Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials

Juliet M Foster, Susan M Sawyer, Lorraine Smith, Helen K Reddel, Tim Usherwood

Primary-care based randomized controlled trials (RCTs) build an important evidence base for general practice but little evidence exists about barriers to recruitment which often hamper such trials. We investigated the issues that impeded and facilitated recruitment to a clinical trial in general practice. GPs participating in a cluster RCT that tested interventions for improving medication adherence and asthma control completed a survey comprising quantitative and free text questions about their recruitment experiences. We used backward regression to analyze quantitative data and coded free text responses into themes. 40/55 of enrolled GPs recruited patients, but only one-third reached the planned recruitment target (5 patients/GP). In univariate analyses, poor patient recruitment by GPs was significantly associated with longer time to first patient enrolment, GP-perceived poor access to eligible patients and GP working in a practice training medical students. In regression analysis, only the first was significant (p = 0.001); the explained variance of the model was 48%. Themes from free text responses described recruitment barriers at the level of GP (e.g. GPs excluding patients for whom research appeared too challenging), practice (e.g. practice cultures disempowered GPs), patient (e.g. reluctance to change treatment for research) and study (e.g. protocol requirements complicating recruitment). Facilitators included GPs perceiving good support from the research team. Targeted recruitment support early in the recruitment phase may enhance recruitment rates. Over time, interventions to enhance a general practice research culture are also likely to enhance skills to recruit patients, even for complex interventions. We recommend systematic evaluation of recruitment approaches and outcomes in future RCTs to optimize feasibility and success of these important trials. Australian and New Zealand Clinical Trials Registry ACTRN12610000854033 (date registered 14/10/2010).