A qualitative evaluation of implementing a randomized controlled trial in general practice.

Abstract

BACKGROUND: For findings of randomized controlled trials in primary care to be applicable, both the sample of clinicians implementing the trial and the recruited patients should be as representative as possible. The processes of conducting trials should be made "user-friendly" to clinician investigators in order to maximize their participation in research. Formal evaluations of trial implementation are unusual. This study reports clinicians' perspectives on acting as a clinician investigator in a randomized controlled trial (the SAVIT study) in general practice. OBJECTIVE: Our purpose was to explore clinicians' accounts of taking part in a randomized controlled trial in which subjects were recruited opportunistically during general practice consultations. METHOD: Individual semi-structured interviews were conducted with nine GPs and one practice nurse practising in the Bro Taf area of South Wales who recruited children into the SAVIT study. A structured interview guide was used and data were analysed using the qualitative method of pattern coding. RESULTS: Major emerging themes included recruitment difficulties and concerns about the safety of the study medication. Participants also outlined positive aspects of the study (clarity and simplicity of the study, potential benefits to clinicians and patients and study team follow-up of recruited patients). Recommendations for possible improvements in study implementation included the simplification and reduction of patient reading materials and improved presentation of study materials. CONCLUSIONS: Difficulty in recruiting patients was the most frequently mentioned problem by clinician investigators. Insufficient time in the consultation was perceived as the main barrier. Ingredients of successful trial implementation include good organization, simple documentation and study procedures, and the ability to allay concerns about patient safety. Findings from this evaluation may assist researchers in the design and implementation of future community-based randomized controlled trials.