Department of Medicine, University of Otago, Wellington, New Zealand
Public Health and General Practice, Christchurch School of Medicine and Health Sciences, Christchurch, New Zealand.
BMJ Open. 2024 Jun 6;14(6):e075727. doi: 10.1136/bmjopen-2023-075727.
A cluster randomised controlled trial, the Meaning, Agency and Nurturing Autonomy (MANA) study, is underway comparing the effects of occupational performance coaching (OPC) and usual care on the social participation, health and well-being of children with neurodisability and their caregivers. This protocol presents the realist process evaluation which is occurring in parallel with the trial to allow testing and further refinement of OPC programme theory, as represented in its logic model. The aim of this realist evaluation is to examine what works, for whom, in the implementation of OPC with caregivers of children with neurodisability (in particular, Māori and Pasifika) in current service delivery contexts.
Guided by OPC programme theory and realist evaluation processes, mixed-methods data collected from the MANA study OPC group will be analysed to elucidate when OPC works (outcomes), for whom, how (mechanisms) and under what circumstances (contexts). This will culminate in the synthesis of Intervention-Actor Context-Mechanism-Outcome configurations. Descriptive analyses will be reported for quantitative measures of treatment fidelity (OPC-Fidelity Measure), caregiver emotional response to OPC (Session Rating Scale) preintervention emotional state (Depression Stress and Anxiety Scale) and client outcomes (Canadian Occupational Performance Measure). Reflexive thematic analysis will be undertaken to analyse realist interviews with therapists who implemented OPC above and below fidelity thresholds and culturally focused interviews with clients of Māori or Pasifika ethnicity, informing understanding of the contexts influencing therapists' implementation of OPC with fidelity, and the mechanisms triggered within therapists or caregivers to elicit a response to the intervention. The MANA study trial outcomes will be reported separately.
Ethical approval for this study was granted by the New Zealand Health and Disability Ethics Committee (20/STH/93). In all participating jurisdictions local area approval was obtained, involving a process of local Māori consultation. Results will be disseminated to all participants, and more broadly to clinicians and policy-makers through conference presentations and peer-reviewed journal publications, which will inform decision-making about resourcing and supporting effective delivery of OPC to optimise outcomes for children and caregivers.
ACTRN12621000519853.
一项名为“意义、能动性和培养自主性(MANA)”的集群随机对照试验正在进行中,旨在比较职业表现辅导(OPC)和常规护理对神经发育障碍儿童及其照顾者的社会参与、健康和幸福感的影响。本方案介绍了正在与试验平行进行的现实主义过程评估,以测试和进一步完善 OPC 方案理论,如其逻辑模型所示。本次评价的目的是检验在当前服务提供背景下,OPC 对神经发育障碍儿童(尤其是毛利人和太平洋岛民)照顾者的实施效果如何、针对哪些人群以及在何种情况下有效。
本研究将以 OPC 方案理论和现实主义评价过程为指导,对来自 MANA 研究 OPC 组的混合方法数据进行分析,以阐明 OPC 何时(结果)、针对谁(机制)以及在何种情况下(环境)起作用。这将最终综合干预-行为者-环境-机制-结果配置。将对治疗一致性(OPC-一致性衡量标准)、照顾者对 OPC 的情绪反应(会话评分量表)、干预前的情绪状态(抑郁、压力和焦虑量表)和患者结果(加拿大职业表现衡量标准)等定量措施进行描述性分析。将对治疗师实施 OPC 高于和低于一致性阈值的情况进行反思性主题分析,并对毛利人或太平洋岛民患者进行以文化为重点的访谈,以了解影响治疗师以一致性实施 OPC 的环境因素,以及在治疗师或照顾者中引发对干预产生反应的机制。MANA 研究的试验结果将单独报告。
本研究已获得新西兰健康和残疾伦理委员会(20/STH/93)的伦理批准。在所有参与的司法管辖区,都获得了当地的批准,涉及当地毛利人的协商过程。研究结果将向所有参与者以及更广泛的临床医生和政策制定者传播,通过会议演讲和同行评审期刊出版物,为资源配置和支持 OPC 的有效提供提供信息,以优化儿童和照顾者的结果。
ACTRN12621000519853。