Achieving target recruitment in a primary care trial: lessons from PRIDE

Abstract

Background: Failure to reach recruitment targets is a widespread problem in RCTs (randomized controlled trials). This paper presents experience of recruiting patients into the PRIDE trial which was carried out in one Primary Care Trust (PCT) in the North West of England. Aim: The aim of this feasibility study was to test the effectiveness of a new model of care for the management of late-life depression. Method: GPs (general practitioners), PNs (practice nurses) and community nurses were invited to refer patients into the study. Over 100 patients were needed (at least 50 in each arm of the trial) for the study to be sufficiently powered. On-target recruitment of over 100 patients over 18 months was achieved. Findings: Data obtained from conversations and from semi-structured interviews with health professionals is presented to give possible explanations for this successful recruitment. Not all practices in the PCT engaged with the study, and the most common reasons given by GPs and their staff for non-participation was being single handed or already having a heavy work-load. All community nurses spoken to agreed to refer patients to the study but only five referrals were made by this group over the course of the study. The main reasons primary care professionals did agree to participate and continue to refer patients was that they felt the trial was offering a local and relevant service to an under-served patient group. The very simple referral process was also an important factor. In addition, the Trial Nurse was perceived to be responsive, responding quickly to referrals made and providing regular and detailed feedback which was perceived to help and support the health professionals in the future management of the patient.