Strengthening care in collaboration with people with lived experience of psychosis in Uganda (SCAPE-U): A protocol for a cluster randomized controlled feasibility trial.

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Byamah Brian Mutamba, Sauharda Rai, Lynn Semakula, David Cappo, Laura Asher, Wilfred Gwaikolo, Brandon A Kohrt
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引用次数: 0

Abstract

Background: Mental health services are most effective and equitable when designed, delivered, and evaluated in collaboration with People With Lived Experience of mental health conditions (PWLE). However, PWLE are rarely involved in health systems strengthening, and when they are, it is limited to specific components (e.g., peer helpers) rather than multi-tiered collaboration in the full continuum of home to community to facility based services. Moreover, programs that do involve PWLE typically involve people with a history of substance use conditions or common mental disorders. The collaboration of People With Lived Experience of Psychosis (PWLP) is especially rare. Therefore, we aim to explore the feasibility of collaborating with PWLP for health systems strengthening in this feasibility trial.

Methods: This pilot cluster randomized controlled feasibility trial will randomize 36 health facilities to a standard implementation arm where primary care workers (PCW) will be trained by mental health specialists (control), or a collaborative care model with added co-facilitation of PCW trainings by PWLP as well as home visits by PWLP to service users (intervention). The intervention condition is referred to as "Strengthening CAre in collaboration with People with lived Experience of psychosis in Uganda" (SCAPE-U). The 36 health facilities will be distributed across six clusters with three clusters in each arm. PhotoVoice will be used to train PWLP to be co-facilitators of PCW training and provide home-based support to service users in the intervention arm. The primary outcomes of the feasibility trial will be the feasibility, acceptability, and safety of collaborating with PWLP. Data will also be collected on individual-level outcomes for PCWs, and service users to inform the feasibility of data collection and obtain effect size estimates.

Discussion: Findings from this feasibility trial will inform a fully powered trial to evaluate the benefits of an implementation strategy characterized by collaboration with PWLP across the continuum of healthcare services.

Trial registration: ClinicalTrials.gov. number: NCT05863572. Date of registration: May 18, 2023. URL of trial registry record: https://clinicaltrials.gov/study/NCT05863572?term=NCT05863572&rank=1 .

Abstract Image

Abstract Image

加强与乌干达有精神病生活经历的人合作的护理(SCAPE-U):一项集群随机对照可行性试验方案。
背景:与有精神健康状况生活经验的人(PWLE)合作设计、提供和评估精神卫生服务是最有效和公平的。然而,残疾人残疾人很少参与加强卫生系统的工作,即使参与,也仅限于具体组成部分(例如同伴帮助者),而不是在从家庭到社区再到设施的全面连续服务中进行多层次合作。此外,涉及PWLE的项目通常涉及有药物使用史或常见精神障碍的人。精神病患者(PWLP)的合作尤其罕见。因此,我们的目标是在这项可行性试验中探索与PWLP合作加强卫生系统的可行性。方法:本试验随机对照可行性试验将36家卫生机构随机纳入标准实施组,其中初级保健工作者(PCW)将由精神卫生专家培训(对照组),或采用协作护理模式,由PWLP共同促进PCW培训,并由PWLP对服务用户进行家访(干预)。干预条件被称为“与乌干达有精神病生活经历的人合作加强护理”(SCAPE-U)。36个保健设施将分布在6个组中,每组3个组。PhotoVoice将用于培训PWLP,使其成为“电讯服务计划”培训的协办人,并在干预部门为服务使用者提供家居支援。可行性试验的主要结果将是与PWLP合作的可行性、可接受性和安全性。此外,我们亦会收集个别情况下的数据,以了解收集数据的可行性,并估计效果大小。讨论:这项可行性试验的结果将为一项全面的试验提供信息,以评估在整个医疗保健服务连续体中与PWLP合作的实施策略的好处。试验注册:ClinicalTrials.gov。号码:NCT05863572。报名日期:2023年5月18日。试用注册表记录的URL: https://clinicaltrials.gov/study/NCT05863572?term=NCT05863572&rank=1。
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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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