Abstract
BackgroundRelapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility.ObjectiveThis study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report.MethodsThe overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies.ResultsThe results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019.ConclusionsThe findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial.Trial RegistrationISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262International Registered Report Identifier (IRRID)DERR1-10.2196/15634
Highlights
BackgroundPsychotic disorders are common [1], and schizophrenia is one of the top 15 leading causes of disability worldwide [2]
Signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER; ISRCTN: 99559262) is a proof-of-concept, cluster randomized controlled trial (c-RCT) to establish the feasibility of conducting a definitive RCT comparing EMPOWER against treatment as usual
We argue that given the complex and multicomponent nature of the EMPOWER intervention, the targeting of service users, carers, and mental health staff within the intervention program theory, and the intervention being tested across 2 international sites, it is doubtful that a process evaluator could identify key evaluation domains utilizing a predefined framework
Summary
BackgroundPsychotic disorders are common [1], and schizophrenia is one of the top 15 leading causes of disability worldwide [2]. Signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. Conclusions: The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. Beyond standard ethnographic observations of how the researcher team carries out implementation processes, trial documents such as protocols and minutes of meetings are recommended as an essential source of ethnographic enquiry to understanding implementation more thoroughly [59]
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