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COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial.

ABSTRACT: Psychotic disorders are a group of severe mental disorders that cause considerable disability to sufferers and a high level of burden to families. In many low- and middle-income countries (LMIC), traditional and faith healers are the main providers of care to affected persons. Even though frequently canvassed as desirable for improved care delivery, collaboration between these complementary alternative health providers (CAPs) and conventional health providers has yet to be rigorously tested for feasibility and effectiveness on patient outcomes.COSIMPO is a single-blind, cluster randomized controlled trial (RCT) being conducted in Nigeria and Ghana to compare the effectiveness of a collaborative shared care (CSC) intervention program implemented by CAPs and primary health care providers (PHCPs) with care as usual (CAU) at improving the outcome of patients with psychosis. The study is designed to test the hypotheses that patients receiving CSC will have a better clinical outcome and experience fewer harmful treatment practices from the CAPs than patients receiving CAU at 6 months after study entry. An estimated sample of 296 participants will be recruited from across 51 clusters, with a cluster consisting of a primary care clinic and its neighboring CAP facilities. CSC is a manualized intervention package consisting of regular and scheduled visits of PHCPs to CAP facilities to assist with the management of trial participants. Assistance includes the administration of antipsychotic medications, management of comorbid physical condition, assisting the CAP to avoid harmful treatment practices, and engaging with CAPs, caregivers and participants in planning discharge and rehabilitation. The primary outcome, assessed at 6 months following trial entry, is improvement on the Positive and Negative Symptom Scale (PANSS). Secondary outcomes, assessed at 3 and 6 months, consist of levels of disability, experience of harmful treatment practices and of victimization, and levels of perceived stigma and of caregivers' burden.Information about whether collaboration between orthodox and complementary health providers is feasible and can lead to improved outcome for patients is important to formulating policies designed to formally engage the services of traditional and faith healers within the public health system.National Institutes of Health Clinical Trial registry, ID: NCT02895269 . Registered on 30 July 2016.

SUBMITTER: Gureje O

PROVIDER: S-EPMC5634898 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial.

Gureje Oye O Makanjuola Victor V Kola Lola L Yusuf Bidemi B Price Leshawndra L Esan Oluyomi O Oladeji Bibilola D BD Appiah-Poku John J Haris Benjamin B Othieno Caleb C Seedat Soraya S

Trials 20171010 1

<h4>Background</h4>Psychotic disorders are a group of severe mental disorders that cause considerable disability to sufferers and a high level of burden to families. In many low- and middle-income countries (LMIC), traditional and faith healers are the main providers of care to affected persons. Even though frequently canvassed as desirable for improved care delivery, collaboration between these complementary alternative health providers (CAPs) and conventional health providers has yet to be rig ...[more]

PMID: 29017605

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Project description:Patients with depression and poorly controlled diabetes mellitus, coronary heart disease (CHD), or both have higher medical complication rates and higher health care costs, suggesting that more effective care management of psychiatric and medical disease control might also reduce medical service use and enhance quality of life.To evaluate the cost-effectiveness of a multicondition collaborative treatment program (TEAMcare) compared with usual primary care (UC) in outpatients with depression and poorly controlled diabetes or CHD.Randomized controlled trial of a systematic care management program aimed at improving depression scores and hemoglobin A(1c) (HbA(1c)), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) levels.Fourteen primary care clinics of an integrated health care system.Population-based screening identified 214 adults with depressive disorder and poorly controlled diabetes or CHD.Physician-supervised nurses collaborated with primary care physicians to provide treatment of multiple disease risk factors.Blinded assessments evaluated depressive symptoms, SBP, and HbA(1c) at baseline and at 6, 12, 18, and 24 months. Fasting LDL-C concentration was assessed at baseline and at 12 and 24 months. Health plan accounting records were used to assess medical service costs. Quality-adjusted life-years (QALYs) were assessed using a previously developed regression model based on intervention vs UC differences in HbA(1c), LDL-C, and SBP levels over 24 months.Over 24 months, compared with UC controls, intervention patients had a mean of 114 (95% CI, 79 to 149) additional depression-free days and an estimated 0.335 (95% CI, -0.18 to 0.85) additional QALYs. Intervention patients also had lower mean outpatient health costs of $594 per patient (95% CI, -$3241 to $2053) relative to UC patients.For adults with depression and poorly controlled diabetes, CHD, or both, a systematic intervention program aimed at improving depression scores and HbA(1c), SBP, and LDL-C levels seemed to be a high-value program that for no or modest additional cost markedly improved QALYs.clinicaltrials.gov Identifier: NCT00468676

Project description:BackgroundCollaborative care for depression is more effective in improving treatment outcomes than primary care physicians' (PCPs) usual care (UC). However, few trials of collaborative care have targeted anxiety.ObjectiveTo examine the impact and 12-month durability of a centralized, telephone-delivered, stepped collaborative care intervention (CC) for treating anxiety disorders across a network of primary care practices.DesignRandomized controlled trial with blinded outcome assessments.ParticipantsA total of 329 patients aged 18-64 referred by their PCPs in response to an electronic medical record (EMR) prompt. They include 250 highly anxious patients randomized to either CC or to UC, and 79 moderately anxious patients who were triaged to a watchful waiting (WW) cohort and later randomized if their conditions clinically deteriorated.InterventionTwelve months of telephone-delivered CC involving non-mental health professionals who provided patients with basic psycho-education, assessed preferences for guideline-based pharmacotherapy, monitored treatment responses, and informed PCPs of their patients' care preferences and progress via the EMR.Main measuresMental health-related quality of life ([HRQoL]; SF-36 MCS); secondary outcomes: anxiety (Hamilton Anxiety Rating Scale [SIGH-A], Panic Disorder Severity Scale) and mood (PHQ-9).Key resultsAt 12-month follow-up, highly anxious patients randomized to CC reported improved mental HRQoL (effect size [ES]: 0.38 [95 % CI: 0.13-0.63]; P = 0.003), anxiety (SIGH-A ES: 0.30 [0.05-0.55]; P = 0.02), and mood (ES: 0.45 [0.19-0.71] P = 0.001) versus UC. These improvements were sustained for 12 months among African-Americans (ES: 0.70-1.14) and men (ES: 0.43-0.93). Of the 79 WW patients, 29 % met severity criteria for randomization, and regardless of treatment assignment, WW patients reported fewer anxiety and mood symptoms and better mental HRQoL over the full 24-month follow-up period than highly anxious patients who were randomized at baseline.ConclusionsTelephone-delivered, centralized, stepped CC improves mental HRQoL, anxiety and mood symptoms. These improvements were durable and particularly evident among those most anxious at baseline, and among African-Americans and men.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Project description:Depressive symptoms commonly follow coronary artery bypass graft (CABG) surgery and are associated with less positive clinical outcomes.To test the effectiveness of telephone-delivered collaborative care for post-CABG depression vs usual physician care.Single-blind effectiveness trial at 7 university-based and community hospitals in or near Pittsburgh, Pennsylvania. Participants were 302 post-CABG patients with depression (150, intervention; 152, usual care) and a comparison group of 151 randomly sampled post-CABG patients without depression recruited between March 2004 and September 2007 and observed as outpatients until June 2008.Eight months of telephone-delivered collaborative care provided by nurses working with patients' primary care physicians and supervised by a psychiatrist and primary care physician from this study.Mental health-related quality of life (HRQL) measured by the Short Form-36 Mental Component Summary (SF-36 MCS) at 8-month follow-up; secondary outcome measures included assessment of mood symptoms (Hamilton Rating Scale for Depression [HRS-D]), physical HRQL (SF-36 PCS), and functional status (Duke Activity Status Index [DASI]); and hospital readmissions.The intervention patients reported greater improvements in mental HRQL (all P < or = .02) (SF-36 MCS: Delta, 3.2 points; 95% confidence interval [CI], 0.5-6.0), physical functioning (DASI: Delta, 4.6 points; 95% CI, 1.9-7.3), and mood symptoms (HRS-D: Delta, 3.1 points; 95% CI, 1.3-4.9); and were more likely to report a 50% or greater decline in HRS-D score from baseline (50.0% vs 29.6%; number needed to treat, 4.9 [95% CI, 3.2-10.4]) than usual care patients (P < .001). Men with depression were particularly likely to benefit from the intervention (SF-36 MCS: Delta, 5.7 points; 95% CI, 2.2-9.2; P = .001). However, the mean HRQL and physical functioning of intervention patients did not reach that of the nondepressed comparison group.Compared with usual care, telephone-delivered collaborative care for treatment of post-CABG depression resulted in improved HRQL, physical functioning, and mood symptoms at 8-month follow-up.clinicaltrials.gov Identifier: NCT00091962.

Project description:Colorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects may last for many years and adversely affect QoL, and they may not be adequately addressed by standard specialist-based follow-up. Optimal management of these effects should harness the expertise of both primary care and specialist care. Shared models of care (involving both the patient's primary care physician [PCP] and specialist) have the potential to better support survivors and enhance health system efficiency.SCORE (Shared care of Colorectal cancer survivors) is a multisite randomised controlled trial designed to optimise and operationalise a shared care model for survivors of CRC, to evaluate the acceptability of the intervention and study processes, and to collect preliminary data regarding the effects of shared care compared with usual care on a range of patient-reported outcomes. The primary outcome is QoL measured using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Secondary outcomes are satisfaction with care, unmet needs, continuity of care and health resource use. The shared care model involves replacement of two routine specialist follow-up visits with PCP visits, as well as the provision of a tailored survivorship care plan and a survivorship booklet and DVD for CRC survivors. All consenting patients will be randomised 1:1 to either shared care or usual care and will complete questionnaires at three time points over a 12-month period (baseline and at 6 and 12 months). Health care resource use data will also be collected and used to evaluate costs.The evaluation and implementation of models of care that are responsive to the holistic needs of cancer survivors while reducing the burden on acute care settings is an international priority. Shared care between specialists and PCPs has the potential to enhance patient care and outcomes for CRC survivors while offering improvements in health care resource efficiency. If the findings of the present study show that the shared care intervention is acceptable and feasible for CRC survivors, the intervention may be readily expanded to other groups of cancer survivors.Australian New Zealand Clinical Trials Registry, ACTRN12617000004369p . Registered on 3 January 2017; protocol version 4 approved 24 February 2017.

Dataset Information

COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial.

Publications

COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial.

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