Perspectives of Trial Staff on the Barriers to Recruitment in a Digital Intervention for Psychosis and How to Work Around Them: Qualitative Study Within a Trial

Abstract

Background Recruitment 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. Objective The primary aim of this study was to understand recruitment from the point of view of trial staff and discover what they consider important. Methods We 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. 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. Conclusions Researchers 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.

Feasibility of an Intervention Delivered via Mobile Phone and Internet to Improve the Continuity of Care in Schizophrenia: A Randomized Controlled Pilot Study

“…Another factor that hindered recruitment in the present trial were organizational challenges, especially due to staff turnover and difficulties of the research team in tracking upcoming discharges and finding the right moment to invite patients to participate in the study before they left the clinic. These observations are equivalent to the ones recently reported by Allan et al [ 32 ] who analyzed in detail barriers to recruitment in a digital intervention study for psychosis. Similar to the present study, these authors also reported that some patients could not be approached by the researchers because mental health professionals on the ward had decided in advance that patients would not be suitable for the study or capable of using the intervention.…”

Recruitment to a trial of antipsychotic reduction: impact of an acceptability study

“…If the individual researchers conducting the acceptability study and trial recruitment can be kept the same, as they were in many instances in the current study, then this establishes rapport and provides further reassurance, thereby improving the chances of recruitment to the trial. Experience from other trials involving people with psychosis has shown that building relationships between researchers participants, as well as clinicians, helps with recruitment [ 37 ].…”

Protocol Development for a Qualitative Methodological Study Within a Trial (Qual-SWAT): The KARMA-Dep-2 Trial

“…A promising approach to address this gap, to improve trial design and conduct, and reduce research waste, is the use of Study Within A Trail (SWAT) methodology ( Ahmed et al ., 2022 ; Allan et al ., 2021 ; Boxall et al ., 2022 ; Thiblin et al ., 2022 ). A SWAT can be defined as a “self-contained research study that has been embedded within a host trial with the aim of evaluating or exploring alternative ways of delivering or organising a particular trial process” ( Treweek et al ., 2018 ).…”