for smokers, thus providing an opportunity to integrate tobacco dependence treatment, and to support post-discharge maintenance of hospital-acquired abstinence. This study is funded by the National Heart, Lung, and Blood Institute (1U01HL1053231). The Inpatient Technology-Supported Assisted Referral study is a multi-center, randomized clinical effectiveness trial being conducted at Kaiser Permanente Northwest (KPNW) and at Oregon Health & Science University (OHSU) hospitals in Portland, Oregon. The study assesses the effectiveness and cost-effectiveness of linking a practical inpatient assisted referral to outpatient cessation services plus interactive voice recognition (AR + IVR) follow-up calls, compared to usual care inpatient counseling (UC). In November 2011, we began recruiting 900 hospital patients age ≥18 years who smoked ≥1 cigarettes in the past 30 days, willing to remain abstinent postdischarge, have a working phone, live within 50 miles of the hospital, speak English, and have no health-related barriers to participation. Each site will randomize 450 patients to AR + IVR or UC using a 2:1 assignment strategy. Participants in the AR + IVR arm will receive a brief inpatient cessation consult plus a referral to available outpatient cessation programs and medications, and four IVR follow-up calls over seven weeks postdischarge. Participants do not have to accept the referral. At KPNW, UC participants will receive brief inpatient counseling and encouragement to self-enroll in available outpatient services. The primary outcome is self-reported thirty-day smoking abstinence at six months postrandomization for AR + IVR participants compared to usual care. Additional outcomes include self-reported and biochemically confirmed seven-day abstinence at six months, self-reported seven-day, thirty-day, and continuous abstinence at twelve months, intervention dose response at six and twelve months for AR + IVR recipients, incremental cost-effectiveness of AR + IVR intervention compared to usual care at six and twelve months, and health-care utilization and expenditures at twelve months for AR + IVR recipients compared to UC. This study will provide important evidence for the effectiveness and cost-effectiveness of linking hospital-based tobacco treatment specialists' services with discharge follow-up care. ClinicalTrials.gov: NCT01236079.

Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).

PubMed

James, Erica L; Ewald, Ben; Johnson, Natalie; Brown, Wendy; Stacey, Fiona G; Mcelduff, Patrick; Booth, Angela; Yang, Fan; Hespe, Charlotte; Plotnikoff, Ronald C

2014-12-29

Physical inactivity is fourth in the list of risk factors for global mortality. General practitioners are well placed to offer physical activity counseling but insufficient time is a barrier. Although referral to an exercise specialist is an alternative, in Australia, these allied health professionals are only publicly funded to provide face-to-face counseling to patients who have an existing chronic illness. Accordingly, this trial aims to determine the efficacy of GP referral of insufficiently active patients (regardless of their chronic disease status) for physical activity counseling (either face-to-face or predominately via telephone) by exercise specialists, based on patients' objectively assessed physical activity levels, compared with usual care. If the trial is efficacious, the equivalence and cost-effectiveness of face-to-face counseling versus telephone counseling will be assessed. This three arm pragmatic randomized trial will involve the recruitment of 261 patients from primary care clinics in metropolitan and regional areas of New South Wales, Australia. Insufficiently active (less than 7000 steps/day) consenting adult patients will be randomly assigned to: 1) five face-to-face counseling sessions, 2) one face-to-face counseling session followed by four telephone calls, or 3) a generic mailed physical activity brochure (usual care). The interventions will operationalize social cognitive theory via a behavior change counseling framework. Participants will complete a survey and seven days of pedometry at baseline, and at three and 12 months post-randomization. The primary analyses will be based on intention-to-treat principles and will compare: (i) mean change in average daily step counts between baseline and 12 months for the combined intervention group (Group 1: face-to-face, and Group 2: telephone) and usual care (Group 3); (ii) step counts at 3 months post-randomization. Secondary outcomes include: self-reported physical activity, sedentary behavior, quality of life, and depression. If referral of primary care patients to exercise specialists increases physical activity, this process offers the prospect of systematically and sustainably reaching a large proportion of insufficiently active adults. If shown to be efficacious this trial provides evidence to expand public funding beyond those with a chronic disease and for delivery via telephone as well as face-to-face consultations. Australian New Zealand Clinical Trials Registry ACTRN12611000884909 .

Lay health educators and print materials for the promotion of colorectal cancer screening among Korean Americans: A randomized comparative effectiveness study.

PubMed

Jo, Angela M; Nguyen, Tung T; Stewart, Susan; Sung, Min J; Gildengorin, Ginny; Tsoh, Janice Y; Tong, Elisa K; Lo, Penny; Cuaresma, Charlene; Sy, Angela; Lam, Hy; Wong, Ching; Jeong, Matthew; Chen, Moon S; Kagawa-Singer, Marjorie

2017-07-15

Colorectal cancer (CRC) is the second most commonly diagnosed cancer among Korean American men and women. Although CRC screening is effective in reducing the burden of this disease, studies have shown that Korean Americans have low screening rates. The authors conducted a 2-arm cluster randomized controlled trial comparing a brochure (print) with a brochure and lay health educator (LHE) outreach (print + LHE) in increasing CRC screening rates among Korean American individuals. Self-administered written surveys at baseline and at 6 months assessed knowledge of CRC and its screening, ever screening, and being up to date with screening. A total of 28 LHEs recruited 348 participants aged 50 to 75 years from their social networks. Significant percentages of participants reported not having health insurance (29.3%) or a usual source of care (35.6%). At 6 months postintervention, the print + LHE participants had a greater increase in knowledge compared with those in the print arm (P = .0013). In multivariable analyses, both groups had significant increases in ever screening (print plus LHE: odds ratio [OR], 1.60 [95% confidence interval (95% CI), 1.26-2.03] and print: OR, 1.42 [95% CI, 1.10-1.82]) and being up to date with screening (print plus LHE: OR, 1.63 [95% CI, 1.23-2.16] and print: OR, 1.40 [95% CI, 1.04-1.89]). However, these increases did not differ significantly between the study arms. Having insurance and having seen a provider within the past year were found to be positively associated with screening. Compared with a brochure, LHE outreach yielded greater increases in knowledge but resulted in similar increases in CRC screening in a Korean American population with barriers to health care access. More work is needed to appropriately address logistical and system barriers in this community. Cancer 2017;123:2705-15. © 2017 American Cancer Society. © 2017 American Cancer Society.

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

PubMed

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

2014-06-25

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

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

PubMed Central

2014-01-01

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

The role of private industry in pragmatic comparative effectiveness trials.

PubMed

Buesching, Don P; Luce, Bryan R; Berger, Marc L

2012-03-01

Comparative effectiveness research (CER) includes pragmatic clinical trials (PCTs) to address 'real-world' effectiveness. CER interest would be expected to stimulate biopharmaceutical manufacturer PCT investment; however, this does not seem to be the case. In this article we identify all industry-sponsored PCT studies from 1996 to 2010; analyze them across a variety of characteristics, including sponsor, research question, design, comparators and results; and suggest methodological and policy changes to spur future manufacturer PCT investment. Nine 'naturalistic', head-to-head versus standard of care or similar agent PCTs were identified. Two included a 'usual care' arm. Chronic care trials' length averaged 12 months (range: 6-24 months), six of which reported equivocal or no difference in effectiveness; results of two chronic and the single acute care PCTs favored the sponsor drug. None reported the sponsor drug inferior. Of seven that evaluated utilization or costs, six reported no differences and four of five studies comparing brand-generic drugs reported no difference. Whereas private investment in PCTs is in the public interest, manufacturers apparently have not yet seen the business case. To induce investment, we propose several methodological and regulatory policy innovations designed to reduce business risk by decreasing outcome variability and increasing trial efficiency, flexibility and market applicability.

Economic evaluation of audio based resilience training for depression in primary care.

PubMed

Koeser, Leonardo; Dobbin, Alastair; Ross, Sheila; McCrone, Paul

2013-07-01

Although there is some evidence on the effectiveness and cost-effectiveness of computerised cognitive behavioural therapy (CCBT) for treating anxiety and depression in primary care, alternative low-cost psychosocial interventions have not been investigated. The cost-effectiveness of an audio based resilience training (Positive Mental Training, PosMT) was examined using a decision model. Patient level cost and effectiveness data from a trial comparing a CCBT treatment and usual care and effectiveness data from a study on PosMT were used to inform this. Net benefits of CCBT and PosMT were approximately equal in individuals with 'moderate' depression at baseline and markedly in favour of PosMT for the 'severe' depression subgroup. With only four observations in the 'mild' depression category for PosMT, the existing evidence base remains unaltered. Efficacy data for the PosMT arm was derived from a study using a partially randomised preference design and the model structure contains simplifications due to lack of data availability. PosMT may represent good value for money in treatment of depression for certain groups of patients. More research in this area may be warranted. Copyright © 2013 Elsevier B.V. All rights reserved.

The clinical effectiveness and cost-effectiveness of telephone triage for managing same-day consultation requests in general practice: a cluster randomised controlled trial comparing general practitioner-led and nurse-led management systems with usual care (the ESTEEM trial).

PubMed

Campbell, John L; Fletcher, Emily; Britten, Nicky; Green, Colin; Holt, Tim; Lattimer, Valerie; Richards, David A; Richards, Suzanne H; Salisbury, Chris; Taylor, Rod S; Calitri, Raff; Bowyer, Vicky; Chaplin, Katherine; Kandiyali, Rebecca; Murdoch, Jamie; Price, Linnie; Roscoe, Julia; Varley, Anna; Warren, Fiona C

2015-02-01

Telephone triage is proposed as a method of managing increasing demand for primary care. Previous studies have involved small samples in limited settings, and focused on nurse roles. Evidence is limited regarding the impact on primary care workload, costs, and patient safety and experience when triage is used to manage patients requesting same-day consultations in general practice. In comparison with usual care (UC), to assess the impact of GP-led telephone triage (GPT) and nurse-led computer-supported telephone triage (NT) on primary care workload and cost, patient experience of care, and patient safety and health status for patients requesting same-day consultations in general practice. Pragmatic cluster randomised controlled trial, incorporating economic evaluation and qualitative process evaluation. General practices (n = 42) in four regions of England, UK (Devon, Bristol/Somerset, Warwickshire/Coventry, Norfolk/Suffolk). Patients requesting same-day consultations. Practices were randomised to GPT, NT or UC. Data collection was not blinded; however, analysis was conducted by a statistician blinded to practice allocation. Primary - primary care contacts [general practice, out-of-hours primary care, accident and emergency (A&E) and walk-in centre attendances] in the 28 days following the index consultation request. Secondary - resource use and costs, patient safety (deaths and emergency hospital admissions within 7 days of index request, and A&E attendance within 28 days), health status and experience of care. Of 20,990 eligible randomised patients (UC n = 7283; GPT n = 6695; NT n = 7012), primary outcome data were analysed for 16,211 patients (UC n = 5572; GPT n = 5171; NT n = 5468). Compared with UC, GPT and NT increased primary outcome contacts (over 28-day follow-up) by 33% [rate ratio (RR) 1.33, 95% confidence interval (CI) 1.30 to 1.36] and 48% (RR 1.48, 95% CI 1.44 to 1.52), respectively. Compared with GPT, NT was associated with a marginal increase in primary outcome contacts by 4% (RR 1.04, 95% CI 1.01 to 1.08). Triage was associated with a redistribution of primary care contacts. Although GPT, compared with UC, increased the rate of overall GP contacts (face to face and telephone) over the 28 days by 38% (RR 1.38, 95% CI 1.28 to 1.50), GP face-to-face contacts were reduced by 39% (RR 0.61, 95% CI 0.54 to 0.69). NT reduced the rate of overall GP contacts by 16% (RR 0.84, 95% CI 0.78 to 0.91) and GP face-to-face contacts by 20% (RR 0.80, 95% CI 0.71 to 0.90), whereas nurse contacts increased. The increased rate of primary care contacts in triage arms is largely attributable to increased telephone contacts. Estimated overall patient-clinician contact time on the index day increased in triage (GPT = 10.3 minutes; NT = 14.8 minutes; UC = 9.6 minutes), although patterns of clinician use varied between arms. Taking account of both the pattern and duration of primary outcome contacts, overall costs over the 28-day follow-up were similar in all three arms (approximately £75 per patient). Triage appeared safe, and no differences in patient health status were observed. NT was somewhat less acceptable to patients than GPT or UC. The process evaluation identified the complexity associated with introducing triage but found no consistency across practices about what works and what does not work when implementing it. Introducing GPT or NT was associated with a redistribution of primary care workload for patients requesting same-day consultations, and at similar cost to UC. Although triage seemed to be safe, investigation of the circumstances of a larger number of deaths or admissions after triage might be warranted, and monitoring of these events is necessary as triage is implemented. Current Controlled Trials ISRCTN20687662. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 13. See the NIHR Journals Library website for further project information.

Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE): a randomized controlled trial protocol.

PubMed

Winstein, Carolee J; Wolf, Steven L; Dromerick, Alexander W; Lane, Christianne J; Nelsen, Monica A; Lewthwaite, Rebecca; Blanton, Sarah; Scott, Charro; Reiss, Aimee; Cen, Steven Yong; Holley, Rahsaan; Azen, Stanley P

2013-01-11

Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC. Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05. ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose. www.ClinicalTrials.gov Identifier: NCT00871715

Primary Care Provider Perceptions of the Effectiveness of Two Self-Management Support Programs for Vulnerable Patients with Diabetes

PubMed Central

Ratanawongsa, Neda; Bhandari, Vijay K; Handley, Margaret; Rundall, Thomas; Hammer, Hali; Schillinger, Dean

2012-01-01

Background Primary care providers (PCPs) in safety net settings face barriers to optimizing care for patients with diabetes. We conducted this study to assess PCPs' perspectives on the effectiveness of two language-concordant diabetes self-management support programs. Methods One year postintervention, we surveyed PCPs whose patients with diabetes participated in a three-arm multiclinic randomized controlled trial comparing usual care (UC), weekly automated telephone self-management (ATSM) support with nurse care management, and monthly group medical visits (GMVs). We compared PCP perspectives on patient activation to create and achieve goals, quality of care, and barriers to care using regression models accounting for within-PCP clustering. Results Of 113 eligible PCPs caring for 330 enrolled patients, 87 PCPs (77%) responded to surveys about 245 (74%) enrolled patients. Intervention patients were more likely to be perceived by PCPs as activated to create and achieve goals for chronic care when compared with UC patients (standardized effect size, ATSM vs UC, +0.41, p = 0.01; GMV vs UC, +0.31, p = 0.05). Primary care providers rated quality of care as higher for patients exposed to ATSM compared to UC (odds ratio 3.6, p < 0.01). Compared with GMV patients, ATSM patients were more likely to be perceived by PCPs as overcoming barriers related to limited English proficiency (82% ATSM vs 44% GMV, p = 0.01) and managing medications (80% ATSM vs 53% GMV, p = 0.01). Conclusions Primary care providers perceived that patients receiving ATSM support had overcome barriers, participated more actively, and received higher quality diabetes care. These views of clinician stakeholders lend additional evidence for the potential to upscale ATSM more broadly to support PCPs in their care of diverse, multilinguistic populations. PMID:22401329

ESCAPS study protocol: a feasibility randomised controlled trial of ‘Early electrical stimulation to the wrist extensors and wrist flexors to prevent the post-stroke complications of pain and contractures in the paretic arm’

PubMed Central

Fletcher-Smith, Joanna C; Walker, Dawn-Marie; Sprigg, Nikola; James, Marilyn; Walker, Marion F; Allatt, Kate; Mehta, Rajnikant; Pandyan, Anand D

2016-01-01

Introduction Approximately 70% of patients with stroke experience impaired arm function, which is persistent and disabling for an estimated 40%. Loss of function reduces independence in daily activities and impacts on quality of life. Muscles in those who do not recover functional movement in the stroke affected arm are at risk of atrophy and contractures, which can be established as early as 6 weeks following stroke. Pain is also common. This study aims to evaluate the feasibility of a randomised controlled trial to test the efficacy and cost-effectiveness of delivering early intensive electrical stimulation (ES) to prevent post-stroke complications in the paretic upper limb. Methods and analysis This is a feasibility randomised controlled trial (n=40) with embedded qualitative studies (patient/carer interviews and therapist focus groups) and feasibility economic evaluation. Patients will be recruited from the Stroke Unit at the Nottingham University Hospitals National Health Service (NHS) Trust within 72 h after stroke. Participants will be randomised to receive usual care or usual care and early ES to the wrist flexors and extensors for 30 min twice a day, 5 days a week for 3 months. The initial treatment(s) will be delivered by an occupational therapist or physiotherapist who will then train the patient and/or their nominated carer to self-manage subsequent treatments. Ethics and dissemination This study has been granted ethical approval by the National Research Ethics Service, East Midlands Nottingham1 Research Ethics Committee (ref: 15/EM/0006). To our knowledge, this is the first study of its kind of the early application (within 72 h post-stroke) of ES to both the wrist extensors and wrist flexors of stroke survivors with upper limb impairment. The results will inform the design of a definitive randomised controlled trial. Dissemination will include 2 peer-reviewed journal publications and presentations at national conferences. Trial registration number ISRCTN1648908; Pre-results. Clinicaltrials.gov ID: NCT02324634. PMID:26729394

Program Director Perceptions of Surgical Resident Training and Patient Care under Flexible Duty Hour Requirements.

PubMed

Saadat, Lily V; Dahlke, Allison R; Rajaram, Ravi; Kreutzer, Lindsey; Love, Remi; Odell, David D; Bilimoria, Karl Y; Yang, Anthony D

2016-06-01

The Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) trial was a national, cluster-randomized, pragmatic, noninferiority trial of 117 general surgery programs, comparing standard ACGME resident duty hour requirements ("Standard Policy") to flexible, less-restrictive policies ("Flexible Policy"). Participating program directors (PDs) were surveyed to assess their perceptions of patient care, resident education, and resident well-being during the study period. A survey was sent to all PDs of the general surgery residency programs participating in the FIRST trial (N = 117 [100% response rate]) in June and July 2015. The survey compared PDs' perceptions of the duty hour requirements in their arm of the FIRST trial during the study period from July 1, 2014 to June 30, 2015. One hundred percent of PDs in the Flexible Policy arm indicated that residents used their additional flexibility in duty hours to complete operations they started or to stabilize a critically ill patient. Compared with the Standard Policy arm, PDs in the Flexible Policy arm perceived a more positive effect of duty hours on the safety of patient care (68.9% vs 0%; p < 0.001), continuity of care (98.3% vs 0%; p < 0.001), and resident ability to attend educational activities (74.1% vs 3.4%; p < 0.001). Most PDs in both arms reported that safety of patient care (71.8%), continuity of care (94.0%), quality of resident education (83.8%), and resident well-being (55.6%) would be improved with a hypothetical permanent adoption of more flexible duty hours. Program directors involved in the FIRST trial perceived improvements in patient safety, continuity of care, and multiple aspects of resident education and well-being with flexible duty hours. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

[Adverse reactions to drugs reported by the primary care physicians of Andalusia. Analysis of underreporting].

PubMed

Torelló Iserte, J; Castillo Ferrando, J R; Laínez, M M; García Morillas, M; Arias González, A

1994-04-15

To discover the sort of adverse reactions to medication (ARM) notified by Primary Care doctors and identify the under-notification of those cases having special clinical-epidemiological interest. Retrospective study in which 2,597 ARM corresponding to 1,467 Yellow Cards (YC) were analysed. These were notified by Primary Care doctors to the Centro Andaluz de Farmacovigilancia (Andalusian Drug-watch centre) during the period from 1/6/90 to 31/12/92. To assess the seriousness of the ARM, their terminological classification and imputability, the criteria used in the WHO's international "Yellow Card" programme of spontaneous notification were followed. 77.2% of all notifications were from Primary Care, of which 7.4% were of special interest due to their serious or novel character. However an undernotification of serious and well-known ARM was detected, such as digestive haemorrhages (1.07/10(6) inhibitants per year), anaphylactic shock (0.34/10(6) inhab/year), agranulocytosis (0.23/10(6) inhab/year) and aplastic anaemia (0.05/10(6) inhab/year), among others. Most of the main under-notified ARM are generated in the community but treated in hospital Casualty departments. Therefore it would be useful to develop specific Drug-watch programmes in the hospitals themselves.

MASTERPLAN: study of the role of nurse practitioners in a multifactorial intervention to reduce cardiovascular risk in chronic kidney disease patients.

PubMed

Van Zuilen, Arjan D; Wetzels, Jack F M; Bots, Michiel L; Van Blankestijn, Peter J

2008-01-01

Moderate to severe chronic kidney disease (CKD) is associated with increased cardiovascular risk. Usually nephrologists are primarily responsible for the care of CKD patients. However, in many cases treatment goals, as formulated in guidelines, are not met. The addition of a nurse practitioner might improve the quality of care. The Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse Practitioners (MASTERPLAN) study is a randomized controlled multicenter trial, aimed at investigating whether a multifactorial approach in patients with moderate to severe CKD (stage 3 and 4) to achieving treatment goals using both a polydrug strategy and lifestyle treatment either with or without the addition of a nurse practitioner will reduce cardiovascular risk and slow the decline of kidney function. Patients (n=793) have been randomized to nurse care or physician care. In the nurse-care arm of the study, nurse practitioners use flowcharts to address risk factors requiring drug and/or lifestyle modification. They have been trained to coach patients by motivational interviewing with the aim of improving patient self-management. At baseline, both treatment groups show equal distributions with regard to key variables in the study. Moreover, in only 1 patient were all risk factors within the limits as defined in various guidelines, which underscores the relevance of our initiative.

Evaluation of a Cluster-Randomized Controlled Trial of a Package of Community-Based Maternal and Newborn Interventions in Mirzapur, Bangladesh

PubMed Central

Darmstadt, Gary L.; Choi, Yoonjoung; Arifeen, Shams E.; Bari, Sanwarul; Rahman, Syed M.; Mannan, Ishtiaq; Seraji, Habibur Rahman; Winch, Peter J.; Saha, Samir K.; Ahmed, A. S. M. Nawshad Uddin; Ahmed, Saifuddin; Begum, Nazma; Lee, Anne C. C.; Black, Robert E.; Santosham, Mathuram; Crook, Derrick; Baqui, Abdullah H.

2010-01-01

Background To evaluate a delivery strategy for newborn interventions in rural Bangladesh. Methods A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality. Findings A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80–1.30) at baseline and 0.87 (95% CI: 0.68–1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported. Conclusion Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management. Trial Registration Clinicaltrials.gov NCT00198627 PMID:20352087

Management of adenolymphangitis and lymphoedema due to lymphatic filariasis in resource-limited North-eastern Nigeria.

PubMed

Akogun, O B; Badaki, J A

2011-09-01

Procedures for health facility-based management of lymphoedema and adenolymphangitis (ADL) have proved very effective in some countries. Unfortunately, in resource-poor communities of Africa where health facilities are few, overburdened and inaccessible, an alternative approach is required. Community-based care (CC), patient care (PC) and health facility care (HC) approaches were compared. In the CC arm, communities were required to select one of their members for care-giving to its affected members, while in the PC, participants were allocated to groups under a leader with responsibility for care giving to group members. In HC, care was given by the nearest health facility. Caregivers from the three arms were trained and supplies were kept at the local government health office. At the sixth month of intervention, 325 lymphoedema and adenolymphangitis patients had been recruited into the study as participants. Within 12 months, compliance with hygiene practices increased from 29.4% to 62.6% and ADL episodes declined from 43.1% to 4.4% in the community designs arm and the cost on the health system was minimal. However, in the patient and health care arms, compliance and accessibility to supplies was severely affected by poor coordination, delay in resource collection leading to very minimal effect on lesions, odour, ADL frequency and duration. Participants abandoned the health facilities after the second visit. Community care approach was more culturally acceptable and effective for the management lymphoedema and ADL than other approaches. Copyright © 2010 Elsevier B.V. All rights reserved.

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.

Improving outcomes in adults with epilepsy and intellectual disability (EpAID) using a nurse-led intervention: study protocol for a cluster randomised controlled trial.

PubMed

Ring, Howard; Gilbert, Nakita; Hook, Roxanne; Platt, Adam; Smith, Christopher; Irvine, Fiona; Donaldson, Cam; Jones, Elizabeth; Kelly, Joanna; Mander, Adrian; Murphy, Caroline; Pennington, Mark; Pullen, Angela; Redley, Marcus; Rowe, Simon; Wason, James

2016-06-24

In adults with intellectual disability (ID) and epilepsy there are suggestions that improvements in management may follow introduction of epilepsy nurse-led care. However, this has not been tested in a definitive clinical trial and results cannot be generalised from general population studies as epilepsy tends to be more severe and to involve additional clinical comorbidities in adults with ID. This trial investigates whether nurses with expertise in epilepsy and ID, working proactively to a clinically defined role, can improve clinical and quality of life outcomes in the management of epilepsy within this population, compared to treatment as usual. The trial also aims to establish whether any perceived benefits represent good value for money. The EpAID clinical trial is a two-arm cluster randomised controlled trial of nurse-led epilepsy management versus treatment as usual. This trial aims to obtain follow-up data from 320 participants with ID and drug-resistant epilepsy. Participants are randomly assigned either to a 'treatment as usual' control or a 'defined epilepsy nurse role' active arm, according to the cluster site at which they are treated. The active intervention utilises the recently developed Learning Disability Epilepsy Specialist Nurse Competency Framework for adults with ID. Participants undergo 4 weeks of baseline data collection, followed by a minimum of 20 weeks intervention (novel treatment or treatment as usual), followed by 4 weeks of follow-up data collection. The primary outcome is seizure severity, including associated injuries and the level of distress manifest by the patient in the preceding 4 weeks. Secondary outcomes include cost-utility analysis, carer strain, seizure frequency and side effects. Descriptive measures include demographic and clinical descriptors of participants and clinical services in which they receive their epilepsy management. Qualitative study of clinical interactions and semi-structured interviews with clinicians and participants' carers are also undertaken. The EpAID clinical trial is the first cluster randomised controlled trial to test possible benefits of a nurse-led intervention in adults with epilepsy and ID. This research will have important implications for ID and epilepsy services. The challenges of undertaking such a trial in this population, and the approaches to meeting these are discussed. International Standard Randomised Controlled Trial Number: ISRCTN96895428 version 1.1. Registered on 26 March 2013.

Whole-arm tactile sensing for beneficial and acceptable contact during robotic assistance.

PubMed

Grice, Phillip M; Killpack, Marc D; Jain, Advait; Vaish, Sarvagya; Hawke, Jeffrey; Kemp, Charles C

2013-06-01

Many assistive tasks involve manipulation near the care-receiver's body, including self-care tasks such as dressing, feeding, and personal hygiene. A robot can provide assistance with these tasks by moving its end effector to poses near the care-receiver's body. However, perceiving and maneuvering around the care-receiver's body can be challenging due to a variety of issues, including convoluted geometry, compliant materials, body motion, hidden surfaces, and the object upon which the body is resting (e.g., a wheelchair or bed). Using geometric simulations, we first show that an assistive robot can achieve a much larger percentage of end-effector poses near the care-receiver's body if its arm is allowed to make contact. Second, we present a novel system with a custom controller and whole-arm tactile sensor array that enables a Willow Garage PR2 to regulate contact forces across its entire arm while moving its end effector to a commanded pose. We then describe tests with two people with motor impairments, one of whom used the system to grasp and pull a blanket over himself and to grab a cloth and wipe his face, all while in bed at his home. Finally, we describe a study with eight able-bodied users in which they used the system to place objects near their bodies. On average, users perceived the system to be safe and comfortable, even though substantial contact occurred between the robot's arm and the user's body.

Extended-release naltrexone opioid treatment at jail reentry (XOR)

PubMed Central

McDonald, Ryan D.; Tofighi, Babak; Laska, Eugene; Goldfeld, Keith; Bonilla, Wanda; Flannery, Mara; Santana-Correa, Nadina; Johnson, Christopher W.; Leibowitz, Neil; Rotrosen, John; Gourevitch, Marc N.; Lee, Joshua D.

2017-01-01

Background Extended-release naltrexone (XR-NTX) is an injectable monthly sustained-release mu opioid receptor antagonist, which blocks the typical effects of heroin and other opioid agonists. Use of XR-NTX among opioid dependent persons leaving jails and prisons is increasing despite scant high-quality evidence regarding XR-NTX’s effectiveness at re-entry. Methods This 24-week, open-label randomized controlled trial examines the effectiveness of XR-NTX as opioid relapse prevention at release from jail (N = 85) compared to enhanced treatment as usual (ETAU, N = 85). A third, non-randomized, quasi-experimental naturalistic arm of participants who have newly initiated a jail-to-community methadone treatment program (MTP, N = 85) allows for comparisons to a methadone standard-of-care. Results We describe the rationale, design, and primary and secondary outcomes of the study. The primary outcome is an opioid relapse event; the primary contrast is a time-to-relapse comparison of XR-NTX and ETAU over a 24-week treatment phase. Secondary outcomes are rates of: (a) post-release opioid treatment participation, (b) opioid, alcohol, and cocaine use, (c) injection drug use and HIV sexual risk behaviors, (d) overdose (fatal and non-fatal) and all-cause mortality, and, (e) re-incarceration. Conclusions XR-NTX is a potentially important, effective treatment and relapse prevention option for a large US population of persons with opioid use disorders leaving jails. This study will estimate XR-NTX’s effectiveness relative to existing standards of care, including counseling-only treatment-as-usual and methadone maintenance. PMID:27178765

Balance of Autonomic Nervous System Predicts Who Benefits from a Self-management Intervention Program for Irritable Bowel Syndrome.

PubMed

Jarrett, Monica E; Cain, Kevin C; Barney, Pamela G; Burr, Robert L; Naliboff, Bruce D; Shulman, Robert; Zia, Jasmine; Heitkemper, Margaret M

2016-01-31

To determine if potential biomarkers can be used to identify subgroups of people with irritable bowel syndrome (IBS) who will benefit the most or the least from a comprehensive self-management (CSM) intervention. In a two-armed randomized controlled trial a CSM (n = 46) was compared to a usual care (n = 46) group with follow-up at 3 and 6 months post randomization. Biomarkers obtained at baseline included heart rate variability, salivary cortisol, interleukin-10 produced by unstimulated peripheral blood mononuclear cells, and lactulose/mannitol ratio. Linear mixed models were used to test whether these biomarkers predicted improvements in the primary outcomes including daily abdominal pain, Gastrointestinal Symptom score and IBS-specific quality of life. The nurse-delivered 8-session CSM intervention is more effective than usual care in reducing abdominal pain, reducing Gastrointestinal Symptom score, and enhancing quality of life. Participants with lower nighttime high frequency heart rate variability (vagal modulation) and increased low frequency/high frequency ratio (sympathovagal balance) had less benefit from CSM on abdominal pain. Salivary cortisol, IL-10, and lactulose/mannitol ratio were not statistically significant in predicting CSM benefit. Baseline symptom severity interacts with treatment, namely the benefit of CSM is greater in those with higher baseline symptoms. Cognitively-focused therapies may be less effective in reducing abdominal pain in IBS patients with higher sympathetic tone. Whether this a centrally-mediated patient characteristic or related to heightened arousal remains to be determined.

Cost-effectiveness of lung volume reduction coil treatment in patients with severe emphysema: results from the 2-year follow-up crossover REVOLENS study (REVOLENS-2 study).

PubMed

Bulsei, Julie; Leroy, Sylvie; Perotin, Jeanne-Marie; Mal, Hervé; Marquette, Charles-Hugo; Dutau, Hervé; Bourdin, Arnaud; Vergnon, Jean-Michel; Pison, Christophe; Kessler, Romain; Jounieaux, Vincent; Salaün, Mathieu; Marceau, Armelle; Dukic, Sylvain; Barbe, Coralie; Bonnaire, Margaux; Deslee, Gaëtan; Durand-Zaleski, Isabelle

2018-05-09

The REVOLENS study compared lung volume reduction coil treatment to usual care in patients with severe emphysema at 1 year, resulting in improved quality-adjusted life-year (QALY) and higher costs. Durability of the coil treatment benefit and its cost-effectiveness at 2 years are now assessed. After one year, the REVOLENS trial's usual care group patients received coil treatment (second-line coil treatment group). Costs and QALYs were assessed in both arms at 2 years and an incremental cost-effectiveness ratio in cost per QALY gained was calculated. The uncertainty of the results was estimated by probabilistic bootstrapping. The average cost of coil treatment in both groups was estimated at €24,356. The average total cost at 2 years was €9655 higher in the first-line coil treatment group (p = 0.07) and the difference in QALY between the two groups was 0.127 (p = 0.12) in favor of first-line coil treatment group. The 2-year incremental cost-effectiveness ratio (ICER) was €75,978 / QALY. The scatter plot of the probabilistic bootstrapping had 92% of the replications in the top right-hand quadrant. First-line coil treatment was more expensive but also more effective than second-line coil treatment at 2 years, with a 2-year ICER of €75,978 / QALY. ClinicalTrials.gov Identifier NCT01822795 .

Home Based Care as an Approach to Improve the Efficiency of treatment for MDR Tuberculosis: A Quasi-Experimental Pilot Study

PubMed Central

Taneja, Neha; Daral, Shailaja; Adhikary, Mrinmoy; Das, Timiresh Kumar

2017-01-01

Introduction Multi Drug Resistant Tuberculosis (MDR TB) has emerged as a significant public health problem in India. The prolonged treatment duration in MDR TB is a challenge in achieving treatment completion and poses a threat to TB control in the country. Home based care is an approach accepted by patients because it helps in ameliorating their understanding of TB, improving the compliance and reducing stigma in the community. Aim To assess the outcome of Home-Based Care (HC) versus No Home-Based Care (NHC) on the treatment of MDR TB patients registered at two chest clinics in Eastern Delhi. Materials and Methods A quasi-experimental study was done among diagnosed MDR TB patients receiving Category IV regimen under Revised National Tuberculosis Control Programme (RNTCP) from two government chest clinics in Eastern Delhi during May 2014 to May 2016. In the control arm, 50 MDR TB patients at one of the chest clinics were offered the standard Category IV regimen under RNTCP; while in the intervention arm, 50 MDR TB patients at the second chest clinic were provided home based care (counselling, support for completion of treatment, rehabilitation, and nutritional support) along with the standard treatment. The primary outcome assessed was outcome of treatment, while secondary outcomes included stigma faced due to the disease, and impact of disease on family and community life. Results The primary outcome data was available for 32 (64%) participants in the intervention arm, and 38 (76%) participants in control arm. The treatment was significantly more successful in the intervention arm (p<0.03). The data on secondary outcomes was available for all participants. Stigma due to disease was significantly lower in the intervention arm (p<0.01); also rejection faced by participants from family and community due to disease was significantly lower among the HC group (p<0.05). Conclusion Home-based care in MDR TB treatment holds potential in improving treatment outcomes of patient. PMID:28969162

Home Based Care as an Approach to Improve the Efficiency of treatment for MDR Tuberculosis: A Quasi-Experimental Pilot Study.

PubMed

Taneja, Neha; Chellaiyan, Vinoth Gnana; Daral, Shailaja; Adhikary, Mrinmoy; Das, Timiresh Kumar

2017-08-01

Multi Drug Resistant Tuberculosis (MDR TB) has emerged as a significant public health problem in India. The prolonged treatment duration in MDR TB is a challenge in achieving treatment completion and poses a threat to TB control in the country. Home based care is an approach accepted by patients because it helps in ameliorating their understanding of TB, improving the compliance and reducing stigma in the community. To assess the outcome of Home-Based Care (HC) versus No Home-Based Care (NHC) on the treatment of MDR TB patients registered at two chest clinics in Eastern Delhi. A quasi-experimental study was done among diagnosed MDR TB patients receiving Category IV regimen under Revised National Tuberculosis Control Programme (RNTCP) from two government chest clinics in Eastern Delhi during May 2014 to May 2016. In the control arm, 50 MDR TB patients at one of the chest clinics were offered the standard Category IV regimen under RNTCP; while in the intervention arm, 50 MDR TB patients at the second chest clinic were provided home based care (counselling, support for completion of treatment, rehabilitation, and nutritional support) along with the standard treatment. The primary outcome assessed was outcome of treatment, while secondary outcomes included stigma faced due to the disease, and impact of disease on family and community life. The primary outcome data was available for 32 (64%) participants in the intervention arm, and 38 (76%) participants in control arm. The treatment was significantly more successful in the intervention arm (p<0.03). The data on secondary outcomes was available for all participants. Stigma due to disease was significantly lower in the intervention arm (p<0.01); also rejection faced by participants from family and community due to disease was significantly lower among the HC group (p<0.05). Home-based care in MDR TB treatment holds potential in improving treatment outcomes of patient.

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 ...

Destruction before detonation: the impact of the arms race on health and health care.

PubMed

Sidel, V W

1985-12-07

Health workers are urged to help end the arms race and advocate that nations transfer funds from nuclear weapons to human services. Statistics on morbidity and mortality in developing countries, hunger and the lack of medical care and resources, and the need for preventive medicine rather than military buildups are discussed. It is contended that even small conversions of funds spent on arms to spending on health could produce enormous benefits, reducing the numbers of children who die daily from preventable illnesses.

Mini-intervention for subacute low back pain: two-year follow-up and modifiers of effectiveness.

PubMed

Karjalainen, Kaija; Malmivaara, Antti; Mutanen, Pertti; Roine, Risto; Hurri, Heikki; Pohjolainen, Timo

2004-05-15

Randomized controlled trial. To Investigate the long-term effectiveness, costs, and effect modifiers of a mini-intervention, provided in addition to the usual care, and the incremental effect of a worksite visit for patients with subacute disabling low back pain (LBP). A mini-intervention was earlier proved to be an effective treatment for subacute LBP. Whether the beneficial effect is sustained is not known. Furthermore, modifiers of a treatment effect are largely unknown. A total of 164 patients with subacute LBP randomized into a mini-intervention (A, n = 56), a mini-intervention plus a worksite visit (B, n = 51), or the usual care (C, n = 57). Mini-intervention consisted of a detailed assessment of the patients' history, beliefs, and physical findings by a physician and a physiotherapist, followed by recommendations and advice. The usual care patients received the conventional care. Pain, disability, health-related quality of life, satisfaction with care, days on sick leave, and health care consumption and costs were measured during a 24-month follow-up. Thirteen candidate modifiers were tested for each outcome. There were no differences between the three treatment arms regarding the intensity of pain, the perceived disability, or the health-related quality of life. However, mini-intervention decreased occurrence of daily (A vs., C, P = 0.01) and bothersome (A vs. C, P < 0.05) pain and increased treatment satisfaction. Costs resulting from LBP were lower in the intervention groups (A 4670 Euros, B 5990 Euros) than in C (C 9510 Euros) (A vs. C, P = 0.04; and B vs. C, not significant). The average number of days on sick leave was 30 in A, 45 in B, and 62 in C (A vs. C, P = 0.03; B vs. C, not significant). The perceived risk for not recovering was the strongest modifier of treatment effect. Mental and mental-physical workers in A and B were less often on sick leave than those in C. Mini-intervention is an effective treatment for subacute LBP. Despite lack of a significant effect on intensity of low back pain and perceived disability, mini-intervention, including proper recommendations and advice, according to the "active approach," is able to reduce LBP-related costs. The perceived risk of not recovering was the strongest modifier of treatment effect. In alleviating pain, the intervention was most effective among the patients with a high perceived risk of not recovering.

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

Improving outcomes for caregivers through treatment of young people affected by war: a randomized controlled trial in Sierra Leone.

PubMed

McBain, Ryan K; Salhi, Carmel; Hann, Katrina; Kellie, Jim; Kamara, Alimamy; Salomon, Joshua A; Kim, Jane J; Betancourt, Theresa S

2015-12-01

To measure the benefits to household caregivers of a psychotherapeutic intervention for adolescents and young adults living in a war-affected area. Between July 2012 and July 2013, we carried out a randomized controlled trial of the Youth Readiness Intervention--a cognitive-behavioural intervention for war-affected young people who exhibit depressive and anxiety symptoms and conduct problems--in Freetown, Sierra Leone. Overall, 436 participants aged 15-24 years were randomized to receive the intervention (n = 222) or care as usual (n = 214). Household caregivers for the participants in the intervention arm (n = 101) or control arm (n = 103) were interviewed during a baseline survey and again, if available (n = 155), 12 weeks later in a follow-up survey. We used a burden assessment scale to evaluate the burden of care placed on caregivers in terms of emotional distress and functional impairment. The caregivers' mental health--i.e. internalizing, externalizing and prosocial behaviour--was evaluated using the Oxford Measure of Psychosocial Adjustment. Difference-in-differences multiple regression analyses were used, within an intention-to-treat framework, to estimate the treatment effects. Compared with the caregivers of participants of the control group, the caregivers of participants of the intervention group reported greater reductions in emotional distress (scale difference: 0.252; 95% confidence interval, CI: 0.026-0.4782) and greater improvements in prosocial behaviour (scale difference: 0.249; 95% CI: 0.012-0.486) between the two surveys. A psychotherapeutic intervention for war-affected young people can improve the mental health of their caregivers.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial.

PubMed

Hollands, Kristen L; Pelton, Trudy A; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M; Wing, Alan M; Tyson, Sarah F; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M

2015-01-01

Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services. Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments. Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Clinicaltrials.gov NCT01600391.

Patient-Centered Tablet Application for Improving Medication Adherence after a Drug-Eluting Stent.

PubMed

Shah, Vicki; Dileep, Anandu; Dickens, Carolyn; Groo, Vicki; Welland, Betty; Field, Jerry; Baumann, Matthew; Flores, Jose D; Shroff, Adhir; Zhao, Zhongsheng; Yao, Yingwei; Wilkie, Diana J; Boyd, Andrew D

2016-01-01

This study's objective was to evaluate a patient-centered educational electronic tablet application, "My Interventional Drug-Eluting Stent Educational App" (MyIDEA) to see if there was an increase in patient knowledge about dual antiplatelet therapy (DAPT) and medication possession ratio (MPR) compared to treatment as usual. In a pilot project, 24 elderly (≥50 years old) research participants were recruited after a drug-eluting stent. Eleven were randomized to the control arm and 13 to the interventional arm. All the participants completed psychological and knowledge questionnaires. Adherence was assessed through MPR, which was calculated at 3 months for all participants who were scheduled for second and third follow-up visits. Relative to control, the interventional group had a 10% average increase in MPR. As compared to the interventional group, more patients in the control group had poor adherence (<80% MPR). The psychological data revealed a single imbalance in anxiety between the control and interventional groups. On average, interventional participants spent 21 min using MyIDEA. Consumer health informatics has enabled us to engage patients with their health data using novel methods. Consumer health technology needs to focus more on patient knowledge and engagement to improve long-term health. MyIDEA takes a unique approach in targeting DAPT from the onset. MyIDEA leverages patient-centered information with clinical care and the electronic health record highlighting the patients' role as a team member in their own health care. The patients think critically about adverse events and how to solve issues before leaving the hospital.

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.

Corticotropin, Repository Injection

MedlinePlus

Corticotropin repository injection is used to treat the following conditions:infantile spasms (seizures that usually begin during the first ... of the arms, hands, feet, and legs). Corticotropin repository injection is in a class of medications called ...

Giant Cell Arteritis

MedlinePlus

Giant cell arteritis is a disorder that causes inflammation of your arteries, usually in the scalp, neck, and arms. ... arteries, which keeps blood from flowing well. Giant cell arteritis often occurs with another disorder called polymyalgia ...

Strengthening malaria service delivery through supportive supervision and community mobilization in an endemic Indian setting: an evaluation of nested delivery models.

PubMed

Das, Ashis; Friedman, Jed; Kandpal, Eeshani; Ramana, Gandham N V; Gupta, Rudra Kumar Das; Pradhan, Madan M; Govindaraj, Ramesh

2014-12-08

Malaria continues to be a prominent global public health challenge. This study tested the effectiveness of two service delivery models for reducing the malaria burden, e.g. supportive supervision of community health workers (CHW) and community mobilization in promoting appropriate health-seeking behaviour for febrile illnesses in Odisha, India. The study population comprised 120 villages from two purposively chosen malaria-endemic districts, with 40 villages randomly assigned to each of the two treatment arms, one with both supportive supervision and community mobilization and one with community mobilization alone, as well as an observational control arm. Outcome measures included changes in the utilization of bed nets and timely care-seeking for fever from a trained provider compared to the control group. Analysis was by intention-to-treat. Significant improvements were observed in the reported utilization of bed nets in both intervention arms (84.5% in arm A and 82.4% in arm B versus 78.6% in the control arm; p < 0.001). While overall rates of treatment-seeking were equal across study arms, treatment-seeking from a CHW was higher in both intervention arms (28%; p = 0.005 and 27.6%; p = 0.007) than in the control arm (19.2%). Fever cases were significantly more likely to visit a CHW and receive a timely diagnosis of fever in the combined interventions arm than in the control arm (82.1% vs. 67.1%; p = 0.025). Care-seeking from trained providers also increased with a substitution away from untrained providers. Further, fever cases from the combined interventions arm (60.6%; p = 0.004) and the community mobilization arm (59.3%; p = 0.012) were more likely to have received treatment from a skilled provider within 24 hours than fever cases from the control arm (50.1%). In particular, women from the combined interventions arm were more likely to have received timely treatment from a skilled provider (61.6% vs. 47.2%; p = 0.028). A community-based intervention combining the supportive supervision of community health workers with intensive community mobilization and can be effective in improving care-seeking and preventive behaviour and may be used to strengthen the national malaria control programme.

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

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.

Web-based guided self-help for employees with depressive symptoms (Happy@Work): design of a randomized controlled trial

PubMed Central

2013-01-01

Background Depressive disorders are highly prevalent in the working population and are associated with excessive costs for both society and companies. Effective treatment for employees with depressive symptoms in occupational health care is limited. The purpose of this study is to investigate the effectiveness and cost-effectiveness of an indicated preventive web-based guided self-help course for employees with depressive symptoms. Methods The study is a two-arm randomized controlled trial comparing a web-based guided self-help course with care-as-usual. The self-help course consists of 6 weekly lessons. Weekly support will be provided by a coach via the website. Subjects in the care-as-usual group do not receive any treatment in addition to regular care. 200 white collar workers from several national and international companies in the Netherlands will be recruited via different methods such as banners on the company’s intranet, pamphlets and posters. Subjects will be included when they: have elevated depressive symptoms (score ≥16 on the Center for Epidemiologic Studies Depression scale), are 18 years of age or older, have access to the Internet and can be contacted via e-mail. Exclusion criteria are: partial or full work absenteeism, a legal labor dispute with the employer and receiving treatment from the company’s occupational health care at study entrance. The primary outcome is depressive symptoms. Secondary outcomes include work absenteeism, work performance, burnout, anxiety, quality of life, health care use and production losses. Outcome data will be collected at 8 weeks, 6 months, and 12 months after baseline. Analyses will be based on the intention-to-treat principle. The cost-effectiveness analyses will be performed from a societal and a company’s perspective. A process evaluation will be conducted alongside the study. Discussion This study evaluates the effectiveness and cost-effectiveness of a web-based guided self-help course for employees with depressive symptoms. This study could stimulate the use of e-mental health interventions in the worksite setting. Trial registration Nederlands Trial Register (NTR): TC2993 PMID:23418886

Genetics Home Reference: Buschke-Ollendorff syndrome

MedlinePlus

... example, a small percentage of affected individuals have melorheostosis , which is characterized by excess bone growth on ... bones in a pattern resembling dripping candle wax. Melorheostosis usually affects the bones in one arm or ...

Neck Injuries and Disorders

MedlinePlus

... tendons, ligaments, or nerves - can cause neck problems. Neck pain is very common. Pain may also come from ... upper arms. Muscle strain or tension often causes neck pain. The problem is usually overuse, such as from ...

A Universal Rig for Supporting Large Hammer Drills: Reduced Injury Risk and Improved Productivity

PubMed Central

Rempel, David; Barr, Alan

2015-01-01

Drilling holes into concrete with heavy hammer and rock drills is one of the most physically demanding tasks performed in commercial construction and poses risks for musculoskeletal disorders, noise induced hearing loss, hand arm vibration syndrome and silicosis. The aim of this study was to (1) use a participatory process to develop a rig to support pneumatic rock drills or large electric hammer drills in order to reduce the health risks and (2) evaluate the usability of the rig. Seven prototype rigs for supporting large hammer drills were developed and modified with feedback from commercial contractors and construction workers. The final design was evaluated by laborers and electricians (N=29) who performed their usual concrete drilling with the usual method and the new rig. Subjective regional fatigue was significantly less in the neck, shoulders, hands and arms, and lower back) when using the universal rig compared to the usual manual method. Usability ratings for the rig were significantly better than the usual method on stability, control, drilling, accuracy, and vibration. Drilling time was reduced by approximately 50% with the rig. Commercial construction contractors, laborers and electricians who use large hammer drills for drilling many holes should consider using such a rig to prevent musculoskeletal disorders, fatigue, and silicosis. PMID:26005290

Nursing Ethics and the 21st-Century Armed Conflict: The Example of Ciudad Juárez.

PubMed

O'Connor, Kathleen

2017-01-01

The purpose of this article is to call attention to the lack of caregiver safety in conflict settings; to bring awareness to nurses and health care professionals of new challenges, specifically the deliberate targeting of health care professionals, that they may encounter in local armed conflict situations; and to address a gap in knowledge about the social and cultural factors surrounding 21st-century armed conflict that directly affect the provision of health care. I argue that these are of interest to transcultural nursing in that violent actors belong to a dangerous subculture, the understanding of which is important to transcultural nursing practice and caregiver safety. The article calls for increased focus on the protection of the nursing workforce and renewed attention on international humanitarian law and the Geneva Conventions that mandate the safety of global health care workers. © The Author(s) 2015.

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

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.

Nurse-delivered counselling intervention for parental HIV disclosure: results from a pilot randomized controlled trial in China.

PubMed

Simoni, Jane M; Yang, Joyce P; Shiu, Cheng-Shi; Chen, Wei-Ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2015-06-01

The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants were 20 HIV-positive outpatients with at least one child (13-25 years old) who was unaware of the parent's HIV diagnosis. The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy, and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a 'large' effect size. Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy.

Affect school and script analysis versus basic body awareness therapy in the treatment of psychological symptoms in patients with diabetes and high HbA1c concentrations: two study protocols for two randomized controlled trials.

PubMed

Melin, Eva O; Svensson, Ralph; Gustavsson, Sven-Åke; Winberg, Agneta; Denward-Olah, Ewa; Landin-Olsson, Mona; Thulesius, Hans O

2016-04-27

Depression is linked with alexithymia, anxiety, high HbA1c concentrations, disturbances of cortisol secretion, increased prevalence of diabetes complications and all-cause mortality. The psycho-educational method 'affect school with script analysis' and the mind-body therapy 'basic body awareness treatment' will be trialled in patients with diabetes, high HbA1c concentrations and psychological symptoms. The primary outcome measure is change in symptoms of depression. Secondary outcome measures are changes in HbA1c concentrations, midnight salivary cortisol concentration, symptoms of alexithymia, anxiety, self-image measures, use of antidepressants, incidence of diabetes complications and mortality. Two studies will be performed. Study I is an open-labeled parallel-group study with a two-arm randomized controlled trial design. Patients are randomized to either affect school with script analysis or to basic body awareness treatment. According to power calculations, 64 persons are required in each intervention arm at the last follow-up session. Patients with type 1 or type 2 diabetes were recruited from one hospital diabetes outpatient clinic in 2009. The trial will be completed in 2016. Study II is a multicentre open-labeled parallel-group three-arm randomized controlled trial. Patients will be randomized to affect school with script analysis, to basic body awareness treatment, or to treatment as usual. Power calculations show that 70 persons are required in each arm at the last follow-up session. Patients with type 2 diabetes will be recruited from primary care. This study will start in 2016 and finish in 2023. For both studies, the inclusion criteria are: HbA1c concentration ≥62.5 mmol/mol; depression, alexithymia, anxiety or a negative self-image; age 18-59 years; and diabetes duration ≥1 year. The exclusion criteria are pregnancy, severe comorbidities, cognitive deficiencies or inadequate Swedish. Depression, anxiety, alexithymia and self-image are assessed using self-report instruments. HbA1c concentration, midnight salivary cortisol concentration, blood pressure, serum lipid concentrations and anthropometrics are measured. Data are collected from computerized medical records and the Swedish national diabetes and causes of death registers. Whether the "affect school with script analysis" will reduce psychological symptoms, increase emotional awareness and improve diabetes related factors will be tried, and compared to "basic body awareness treatment" and treatment as usual. ClinicalTrials.gov: NCT01714986.

Effectiveness of the Comprehensive Approach to Rehabilitation (CARe) methodology: design of a cluster randomized controlled trial.

PubMed

Bitter, Neis A; Roeg, Diana P K; van Nieuwenhuizen, Chijs; van Weeghel, Jaap

2015-07-22

There is an increasing amount of evidence for the effectiveness of rehabilitation interventions for people with severe mental illness (SMI). In the Netherlands, a rehabilitation methodology that is well known and often applied is the Comprehensive Approach to Rehabilitation (CARe) methodology. The overall goal of the CARe methodology is to improve the client's quality of life by supporting the client in realizing his/her goals and wishes, handling his/her vulnerability and improving the quality of his/her social environment. The methodology is strongly influenced by the concept of 'personal recovery' and the 'strengths case management model'. No controlled effect studies have been conducted hitherto regarding the CARe methodology. This study is a two-armed cluster randomized controlled trial (RCT) that will be executed in teams from three organizations for sheltered and supported housing, which provide services to people with long-term severe mental illness. Teams in the intervention group will receive the multiple-day CARe methodology training from a specialized institute and start working according the CARe Methodology guideline. Teams in the control group will continue working in their usual way. Standardized questionnaires will be completed at baseline (T0), and 10 (T1) and 20 months (T2) post baseline. Primary outcomes are recovery, social functioning and quality of life. The model fidelity of the CARe methodology will be assessed at T1 and T2. This study is the first controlled effect study on the CARe methodology and one of the few RCTs on a broad rehabilitation method or strength-based approach. This study is relevant because mental health care organizations have become increasingly interested in recovery and rehabilitation-oriented care. The trial registration number is ISRCTN77355880 .

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.

Return to work in sick-listed cancer survivors with job loss: design of a randomised controlled trial.

PubMed

van Egmond, Martine P; Duijts, Saskia F A; Vermeulen, Sylvia J; van der Beek, Allard J; Anema, Johannes R

2015-02-18

Despite long-term or permanent health problems, cancer survivors are often motivated to return to work. For cancer survivors who have lost their job, return to work can be more challenging compared to employed survivors, as they generally find themselves in a more vulnerable social and financial position. Cancer survivors with job loss may therefore be in need of tailored return to work support. However, there is a lack of return to work intervention programs specifically targeting these cancer survivors. The number of cancer survivors with job loss in developed countries is rising due to, amongst others, increases in the incidence and survivor rate of cancer, the retirement age and the proportion of flexible employment contracts. Hence, we consider it important to develop a tailored return to work intervention program for cancer survivors with job loss, and to evaluate its effectiveness compared to usual care. This study employs a two-armed randomised controlled trial with a follow-up period of 12 months. The study population (n = 164) will be recruited from a national sample of cancer survivors (18-60 years), who have been sick-listed for 12-36 months. Participants will be randomised by using computerized blocked randomisation (blocks of four). All participants will receive usual care as provided by the Dutch Social Security Agency. Additionally, participants in the intervention group will receive a tailored return to work intervention program, which includes vocational rehabilitation and supportive psychosocial components, as well as (therapeutic) placement at work. The primary outcome measure is duration until sustainable return to work; the secondary outcome measure is rate of return to work. Other parameters include, amongst others, fatigue, coping strategy and quality of life. We will perform Cox regression analyses to estimate hazard ratios for time to sustainable return to work. The hypothesis of this study is that a tailored approach for cancer survivors with job loss is more effective, regarding return to work, compared to usual care. The results of this study will provide insight into the ways in which return to work can be facilitated for cancer survivors with job loss. Netherlands Trial Register: NTR3562 .

Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial.

PubMed

Ortblad, Katrina; Kibuuka Musoke, Daniel; Ngabirano, Thomson; Nakitende, Aidah; Magoola, Jonathan; Kayiira, Prossy; Taasi, Geoffrey; Barresi, Leah G; Haberer, Jessica E; McConnell, Margaret A; Oldenburg, Catherine E; Bärnighausen, Till

2017-11-01

HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants' median age was 28 years (IQR 24-32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing-to understand the intervention effects on frequent testing-and self-reported facility-based testing-to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17-1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07-1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07-1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01-1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29-1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08-1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. ClinicalTrials.gov NCT02846402.

Genetics Home Reference: hypomyelination and congenital cataract

MedlinePlus

... have reduced sensation in their arms and legs (peripheral neuropathy). In addition, affected individuals typically have speech difficulties ( ... need support, and they usually do not have peripheral neuropathy. Learn more about the gene associated with hypomyelination ...

Dronedarone

MedlinePlus

Dronedarone comes as a tablet to take by mouth. It is usually taken twice a day, with the morning meal and the evening meal. Take ... arm or leg difficulty thinking clearly, remembering, or learning new things Dronedarone may cause other side effects. ...

Complex Regional Pain Syndrome

MedlinePlus

Complex regional pain syndrome (CRPS) is a chronic pain condition. It causes intense pain, usually in the arms, hands, legs, or feet. ... in skin temperature, color, or texture Intense burning pain Extreme skin sensitivity Swelling and stiffness in affected ...

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.

Methods for a study of Anticipatory and Preventive multidisciplinary Team Care in a family practice.

PubMed

Dahrouge, Simone; Hogg, William; Lemelin, Jacques; Liddy, Clare; Legault, Frances

2010-02-01

BACKGROUND T o examine the methodology used to evaluate whether focusing the work of nurse practitioners and a pharmacist on frail and at-risk patients would improve the quality of care for such patients. Evaluation of methodology of a randomized controlled trial including analysis of quantitative and qualitative data over time and analysis of cost-effectiveness. A single practice in a rural area near Ottawa, Ont. A total of 241 frail patients, aged 50 years and older, at risk of experiencing adverse health outcomes. At-risk patients were randomly assigned to receive Anticipatory and Preventive Team Care (from their family physicians, 1 of 3 nurse practitioners, and a pharmacist) or usual care. The principal outcome for the study was the quality of care for chronic disease management. Secondary outcomes included other quality of care measures and evaluation of the program process and its cost-effectiveness. This article examines the effectiveness of the methodology used. Quantitative data from surveys, administrative databases, and medical records were supplemented with qualitative information from interviews, focus groups, work logs, and study notes. Three factors limit our ability to fully demonstrate the potential effects of this team structure. For reasons outside our control, the intervention duration was shorter than intended; the practice's physical layout did not facilitate interactions between the care providers; and contamination of the intervention effect into the control arm cannot be excluded. The study used a randomized design, relied on a multifaceted approach to evaluating its effects, and used several sources of data. TRIAL REGISTRATION NUMBER NCT00238836 (CONSORT).

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.

A combination strategy for enhancing linkage to and retention in HIV care among adults newly diagnosed with HIV in Mozambique: study protocol for a site-randomized implementation science study.

PubMed

Elul, Batya; Lahuerta, Maria; Abacassamo, Fatima; Lamb, Matthew R; Ahoua, Laurence; McNairy, Margaret L; Tomo, Maria; Horowitz, Deborah; Sutton, Roberta; Mussa, Antonio; Gurr, Danielle; Jani, Ilesh

2014-10-15

Despite the extraordinary scale up of HIV prevention, care and treatment services in sub-Saharan Africa (SSA) over the past decade, the overall effectiveness of HIV programs has been significantly hindered by high levels of attrition across the HIV care continuum. Data from "real-life" settings are needed on the effectiveness of an easy to deliver package of services that can improve overall performance of the HIV care continuum. We are conducting an implementation science study using a two-arm cluster site-randomized design to determine the effectiveness of a combination intervention strategy (CIS) using feasible, evidence-based, and practical interventions-including (1) point-of-care (POC) CD4 count testing, (2) accelerated antiretroviral therapy initiation for eligible individuals, and (3) SMS reminders for linkage to and retention in care-as compared to the standard of care (SOC) in Mozambique in improving linkage and retention among adults following HIV diagnosis. A pre-post intervention two-sample design is nested within the CIS arm to assess the incremental effectiveness of the CIS plus financial incentives (CIS + FI) compared to the CIS without FI on study outcomes. Randomization is done at the level of the study site, defined as a primary health facility. Five sites are included from the City of Maputo and five from Inhambane Province. Target enrollment is a total of 2,250 adults: 750 in the SOC arm, 750 in the CIS cohort of the intervention arm and 750 in the CIS + FI cohort of the intervention arm (average of 150 participants per site). Participants are followed for 12 months from time of HIV testing to ascertain a combined endpoint of linkage to care within 1 month after testing and retention in care 12 months from HIV test. Cost-effectiveness analyses of CIS compared to SOC and CIS + FI compared to CIS will also be conducted. Study findings will provide evidence on the effectiveness of a CIS and the incremental effectiveness of a CIS + FI in a "real-life" service delivery system in a SSA country severely impacted by HIV. Clinicaltrials.gov, NCT01930084.

Assessing treatment fidelity and contamination in a cluster randomised controlled trial of motivational interviewing and cognitive behavioural therapy skills in type 2 diabetes.

PubMed

Magill, Nicholas; Graves, Helen; de Zoysa, Nicole; Winkley, Kirsty; Amiel, Stephanie; Shuttlewood, Emma; Landau, Sabine; Ismail, Khalida

2018-05-10

Competencies in psychological techniques delivered by primary care nurses to support diabetes self-management were compared between the intervention and control arms of a cluster randomised controlled trial as part of a process evaluation. The trial was pragmatic and designed to assess effectiveness. This article addresses the question of whether the care that was delivered in the intervention and control trial arms represented high fidelity treatment and attention control, respectively. Twenty-three primary care nurses were either trained in motivational interviewing (MI) and cognitive behavioural therapy (CBT) skills or delivered attention control. Nurses' skills in these treatments were evaluated soon after training (treatment arm) and treatment fidelity was assessed after treatment delivery for sessions midway through regimen (both arms) using the Motivational Interviewing Treatment Integrity (MITI) domains and Behaviour Change Counselling Index (BECCI) based on consultations with 151 participants (45% of those who entered the study). The MITI Global Spirit subscale measured demonstration of MI principles: evocation, collaboration, autonomy/support. After training, median MITI MI-Adherence was 86.2% (IQR 76.9-100%) and mean MITI Empathy was 4.09 (SD 1.04). During delivery of treatment, in the intervention arm mean MITI Spirit was 4.03 (SD 1.05), mean Empathy was 4.23 (SD 0.89), and median Percentage Complex Reflections was 53.8% (IQR 40.0-71.4%). In the attention control arm mean Empathy was 3.40 (SD 0.98) and median Percentage Complex Reflections was 55.6% (IQR 41.9-71.4%). After MI and CBT skills training, detailed assessment showed that nurses had basic competencies in some psychological techniques. There appeared to be some delivery of elements of psychological treatment by nurses in the control arm. This model of training and delivery of MI and CBT skills integrated into routine nursing care to support diabetes self-management in primary care was not associated with high competency levels in all skills. ISRCTN75776892 ; date registered: 19/05/2010.

The Patient Remote Intervention and Symptom Management System (PRISMS) - a Telehealth- mediated intervention enabling real-time monitoring of chemotherapy side-effects in patients with haematological malignancies: study protocol for a randomised controlled trial.

PubMed

Breen, Sibilah; Ritchie, David; Schofield, Penelope; Hsueh, Ya-Seng; Gough, Karla; Santamaria, Nick; Kamateros, Rose; Maguire, Roma; Kearney, Nora; Aranda, Sanchia

2015-10-19

Outpatient chemotherapy is a core treatment for haematological malignancies; however, its toxicities frequently lead to distressing/potentially life-threatening side-effects (neutropenia/infection, nausea/vomiting, mucositis, constipation/diarrhoea, fatigue). Early detection/management of side-effects is vital to improve patient outcomes, decrease morbidity and limit lengthy/costly hospital admissions. The ability to capture patient-reported health data in real-time, is regarded as the 'gold-standard' to allow rapid clinical decision-making/intervention. This paper presents the protocol for a Phase 3 multi-site randomised controlled trial evaluating a novel nurse-led Telehealth intervention for remote monitoring/management of chemotherapy side-effects in Australian haematological cancer patients. Two hundred and twenty-two patients will be recruited from two hospitals. Eligibility criteria include: diagnosis of chronic lymphocytic leukaemia/Hodgkin's/non-Hodgkin's lymphoma; aged ≥ 18 years; receiving ≥ 2 cycles chemotherapy. Patients will be randomised 1:1 to either the control or intervention arm with stratification by diagnosis, chemotherapy toxicity (high versus low), receipt of previous chemotherapy and hospital. Patients allocated to the control arm will receive 'Usual Care' whilst those allocated to the intervention will receive the intervention in addition to 'Usual Care'. Intervention patients will be provided with a computer tablet and software prompting twice-daily completion of physical/emotional scales for up to four chemotherapy cycles. Should patient data exceed pre-determined limits an Email alert is delivered to the treatment team, prompting nurses to view patient data, and contact the patient to provide clinical intervention. In addition, six scheduled nursing interventions will be completed to educate/support patients in use of the software. Patient outcomes will be measured cyclically (midpoint and end of cycles) via pen-and-paper self-report alongside review of the patient medical record. The primary outcome is burden due to nausea, mucositis, constipation and fatigue. Secondary outcomes include: burden due to vomiting and diarrhoea; psychological distress; ability to self-manage health; level of cancer information/support needs and; utilisation of health services. Analyses will be intention-to-treat. A cost-effectiveness analysis is planned. This trial is the first in the world to test a remote monitoring/management intervention for adult haematological cancer patients receiving chemotherapy. Future use of such interventions have the potential to improve patient outcomes/safety and decrease health care costs by enabling early detection/clinical intervention. ACTRN12614000516684 . Date registered: 12 March 2014 (registered retrospectively).

Evaluation of a WeChat-based dementia-specific training program for nurses in primary care settings: A randomized controlled trial.

PubMed

Wang, Feilong; Xiao, Lily Dongxia; Wang, Kaifa; Li, Min; Yang, Yanni

2017-12-01

Community nurses play a crucial role in early detection and timely diagnosis of dementia. However, they are usually not prepared for the role through their formal education, particularly in low- and middle-income countries due to undeveloped nursing curriculum in dementia care. This paper describes a two-arm cluster-randomized controlled trial to improve community nurses' knowledge, attitudes, and practice changes using an innovative and interactive mobile phone applet-based activity in primary care settings. The intervention sites received dementia-specific training and control sites received care training for older people with disability. Both groups completed measures assessing dementia knowledge, attitudes, and intentions to make changes to achieve early detection and a timely diagnosis of dementia immediately after training and at 3-month follow-up. The intervention group provided feedback immediately after training and at 3-month follow-up. The main results show that the intervention group demonstrated significant improvement in dementia knowledge and attitudes from baseline immediately after training and at the 3-month follow-up. The intervention group also showed more intentions to make changes to achieve early detection of dementia. Feedback suggested the program was well-received. Overall, the program showed acceptability and feasibility in improving nurses' dementia knowledge, attitudes, and intentions to achieve early detection of dementia. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of hand-arm exercise on venous blood constituents during leg exercise

NASA Technical Reports Server (NTRS)

Wong, N.; Silver, J. E.; Greenawalt, S.; Kravik, S. E.; Geelen, G.

1985-01-01

Contributions by ancillary hand and arm actions to the changes in blood constituents effected by leg exercises on cycle ergometer were assessed. Static or dynamic hand-arm exercises were added to the leg exercise (50 percent VO2 peak)-only control regimens for the subjects (19-27 yr old men) in the two experimental groups. Antecubital venous blood was analyzed at times 0, 15, and 30 min (T0, T15, and T30) for serum Na(+), K(+), osmolality, albumin, total CA(2+), and glucose; blood hemoglobin, hematocrit, and lactic acid; and change in plasma volume. Only glucose and lactate values were affected by additional arm exercise. Glucose decreased 4 percent at T15 and T30 after static exercise, and by 2 percent at T15 (with no change at T30) after dynamic arm exercise. Conversely, lactic acid increased by 20 percent at T30 after static exercise, and by 14 percent by T15 and 6 percent at T30 after dynamic arm exercise. It is concluded that additional arm movements, performed usually when gripping the handle-bar on the cycle ergometer, could introduce significant errors in measured venous concentrations of glucose and lactate in the leg-exercised subjects.

Web-based Therapy Plus Support by a Coach in Depressed Patients Referred to Secondary Mental Health Care: Randomized Controlled Trial.

PubMed

Hatcher, Simon; Whittaker, Robyn; Patton, Murray; Miles, Wayne Sylvester; Ralph, Nicola; Kercher, Katharina; Sharon, Cynthia

2018-01-23

The evidence for the effectiveness of Web-based therapies comes mainly from nonclinical populations, with a few studies in primary care. There is little evidence from patients referred to secondary mental health care with depression. Adherence to Web-based therapies is often poor. One way to increase this is to create a new health service role of a coach to guide people through the therapy. This study aimed to test in people referred to secondary care with depression if a Web-based therapy (The Journal) supported by a coach plus usual care would be more effective in reducing depression compared with usual care plus an information leaflet about Web-based resources after 12 weeks. We conducted a randomized controlled trial with two parallel arms and a process evaluation that included structured qualitative interviews analyzed using thematic analysis. The coach had a background in occupational therapy. Participants were recruited face-to-face at community mental health centers. We recruited 63 people into the trial (intervention 35, control 28). There were no statistically significant differences in the change from baseline in Patient Health Questionnaire-9 (PHQ-9) scores at 12 weeks comparing The Journal with usual care (mean change in PHQ-9 score 9.4 in the intervention group and 7.1 in the control group, t 41 =1.05, P=.30; mean difference=2.3, 95% CI -2.1 to 6.7). People who were offered The Journal attended on average about one less outpatient appointment compared with usual care, although this difference was not statistically significant (intervention mean number of visits 2.8 (SD 5.5) compared with 4.1 (SD 6.7) in the control group, t 45 =-0.80, P=.43; mean difference=1.3, 95% CI -4.5 to 2.0). The process evaluation found that the mean number of lessons completed in the intervention group was 2.5 (SD=1.9; range=0-6) and the number of contacts with the coach was a mean of 8.1 (SD=4.4; range=0-17). The qualitative interviews highlighted the problem of engaging clinicians in research and their resistance to recruitment: technical difficulties with The Journal, which prevented people logging in easily; difficulty accessing The Journal as it was not available on mobile devices; participants finding some lessons difficult; and participants saying they were too busy to complete the sessions. The study demonstrated that it is feasible to use a coach in this setting, that people found it helpful, and that it did not conflict with other care that participants were receiving. Future trials need to engage clinicians at an early stage to articulate where Web-based therapies fit into existing clinical pathways; Web-based therapies should be available on mobile devices, and logging in should be easy. The role of the coach should be explored in larger trials. Australian New Zealand Clinical Trials Registry (ACTRN): 12613000015741; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363351&isReview=true (Archived by WebCite at http://www.webcitation.org/6wEyCc6Ss). ©Simon Hatcher, Robyn Whittaker, Murray Patton, Wayne Sylvester Miles, Nicola Ralph, Katharina Kercher, Cynthia Sharon. Originally published in JMIR Mental Health (http://mental.jmir.org), 23.01.2018.

A Wireless Electroceutical Dressing Lowers Cost of Negative Pressure Wound Therapy

PubMed Central

Ghatak, Piya Das; Schlanger, Richard; Ganesh, Kasturi; Lambert, Lynn; Gordillo, Gayle M.; Martinsek, Patsy; Roy, Sashwati

2015-01-01

Objective: To test whether the use of a wireless electroceutical dressing (WED) (Procellera®) in conjunction with a 5-day negative pressure wound therapy (NPWT) may reduce the number of dressing changes required per week with this therapy. Approach: At the Ohio State University Comprehensive Wound Center, chronic wound patients (n=30) undergoing NPWT were randomized into two arms following consent as approved by the institutional review board. The control arm received standard of care NPWT, where the dressing change was performed thrice a week. The test arm received the same care except that the WED was added as an interface layer and dressing change was limited to twice a week. Results: A reduced cost of care was achieved using the WED in conjunction with NPWT. Despite fewer dressing changes in wounds dressed with the WED, closure outcomes were comparable with no overt signs of any wound complication, including infection. The cost of NPWT care during the week was significantly lower (from $2918 to $2346) in the WED-treated group compared with patients in the control arm. Innovation: This work introduces a novel technology platform involving a WED, which may be used in conjunction with NPWT. If used as such, NPWT is effective in decreasing the frequency of dressing change and lowering the cost of care. Conclusion: This work points toward the benefit of using the WED combined with NPWT. A larger clinical trial investigating the cost-effectiveness of WED in wound care is warranted. PMID:26005596

Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

PubMed

Ribas, Antoni; Kefford, Richard; Marshall, Margaret A; Punt, Cornelis J A; Haanen, John B; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A; Dreno, Brigitte; Nathan, Paul D; Mackiewicz, Jacek; Kirkwood, John M; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

2013-02-10

In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.

Breast radiation - discharge

MedlinePlus

... underwire. Ask your provider about wearing your breast prosthesis, if you have one. Self-care You need ... swelling ( edema ) in your arm. You have a feeling of tightness in your arm. Rings on your ...

Study protocol for "MOVEdiabetes": a trial to promote physical activity for adults with type 2 diabetes in primary health care in Oman.

PubMed

Alghafri, Thamra S; Alharthi, Saud M; Al-Farsi, Yahya M; Craigie, Angela M; Mcleod, Maureen; Anderson, Annie S

2017-01-06

Benefits of physical activity in the management of diabetes are well documented. However, evidence on the effectiveness of interventions integrating physical activity in diabetes care is sparse especially in the countries of the Gulf Cooperation Council. The results from this study will increase our understanding of the use of multi-component interventions aimed at increasing physical activity levels in inactive adults with type 2 diabetes in primary health care in Oman. The study is a one year 1:1 cluster randomized controlled trial of the MOVEdiabetes programme (intervention) versus usual care in eight primary health care centres in Oman. The MOVEdiabetes programme utilizes face to face physical activity consultations promoting 150 min of moderate to vigorous physical activity per week (≥600MET-mins/week), pedometers to self-monitor step counts and monthly telephone WhatsApp messages for follow up support. Inactive adults with type 2 diabetes and no contraindication to physical activity will be recruited over a two months period, and followed up for 12 months. To demonstrate a 50% between group difference in physical activity levels (MET-mins/week) over 12 months, (at a power of 80%, and significance level of 5%), 128 participants would be required to complete the study (64 in each arm). Based on a drop-out rate of 20%, 154 participants would require to be recruited (77 in each arm). Assuming a recruitment rate of 70%, 220 potential eligible participants would need to be approached. The primary outcome is change in levels of physical activity measured by the Global Physical Activity Questionnaire. In addition, accelerometers will be used in a sub group to objectively assess physical activity. Secondary outcomes include changes in metabolic and cardiovascular biomarkers, change in self-reported health, social support, self-efficacy for physical activity, and perceived acceptability of the program. All intervention delivery and support costs will be monitored. This study will contribute to the evidence on the feasibility, cultural acceptability and efficacy of interventional approaches for increasing physical activity in primary care for persons with type 2 diabetes in Oman. International Standard Randomised Controlled Trials No: ISRCTN14425284 . Registered 12 April 2016.

Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

PubMed Central

Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill

2018-01-01

Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health systems officials. Trial registration number NCT0280469; Pre-results. PMID:29530914

Promoting child safety in primary care: a cluster randomised controlled trial to reduce baby walker use.

PubMed

Kendrick, Denise; Illingworth, Rachel; Woods, Amanda; Watts, Kim; Collier, Jacqueline; Dewey, Michael; Hapgood, Rhydian; Chen, Chih-Mei

2005-08-01

Baby walkers are commonly used items of nursery equipment, but cause more than 3000 injuries each year in the UK. There is currently little evidence regarding the effectiveness of interventions in primary care to reduce walker use. To evaluate the effectiveness of an educational package provided by midwives and health visitors to reduce baby walker possession and use. Cluster randomised controlled trial. Sixty-four general practices in Nottingham and North Nottinghamshire, UK. An educational package aimed at discouraging mothers-to-be from obtaining and using a walker was delivered by midwives and health visitors to 1174 mothers-to-be of at least 28 weeks gestation. The control arm received usual care. Primary outcome measures were the possession and use of a walker. Secondary outcome measures included the frequency and duration of walker use, knowledge and attitudes towards walkers, plans to use a walker with future children, recommending a walker to a friend, and use of stair gates and fire guards. Intervention arm participants were significantly less likely to own (odds ratio [OR] = 0.63, 95% confidence interval [CI] = 0.43 to 0.93) or to use a walker (OR = 0.26, 95% CI = 0.08 to 0.84). They were significantly less likely to plan to use a walker with their next child (OR = 0.52, 95% CI = 0.31 to 0.86) or to agree that walkers keep children safe (OR = 0.35, 95% CI = 0.16 to 0.78). There was some evidence that they were less likely to recommend a walker to a friend (OR = 0.51, 95% CI = 0.28 to 0.91) or to agree that they help children to walk more quickly (OR = 0.53, 95% CI = 0.29 to 0.95). An educational package delivered by midwives and health visitors was effective in reducing baby walker possession and use. Providers of primary healthcare services should include baby walker education in their injury prevention strategy and child health promotion programme.

Behavioral Treatment for Weight Gain Prevention Among Black Women in Primary Care Practice

PubMed Central

Bennett, Gary G.; Foley, Perry; Levine, Erica; Whiteley, Jessica; Askew, Sandy; Steinberg, Dori M.; Batch, Bryan; Greaney, Mary L.; Miranda, Heather; Wroth, Thomas H.; Holder, Marni Gwyther; Emmons, Karen M.; Puleo, Elaine

2014-01-01

IMPORTANCE Few weight loss treatments produce clinically meaningful weight loss outcomes among black women, particularly in the primary care setting. New weight management strategies are necessary for this population. Weight gain prevention might be an effective treatment option, with particular benefits for overweight and class 1 obese black women. OBJECTIVE To compare changes in weight and cardiometabolic risk during a 12-month period among black women randomized to a primary care–based behavioral weight gain prevention intervention, relative to usual care. DESIGN, SETTING, AND PARTICIPANTS Two-arm randomized clinical trial (the Shape Program). We recruited patients from a 6-site community health center system. We randomized 194 overweight and class 1 obese (body mass index [calculated as weight in kilograms divided by height in meters squared], 25–34.9) premenopausal black women aged 25 to 44 years. Enrollment began on December 7, 2009; 12- and 18-month assessments were completed in February and October 2, 2012. INTERVENTIONS The medium-intensity intervention included tailored behavior change goals, weekly self-monitoring via interactive voice response, monthly counseling calls, tailored skills training materials, and a gym membership. MAIN OUTCOMES AND MEASURES Twelve-month change in weight and body mass index and maintenance of change at 18 months. RESULTS Participants had a mean age of 35.4 years, a mean weight of 81.1 kg, and a mean body mass index of 30.2 at baseline. Most were socioeconomically disadvantaged (79.7% with educational level less than a college degree; 74.3% reporting annual income <$30 000). The 12-month weight change was larger among intervention participants (mean [SD], −1.0 [0.5] kg), relative to usual care (0.5 [0.5] kg; mean difference, −1.4 kg [95%CI, −2.8 to −0.1 kg]; P = .04). At month 12, 62% of intervention participants were at or below their baseline weights compared with 45% of usual-care participants (P = .03). By 18 months, intervention participants maintained significantly larger changes in weight (mean difference, −1.7 kg; 95% CI, −3.3 to −0.2 kg). CONCLUSIONS AND RELEVANCE A medium-intensity primary care–based behavioral intervention demonstrated efficacy for weight gain prevention among socioeconomically disadvantaged black women. A “maintain, don’t gain” approach might be a useful alternative treatment for reducing obesity-associated disease risk among some premenopausal black women. PMID:23979005

Lifestyle intervention to improve quality of life and prevent weight gain after renal transplantation: Design of the Active Care after Transplantation (ACT) randomized controlled trial.

PubMed

Klaassen, Gerald; Zelle, Dorien M; Navis, Gerjan J; Dijkema, Desie; Bemelman, Frederike J; Bakker, Stephan J L; Corpeleijn, Eva

2017-09-15

Low physical activity and reduced physical functioning are common after renal transplantation, resulting in a reduced quality of life. Another common post-transplantation complication is poor cardio-metabolic health, which plays a main role in long-term outcomes in renal transplant recipients (RTR). It is increasingly recognized that weight gain in the first year after transplantation, especially an increase in fat mass, is a highly common contributor to cardio-metabolic risk. The aim of this study is to compare the outcomes of usual care to the effects of exercise alone, and exercise combined with dietary counseling, on physical functioning, quality of life and post-transplantation weight gain in RTR. The Active Care after Transplantation study is a multicenter randomized controlled trial with three arms in which RTR from 3 Dutch hospitals are randomized within the first year after transplantation to usual care, to exercise intervention (3 months supervised exercise 2 times per week followed by 12 months active follow-up), or to an exercise + diet intervention, consisting of the exercise training with additional dietary counseling (12 sessions over 15 months by a renal dietician). In total, 219 participants (73 per group) will be recruited. The primary outcome is the subdomain physical functioning of quality of life, (SF-36 PF). Secondary outcomes include other evaluations of quality of life (SF-36, KDQOL-SF, EQ-5D), objective measures of physical functioning (aerobic capacity and muscle strength), level of physical activity, gain in adiposity (body fat percentage by bio-electrical impedance assessment, BMI, waist circumference), and cardiometabolic risk factors (blood pressure, lipids, glucose metabolism). Furthermore, data on renal function, medical history, medication, psychological factors (motivation, kinesiophobia, coping style), nutrition knowledge, nutrition intake, nutrition status, fatigue, work participation, process evaluation and cost-effectiveness are collected. Evidence on the effectiveness of an exercise intervention, or an exercise + diet intervention on physical functioning, weight gain and cardiometabolic health in RTR is currently lacking. The outcomes of the present study may help to guide future evidence-based lifestyle care after renal transplantation. Number: NCT01047410 .

Pulled elbow in children.

PubMed

Yamanaka, Syunsuke; Goldman, Ran D

2018-06-01

Question Our practice is seeing children with relatively minor injuries to their elbows, with a history of "swinging" them when their hands are being held to cross the road. Nothing is usually found on a physical examination. I know that this is likely a "pulled elbow." Can we manage this in the clinic setting rather than sending the family to the emergency department? What would be the best course of action in the clinic setting? Answer Pulled elbow, also called nursemaid's elbow , is a radial head subluxation caused by axial traction or a sudden pull of the extended pronated arm, and it is a very common phenomenon. The practice of swinging children while holding their hands should be abandoned. In the case of pulled elbow, the child usually avoids moving the affected arm, holding it close to his or her body, without considerable pain, and no obvious swelling or deformity can be seen. While a fracture should be excluded, pulled elbow can usually be identified based on this presentation. The reduction procedure can easily be done in the office setting, with an 80% success rate and no complications. The hyperpronation maneuver (holding the elbow at 90° and then firmly pronating the wrist) to reduce pulled elbow has been found to be better than a supination-flexion maneuver (holding the elbow at 90° with one hand, supinating and flexing the elbow rapidly with the other) and should be exercised first. When 2 trials of reduction are unsuccessful, the child's arm should be splinted and the family should be sent for further evaluation. Copyright© the College of Family Physicians of Canada.

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.

Long-chain omega-3 fatty acids in aneurysmal subarachnoid hemorrhage: A randomized pilot trial of pharmaconutrition.

PubMed

Saito, Geisi; Zapata, Rodrigo; Rivera, Rodrigo; Zambrano, Héctor; Rojas, David; Acevedo, Hernán; Ravera, Franco; Mosquera, John; Vásquez, Juan E; Mura, Jorge

2017-01-01

Functional recovery after aneurysmal subarachnoid hemorrhage (SAH) remains a significant problem. We tested a novel therapeutic approach with long-chain omega-3 polyunsaturated fatty acids (n-3 PUFAs) to assess the safety and feasibility of an effectiveness trial. We conducted a multicentre, parallel, randomized, open-label pilot trial. Patients admitted within 72 hours after SAH with modified Fisher scale scores of 3 or 4 who were selected for scheduled aneurysm clipping were allocated to receive either n-3 PUFA treatment (parenteral perioperative: 5 days; oral: 8 weeks) plus usual care or usual care alone. Exploratory outcome measures included major postoperative intracranial bleeding complications (PIBCs), cerebral infarction caused by delayed cerebral ischemia, shunt-dependent hydrocephalus, and consent rate. The computed tomography evaluator was blinded to the group assignment. Forty-one patients were randomized, but one patient had to be excluded after allocation. Twenty patients remained for intention to treat analysis in each trial arm. No PIBs (95% confidence interval [CI]: 0.00 to 0.16) or other unexpected harm were observed in the intervention group (IG). No patient suspended the intervention due to side effects. There was a trend towards improvements in all benefit-related outcomes in the IG. The overall consent rate was 0.91 (95% CI: 0.78 to 0.96), and there was no consent withdrawal. Although the balance between the benefit and harm of the intervention appears highly favourable, further testing on SAH patients is required. We recommend proceeding with amendments in a dose-finding trial to determine the optimal duration of parenteral treatment.

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

Awareness of and memory for arm weakness during intracarotid sodium amytal testing.

PubMed

Carpenter, K; Berti, A; Oxbury, S; Molyneux, A J; Bisiach, E; Oxbury, J M

1995-02-01

The traditional association between anosognosia for hemiplegia and the right hemisphere was investigated in 31 patients with unilateral temporal lobe pathology during intracarotid sodium amytal testing (ISA) before epilepsy surgery. Recall of arm weakness was examined by questioning at the end of the test, when memory for items presented during the hemiplegia was also examined. Significantly more patients were amnesic for left arm weakness than for right. Amnesia for right arm weakness (and speech arrest) was significantly associated with pathology in the temporal lobe on the non-injected side and with impaired recognition of the memory items. Amnesia for left arm weakness was independent of both. Examination of cases where injection was contralateral to a hemisphere without pathology, and which showed normal memory capacity under ISA conditions, revealed that 87% recalled right arm weakness, but only 22% recalled left arm weakness. Awareness of arm weakness during left hemiplegia was examined in nine patients. Five of them were not aware of the weakness. Three of the four others could not subsequently recall it. By inference from the generally unimpaired recall of right arm weakness, following left hemisphere inactivation by amytal, an intact right hemisphere is capable of both recognizing right arm weakness and mediating its subsequent recall. In contrast, the left hemisphere was aware of left arm weakness only in approximately 50% of cases and even when there had been awareness usually could not mediate its subsequent recall. The suggestion is made that the right hemisphere may have a specific mnestic function for arm weakness, and presumably for hemiplegia, additional to the gnostic function.

[ Modern condition and prospects of development of cardiac surgery in the Armed Forces].

PubMed

Khubulava, G G; Ryzhman, N N; Ovchinnikov, Iu V; Tyrenko, V V; Peleshko, A S

2014-04-01

Authors consider the problem of delivery cardiac surgical care to contingent of the Defence Ministry. Perspective directions of development of cardiac surgery in the Armed Forces of the Russian Federation are the development of minimally invasive cardio surgery, endovascular development of modern methods of diagnosis and treatment, further development of electrophysiological methods for diagnosis and treatment of disorders of rhythm and conduction, the introduction of various kinds of auxiliary mechanical circulatory support systems in acute and chronic heart failure, development of transplantation in cardiac surgery, improvement of algorithm selection and referral of patients requiring cardiac care by providing primary health care to troop central military medical institutions, creating a single register of cardiac patients as part of the Armed Forces in order to determine the order and place of treatment, etc.

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

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.

Cost Analysis of a Home-Based Nurse Care Coordination Program

PubMed Central

Marek, Karen Dorman; Stetzer, Frank; Adams, Scott J; Bub, Linda Denison; Schlidt, Andrea; Colorafi, Karen Jiggins

2014-01-01

Objectives To determine whether a home-based care coordination program focused on medication self-management would affect the cost of care to the Medicare program and whether the addition of technology, a medication-dispensing machine, would further reduce cost. Design Randomized, controlled, three-arm longitudinal study. Setting Participant homes in a large Midwestern urban area. Participants Older adults identified as having difficulty managing their medications at discharge from Medicare Home Health Care (N = 414). Intervention A team consisting of advanced practice nurses (APNs) and registered nurses (RNs) coordinated care for two groups: home-based nurse care coordination (NCC) plus a pill organizer group and NCC plus a medication-dispensing machine group. Measurements To measure cost, participant claims data from 2005 to 2011 were retrieved from Medicare Part A and B Standard Analytical Files. Results Ordinary least squares regression with covariate adjustment was used to estimate monthly dollar savings. Total Medicare costs were $447 per month lower in the NCC plus pill organizer group (P = .11) than in a control group that received usual care. For participants in the study at least 3 months, total Medicare costs were $491 lower per month in the NCC plus pill organizer group (P = .06) than in the control group. The cost of the NCC plus pill organizer intervention was $151 per month, yielding a net savings of $296 per month or $3,552 per year. The cost of the NCC plus medication-dispensing machine intervention was $251 per month, and total Medicare costs were $409 higher per month than in the NCC plus pill organizer group. Conclusion Nurse care coordination plus a pill organizer is a cost-effective intervention for frail elderly Medicare beneficiaries. The addition of the medication machine did not enhance the cost effectiveness of the intervention. PMID:25482242

Implementing practice-linked pre-visit electronic journals in primary care: patient and physician use and satisfaction

PubMed Central

Businger, Alexandra; Gandhi, Tejal K; Grant, Richard W; Poon, Eric G; Schnipper, Jeffrey L; Volk, Lynn A; Middleton, Blackford

2010-01-01

Electronic health records (EHRs) and EHR-connected patient portals offer patient–provider collaboration tools for visit-based care. During a randomized controlled trial, primary care patients completed pre-visit electronic journals (eJournals) containing EHR-based medication, allergies, and diabetes (study arm 1) or health maintenance, personal history, and family history (study arm 2) topics to share with their provider. Assessment with surveys and usage data showed that among 2027 patients invited to complete an eJournal, 70.3% submitted one and 71.1% of submitters had one opened by their provider. Surveyed patients reported they felt more prepared for the visit (55.9%) and their provider had more accurate information about them (58.0%). More arm 1 versus arm 2 providers reported that eJournals were visit-time neutral (100% vs 53%; p<0.013), helpful to patients in visit preparation (66% vs 20%; p=0.082), and would recommend them to colleagues (78% vs 22%; p=0.0143). eJournal integration into practice warrants further study. PMID:20819852

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial

PubMed Central

2011-01-01

Background Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. Methods The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Discussion Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change. Trial Registration Current Controlled Trials ISRCTN34326236. PMID:22168530

Effect of a web-based chronic disease management system on asthma control and health-related quality of life: study protocol for a randomized controlled trial.

PubMed

Ahmed, Sara; Bartlett, Susan J; Ernst, Pierre; Paré, Guy; Kanter, Maria; Perreault, Robert; Grad, Roland; Taylor, Laurel; Tamblyn, Robyn

2011-12-14

Asthma is a prevalent and costly disease resulting in reduced quality of life for a large proportion of individuals. Effective patient self-management is critical for improving health outcomes. However, key aspects of self-management such as self-monitoring of behaviours and symptoms, coupled with regular feedback from the health care team, are rarely addressed or integrated into ongoing care. Health information technology (HIT) provides unique opportunities to facilitate this by providing a means for two way communication and exchange of information between the patient and care team, and access to their health information, presented in personalized ways that can alert them when there is a need for action. The objective of this study is to evaluate the acceptability and efficacy of using a web-based self-management system, My Asthma Portal (MAP), linked to a case-management system on asthma control, and asthma health-related quality of life. The trial is a parallel multi-centered 2-arm pilot randomized controlled trial. Participants are randomly assigned to one of two conditions: a) MAP and usual care; or b) usual care alone. Individuals will be included if they are between 18 and 70, have a confirmed asthma diagnosis, and their asthma is classified as not well controlled by their physician. Asthma control will be evaluated by calculating the amount of fast acting beta agonists recorded as dispensed in the provincial drug database, and asthma quality of life using the Mini Asthma Related Quality of Life Questionnaire. Power calculations indicated a needed total sample size of 80 subjects. Data are collected at baseline, 3, 6, and 9 months post randomization. Recruitment started in March 2010 and the inclusion of patients in the trial in June 2010. Self-management support from the care team is critical for improving chronic disease outcomes. Given the high volume of patients and time constraints during clinical visits, primary care physicians have limited time to teach and reinforce use of proven self-management strategies. HIT has the potential to provide clinicians and a large number of patients with tools to support health behaviour change. Current Controlled Trials ISRCTN34326236.

Financial incentives and physician commitment to guideline-recommended hypertension management.

PubMed

Hysong, Sylvia J; Simpson, Kate; Pietz, Kenneth; SoRelle, Richard; Broussard Smitham, Kristen; Petersen, Laura A

2012-10-01

To examine the impact of financial incentives on physician goal commitment to guideline-recommended hypertension care. Clinic-level cluster-randomized trial with 4 arms: individual, group, or combined incentives, and control. A total of 83 full-time primary care physicians at 12 Veterans Affairs medical centers completed web-based surveys measuring their goal commitment to guideline-recommended hypertension care every 4 months and telephone interviews at months 8 and 16. Intervention arm participants received performance-based incentives every 4 months for 5 periods. All participants received guideline education at baseline and audit and feedback every 4 months. Physician goal commitment did not vary over time or across arms. Participants reported patient nonadherence was a perceived barrier and consistent follow-up was a perceived facilitator to successful hypertension care, suggesting that providers may perceive hypertension management as more of a patient responsibility (external locus of control). Financial incentives may constitute an insufficiently strong intervention to influence goal commitment when providers attribute performance to external forces beyond their control.

A pragmatic randomised controlled trial and economic evaluation of family therapy versus treatment as usual for young people seen after second or subsequent episodes of self-harm: the Self-Harm Intervention - Family Therapy (SHIFT) trial.

PubMed

Cottrell, David J; Wright-Hughes, Alex; Collinson, Michelle; Boston, Paula; Eisler, Ivan; Fortune, Sarah; Graham, Elizabeth H; Green, Jonathan; House, Allan O; Kerfoot, Michael; Owens, David W; Saloniki, Eirini-Christina; Simic, Mima; Tubeuf, Sandy; Farrin, Amanda J

2018-03-01

Self-harm in adolescents is common and repetition rates high. There is limited evidence of the effectiveness of interventions to reduce self-harm. To assess the clinical effectiveness and cost-effectiveness of family therapy (FT) compared with treatment as usual (TAU). A pragmatic, multicentre, individually randomised controlled trial of FT compared with TAU. Participants and therapists were aware of treatment allocation; researchers were blind to allocation. Child and Adolescent Mental Health Services (CAMHS) across three English regions. Young people aged 11-17 years who had self-harmed at least twice presenting to CAMHS following self-harm. Eight hundred and thirty-two participants were randomised to manualised FT delivered by trained and supervised family therapists ( n  = 415) or to usual care offered by local CAMHS following self-harm ( n  = 417). Rates of repetition of self-harm leading to hospital attendance 18 months after randomisation. Out of 832 young people, 212 (26.6%) experienced a primary outcome event: 118 out of 415 (28.4%) randomised to FT and 103 out of 417 (24.7%) randomised to TAU. There was no evidence of a statistically significant difference in repetition rates between groups (the hazard ratio for FT compared with TAU was 1.14, 95% confidence interval 0.87 to 1.49; p  = 0.3349). FT was not found to be cost-effective when compared with TAU in the base case and most sensitivity analyses. FT was dominated (less effective and more expensive) in the complete case. However, when young people's and caregivers' quality-adjusted life-year gains were combined, FT incurred higher costs and resulted in better health outcomes than TAU within the National Institute for Health and Care Excellence cost-effectiveness range. Significant interactions with treatment, indicating moderation, were detected for the unemotional subscale on the young person-reported Inventory of Callous-Unemotional Traits ( p  = 0.0104) and the affective involvement subscale on the caregiver-reported McMaster Family Assessment Device ( p  = 0.0338). Caregivers and young people in the FT arm reported a range of significantly better outcomes on the Strengths and Difficulties Questionnaire. Self-reported suicidal ideation was significantly lower in the FT arm at 12 months but the same in both groups at 18 months. No significant unexpected adverse events or side effects were reported, with similar rates of expected adverse events across trial arms. For adolescents referred to CAMHS after self-harm, who have self-harmed at least once before, FT confers no benefits over TAU in reducing self-harm repetition rates. There is some evidence to support the effectiveness of FT in reducing self-harm when caregivers reported poor family functioning. When the young person themselves reported difficulty expressing emotion, FT did not seem as effective as TAU. There was no evidence that FT is cost-effective when only the health benefits to participants were considered but there was a suggestion that FT may be cost-effective if health benefits to caregivers are taken into account. FT had a significant, positive impact on general emotional and behavioural problems at 12 and 18 months. There was significant loss to follow-up for secondary outcomes and health economic analyses; the primary outcome misses those who do not attend hospital following self-harm; and the numbers receiving formal FT in the TAU arm were higher than expected. Evaluation of interventions targeted at subgroups of those who self-harm, longer-term follow-up and methods for evaluating health benefits for family groups rather than for individuals. Current Controlled Trials ISRCTN59793150. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 12. See the NIHR Journals Library website for further project information.

Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses.

PubMed

Rehackova, L; Arnott, B; Araujo-Soares, V; Adamson, A A; Taylor, R; Sniehotta, F F

2016-05-01

To explore the efficacy and acceptability of very low energy diets in overweight or obese adults with Type 2 diabetes. Controlled trials and qualitative studies of individuals with Type 2 diabetes that compared very low energy diets with standard care, minimal interventions, other weight loss interventions, less intensive very low energy diet interventions and very low energy diets with additional components were eligible for inclusion. Meta-analyses of changes in weight, blood glucose levels and attrition rates were performed. Acceptability of very low energy diets was assessed by attrition rates, number and severity of side effects, and by qualitative evaluations of the interventions. Four randomized, five non-randomized controlled trials and no qualitative studies (21 references, 9 studies, 346 participants) were identified. Meta-analyses showed that very low energy diets induced greater weight losses than minimal interventions, standard care or low energy diets at 3 and 6 months. No conclusive evidence for differences in outcomes between very low energy diets and Roux-en-Y gastric bypass surgery was found. Greater differences in energy prescription between intervention and comparator arms were associated with greater differences in weight loss and fasting blood glucose levels at 3 months. Attrition rates did not differ between the very low energy diets and the comparator arms at any measurement point. Very low energy diets are effective in substantial weight loss among people with Type 2 diabetes. Levels of adherence to very low energy diets in controlled studies appear to be high, although details about behaviour support provided are usually poorly described. © 2015 Diabetes UK.

Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial.

PubMed

Williams, Grant R; Nyrop, Kirsten A; Deal, Allison M; Muss, Hyman B; Sanoff, Hanna K

2015-05-01

Colorectal cancer (CRC) diagnosis and treatment can have substantial detrimental impacts on health related quality of life (HRQOL) and physical function. This is especially true for older CRC patients and is of paramount concern in chemotherapy treatment decision making; yet, few studies to date have focused on understanding and managing fatigue in older CRC patients. We present the design of a study to evaluate the feasibility and impact of a home-based, self-directed physical activity intervention on fatigue in older CRC patients receiving adjuvant chemotherapy treatment. Secondary aims pertain to intervention impact on HRQOL, physical function, and self-efficacy for managing fatigue. Multi-site, randomized controlled trial of physical activity intervention compared to usual care in a sample of older adults undergoing adjuvant chemotherapy for CRC. Forty CRC patients will be recruited and study questionnaires/assessments will be performed at baseline, 3 months, and after completion of adjuvant chemotherapy. The primary outcome is a comparison of the change in fatigue from baseline to 3 months between Intervention and Control arms. We will also compare changes in engagement in physical activity, HRQOL, physical function, and self-efficacy. Exploratory analyses will compare Intervention and Control arms with regard to changes in muscle mass and a biomarker aging that is known to increase during chemotherapy (p16(INK4a)). If positive, findings from this pilot study would suggest the potential for improving the care of older persons with CRC undergoing adjuvant chemotherapy through a home-based physical activity intervention to manage fatigue, HRQOL, and physical function. NCT02191969. Copyright © 2015 Elsevier Inc. All rights reserved.

Automated Software System to Promote Anticoagulation and Reduce Stroke Risk: Cluster-Randomized Controlled Trial.

PubMed

Holt, Tim A; Dalton, Andrew; Marshall, Tom; Fay, Matthew; Qureshi, Nadeem; Kirkpatrick, Susan; Hislop, Jenny; Lasserson, Daniel; Kearley, Karen; Mollison, Jill; Yu, Ly-Mee; Hobbs, F D Richard; Fitzmaurice, David

2017-03-01

Oral anticoagulants (OAC) substantially reduce risk of stroke in atrial fibrillation, but uptake is suboptimal. Electronic health records enable automated identification of people at risk but not receiving treatment. We investigated the effectiveness of a software tool (AURAS-AF [Automated Risk Assessment for Stroke in Atrial Fibrillation]) designed to identify such individuals during routine care through a cluster-randomized trial. Screen reminders appeared each time the electronic health records of an eligible patient was accessed until a decision had been taken over OAC treatment. Where OAC was not started, clinicians were prompted to indicate a reason. Control practices continued usual care. The primary outcome was the proportion of eligible individuals receiving OAC at 6 months. Secondary outcomes included rates of cardiovascular events and reports of adverse effects of the software on clinical decision-making. Forty-seven practices were randomized. The mean proportion-prescribed OAC at 6 months was 66.3% (SD=9.3) in the intervention arm and 63.9% (9.5) in the control arm (adjusted difference 1.21% [95% confidence interval -0.72 to 3.13]). Incidence of recorded transient ischemic attack was higher in the intervention practices (median 10.0 versus 2.3 per 1000 patients with atrial fibrillation; P =0.027), but at 12 months, we found a lower incidence of both all cause stroke ( P =0.06) and hemorrhage ( P =0.054). No adverse effects of the software were reported. No significant change in OAC prescribing occurred. A greater rate of diagnosis of transient ischemic attack (possibly because of improved detection or overdiagnosis) was associated with a reduction (of borderline significance) in stroke and hemorrhage over 12 months. URL: http://www.isrctn.com. Unique Identifier: ISRCTN55722437. © 2017 American Heart Association, Inc.

Diet and anthropometry at 2 years of age following an oral health promotion programme for Australian Aboriginal children and their carers: a randomised controlled trial.

PubMed

Smithers, Lisa G; Lynch, John; Hedges, Joanne; Jamieson, Lisa M

2017-12-01

There are marked disparities between indigenous and non-indigenous children's diets and oral health. Both diet and oral health are linked to longer-term health problems. We aimed to investigate whether a culturally appropriate multi-faceted oral health promotion intervention reduced Aboriginal children's intake of sugars from discretionary foods at 2 years of age. We conducted a single-blind, parallel-arm randomised controlled trial involving women who were pregnant or had given birth to an Aboriginal child in the previous 6 weeks. The treatment group received anticipatory guidance, Motivational Interviewing, health and dental care for mothers during pregnancy and children at 6, 12 and 18 months. The control group received usual care. The key dietary outcome was the percent energy intake from sugars in discretionary foods (%EI), collected from up to three 24-h dietary recalls by trained research officers who were blind to intervention group. Secondary outcomes included intake of macronutrients, food groups, anthropometric z scores (weight, height, BMI and mid-upper arm circumference) and blood pressure. We enrolled 224 children to the treatment group and 230 to the control group. Intention-to-treat analyses showed that the %EI of sugars in discretionary foods was 1·6 % lower in the treatment group compared with control (95 % CI -3·4, 0·2). This culturally appropriate intervention at four time-points from pregnancy to 18 months resulted in small changes to 2-year-old Aboriginal children's diets, which was insufficient to warrant broader implementation of the intervention. Further consultation with Aboriginal communities is necessary for understanding how to improve the diet and diet-related health outcomes of young Aboriginal children.

Feasibility and Preliminary Efficacy of Visual Cue Training to Improve Adaptability of Walking after Stroke: Multi-Centre, Single-Blind Randomised Control Pilot Trial

PubMed Central

Hollands, Kristen L.; Pelton, Trudy A.; Wimperis, Andrew; Whitham, Diane; Tan, Wei; Jowett, Sue; Sackley, Catherine M.; Wing, Alan M.; Tyson, Sarah F.; Mathias, Jonathan; Hensman, Marianne; van Vliet, Paulette M.

2015-01-01

Objectives Given the importance of vision in the control of walking and evidence indicating varied practice of walking improves mobility outcomes, this study sought to examine the feasibility and preliminary efficacy of varied walking practice in response to visual cues, for the rehabilitation of walking following stroke. Design This 3 arm parallel, multi-centre, assessor blind, randomised control trial was conducted within outpatient neurorehabilitation services Participants Community dwelling stroke survivors with walking speed <0.8m/s, lower limb paresis and no severe visual impairments Intervention Over-ground visual cue training (O-VCT), Treadmill based visual cue training (T-VCT), and Usual care (UC) delivered by physiotherapists twice weekly for 8 weeks. Main outcome measures: Participants were randomised using computer generated random permutated balanced blocks of randomly varying size. Recruitment, retention, adherence, adverse events and mobility and balance were measured before randomisation, post-intervention and at four weeks follow-up. Results Fifty-six participants participated (18 T-VCT, 19 O-VCT, 19 UC). Thirty-four completed treatment and follow-up assessments. Of the participants that completed, adherence was good with 16 treatments provided over (median of) 8.4, 7.5 and 9 weeks for T-VCT, O-VCT and UC respectively. No adverse events were reported. Post-treatment improvements in walking speed, symmetry, balance and functional mobility were seen in all treatment arms. Conclusions Outpatient based treadmill and over-ground walking adaptability practice using visual cues are feasible and may improve mobility and balance. Future studies should continue a carefully phased approach using identified methods to improve retention. Trial Registration Clinicaltrials.gov NCT01600391 PMID:26445137

Translating knowledge for action against stroke--using 5-minute videos for stroke survivors and caregivers to improve post-stroke outcomes: study protocol for a randomized controlled trial (Movies4Stroke).

PubMed

Kamal, Ayeesha Kamran; Khoja, Adeel; Usmani, Bushra; Muqeet, Abdul; Zaidi, Fabiha; Ahmed, Masood; Shakeel, Saadia; Soomro, Nabila; Gowani, Ambreen; Asad, Nargis; Ahmed, Asma; Sayani, Saleem; Azam, Iqbal; Saleem, Sarah

2016-01-27

Two thirds of the global mortality of stroke is borne by low and middle income countries (LMICs). Pakistan is the world's sixth most populous country with a stroke-vulnerable population and is without a single dedicated chronic care center. In order to provide evidence for a viable solution responsive to this health care gap, and leveraging the existing >70% mobile phone density, we thought it rational to test the effectiveness of a mobile phone-based video intervention of short 5-minute movies to educate and support stroke survivors and their primary caregivers. Movies4Stroke will be a randomized control, outcome assessor blinded, parallel group, single center superiority trial. Participants with an acute stroke, medically stable, with mild to moderate disability and having a stable primary caregiver will be included. After obtaining informed consent the stroke survivor-caregiver dyad will be randomized. Intervention participants will have the movie program software installed in their phone, desktop, or Android device which will allow them to receive, view and repeat 5-minute videos on stroke-related topics at admission, discharge and first and third months after enrollment. The control arm will receive standard of care at an internationally accredited center with defined protocols. The primary outcome measure is medication adherence as ascertained by a locally validated Morisky Medication Adherence Scale and control of major risk factors such as blood pressure, blood sugar and blood cholesterol at 12 months post discharge. Secondary outcome measures are post-stroke complications and mortality, caregiver knowledge and change in functional outcomes after acute stroke at 1, 3, 6, 9 and 12 months. Movies4Stroke is designed to enroll 300 participant dyads after inflating 10% to incorporate attrition and non-compliance and has been powered at 95% to detect a 15% difference between intervention and usual care arm. Analysis will be done by the intention-to-treat principle. Movies4Stroke is a randomized trial testing an application aimed at supporting caregivers and stroke survivors in a LMIC with no rehabilitation or chronic support systems. NCT02202330 (28 January 2015).

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.

Effectiveness of medicines review with web-based pharmaceutical treatment algorithms in reducing potentially inappropriate prescribing in older people in primary care: a cluster randomized trial (OPTI-SCRIPT study protocol).

PubMed

Clyne, Barbara; Bradley, Marie C; Smith, Susan M; Hughes, Carmel M; Motterlini, Nicola; Clear, Daniel; McDonnell, Ronan; Williams, David; Fahey, Tom

2013-03-13

Potentially inappropriate prescribing in older people is common in primary care and can result in increased morbidity, adverse drug events, hospitalizations and mortality. In Ireland, 36% of those aged 70 years or over received at least one potentially inappropriate medication, with an associated expenditure of over €45 million.The main objective of this study is to determine the effectiveness and acceptability of a complex, multifaceted intervention in reducing the level of potentially inappropriate prescribing in primary care. This study is a pragmatic cluster randomized controlled trial, conducted in primary care (OPTI-SCRIPT trial), involving 22 practices (clusters) and 220 patients. Practices will be allocated to intervention or control arms using minimization, with intervention participants receiving a complex multifaceted intervention incorporating academic detailing, medicines review with web-based pharmaceutical treatment algorithms that provide recommended alternative treatment options, and tailored patient information leaflets. Control practices will deliver usual care and receive simple patient-level feedback on potentially inappropriate prescribing. Routinely collected national prescribing data will also be analyzed for nonparticipating practices, acting as a contemporary national control. The primary outcomes are the proportion of participant patients with potentially inappropriate prescribing and the mean number of potentially inappropriate prescriptions per patient. In addition, economic and qualitative evaluations will be conducted. This study will establish the effectiveness of a multifaceted intervention in reducing potentially inappropriate prescribing in older people in Irish primary care that is generalizable to countries with similar prescribing challenges. Current controlled trials ISRCTN41694007.

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.

The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial

PubMed Central

Ernst, Pierre; Bartlett, Susan J; Valois, Marie-France; Zaihra, Tasneem; Paré, Guy; Grad, Roland; Eilayyan, Owis; Perreault, Robert; Tamblyn, Robyn

2016-01-01

Background Whether Web-based technologies can improve disease self-management is uncertain. My Asthma Portal (MAP) is a Web-based self-management support system that couples evidence-based behavioral change components (self-monitoring of symptoms, physical activity, and medication adherence) with real-time monitoring, feedback, and support from a nurse case manager. Objective The aim of this study was to compare the impact of access to a Web-based asthma self-management patient portal linked to a case-management system (MAP) over 6 months compared with usual care on asthma control and quality of life. Methods A multicenter, parallel, 2-arm, pilot, randomized controlled trial was conducted with 100 adults with confirmed diagnosis of asthma from 2 specialty clinics. Asthma control was measured using an algorithm based on overuse of fast-acting bronchodilators and emergency department visits, and asthma-related quality of life was assessed using the Mini-Asthma Quality of Life Questionnaire (MAQLQ). Secondary mediating outcomes included asthma symptoms, depressive symptoms, self-efficacy, and beliefs about medication. Process evaluations were also included. Results A total of 49 individuals were randomized to MAP and 51 to usual care. Compared with usual care, participants in the intervention group reported significantly higher asthma quality of life (mean change 0.61, 95% CI 0.03 to 1.19), and the change in asthma quality of life for the intervention group between baseline and 3 months (mean change 0.66, 95% CI 0.35 to 0.98) was not seen in the control group. No significant differences in asthma quality of life were found between the intervention and control groups at 6 (mean change 0.46, 95% CI –0.12 to 1.05) and 9 months (mean change 0.39, 95% CI –0.2 to 0.98). For poor control status, there was no significant effect of group, time, or group by time. For all self-reported measures, the intervention group had a significantly higher proportion of individuals, demonstrating a minimal clinically meaningful improvement compared with the usual care group. Conclusions This study supported the use of MAP to enhance asthma quality of life but not asthma control as measured by an administrative database. Implementation of MAP beyond 6 months with tailored protocols for monitoring symptoms and health behaviors as individuals’ knowledge and self-management skills improve may result in long-term gains in asthma control. ClinicalTrial International Standard Randomized Controlled Trial Number (ISRCTN): 34326236; http://www.isrctn.com/ISRCTN34326236 (Archived by Webcite at http://www.webcitation.org/6mGxoI1R7). PMID:27908846

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.

Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial.

PubMed

Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

2014-01-01

Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), p<0.001; 57% vs 33%, adjusted/clustered OR 3.08 (95% CI 1.43 to 6.66), p=0.004, respectively). Intervention attending physicians tended to be more aware of actionable TPAD results (59% vs 29%, adjusted/clustered OR 4.25 (0.65, 27.85), p=0.13). One hundred and eighteen (85%) and 43 (63%) intervention attending physician and PCP survey respondents, respectively, were satisfied with this intervention. Automated email notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. ClinicalTrials.gov (NCT01153451).

Trained lay health workers reduce common mental disorder symptoms of adults with suicidal ideation in Zimbabwe: a cohort study.

PubMed

Munetsi, Epiphany; Simms, Victoria; Dzapasi, Lloyd; Chapoterera, Georgina; Goba, Nyaradzo; Gumunyu, Tichaona; Weiss, Helen A; Verhey, Ruth; Abas, Melanie; Araya, Ricardo; Chibanda, Dixon

2018-02-08

Suicidal ideation may lead to deliberate self-harm which increases the risk of death by suicide. Globally, the main cause of deliberate self-harm is depression. The aim of this study was to explore prevalence of, and risk factors for, suicidal ideation among men and women with common mental disorder (CMD) symptoms attending public clinics in Zimbabwe, and to determine whether problem solving therapy delivered by lay health workers can reduce common mental disorder symptoms among people with suicidal ideation, using secondary analysis of a randomised controlled trial. At trial enrolment, the Shona Symptom Questionnaire (SSQ) was used to screen for CMD symptoms. In the intervention arm, participants received six problem-solving therapy sessions conducted by trained and supervised lay health workers, while those in the control arm received enhanced usual care. We used multivariate logistic regression to identify risk factors for suicidal ideation at enrolment, and cluster-level logistic regression to compare SSQ scores at endline (6 months follow-up) between trial arms, stratified by suicidal ideation at enrolment. There were 573 participants who screened positive for CMD symptoms and 75 (13.1%) reported suicidal ideation at baseline. At baseline, after adjusting for confounders, suicidal ideation was independently associated with being aged over 24, lack of household income (household income yes/no; adjusted odds ratio 0.52 (95% CI 0.29, 0.95); p = 0.03) and with having recently skipped a meal due to lack of food (adjusted odds ratio 3.06 (95% CI 1.81, 5.18); p < 0.001). Participants who reported suicidal ideation at enrolment experienced similar benefit to CMD symptoms from the Friendship Bench intervention (adjusted mean difference - 5.38, 95% CI -7.85, - 2.90; p < 0.001) compared to those who had common mental disorder symptoms but no suicidal ideation (adjusted mean difference - 4.86, 95% CI -5.68, - 4.04; p < 0.001). Problem-solving therapy delivered by trained and supervised lay health workers reduced common mental disorder symptoms among participants with suicidal thoughts who attended primary care facilities in Zimbabwe. pactr.org ldentifier: PACTR201410000876178.

Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial

PubMed Central

Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

2014-01-01

Background and objective Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. Methods We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. Results We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), p<0.001; 57% vs 33%, adjusted/clustered OR 3.08 (95% CI 1.43 to 6.66), p=0.004, respectively). Intervention attending physicians tended to be more aware of actionable TPAD results (59% vs 29%, adjusted/clustered OR 4.25 (0.65, 27.85), p=0.13). One hundred and eighteen (85%) and 43 (63%) intervention attending physician and PCP survey respondents, respectively, were satisfied with this intervention. Conclusions Automated email notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. Clinical Trial Registration: ClinicalTrials.gov (NCT01153451) PMID:24154834

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.

Study protocol: identifying and delivering point-of-care information to improve care coordination.

PubMed

Hysong, Sylvia J; Che, Xinxuan; Weaver, Sallie J; Petersen, Laura A

2015-10-19

The need for deliberately coordinated care is noted by many national-level organizations. The Department of Veterans Affairs (VA) recently transitioned primary care clinics nationwide into Patient Aligned Care Teams (PACTs) to provide more accessible, coordinated, comprehensive, and patient-centered care. To better serve this purpose, PACTs must be able to successfully sequence and route interdependent tasks to appropriate team members while also maintaining collective situational awareness (coordination). Although conceptual frameworks of care coordination exist, few explicitly articulate core behavioral markers of coordination or the related information needs of team members attempting to synchronize complex care processes across time for a shared patient population. Given this gap, we partnered with a group of frontline primary care personnel at ambulatory care sites to identify the specific information needs of PACT members that will enable them to coordinate their efforts to provide effective, coordinated care. The study has three objectives: (1) development of measurable, prioritized point-of-care criteria for effective PACT coordination; (2) identifying the specific information needed at the point of care to optimize coordination; and (3) assessing the effect of adopting the aforementioned coordination standards on PACT clinicians' coordination behaviors. The study consists of three phases. In phase 1, we will employ the Productivity Measurement and Enhancement System (ProMES), a structured approach to performance measure creation from industrial/organizational psychology, to develop coordination measures with a design team of 6-10 primary care personnel; in phase 2, we will conduct focus groups with the phase 1 design team to identify point-of-care information needs. Phase 3 is a two-arm field experiment (n PACT = 28/arm); intervention arm PACTs will receive monthly feedback reports using the measures developed in phase 1 and attend brief monthly feedback sessions. Control arm PACTs will receive no intervention. PACTs will be followed prospectively for up to 1 year. This project combines both action research and implementation science methods to address important gaps in the existing care coordination literature using a partnership-based research design. It will provide an evidence-based framework for care coordination by employing a structured methodology for a systematic approach to care coordination in PACT settings and identifying the information needs that produce the most successful coordination of care. ISRCTN15412521.

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.

A pragmatic randomised controlled trial to evaluate the cost-effectiveness of a physical activity intervention as a treatment for depression: the treating depression with physical activity (TREAD) trial.

PubMed

Chalder, M; Wiles, N J; Campbell, J; Hollinghurst, S P; Searle, A; Haase, A M; Taylor, A H; Fox, K R; Baxter, H; Davis, M; Thorp, H; Winder, R; Wright, C; Calnan, M; Lawlor, D A; Peters, T J; Sharp, D J; Turner, K M; Montgomery, A A; Lewis, G

2012-01-01

The TREAting Depression with physical activity (TREAD) study investigated the cost-effectiveness of a physical activity intervention, in addition to usual general practitioner care, as a treatment for people with depression. An individually randomised, pragmatic, multicentre randomised controlled trial with follow-up at 4, 8 and 12 months. A subset of participants took part in a qualitative study that investigated the acceptability and perceived benefits of the intervention. General practices in the Bristol and Exeter areas. Aged 18-69 years with an International Statistical Classification of Diseases and Related Health Problems, 10th Edition (ICD-10) diagnosis of depression and scoring ≥ 14 on the Beck Depression Inventory (BDI). Those who were unable to complete self-administered questionnaires in English, with medical contraindications to physical activity or with psychosis, bipolar disorder or serious drug abuse were excluded. We devised an intervention designed to encourage choice and autonomy in the adoption of physical activity. It consisted of up to three face-to-face and ten telephone contacts delivered by a trained physical activity facilitator over an 8-month period. The primary outcome was the BDI score measured at 4 months. Secondary outcomes included depressive symptoms over the 12 months and quality of life, antidepressant use and level of physical activity. The study recruited 361 patients, with 182 randomised to the intervention arm and 179 to the usual care arm; there was 80% retention at the 4-month follow-up. The intervention group had a slightly lower BDI score at 4 months [-0.54, 95% confidence interval (CI) -3.06 to 1.99] but there was no evidence that the intervention improved outcome for depression. Neither was there any evidence to suggest a difference in the prescription of or self-reported use of antidepressants. However, the amount of physical activity undertaken by those who had received the intervention was increased (odds ratio 2.3, 95% CI 1.3 to 3.9) and was sustained beyond the end of the intervention. From a health-care perspective, the intervention group was more costly than the usual care group, with the cost of the intervention £220 per person on average. It is therefore extremely unlikely that the intervention is cost-effective as a treatment for depression using current willingness-to-pay thresholds. This physical activity intervention is very unlikely to lead to any clinical benefit in terms of depressive symptoms or to be a cost-effective treatment for depression. Previous research has reported some benefit and there are three possible reasons for this discrepancy: first, even though the intervention increased self-reported physical activity, the increase in activity was not sufficiently large to lead to a measurable influence; second, only more vigorous activity might be of benefit; and third, previous studies had recruited individuals with a pre-existing commitment to physical activity. Future research is needed to identify and explain the mechanisms by which depression might be effectively treated, including, in particular, specific guidance on the optimum type, intensity and duration of physical activity required to produce a therapeutic effect. Current Controlled Trials ISRCTN16900744. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 10. See the HTA programme website for further project information.

Effect of HIV self-testing on the number of sexual partners among female sex workers in Zambia

PubMed Central

Oldenburg, Catherine E.; Chanda, Michael M.; Ortblad, Katrina F.; Mwale, Magdalene; Chongo, Steven; Kamungoma, Nyambe; Kanchele, Catherine; Fullem, Andrew; Moe, Caitlin; Barresi, Leah G.; Harling, Guy D.; Bärnighausen, Till

2018-01-01

Objectives: To assess the effect of two health system approaches to distribute HIV self-tests on the number of female sex workers’ client and nonclient sexual partners. Design: Cluster randomized controlled trial. Methods: Peer educators recruited 965 participants. Peer educator–participant groups were randomized 1 : 1 : 1 to one of three arms: delivery of HIV self-tests directly from a peer educator, free facility-based delivery of HIV self-tests in exchange for coupons, or referral to standard-of-care HIV testing. Participants in all three arms completed four peer educator intervention sessions, which included counseling and condom distribution. Participants were asked the average number of client partners they had per night at baseline, 1 and 4 months, and the number of nonclient partners they had in the past 12 months (at baseline) and in the past month (at 1 month and 4 months). Results: At 4 months, participants reported significantly fewer clients per night in the direct delivery arm (mean difference −0.78 clients, 95% CI −1.28 to −0.28, P = 0.002) and the coupon arm (−0.71, 95% CI −1.21 to −0.21, P = 0.005) compared with standard of care. Similarly, they reported fewer nonclient partners in the direct delivery arm (−3.19, 95% CI −5.18 to −1.21, P = 0.002) and in the coupon arm (−1.84, 95% CI −3.81 to 0.14, P = 0.07) arm compared with standard of care. Conclusion: Expansion of HIV self-testing may have positive behavioral effects enhancing other HIV prevention efforts among female sex workers in Zambia. Trial Registration: ClinicalTrials.gov NCT02827240. PMID:29494424

A randomized trial of nature scenery and sounds versus urban scenery and sounds to reduce pain in adults undergoing bone marrow aspirate and biopsy.

PubMed

Lechtzin, Noah; Busse, Anne M; Smith, Michael T; Grossman, Stuart; Nesbit, Suzanne; Diette, Gregory B

2010-09-01

Bone marrow aspiration and biopsy (BMAB) is painful when performed with only local anesthetic. Our objective was to determine whether viewing nature scenes and listening to nature sounds can reduce pain during BMAB. This was a randomized, controlled clinical trial. Adult patients undergoing outpatient BMAB with only local anesthetic were assigned to use either a nature scene with accompanying nature sounds, city scene with city sounds, or standard care. The primary outcome was a visual analog scale (0-10) of pain. Prespecified secondary analyses included categorizing pain as mild and moderate to severe and using multiple logistic regression to adjust for potential confounding variables. One hundred and twenty (120) subjects were enrolled: 44 in the Nature arm, 39 in the City arm, and 37 in the Standard Care arm. The mean pain scores, which were the primary outcome, were not significantly different between the three arms. A higher proportion in the Standard Care arm had moderate-to-severe pain (pain rating ≥4) than in the Nature arm (78.4% versus 60.5%), though this was not statistically significant (p = 0.097). This difference was statistically significant after adjusting for differences in the operators who performed the procedures (odds ratio = 3.71, p = 0.02). We confirmed earlier findings showing that BMAB is poorly tolerated. While mean pain scores were not significantly different between the study arms, secondary analyses suggest that viewing a nature scene while listening to nature sounds is a safe, inexpensive method that may reduce pain during BMAB. This approach should be considered to alleviate pain during invasive procedures.

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.

A Randomized Controlled Trial of a Cardiopulmonary Resuscitation Video in Advance Care Planning for Progressive Pancreas and Hepatobiliary Cancer Patients

PubMed Central

Volandes, Angelo E.; Chen, Ling Y.; Gary, Kristen A.; Li, Yuelin; Agre, Patricia; Levin, Tomer T.; Reidy, Diane L.; Meng, Raymond D.; Segal, Neil H.; Yu, Kenneth H.; Abou-Alfa, Ghassan K.; Janjigian, Yelena Y.; Kelsen, David P.; O'Reilly, Eileen M.

2013-01-01

Abstract Background Cardiopulmonary resuscitation (CPR) is an important advance directive (AD) topic in patients with progressive cancer; however such discussions are challenging. Objective This study investigates whether video educational information about CPR engenders broader advance care planning (ACP) discourse. Methods Patients with progressive pancreas or hepatobiliary cancer were randomized to an educational CPR video or a similar CPR narrative. The primary end-point was the difference in ACP documentation one month posttest between arms. Secondary end-points included study impressions; pre- and post-intervention knowledge of and preferences for CPR and mechanical ventilation; and longitudinal patient outcomes. Results Fifty-six subjects were consented and analyzed. Rates of ACP documentation (either formal ADs or documented discussions) were 40% in the video arm (12/30) compared to 15% in the narrative arm (4/26), OR=3.6 [95% CI: 0.9–18.0], p=0.07. Post-intervention knowledge was higher in both arms. Posttest, preferences for CPR had changed in the video arm but not in the narrative arm. Preferences regarding mechanical ventilation did not change in either arm. The majority of subjects in both arms reported the information as helpful and comfortable to discuss, and they recommended it to others. More deaths occurred in the video arm compared to the narrative arm, and more subjects died in hospice settings in the video arm. Conclusions This pilot randomized trial addressing downstream ACP effects of video versus narrative decision tools demonstrated a trend towards more ACP documentation in video subjects. This trend, as well as other video effects, is the subject of ongoing study. PMID:23725233

Tailored Behavioral Intervention Among Blacks With Metabolic Syndrome and Sleep Apnea: Results of the MetSO Trial.

PubMed

Jean-Louis, Girardin; Newsome, Valerie; Williams, Natasha J; Zizi, Ferdinand; Ravenell, Joseph; Ogedegbe, Gbenga

2017-01-01

To assess effectiveness of a culturally and linguistically tailored telephone-delivered intervention to increase adherence to physician-recommended evaluation and treatment of obstructive sleep apnea (OSA) among blacks. In a two-arm randomized controlled trial, we evaluated effectiveness of the tailored intervention among blacks with metabolic syndrome, relative to those in an attention control arm (n = 380; mean age = 58 ± 13; female = 71%). The intervention was designed to enhance adherence using culturally and linguistically tailored OSA health messages delivered by a trained health educator based on patients' readiness to change and unique barriers preventing desired behavior changes. Analysis showed 69.4% of the patients in the intervention arm attended initial consultation with a sleep specialist, compared to 36.7% in the control arm; 74.7% of those in the intervention arm and 66.7% in the control arm completed diagnostic evaluation; and 86.4% in the intervention arm and 88.9% in the control arm adhered to PAP treatment based on subjective report. Logistic regression analyses adjusting for sociodemographic factors indicated patients in the intervention arm were 3.17 times more likely to attend initial consultation, compared to those in the control arm. Adjusted models revealed no significant differences between the two arms regarding adherence to OSA evaluation or treatment. The intervention was successful in promoting importance of sleep consultation and evaluation of OSA among blacks, while there was no significant group difference in laboratory-based evaluation and treatment adherence rates. It seems that the fundamental barrier to OSA care in that population may be the importance of seeking OSA care. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

Relationship of task strain and physical strength to end-of-work fatigue among nurses at social welfare facilities.

PubMed

Shimaoka, M; Hiruta, S; Ono, Y; Yabe, K

1995-07-01

To study the relationship of task strain and physical fitness to fatigue among nurses employed at social welfare facilities, we investigated the degree of habitual end-of-work fatigue among 99 nurses (ages 20-49 years) in its relationship to both the degree of strain in various tasks and various indices of physical fitness. Results were as follows: (1) Fatigue complaint rates were nearly the same (35-38%) regardless of age. (2) Mean arm power and maximal oxygen uptake (VO2max) were significantly lower in a high degree of fatigue group than a low degree of fatigue group. (3) Four of 21 tasks elicited strain complaint rates greater than 50%: "nursing of seriously ill patients", "nursing of medical device-assisted patients", "bathing care", and "excretory/diaper changing care". (4) Significant positive correlations were noted between the degree of fatigue and the degree of strain complaint with regard to "nursing of medical device-assisted patients", "bathing care", and "excretory/diaper changing care". (5) Strain complaint rates were significantly higher in a low arm power group than a high arm power group with regard to "nursing of seriously ill patients", "nursing of medical device-assisted patients", and "excretory/diaper changing care". (6) Strain complaint rates were significantly higher in a low VO2max group than a high VO2max group with regard to "nursing of medical device-assisted patients", "bathing care", and "excretory/diaper changing care". These results suggest the need for measures to alleviate task strain and to increase arm strength and overall stamina so that nursing work does not result in excessive fatigue.

Effects of antenatal care and HIV treatment integration on elements of the PMTCT cascade: Results from the SHAIP cluster-randomized controlled trial in Kenya

PubMed Central

Turan, Janet M.; Onono, Maricianah; Steinfeld, Rachel L.; Shade, Starley B.; Owuor, Kevin; Washington, Sierra; Bukusi, Elizabeth A.; Ackers, Marta L.; Kioko, Jackson; Interis, Evelyn C.; Cohen, Craig R.

2015-01-01

Background Integrating antenatal care (ANC) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission (PMTCT) cascade. The current study aimed to determine if integration of HIV services into ANC settings improves PMTCT service utilization outcomes. Methods ANC clinics in rural Kenya were randomized to integrated (6 clinics, 569 women) or non-integrated (6 clinics, 603 women) services. Intervention clinics provided all HIV services, including highly active antiretroviral therapy (HAART), while control clinics provided PMTCT services but referred women to HIV care clinics within the same facility. PMTCT utilization outcomes among HIV-infected women (maternal HIV care enrollment, HAART initiation, and 3-month infant HIV testing uptake) were compared using generalized estimating equations and Cox regression. Results HIV care enrollment was higher in intervention compared to control clinics (69% versus 36%, Odds Ratio (OR)=3.94, 95% Confidence Interval (CI): 1.14–13.63). Median time to enrollment was significantly shorter among intervention arm women (0 versus 8 days, Hazard Ratio (HR)=2.20, 95% CI: 1.62–3.01). Eligible women in the intervention arm were more likely to initiate HAART (40% versus 17%, OR=3.22, 95% CI: 1.81–5.72). Infant testing was more common in the intervention arm (25% versus 18%), however not statistically different. No significant differences were detected in postnatal service uptake or maternal retention. Conclusions Service integration increased maternal HIV care enrollment and HAART uptake. However, PMTCT utilization outcomes were still suboptimal, and postnatal service utilization remained poor in both study arms. Further improvements in the PMTCT cascade will require additional research and interventions. PMID:25967269

Pelvic floor muscle training for prevention and treatment of urinary and faecal incontinence in antenatal and postnatal women.

PubMed

Hay-Smith, Jean; Mørkved, Siv; Fairbrother, Kate A; Herbison, G Peter

2008-10-08

About a third of women have urinary incontinence and up to a tenth have faecal incontinence after childbirth. Pelvic floor muscle training is commonly recommended during pregnancy and after birth both for prevention and treatment of incontinence. To determine the effect of pelvic floor muscle training compared to usual antenatal and postnatal care on incontinence. We searched the Cochrane Incontinence Group Specialised Register (searched 24 April 2008) and the references of relevant articles. Randomised or quasi-randomised trials in pregnant or postnatal women. One arm of the trials needed to include pelvic floor muscle training (PFMT). Another arm was either no pelvic floor muscle training or usual antenatal or postnatal care. The pelvic floor muscle training programmes were divided into either: intensive; or unspecified if training elements were lacking or information was not provided. Reasons for classifying as intensive included one to one instruction, checking for correct contraction, continued supervision of training, or choice of an exercise programme with sufficient exercise dose to strengthen muscle. Trials were independently assessed for eligibility and methodological quality. Data were extracted then cross checked. Disagreements were resolved by discussion. Data were processed as described in the Cochrane Handbook. Three different populations of women were considered separately: women dry at randomisation (prevention); women wet at randomisation (treatment); and a population-based approach in women who might be one or the other (prevention or treatment). Trials were further divided into: those which started during pregnancy (antenatal); and after delivery (postnatal). Sixteen trials met the inclusion criteria. Fifteen studies involving 6181 women (3040 PFMT, 3141 controls) contributed to the analysis. Based on the trial reports, four trials appeared to be at low risk of bias, two at low to moderate risk, and the remainder at moderate risk of bias.Pregnant women without prior urinary incontinence who were randomised to intensive antenatal PFMT were less likely than women randomised to no PFMT or usual antenatal care to report urinary incontinence in late pregnancy (about 56% less; RR 0.44, 95% CI 0.30 to 0.65) and up to six months postpartum (about 30% less; RR 0.71, 95% CI 0.52 to 0.97).Postnatal women with persistent urinary incontinence three months after delivery and who received PFMT were less likely than women who did not receive treatment or received usual postnatal care (about 20% less; RR 0.79, 95% CI 0.70 to 0.90) to report urinary incontinence 12 months after delivery. It seemed that the more intensive the programme the greater the treatment effect. Faecal incontinence was also reduced at 12 months after delivery: women receiving PFMT were about half as likely to report faecal incontinence (RR 0.52, 95% CI 0.31 to 0.87).Based on the trial data to date, the extent to which population-based approaches to PFMT are effective is less clear (that is, offering advice on PFMT to all pregnant or postpartum women whether they have incontinence symptoms or not). It is possible that population-based approaches might be effective when the intervention is intensive enough.There was not enough evidence about long-term effects for either urinary or faecal incontinence. There is some evidence that PFMT in women having their first baby can prevent urinary incontinence in late pregnancy and postpartum. In common with older women with stress incontinence, there is support for the widespread recommendation that PFMT is an appropriate treatment for women with persistent postpartum urinary incontinence. It is possible that the effects of PFMT might be greater with targeted rather than population-based approaches and in certain groups of women (for example primiparous women; women who had bladder neck hypermobility in early pregnancy, a large baby, or a forceps delivery). These and other uncertainties, particularly long-term effectiveness, require further testing.

Note: Model-based identification method of a cable-driven wearable device for arm rehabilitation

NASA Astrophysics Data System (ADS)

Cui, Xiang; Chen, Weihai; Zhang, Jianbin; Wang, Jianhua

2015-09-01

Cable-driven exoskeletons have used active cables to actuate the system and are worn on subjects to provide motion assistance. However, this kind of wearable devices usually contains uncertain kinematic parameters. In this paper, a model-based identification method has been proposed for a cable-driven arm exoskeleton to estimate its uncertainties. The identification method is based on the linearized error model derived from the kinematics of the exoskeleton. Experiment has been conducted to demonstrate the feasibility of the proposed model-based method in practical application.

Emergency department-initiated palliative care for advanced cancer patients: protocol for a pilot randomized controlled trial.

PubMed

Kandarian, Brandon; Morrison, R Sean; Richardson, Lynne D; Ortiz, Joanna; Grudzen, Corita R

2014-06-25

For patients with advanced cancer, visits to the emergency department (ED) are common. Such patients present to the ED with a specific profile of palliative care needs, including burdensome symptoms such as pain, dyspnea, or vomiting that cannot be controlled in other settings and a lack of well-defined goals of care. The goals of this study are: i) to test the feasibility of recruiting, enrolling, and randomizing patients with serious illness in the ED; and ii) to evaluate the impact of ED-initiated palliative care on health care utilization, quality of life, and survival. This is a protocol for a single center parallel, two-arm randomized controlled trial in ED patients with metastatic solid tumors comparing ED-initiated palliative care referral to a control group receiving usual care. We plan to enroll 125 to 150 ED-advanced cancer patients at Mount Sinai Hospital in New York, USA, who meet the following criteria: i) pass a brief cognitive screen; ii) speak fluent English or Spanish; and iii) have never been seen by palliative care. We will use balanced block randomization in groups of 50 to assign patients to the intervention or control group after completion of a baseline questionnaire. All research staff performing assessment or analysis will be blinded to patient assignment. We will measure the impact of the palliative care intervention on the following outcomes: i) timing and rate of palliative care consultation; ii) quality of life and depression at 12 weeks, measured using the FACT-G and PHQ-9; iii) health care utilization; and iv) length of survival. The primary analysis will be based on intention-to-treat. This pilot randomized controlled trial will test the feasibility of recruiting, enrolling, and randomizing patients with advanced cancer in the ED, and provide a preliminary estimate of the impact of palliative care referral on health care utilization, quality of life, and survival. Clinical Trials.gov identifier: NCT01358110 (Entered 5/19/2011).

Nurse-delivered counselling intervention for parental HIV disclosure: Results from a pilot randomized controlled trial in China

PubMed Central

Simoni, Jane M.; Yang, Joyce P.; Shiu, Cheng-Shi; Chen, Wei-ti; Udell, Wadiya; Bao, Meijuan; Zhang, Lin; Lu, Hongzhou

2016-01-01

Objective The objective of this study was to design and conduct a preliminary evaluation of an intervention to assist parents in decision-making about disclosure of their HIV diagnosis to their children. Design This was a pilot randomized controlled trial (RCT) with blinded assessment. Participants were randomized to intervention or treatment-as-usual (TAU) arms. Setting The study occurred at an outpatient HIV primary care centre in Shanghai, China. Participants Participants were 20 HIV-positive outpatients with at least one child (13–25 years old) who was unaware of the parent’s HIV diagnosis. Intervention The nurse-delivered intervention involved three, hour-long, individual sessions over 4 weeks. Intervention content comprised family assessment, discussion of advantages and disadvantages of disclosure, psycho-education about cognitive, social and emotional abilities of children at different developmental stages, and disclosure planning and practicing via role-plays. Main outcome measure(s) Primary study outcomes for intervention versus TAU arms were self-reported disclosure distress, self-efficacy and behaviours along a continuum from no disclosure to full disclosure and open communication about HIV. Results In all cross-sectional (Wald tests) and longitudinal (general estimating equations) analyses, at both postintervention (4 weeks) and follow-up (13 weeks), effects were in the hypothesized directions. Despite the small sample size, most of these between-arm comparisons were statistically significant, with at least one result for each outcome indicating a ‘large’ effect size. Conclusion Our results suggest that nurses are able to deliver a counselling intervention in a clinic setting with the potential to alleviate parental distress around HIV disclosure to their children. Findings warrant future trials powered for efficacy. PMID:26049544

Predictors of Study Attrition in a Randomized Controlled Trial Evaluating a Perinatal Home-Visiting Program with Mothers with Psychosocial Vulnerabilities

PubMed Central

Foulon, Stéphanie; Greacen, Tim; Pasquet, Blandine; Dugravier, Romain; Saïas, Thomas; Guedeney, Nicole; Guedeney, Antoine; Tubach, Florence

2015-01-01

Objective Randomised controlled trials evaluating perinatal home-visiting programs are frequently confronted with the problem of high attrition rates. The aim of the present study is to identify predictors of study attrition in a trial evaluating a perinatal home-visiting program in France. Materials and Methods CAPEDP is a French randomized trial comparing a perinatal home-visiting program using psychologists versus usual care (N = 440). The first assessment was at inclusion into the trial at the 27th week of pregnancy and the final assessment when the child reached the age of two. Attrition rates were calculated at 3 and 24 months postpartum. Stepwise logistic regression was used to identify predictors of early (between inclusion and 3 months postpartum) and later (between 3 and 24 months postpartum) attrition among social, psychological and parenting factors. Results Attrition rates were 17% and 63% at 3 and 24 months respectively. At 24 months, there was significantly more attrition in the control arm (70.6%) compared to the intervention arm (55.2%). Five independent predictors of early attrition were identified: having already had an abortion; having greater attachment insecurity as measured with the Vulnerable Attachment Style Questionnaire (VASQ); having lower global severity of psychiatric symptoms as assessed with the Symptom Check-List (SCL-90) at inclusion, being neither currently employed nor studying; and declaring no tobacco consumption during pregnancy. Being randomized into the control arm, having undergone early parental loss before age 11 and having lower global severity of psychiatric symptoms (SCL-90) at 3 months postpartum were the only variables associated with later attrition. Conclusion This study provides key information for identifying mothers who may require specific support to avoid study attrition in trials evaluating a home-visiting program. PMID:26554839

Acupuncture for breast cancer-related lymphedema: a randomized controlled trial.

PubMed

Bao, Ting; Iris Zhi, Wanqing; Vertosick, Emily A; Li, Qing Susan; DeRito, Janice; Vickers, Andrew; Cassileth, Barrie R; Mao, Jun J; Van Zee, Kimberly J

2018-03-08

Approximately 20% of breast cancer survivors develop breast cancer-related lymphedema (BCRL), and current therapies are limited. We compared acupuncture (AC) to usual care wait-list control (WL) for treatment of persistent BCRL. Women with moderate BCRL lasting greater than six months were randomized to AC or WL. AC included twice weekly manual acupuncture over six weeks. We evaluated the difference in circumference and bioimpedance between affected and unaffected arms. Responders were defined as having a decrease in arm circumference difference greater than 30% from baseline. We used analysis of covariance for circumference and bioimpedance measurements and Fisher's exact to determine the proportion of responders. Among 82 patients, 73 (89%) were evaluable for the primary endpoint (36 in AC, 37 in WL). 79 (96%) patients received lymphedema treatment before enrolling in our study; 67 (82%) underwent ongoing treatment during the trial. We found no significant difference between groups for arm circumference difference (0.38 cm greater reduction in AC vs. WL, 95% CI - 0.12 to 0.89, p = 0.14) or bioimpedance difference (1.06 greater reduction in AC vs. WL, 95% CI - 5.72 to 7.85, p = 0.8). There was also no difference in the proportion of responders: 17% AC versus 11% WL (6% difference, 95% CI - 10 to 22%, p = 0.5). No severe adverse events were reported. Our acupuncture protocol appeared to be safe and well tolerated. However, it did not significantly reduce BCRL in pretreated patients receiving concurrent lymphedema treatment. This regimen does not improve upon conventional lymphedema treatment for breast cancer survivors with persistent BCRL.

Motivational tools to improve probationer treatment outcomes.

PubMed

Taxman, Faye S; Walters, Scott T; Sloas, Lincoln B; Lerch, Jennifer; Rodriguez, Mayra

2015-07-01

Motivational interviewing (MI) is a promising practice to increase motivation, treatment retention, and reducing recidivism among offender populations. Computer-delivered interventions have grown in popularity as a way to change behaviors associated with drug and alcohol use. Motivational Assistance Program to Initiate Treatment (MAPIT) is a three arm, multisite, randomized controlled trial, which examines the impact of Motivational interviewing (MI), a motivational computer program (MC), and supervision as usual (SAU) on addiction treatment initiation, engagement, and retention. Secondary outcomes include drug/alcohol use, probation progress, recidivism (i.e., criminal behavior) and HIV/AIDS testing and treatment among probationers. Participant characteristics are measured at baseline, 2, and 6 months after assignment. The entire study will include 600 offenders, with each site recruiting 300 offenders (Baltimore City, Maryland and Dallas, Texas). All participants will go through standard intake procedures for probation and participate in probation requirements as usual. After standard intake, participants will be recruited and screened for eligibility. The results of this clinical trial will fill a gap in knowledge about ways to motivate probationers to participate in addiction treatment and HIV care. This randomized clinical trial is innovative in the way it examines the use of in-person vs. technological approaches to improve probationer success. NCT01891656. Copyright © 2015. Published by Elsevier Inc.

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.

A high-dose preparation of lactobacilli and bifidobacteria in the prevention of antibiotic-associated and Clostridium difficile diarrhoea in older people admitted to hospital: a multicentre, randomised, double-blind, placebo-controlled, parallel arm trial (PLACIDE).

PubMed

Allen, S J; Wareham, K; Wang, D; Bradley, C; Sewell, B; Hutchings, H; Harris, W; Dhar, A; Brown, H; Foden, A; Gravenor, M B; Mack, D; Phillips, C J

2013-12-01

Antibiotic-associated diarrhoea (AAD) occurs most commonly in older people admitted to hospital and within 12 weeks of exposure to broad-spectrum antibiotics. Although usually a mild and self-limiting illness, the 15-39% of cases caused by Clostridium difficile infection [C. difficile diarrhoea (CDD)] may result in severe diarrhoea and death. Previous research has shown that probiotics, live microbial organisms that, when administered in adequate numbers, are beneficial to health, may be effective in preventing AAD and CDD. To determine the clinical effectiveness and cost-effectiveness of a high-dose, multistrain probiotic in the prevention of AAD and CDD in older people admitted to hospital. A multicentre, randomised, double-blind, placebo-controlled, parallel-arm trial. Medical, surgical and elderly care inpatient wards in five NHS hospitals in the UK. Eligible patients were aged ≥ 65 years, were exposed to one or more oral or parenteral antibiotics and were without pre-existing diarrhoeal disorders, recent CDD or at risk of probiotic adverse effects. Out of 17,420 patients screened, 2981 (17.1%) were recruited. Participants were allocated sequentially according to a computer-generated random allocation sequence; 1493 (50.1%) were allocated to the probiotic and 1488 (49.9%) to the placebo arm. Vegetarian capsules containing two strains of lactobacilli and two strains of bifidobacteria (a total of 6 × 10(10) organisms per day) were taken daily for 21 days. The placebo was inert maltodextrin powder in identical capsules. The occurrence of AAD within 8 weeks and CDD within 12 weeks of recruitment was determined by participant follow-up and checking hospital laboratory records by research nurses who were blind to arm allocation. Analysis based on the treatment allocated included 2941 (98.7%) participants. Potential risk factors for AAD at baseline were similar in the two study arms. Frequency of AAD (including CDD) was similar in the probiotic (159/1470, 10.8%) and placebo arms [153/1471, 10.4%; relative risk (RR) 1.04; 95% confidence interval (CI) 0.84 to 1.28; p = 0.71]. CDD was an uncommon cause of AAD and occurred in 12/1470 (0.8%) participants in the probiotic and 17/1471 (1.2%) in the placebo arm (RR 0.71; 95% CI 0.34 to 1.47; p = 0.35). Duration and severity of diarrhoea, common gastrointestinal symptoms, serious adverse events and quality of life measures were also similar in the two arms. Total health-care costs per patient did not differ significantly between the probiotic (£8020; 95% CI £7620 to £8420) and placebo (£8010; 95% CI £7600 to £8420) arms. We found no evidence that probiotic administration was effective in preventing AAD. Although there was a trend towards reduced CDD in the probiotic arm, on balance, the administration of this probiotic seems unlikely to benefit older patients exposed to antibiotics. A better understanding of the pathogenesis of AAD and CDD and the strain-specific effects of probiotics is needed before further clinical trials of specific microbial preparations are undertaken. Evaluation of the effectiveness of other probiotics will be difficult where other measures, such as antibiotic stewardship, have reduced CDD rates. This trial is registered as ISRCTN70017204. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 57. See the NIHR Journals Library website for further project information.

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2017-08-23

The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: study protocol for a pragmatic randomised controlled trial.

PubMed

Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

2013-10-18

Restorative home care services help older people maximise their independence using a multi-dimensional approach. They usually include an exercise program designed to improve the older person's strength, balance and function. The types of programs currently offered require allocation of time during the day to complete specific exercises. This is not how the majority of home care clients prefer to be active and may be one of the reasons that few older people do the exercises regularly and continue the exercises post discharge.This paper describes the study protocol to test whether a Lifestyle Functional Exercise (LiFE) program: 1) is undertaken more often; 2) is more likely to be continued over the longer term; and, 3) will result in greater functional gains compared to a standard exercise program for older people receiving a restorative home care service. A pragmatic randomised controlled trial (RCT) design was employed with two study arms: LiFE program (intervention) and the current exercise program (control). Silver Chain, a health and community care organisation in Perth, Western Australia. One hundred and fifty restorative home care clients, aged 65 years and older. The primary outcome is a composite measure incorporating balance, strength and mobility. Other outcome measures include: physical functioning, falls efficacy, and levels of disability and functioning. If LiFE is more effective than the current exercise program, the evidence will be presented to the service management accompanied by the recommendation that it be adopted as the generic exercise program to be used within the restorative home care service. Australian and New Zealand Clinical Trials Registry ACTRN12611000788976.

Randomised controlled trial of the clinical and cost effectiveness of a specialist team for managing refractory unipolar depressive disorder.

PubMed

Morriss, Richard; Marttunnen, Sarah; Garland, Anne; Nixon, Neil; McDonald, Ruth; Sweeney, Tim; Flambert, Heather; Fox, Richard; Kaylor-Hughes, Catherine; James, Marilyn; Yang, Min

2010-11-29

Around 40 per cent of patients with unipolar depressive disorder who are treated in secondary care mental health services do not respond to first or second line treatments for depression. Such patients have 20 times the suicide rate of the general population and treatment response becomes harder to achieve and sustain the longer they remain depressed. Despite this there are no randomised controlled trials of community based service delivery interventions delivering both algorithm based pharmacotherapy and psychotherapy for patients with chronic depressive disorder in secondary care mental health services who remain moderately or severely depressed after six months treatment. Without such trials evidence based guidelines on services for such patients cannot be derived. Single blind individually randomised controlled trial of a specialist depression disorder team (psychiatrist and psychotherapist jointly assessing and providing algorithm based drug and psychological treatment) versus usual secondary care treatment. We will recruit 174 patients with unipolar depressive disorder in secondary mental health services with a Hamilton Depression Rating Scale (HDRS) score ≥ 16 and global assessment of function (GAF) ≤ 60 after ≥ 6 months treatment. The primary outcome measures will be the HDRS and GAF supplemented by economic analysis including the EQ5 D and analysis of barriers to care, implementation and the process of care. Audits to benchmark both treatment arms against national standards of care will aid the interpretation of the results of the study. This trial will be the first to assess the effectiveness and implementation of a community based specialist depression disorder team. The study has been specially designed as part of the CLAHRC Nottinghamshire, Derbyshire and Lincolnshire joint collaboration between university, health and social care organisations to provide information of direct relevance to decisions on commissioning, service provision and implementation.

The effects of cash transfers and vouchers on the use and quality of maternity care services: A systematic review.

PubMed

Hunter, Benjamin M; Harrison, Sean; Portela, Anayda; Bick, Debra

2017-01-01

Cash transfers and vouchers are forms of 'demand-side financing' that have been widely used to promote maternal and newborn health in low- and middle-income countries during the last 15 years. This systematic review consolidates evidence from seven published systematic reviews on the effects of different types of cash transfers and vouchers on the use and quality of maternity care services, and updates the systematic searches to June 2015 using the Joanna Briggs Institute approach for systematic reviewing. The review protocol for this update was registered with PROSPERO (CRD42015020637). Data from 51 studies (15 more than previous reviews) and 22 cash transfer and voucher programmes suggest that approaches tied to service use (either via payment conditionalities or vouchers for selected services) can increase use of antenatal care, use of a skilled attendant at birth and in the case of vouchers, postnatal care too. The strongest evidence of positive effect was for conditional cash transfers and uptake of antenatal care, and for vouchers for maternity care services and birth with a skilled birth attendant. However, effects appear to be shaped by a complex set of social and healthcare system barriers and facilitators. Studies have typically focused on an initial programme period, usually two or three years after initiation, and many lack a counterfactual comparison with supply-side investment. There are few studies to indicate that programmes have led to improvements in quality of maternity care or maternal and newborn health outcomes. Future research should use multiple intervention arms to compare cost-effectiveness with similar investment in public services, and should look beyond short- to medium-term service utilisation by examining programme costs, longer-term effects on service utilisation and health outcomes, and the equity of those effects.

A cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents.

PubMed

Stallard, P; Phillips, R; Montgomery, A A; Spears, M; Anderson, R; Taylor, J; Araya, R; Lewis, G; Ukoumunne, O C; Millings, A; Georgiou, L; Cook, E; Sayal, K

2013-10-01

Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Although this is a major problem, relatively few adolescents with, or at risk of developing, depression are identified and referred for treatment. This suggests the need to investigate alternative approaches whereby preventative interventions are made widely available in schools. To investigate the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents. Cluster randomised controlled trial. Year groups ( n = 28) randomly allocated on a 1 : 1 : 1 basis to one of three trial arms once all schools were recruited and balanced for number of classes, number of students, Personal, Social and Health Education (PSHE) lesson frequency, and scheduling of PSHE. Year groups 8 to 11 (ages 12-16 years) in mixed-sex secondary schools in the UK. Data were collected between 2009 and 2011. Young people who attended PSHE at participating schools were eligible ( n = 5503). Of the 5030 who agreed to participate, 1064 (21.2%) were classified as 'high risk': 392 in the classroom-based CBT arm, 374 in the attention control PSHE arm and 298 in the usual PSHE arm. Primary outcome data on the high-risk group at 12 months were available for classroom-based CBT ( n = 296), attention control PSHE ( n = 308) and usual PSHE ( n = 242). The Resourceful Adolescent Programme (RAP) is a focused CBT-based intervention adapted for the UK (RAP-UK) and delivered by two facilitators external to the school. Control groups were usual PSHE (usual school curriculum delivered by teachers) and attention control (usual school PSHE with additional support from two facilitators). Interventions were delivered universally to whole classes. Clinical effectiveness: symptoms of depression [Short Mood and Feelings Questionnaire (SMFQ)] in adolescents at high risk of depression 12 months from baseline. Cost-effectiveness: incremental cost-effectiveness ratios (ICERs) based on SMFQ score and quality-adjusted life-years (from European Quality of Life-5 Dimensions scores) between baseline and 12 months. Process evaluation: reach, attrition and qualitative feedback from service recipients and providers. SMFQ scores had decreased for high-risk adolescents in all trial arms at 12 months, but there was no difference between arms [classroom-based CBT vs. usual PSHE adjusted difference in means 0.97, 95% confidence interval (CI) -0.34 to 2.28; classroom-based CBT vs. attention control PSHE -0.63, 95% CI -1.99 to 0.73]. Costs of interventions per child were estimated at £41.96 for classroom-based CBT and £34.45 for attention control PSHE. Fieller's method was used to obtain a parametric estimate of the 95% CI for the ICERs and construct the cost-effectiveness acceptability curve, confirming that classroom-based CBT was not cost-effective relative to the controls. Reach of classroom-based CBT was good and attrition was low (median 80% attending ≥ 60% of sessions), but feedback indicated some difficulties with acceptability and sustainability. Classroom-based CBT, attention control PSHE and usual PSHE produced similar outcomes. Classroom-based CBT may result in increased self-awareness and reporting of depressive symptoms. Classroom-based CBT was not shown to be cost-effective. While schools are a convenient way of reaching a wide range of young people, implementing classroom-based CBT within schools is challenging, particularly with regard to fitting programmes into a busy timetable, the lack of value placed on PSHE, and difficulties engaging with teachers and young people. Wider use of classroom-based depression prevention programmes should not be undertaken without further research. If universal preventative approaches are to be pursued, their clinical effectiveness and cost-effectiveness with younger children (aged 10-11 years), before the incidence of depression increases, should be investigated. Alternatively, the clinical effectiveness of indicated school-based programmes targeting those already displaying symptoms of depression should be investigated. Current Controlled Trials ISRCTN19083628. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 47. See the HTA programme website for further project information.

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial

PubMed Central

2012-01-01

Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Conclusion Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. Trial registration National Medical Research Registration (NMRR) Number: NMRR-08-287-1442 Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370 PMID:23046818

The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial.

PubMed

Selvaraj, Francis Jude; Mohamed, Mafauzy; Omar, Khairani; Nanthan, Sudha; Kusiar, Zainab; Subramaniam, Selvaraj Y; Ali, Norsiah; Karanakaran, Kamalakaran; Ahmad, Fauziah; Low, Wilson H H

2012-10-10

To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were -30.09% and -27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Patients who received coaching and advice from primary care physicians (with or without the assistance by nurse educators) showed improvement in LDL-cholesterol. Disease management services delivered by PCP-NE demonstrated a trend towards add-on improvements in cholesterol control compared to care delivered by physicians alone; however, the improvements were not maintained when the services were withdrawn. National Medical Research Registration (NMRR) Number: NMRR-08-287-1442Trial Registration Number (ClinicalTrials.gov Identifier): NCT00708370.

Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial

PubMed Central

Kibuuka Musoke, Daniel; Ngabirano, Thomson; Nakitende, Aidah; Magoola, Jonathan; Kayiira, Prossy; Taasi, Geoffrey; Barresi, Leah G.; McConnell, Margaret A.; Bärnighausen, Till

2017-01-01

Background HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. Methods and findings We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of 2 HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (1 peer educator and 8 participants) were randomized to either (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard of care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18, 2016, to November 16, 2016. Participants’ median age was 28 years (IQR 24–32). Our prespecified primary outcomes were self-report of any HIV testing at 1 month and at 4 months; our prespecified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care and ART initiation. In addition, we analyzed 2 secondary outcomes that were not prespecified: self-report of repeat HIV testing—to understand the intervention effects on frequent testing—and self-reported facility-based testing—to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard of care arm, both at 1 month (risk ratio [RR] 1.33, 95% CI 1.17–1.51, p < 0.001) and at 4 months (RR 1.14, 95% CI 1.07–1.22, p < 0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at 1 month (RR 1.18, 95% CI 1.07–1.31, p = 0.001) and at 4 months (RR 1.03, 95% CI 1.01–1.05, p = 0.02). At 1 month, fewer participants in the intervention arms had sought medical care for HIV than in the standard of care arm, but these differences were not significant and were reduced in magnitude at 4 months. There were no statistically significant differences in ART initiation across study arms. At 4 months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard of care arm (RR 1.51, 95% CI 1.29–1.77, p < 0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.08–1.37, p = 0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. Conclusions In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. We found that direct provision of HIV self-tests was significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities. HIV self-testing could play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment as prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. Trial registration ClinicalTrials.gov NCT02846402 PMID:29182634

Effectiveness of app-based self-acupressure for women with menstrual pain compared to usual care: a randomized pragmatic trial.

PubMed

Blödt, Susanne; Pach, Daniel; Eisenhart-Rothe, Sanna von; Lotz, Fabian; Roll, Stephanie; Icke, Katja; Witt, Claudia M

2018-02-01

Primary dysmenorrhea is common among women of reproductive age. Nonsteroidal anti-inflammatory drugs and oral contraceptives are effective treatments, although the failure rate is around 20% to 25%. Therefore additional evidence-based treatments are needed. In recent years, the use of smartphone applications (apps) has increased rapidly and may support individuals in self-management strategies. We aimed to investigate the effectiveness of app-based self-acupressure in women with menstrual pain. A 2-armed, randomized, pragmatic trial was conducted from December 2012 to April 2015 with recruitment until August 2014 in Berlin, Germany, among women aged 18 to 34 years with self-reported cramping pain of 6 or more on a numeric rating scale (NRS) for the worst pain intensity during the previous menstruation. After randomization, women performed either app-based self-acupressure (n = 111) or followed usual care only (n = 110) for 6 consecutive menstruation cycles. The primary outcome was the mean pain intensity (NRS 0-10) on the days with pain during the third menstruation. Secondary outcomes included worst pain intensity during menstruation, duration of pain, 50% responder rates (reduction of mean pain by at least 50%), medication intake, sick leave days, and body efficacy expectation assessed at the first, second, third, and sixth menstruation cycles. We included 221 women (mean age, 24.0 years; standard deviation [SD], 3.6 years). The mean pain intensity difference during the third menstruation was statistically significant in favor of acupressure (acupressure: 4.4; 95% confidence interval [CI], 4.0-4.7; usual care 5.0; 95% CI, 4.6-5.3; mean difference -0.6; 95% CI, - 1.2 to -0.1; P = .026). At the sixth cycle, the mean difference between the groups (-1.4; 95% CI, -2.0 to -0.8; P < .001) reached clinical relevance. At the third and sixth menstruation cycles, responder rates were 37% and 58%, respectively, in the acupressure group, in contrast to 23% and 24% in the usual care group. Moreover, the worst pain intensity (group difference -0.6; 95% CI, -1.2 to -0.02; and -1.4; 95% CI, -2.0 to -0.7), the number of days with pain (-0.4; 95% CI, -0.9 to -0.01; and -1.2; 95% CI, -1.6 to -0.7) and the proportion of women with pain medication at the third and sixth menstruation cycles (odds ratio [OR], 0.5; 95% CI, 0.3-0.9] and 0.3 (95% CI, 0.2-0.5) were lower in the acupressure group. At the third cycle, hormonal contraceptive use was more common in the usual care group than in the acupressure group (OR, 0.5; 95% CI, 0.3-0.97) but not statistically significantly different at the sixth cycle (OR, 0.6; 95% CI, 0.3-1.1]). The number of sick leave days and body efficacy expectation (self-efficacy scale) did not differ between groups. On a scale of 0 to 6, mean satisfaction with the intervention at the third cycle was 3.7 (SD 1.3), recommendation of the intervention to others 4.3 (1.5), appropriateness of acupressure for menstrual pain 3.9 (1.4), and application of acupressure for other pain 4.3 (1.5). The intervention was safe, and after the sixth cycle, two-thirds of the women (67.6%) still applied acupressure on all days with pain. Smartphone app-delivered self-acupressure resulted in a reduction of menstrual pain compared to usual care only. Effects were increasing over time, and adherence was good. Future trials should include comparisons with other active treatment options. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Design of a multi-arm randomized clinical trial with no control arm.

PubMed

Magaret, Amalia; Angus, Derek C; Adhikari, Neill K J; Banura, Patrick; Kissoon, Niranjan; Lawler, James V; Jacob, Shevin T

2016-01-01

Clinical trial designs that include multiple treatments are currently limited to those that perform pairwise comparisons of each investigational treatment to a single control. However, there are settings, such as the recent Ebola outbreak, in which no treatment has been demonstrated to be effective; and therefore, no standard of care exists which would serve as an appropriate control. For illustrative purposes, we focused on the care of patients presenting in austere settings with critically ill 'sepsis-like' syndromes. Our approach involves a novel algorithm for comparing mortality among arms without requiring a single fixed control. The algorithm allows poorly-performing arms to be dropped during interim analyses. Consequently, the study may be completed earlier than planned. We used simulation to determine operating characteristics for the trial and to estimate the required sample size. We present a potential study design targeting a minimal effect size of a 23% relative reduction in mortality between any pair of arms. Using estimated power and spurious significance rates from the simulated scenarios, we show that such a trial would require 2550 participants. Over a range of scenarios, our study has 80 to 99% power to select the optimal treatment. Using a fixed control design, if the control arm is least efficacious, 640 subjects would be enrolled into the least efficacious arm, while our algorithm would enroll between 170 and 430. This simulation method can be easily extended to other settings or other binary outcomes. Early dropping of arms is efficient and ethical when conducting clinical trials with multiple arms. Copyright © 2015 Elsevier Inc. All rights reserved.

Educational intervention for physicians to address the risk of opioid abuse.

PubMed

Pasquale, Margaret K; Sheer, Richard L; Mardekian, Jack; Masters, Elizabeth T; Patel, Nick C; Hurwitch, Amy R; Weber, Jennifer J; Jorga, Anamaria; Roland, Carl L

To evaluate the impact of a pilot intervention for physicians to support their treatment of patients at risk for opioid abuse. Patients at risk for opioid abuse enrolled in Medicare plans were identified from July 1, 2012 to April 30, 2014 (N = 2,391), based on a published predictive model, and linked to 4,353 opioid-prescribing physicians. Patient-physician clusters were randomly assigned to one of four interventions using factorial design. Physicians received one of the following: Arm 1, patient information; Arm 2, links to educational materials for diagnosis and management of pain; Arm 3, both patient information and links to educational materials; or Arm 4, no communication. Difference-in-difference analyses compared opioid and pain prescriptions, chronic high-dose opioid use, uncoordinated opioid use, and opioid-related emergency department (ED) visits. Logistic regression compared diagnosis of opioid abuse between cases and controls postindex. Mailings had no significant impact on numbers of opioid or pain medications filled, chronic high-dose opioid use, uncoordinated opioid use, ED visits, or rate of diagnosed opioid abuse. Relative to Arm 4, odds ratios (95% CI) for diagnosed opioid abuse were Arm 1, 0.95(0.63-1.42); Arm 2, 0.83(0.55-1.27); Arm 3, 0.72(0.46-1.13). While 84.7 percent had ≥1 psychiatric diagnoses during preindex (p = 0.89 between arms), only 9.5 percent had ≥1 visit with mental health specialists (p = 0.53 between arms). Although this intervention did not affect pain-related outcomes, future interventions involving care coordination across primary care and mental health may impact opioid abuse and improve quality of life of patients with pain.

A Pilot Study: Comparison of Arm Versus Ankle Noninvasive Blood Pressure Measurement at 2 Different Levels of Backrest Elevation.

PubMed

Henley, Nicole; Quatrara, Beth D; Conaway, Mark

2015-01-01

Standard practice for obtaining noninvasive blood pressure includes arm blood pressure (BP) cuff placement at the level of the heart; however, some critical care patients cannot have BPs taken in their arm because of various conditions, and ankle BPs are frequently used as substitutes. The aim of this study was to determine if there was a significant variation between upper arm and ankle BP measurements at different backrest elevations with consideration of peripheral edema factors. After institutional review board approval was obtained, a pilot study was implemented to evaluate noninvasive BP measurements of the arm and ankle with backrest elevation at 0° and 30° in a population of medical intensive care unit patients. Participants served as their own controls and were randomly assigned to left- versus right-side BP readings. Data were also collected on presence of arm versus ankle edema. A total of 30 participants enrolled in the study and provided 120 BP measurements. Blood pressure readings were analyzed in terms of diastolic and systolic findings as well as backrest elevations and edema presence. Thirteen participants presented with either arm or ankle edema. There was a statistical difference between the systolic arm and ankle BP measurements in the 0° (P = .008) and 30° (P < .001) backrest elevation positions. The correlation between arm and ankle diastolic BP is greater for participants without ankle edema (P = .038, r = 0.54) than for participants with ankle edema (P = .650, r = 0.14), but it is not statistically significant (P = .47). Even though ankle BPs are often substituted for arm BPs when the arm is unable to be used, ankle BPs and arm BPs are not interchangeable. Adjustments in backrest elevation and considerations of edema do not normalize the differences. Blood pressures obtained from the ankle are significantly greater than those obtained from the arm. This information needs to be considered when arms are not available and legs are used as surrogates for the upper arm.

Developing a dashboard for benchmarking the productivity of a medication therapy management program.

PubMed

Umbreit, Audrey; Holm, Emily; Gander, Kelsey; Davis, Kelsie; Dittrich, Kristina; Jandl, Vanda; Odell, Laura; Sweeten, Perry

To describe a method for internal benchmarking of medication therapy management (MTM) pharmacist activities. Multisite MTM pharmacist practices within an integrated health care system. MTM pharmacists are located within primary care clinics and provide medication management through collaborative practice. MTM pharmacist activity is grouped into 3 categories: direct patient care, nonvisit patient care, and professional activities. MTM pharmacist activities were tracked with the use of the computer-based application Pharmacist Ambulatory Resource Management System (PhARMS) over a 12-month period to measure growth during a time of expansion. A total of 81% of MTM pharmacist time was recorded. A total of 1655.1 hours (41%) was nonvisit patient care, 1185.2 hours (29%) was direct patient care, and 1190.4 hours (30%) was professional activities. The number of patient visits per month increased during the study period. There were 1496 direct patient care encounters documented. Of those, 1051 (70.2%) were face-to-face visits, 257 (17.2%) were by telephone, and 188 (12.6%) were chart reviews. Nonvisit patient care and professional activities also increased during the period. PhARMS reported MTM pharmacist activities and captured nonvisit patient care work not tracked elsewhere. Internal benchmarking data proved to be useful for justifying increases in MTM pharmacist personnel resources. Reviewing data helped to identify best practices from high-performing sites. Limitations include potential for self-reporting bias and lack of patient outcomes data. Implementing PhARMS facilitated internal benchmarking of patient care and nonpatient care activities in a regional MTM program. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Health care workers in danger zones: a special report on safety and security in a changing environment.

PubMed

Redwood-Campbell, Lynda J; Sekhar, Sharonya N; Persaud, Christine R

2014-10-01

Violence against humanitarian health care workers and facilities in situations of armed conflict is a serious humanitarian problem. Targeting health care workers and destroying or looting medical facilities directly or indirectly impacts the delivery of emergency and life-saving medical assistance, often at a time when it is most needed. Attacks may be intentional or unintentional and can take a range of forms from road blockades and check points which delay or block transport, to the direct targeting of hospitals, attacks against medical personnel, suppliers, patients, and armed entry into health facilities. Lack of access to vital health care services weakens the entire health system and exacerbates existing vulnerabilities, particularly among communities of women, children, the elderly, and the disabled, or anyone else in need of urgent or chronic care. Health care workers, especially local workers, are often the target. This report reviews the work being spearheaded by the Red Cross and Red Crescent Movement on the Health Care in Danger initiative, which aims to strengthen the protections for health care workers and facilities in armed conflicts and ensure safe access for patients. This includes a review of internal reports generated from the expert workshops on a number of topics as well as a number of public sources documenting innovative coping mechanisms adopted by National Red Cross and Red Crescent Societies. The work of other organizations is also briefly examined. This is followed by a review of security mechanisms within the humanitarian sector to ensure the safety and security of health care personnel operating in armed conflicts. From the existing literature, a number of gaps have been identified with current security frameworks that need to be addressed to improve the safety of health care workers and ensure the protection and access of vulnerable populations requiring assistance. A way forward for policy, research, and practice is proposed for consideration. While there is work being done to improve conditions for health care personnel and patients, there need to be concerted actions to stigmatize attacks against workers, facilities, and patients to protect the neutrality of the medical mission.

Case management in oncology rehabilitation (CAMON): the effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. a study protocol for a randomized controlled clinical trial in oncology rehabilitation.

PubMed

Bachmann-Mettler, Irene; Steurer-Stey, Claudia; Senn, Oliver; Wang, Mathyas; Bardheci, Katarina; Rosemann, Thomas

2011-04-28

Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent of rehabilitation after cancer treatment. Case management wants to support the complex information needs of the patients in addition to the segmented structure of the health care system. Emphasis is put on support for self-management in order to enhance health - conscious behaviour, learning to deal with the burden of the illness and providing the opportunity for regular contacts with care providers. We present a study protocol to investigate the efficacy of a case management in patients following oncology rehabilitation after cancer treatment. The trial is a multicentre, two-arm randomised controlled study. Patients are randomised parallel in either 'usual care' plus case management or 'usual care' alone. Patients with all types of cancer can be included in the study, if they have completed the therapy with chemo- and/or radiotherapy/surgery with curative intention and are expected to have a survival time >1 year. To determine the health-related quality of life the general questionnaire FACT G is used. The direct correlation between self-management and perceived self-efficacy is measured with the Jerusalem & Schwarzer questionnaire. Patients satisfaction with the care received is measured using the Patient Assessment of Chronic Illness Care 5 As (PACIC-5A). Data are collected at the beginning of the trial and after 3, 6 and 12 months. The power analysis revealed a sample size of 102 patients. The recruitment of the centres began in 2009. The inclusion of patients began in May 2010. Case management has proved to be effective regarding quality of life of patients with chronic diseases. When it comes to oncology, case management is mainly used in cancer treatment, but it is not yet common in the rehabilitation of cancer patients. Case management in oncology rehabilitation is not well-established in Switzerland. A major challenge of the study will therefore probably be the recruitment of the patients due to the physicians' and patients' scarcely existing awareness of this issue. Trial registrationISRCTN41474586

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.…

BP Control and Long-Term Risk of ESRD and Mortality

PubMed Central

Gassman, Jennifer; Appel, Lawrence J.; Smogorzewski, Miroslaw; Sarnak, Mark J.; Glidden, David V.; Bakris, George; Gutiérrez, Orlando M.; Hebert, Lee A.; Ix, Joachim H.; Lea, Janice; Lipkowitz, Michael S.; Norris, Keith; Ploth, David; Pogue, Velvie A.; Rostand, Stephen G.; Siew, Edward D.; Sika, Mohammed; Tisher, C. Craig; Toto, Robert; Wright, Jackson T.; Wyatt, Christina; Hsu, Chi-yuan

2017-01-01

We recently showed an association between strict BP control and lower mortality risk during two decades of follow-up of prior participants in the Modification of Diet in Renal Disease (MDRD) trial. Here, we determined the risk of ESRD and mortality during extended follow-up of the African American Study of Kidney Disease and Hypertension (AASK) trial. We linked 1067 former AASK participants with CKD previously randomized to strict or usual BP control (mean arterial pressure ≤92 mmHg or 102–107 mmHg, respectively) to the US Renal Data System and Social Security Death Index; 397 patients had ESRD and 475 deaths occurred during a median follow-up of 14.4 years from 1995 to 2012. Compared with the usual BP arm, the strict BP arm had unadjusted and adjusted relative risks of ESRD of 0.92 (95% confidence interval [95% CI], 0.75 to 1.12) and 0.95 (95% CI, 0.78 to 1.16; P=0.64), respectively, and unadjusted and adjusted relative risks of death of 0.92 (95% CI, 0.77 to 1.10) and 0.81 (95% CI, 0.68 to 0.98; P=0.03), respectively. In meta-analyses of individual-level data from the MDRD and the AASK trials, unadjusted relative risk of ESRD was 0.88 (95% CI, 0.78 to 1.00) and unadjusted relative risk of death was 0.87 (95% CI, 0.76 to 0.99) for strict versus usual BP arms. Our findings suggest that, during long–term follow-up, strict BP control does not delay the onset of ESRD but may reduce the relative risk of death in CKD. PMID:27516235

A Randomized Trial of Displaying Paid Price Information on Imaging Study and Procedure Ordering Rates.

PubMed

Chien, Alyna T; Lehmann, Lisa Soleymani; Hatfield, Laura A; Koplan, Kate E; Petty, Carter R; Sinaiko, Anna D; Rosenthal, Meredith B; Sequist, Thomas D

2017-04-01

Prior studies have demonstrated how price transparency lowers the test-ordering rates of trainees in hospitals, and physician-targeted price transparency efforts have been viewed as a promising cost-controlling strategy. To examine the effect of displaying paid-price information on test-ordering rates for common imaging studies and procedures within an accountable care organization (ACO). Block randomized controlled trial for 1 year. A total of 1205 fully licensed clinicians (728 primary care, 477 specialists). Starting January 2014, clinicians in the Control arm received no price display; those in the intervention arms received Single or Paired Internal/External Median Prices in the test-ordering screen of their electronic health record. Internal prices were the amounts paid by insurers for the ACO's services; external paid prices were the amounts paid by insurers for the same services when delivered by unaffiliated providers. Ordering rates (orders per 100 face-to-face encounters with adult patients): overall, designated to be completed internally within the ACO, considered "inappropriate" (e.g., MRI for simple headache), and thought to be "appropriate" (e.g., screening colonoscopy). We found no significant difference in overall ordering rates across the Control, Single Median Price, or Paired Internal/External Median Prices study arms. For every 100 encounters, clinicians in the Control arm ordered 15.0 (SD 31.1) tests, those in the Single Median Price arm ordered 15.0 (SD 16.2) tests, and those in the Paired Prices arms ordered 15.7 (SD 20.5) tests (one-way ANOVA p-value 0.88). There was no difference in ordering rates for tests designated to be completed internally or considered to be inappropriate or appropriate. Displaying paid-price information did not alter how frequently primary care and specialist clinicians ordered imaging studies and procedures within an ACO. Those with a particular interest in removing waste from the health care system may want to consider a variety of contextual factors that can affect physician-targeted price transparency.

The feasibility, time savings and economic impact of a designated time appointment system at a busy HIV care clinic in Kenya: a randomized controlled trial.

PubMed

Kwena, Zachary A; Njoroge, Betty W; Cohen, Craig R; Oyaro, Patrick; Shikari, Rosemary; Kibaara, Charles K; Bukusi, Elizabeth A

2015-01-01

As efforts are made to reach universal access to ART in Kenya, the problem of congestion at HIV care clinics is likely to worsen. We evaluated the feasibility and the economic benefits of a designated time appointment system as a solution to decongest HIV care clinics. This was an explanatory two-arm open-label randomized controlled trial that enrolled 354 consenting participants during their normal clinic days and followed-up at subsequent clinic appointments for up to nine months. Intervention arm participants were given specific dates and times to arrive at the clinic for their next appointment while those in the control arm were only given the date and had the discretion to decide on the time to arrive as is the standard practice. At follow-up visits, we recorded arrival and departure times and asked the monetary value of work participants engaged in before and after clinic. We conducted multiple imputation to replace missing data in our primary outcome variables to allow for intention-to-treat analysis; and analyzed the data using Mann-Whitney U test. Overall, 72.1% of the intervention participants arrived on time, 13.3% arrived ahead of time and 14.6% arrived past scheduled time. Intervention arm participants spent a median of 65 [interquartile range (IQR), 52-87] minutes at the clinic compared to 197 (IQR, 173-225) minutes for control participants (p<0.01). Furthermore, intervention arm participants were more productively engaged on their clinic days valuing their cumulative work at a median of USD 10.5 (IQR, 60.0-16.8) compared to participants enrolled in the control arm who valued their work at USD 8.3 (IQR, 5.5-12.9; p=0.02). A designated time appointment system is feasible and provides substantial time savings associated with greater economic productivity for HIV patients attending a busy HIV care clinic.

The Telehealth Enhancement of Adherence to Medication in Pediatric IBD (TEAM) Trial: Design and Methodology

PubMed Central

Hommel, Kevin A.; Gray, Wendy N.; Hente, Elizabeth; Loreaux, Katherine; Ittenbach, Richard F.; Maddux, Michele; Baldassano, Robert; Sylvester, Francisco; Crandall, Wallace; Doarn, Charles; Heyman, Melvin B.; Keljo, David; Denson, Lee A.

2015-01-01

Medication nonadherence is a significant health care issue requiring regular behavioral treatment. Lack of sufficient health care resources and patient/family time commitment for weekly treatment are primary barriers to receiving appropriate self-management support. We describe the methodology of the Telehealth Enhancement of Adherence to Medication (TEAM) trial for medication nonadherence in pediatric inflammatory bowel disease (IBD). For this trial, participants 11–18 years of age will be recruited from seven pediatric hospitals and will complete an initial 4-week run in to assess adherence to a daily medication. Those who take less than 90% of their prescribed medication will be randomized. A total of 194 patients with IBD will be randomized to either a telehealth behavioral treatment (TBT) arm or education only (EO) arm. All treatment will be delivered via telehealth video conferencing. Patients will be assessed at baseline, post-treatment, 3-, 6-, and 12-months. We anticipate that participants in the TBT arm will demonstrate a statistically significant improvement at post-treatment and 3-, 6-, and 12-month follow-up compared to participants in the EO arm for both medication adherence and secondary outcomes (i.e., disease severity, patient quality of life, and health care utilization). If efficacious, the TEAM intervention could be disseminated broadly and reduce health care access barriers so that patients could receive much needed self-management intervention. PMID:26003436

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.

Effectiveness of treat-to-target strategy for LDL-cholesterol control in type 2 diabetes: post-hoc analysis of data from the MIND.IT study.

PubMed

Ardigò, Diego; Vaccaro, Olga; Cavalot, Franco; Rivellese, Albarosa Angela; Franzini, Laura; Miccoli, Roberto; Patti, Lidia; Boemi, Massimo; Trovati, Mariella; Zavaroni, Ivana

2014-04-01

The paper presents a post-hoc analysis of the intensity of dyslipidaemia care operated in the first 2 years of Multiple-Intervention-in-type-2-Diabetes.ITaly (MIND.IT) study. MIND.IT is a multicentric, randomized, two-parallel arm trial involving 1461 type 2 diabetic patients at high cardiovascular (CV) risk. The study compares the usual care (UC) of CV prevention with a multifactorial intensive care (IC) approach aiming at achieving target values for the main CV risk factors according to a step-wise treat-to-target approach. Proportion of patients on target for low-density lipoprotein cholesterol (LDL-C) was about 10% at baseline and increased significantly more with IC than UC (43 vs. 27%; p < 0.001). However, the majority (57%) of patients, in this intended intensively treated cohort, failed to achieve the proposed target. Average LDL-C decreased from 144 ± 35 to 108 ± 31 mg/dl with IC and from 142 ± 28 to 118 ± 32 with UC (p-for-interaction <0.0001). IC was associated with a significantly greater increase in statin prescription and lower withdrawal from treatment than UC (43 vs. 11% and 28 vs. 61%, respectively; both p < 0.001). However, the new treatments were characterized in both groups by the use of low starting doses (≤ 10 mg of atorvastatin, equivalent dose in more than 90% of patients) without increase in case of missed target. The application of a multifactorial treat-to-target intervention is associated with a significant improvement in LDL-C beyond usual practice. However, the change in LDL-C appears to be more related to an increased number of treated patients and a decreased treatment withdrawal than to a true treat-to-target approach.

Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

PubMed

Grünzig, Sasha-Denise; Baumeister, Harald; Bengel, Jürgen; Ebert, David; Krämer, Lena

2018-05-22

Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy. In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age ≥ 18) with depressive symptoms above cut-off (CES-D scale > 22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants' acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction. This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment. This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration number DRKS00010282 .

Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial.

PubMed

Cullington, Helen; Kitterick, Padraig; Weal, Mark; Margol-Gromada, Magdalena

2018-04-20

Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required. To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants. Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation. University of Southampton Auditory Implant Service: provider of National Health Service care. 60 adults who had used cochlear implants for at least 6 months. Control group (n=30) followed usual care pathway.Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment). Primary: change in patient activation; measured using the Patient Activation Measure.Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians. One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue. Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients. ISRCTN14644286. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.