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

COllaborative Shared care to IMprove Psychosis Outcome (COSIMPO): study protocol for a randomized controlled trial.
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DOI:
10.1186/s13063-017-2187-x
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发表时间:
2017-10-10
期刊:
影响因子:
2.5
通讯作者:
Seedat S
Seedat S
中科院分区:
医学4区
文献类型:
--
作者:
Gureje O;Makanjuola V;Kola L;Yusuf B;Price L;Esan O;Oladeji BD;Appiah-Poku J;Haris B;Othieno C;Seedat S

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精神障碍是一组严重的精神障碍,对患者造成相当大的残疾,对家庭造成很高的负担。在许多低收入和中等收入国家,传统和信仰治疗师是向受影响者提供护理的主要提供者。尽管这些补充性替代医疗服务提供者(CAPs)与传统医疗服务提供者之间的合作经常被认为是改善医疗服务的理想选择,但对患者预后的可行性和有效性尚未进行严格的测试。COSIMPO是一项在尼日利亚和加纳进行的单盲、集群随机对照试验(RCT),目的是比较由cap和初级卫生保健提供者(phcp)实施的协作共享护理(CSC)干预计划与常规护理(CAU)在改善精神病患者预后方面的有效性。该研究旨在验证在研究开始后6个月接受CSC的患者比接受CAU的患者有更好的临床结果和更少的cap有害治疗实践的假设。估计将从51个组中招募296名参与者,其中一个组由初级保健诊所及其邻近的CAP设施组成。CSC是一种人工干预方案,由初级保健医师定期和定期访问CAP设施,以协助管理试验参与者。协助包括抗精神病药物的管理,共病身体状况的管理,协助CAP避免有害的治疗做法,并与CAP、护理人员和参与者一起规划出院和康复。在试验开始后6个月评估的主要结果是阳性和阴性症状量表(PANSS)的改善。在3个月和6个月时评估的次要结果包括残疾程度、有害治疗做法和受害经历、感知到的耻辱程度和照顾者负担。关于正统和补充卫生服务提供者之间的合作是否可行以及是否能够改善患者的结果的信息,对于制定旨在使传统和信仰治疗师正式参与公共卫生系统服务的政策非常重要。美国国立卫生研究院临床试验登记处,ID: NCT02895269。本文的在线版本(doi:10.1186/s13063-017-2187-x)包含补充材料,仅供授权用户使用。
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 The online version of this article (doi:10.1186/s13063-017-2187-x) contains supplementary material, which is available to authorized users.
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