Barriers and Facilitators in Recruiting to a Complex Rehabilitation Intervention: A Qualitative Process Evaluation of FEMuR III

Problem

Randomised controlled trials (RCTs) often struggle with recruitment and may need extensions. Poor recruitment can result in an underpowered study and lead to delayed implementation of effective interventions (1). Research has shown that many recruitment issues can be anticipated. The aim of this study is to look at facilitators and barriers to recruitment from the recruiter’s perspective.

Approach

FEMuR III was an RCT of a complex intervention post-surgery for hip fracture in patients over 65 years of age. Recruitment took place in secondary care for an intervention delivered in the community. A process evaluation was undertaken and semi-structured interviews were conducted with seven recruiters between November 2022 and March 2023 to identify barriers and facilitators to recruitment. A thematic analysis was undertaken in NVIVO using a critical realist perspective.

Findings

Barriers to approaching potential participants included difficulties in access, concerns around patient capacity, ethical dilemmas and family influence. There were instances where recruiters felt uncomfortable approaching patients who they felt would not benefit from the trial due to other factors (eg. comorbidities or complex living situations). Barriers for patient involvement from the recruiter’s perspective included fear or reluctance, information overload and negative perceptions of research. The barriers to recruitment of carers included access, reluctance to take part and difficulty identifying carers. Recruiters found that carers did not always relate to the label of ‘carer’.

Facilitators of recruitment included approaching patients with colleagues, reducing stress through limiting initial information or recruiting at home and having more time to develop relationships with patients. Three factors encouraged patients to take part: research knowledge, contact with others and motivation/interest.

Recruiters made several suggestions: increased involvement of clinical staff in recruitment, additional recruitment guidance, shorter patient information leaflets, increased teamwork between sites, increased teamwork between secondary care and community services, improved access to wards and clinical notes, and more recognition of the time taken to conduct research activities.

Consequences

It is important to evaluate recruitment during the trial to identify issues early and there are tools that can assist with this. This study examined the perspective of recruiters, however it is important to consider other perspectives (patients, carers, clinical staff) in future studies. For future RCTs, alternative terms to ‘carer’ should be considered that may resonate with family members more as the identity development of ‘carer’ is complex and multifaceted. It is important to consider the unease felt by recruiters in approaching certain patients and how this may lead to selection bias. It is likely that further training on RCTs and support for recruiters is needed.

(1) Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ open. 2013;3(2).