Recruiting to inpatient-based rehabilitation trials: lessons learned

Sarah F Tyson, Nessa Thomas, Andy Vail, Pippa Tyrrell

Effective recruitment is central to successful trials but is often problematic. This article reports the lessons learnt while recruiting stroke rehabilitation patients to a multi-centre randomised control trial. As intended, 94 participants were recruited from 12 inpatient stroke rehabilitation services in Northwest England over 12 months; however, recruitment rates were highly varied (from 0.6 to 2.5 participants per site per month) as were the nature of the stroke services and the personnel available. Consequently, bespoke recruitment procedures were needed at each site. As the assessment skills needed to screen for the selection criteria were specific to therapists, our most common strategy was for the hospital therapists to screen patients and make referrals directly to the trial team. However, we identified several strategies undertaken by the research nurse in the highest recruiting site that appeared to positively impact on recruitment. These strategies included involving the whole multidisciplinary team, being part of the stroke team, facilitating contact between the clinical and trial teams and using inclusive recruitment and watchful waiting strategies. Rehabilitation trials frequently require skilled assessments by therapists, rather than by doctors or nurses to identify potential participants. Thus, research support models need to include suitably skilled trial therapists. Recruitment can be enhanced by enthusiastic, regular and structured engagement with the entire stroke multidisciplinary team and by using inclusive recruitment and 'watchful waiting' strategies to identify and monitor potential participants. ISRCTN29533052 . Registered May 2011.