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

Abstract

BackgroundPrimary-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.MethodsGPs 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.Results40/55 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.ConclusionTargeted 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.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12610000854033 (date registered 14/10/2010).

Barriers and facilitators to participant recruitment to randomised controlled trials: A qualitative perspective

“…The barriers to participant recruitment in RCTs in various health fields reported to date are classified into 4 major groups; these are: participant‐related, health professional‐related, practice‐related, and study‐related . These groupings were confirmed by a recent systematic review of barriers and facilitators to RCTs in chronic wound management conducted by Bugeja and associates .…”

“…These groupings were confirmed by a recent systematic review of barriers and facilitators to RCTs in chronic wound management conducted by Bugeja and associates . The main facilitators to patient recruitment for RCTs in other health fields were reported as follows: support provided by the project researchers to health professionals and health professionals’ perceived benefits of the study results for their practice . Unfortunately, in the field of chronic wound management, study facilitators/enablers to participant recruitment in RCTs were not identified …”

“…Well‐designed randomised controlled trials (RCTs) are considered the “gold standard” in clinical research because they provide high‐quality evidence related to the management of specific conditions, including VLUs . Unfortunately, recruitment issues for participation in the RCTs experienced by health professionals are not uncommon . These issues are related to researchers’ inability to recruit the required number of participants or to retain the recruited participants in the study .…”

Barriers and enablers to patient recruitment for randomised controlled trials on treatment of chronic wounds: A systematic review

“…Study‐related barriers include narrow inclusion and exclusion criteria and overestimation of potential recruits. Comorbid conditions, language proficiency, cognitive ability, and patient's lack of interest are some of the participant‐related factors . Researcher‐related factors include differences in perception between principal investigators and research nurses .…”

“…Comorbid conditions, language proficiency, cognitive ability, and patient's lack of interest are some of the participant‐related factors . Researcher‐related factors include differences in perception between principal investigators and research nurses . Organisational factors include a busy clinical practice, lack of clinician time, and inadequate incentives for clinician to engage in recruitment …”