Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness

Abstract

BackgroundUnder-recruitment to randomised controlled trials (RCTs) is often problematic and there may be particular difficulties in recruiting patients with severe mental illness.AimTo evaluate reasons for under-recruitment in an RCT of patients with severe mental illnessMethodsQualitative study during the recruitment phase of an RCT of supported employment. Trial staff and recruiting clinicians were interviewed. Data were analyzed thematically using constant comparative techniques.ResultsRecruitment rates were low. Five main reasons for recruitment difficulties were found. These included: (i) misconceptions about trials, (ii) lack of equipoise, (iii) misunderstanding of the trial arms, (iv) variable interpretations of eligibility criteria, (v) paternalism.ConclusionReasons for recruitment difficulties in trials involving patients with severe mental illness include issues that occur in trials in general, but others are more specific to these patients. Clinician and patient involvement in the study design may improve recruitment in future similar trials.

Barriers to participation in mental health research: Findings from the Genetics and Psychosis (GAP) Study

“…Patients approached soon after admission discussed being focused on themselves at that time and that perhaps research participation would be viewed more positively when they felt more 'over the problem'. This suggests that recruiting patients at the beginning of an admission can be particularly challenging as has been found by others (Howard, de Salis, Tomlin, Thornicroft, & Donovan, 2009a).The way in which the study was initially described to patients also influenced their decision, and patients particularly appreciated researchers with good communication skills who were open about the research process and appeared very professional.…”

A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance

“…The evaluation should incorporate site initiation and closeout as inexperienced sites and staff may require more assistance at these stages [23,31]. A major advantage of PRIME is that it can be undertaken by existing staff, which can enhance study cohesion and potentially reduce costs.…”

Clinicians' attitudes towards patient involvement in mental health research

“…Other studies have reported a feeling among staff of needing to 'protect' patients, which can act as a barrier to recruitment. 10,11 In order to increase patient participation in research, it is important to ensure that clinicians feel confident and empowered to operate their brokerage roles effectively.…”