Abstract

BackgroundRecruitment processes for clinical trials of digital interventions for psychosis are seldom described in detail in the literature. Although trial staff have expertise in describing barriers to and facilitators of recruitment, a specific focus on understanding recruitment from the point of view of trial staff is rare, and because trial staff are responsible for meeting recruitment targets, a lack of research on their point of view is a key limitation.ObjectiveThe primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important.MethodsWe applied pluralistic ethnographic methods, including analysis of trial documents, observation, and focus groups, and explored the recruitment processes of the EMPOWER (Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-being, Engagement, and Recovery) feasibility trial, which is a digital app–based intervention for people diagnosed with schizophrenia.ResultsRecruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams.ConclusionsResearchers in clinical trials for digital psychosis interventions face numerous recruitment barriers and do their best to work flexibly and to negotiate these barriers and meet recruitment targets. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial.

Highlights

  • BackgroundTo better understand how interventions could be developed, evaluated, and implemented in routine care, it is important to fully understand which aspects of the implementation of randomized control trials (RCTs) are most challenging [1]

  • Trial work is a broad concept related to the work done to overcome barriers during the recruitment process engagement, buy in to the trial across a range of stakeholders, and work involved in managing the organizational complexity necessary to reach recruitment targets [54]

  • Rather than people diagnosed with schizophrenia being a hard-to-reach group, it seems that difficulties in recruiting people diagnosed with schizophrenia to clinical trials emerge from complex dynamic interactions within health care systems

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Summary

Introduction

BackgroundTo better understand how interventions could be developed, evaluated, and implemented in routine care, it is important to fully understand which aspects of the implementation of randomized control trials (RCTs) are most challenging [1]. Results: Recruitment barriers were categorized into 2 main themes: service characteristics (lack of time available for mental health staff to support recruitment, staff turnover, patient turnover [within Australia only], management styles of community mental health teams, and physical environment) and clinician expectations (filtering effects and resistance to research participation). Trial staff negotiated these barriers through strategies such as emotional labor (trial staff managing feelings and expressions to successfully recruit participants) and trying to build relationships with clinical staff working within community mental health teams. The recruitment process appeared to be enhanced by trial staff supporting each other throughout the recruitment stage of the trial

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