Recruiting Individuals with Serious Mental Illnesses for a Randomized Control Trial in a Prison Setting: Barriers and Lessons Learned

Background/Purpose:  The rigorous evaluation of interventions for justice-involved people with serious mental illnesses (SMI) is imperative to improving programming and outcomes for these individuals. While a Randomized Control Trial (RCT) design is regarded as the “gold standard” of intervention research, RCTs among incarcerated individuals with SMI face a number of recruitment barriers that can impeded the success of trials.

Study recruitment is foundational to study success. Yet, over half of all clinical trials fail to reach their recruitment goals on time- the consequences of which can be study termination, loss of funder confidence, staff and participant demoralization, and a failure to contribute to the evidence-base.  Little research exists that delineates recruitment barriers at the intersection of clinical trials, mental health, and corrections research and possible strategies to overcome these barriers. The current paper addresses this gap by leveraging information and experiences gathered during the open-trial phase of a group-based intervention done with incarcerated individuals with SMI in a prison setting.

Methods: This analysis used project meeting notes, study memos, site correspondences, and staff and participant feedback from the open-trial study phase to examine recruitment patterns as well as facilitators and barriers to recruitment goals and timelines.  Open-coding methods were used to analyze these study materials to identify and categorize factors that impacted recruitment efforts. Member checking techniques where then used with research staff to further develop emergent themes.  Additionally, recruitment tracking forms were used during the open-trial phase to document every step in the recruitment process. Information from these forms were used to construct study flow charts which were used to analyze recruitment efforts and progress during each of the three recruitment cycles in the open-trial phase.

Results: Analysis of recruitment tracking forms identified 6 stages in the recruitment process including referral, initial approach, informed consent, study screening, determination of eligibility, and study enrollment. In total, 32 participants, out of 99 referred, were enrolled in 14 days across 3 open-trial phases (9 enrolled in the first cycle, 12 in the second cycle, and 11 in the third cycle).  The primary sources of drop-out during the recruitment process were “no shows” for the initial contact with study staff (23%). Among individuals who had contact with study staff, the majority of refusals occurred during the initial approach (19%) or were found ineligible during the recruitment process (12%).  Analysis of the study materials found that building rapport with potential participants and prison staff and maintaining flexibility with prison schedules facilitated recruitment efforts. Limited prison resources (personnel and space), difficulty of accessing study sites (distance, prison training, entry/exit procedures), prison restrictions on materials, and “cold calling” potential participants were challenges that slowed the recruitment process.

Implications:  Correctional settings create a unique set of challenges for the recruitment of individuals with SMI into clinical trials. Recruitment goals and timelines should take these barriers into account and researchers should employ strategies to mitigate delays and maximize recruitment success.