Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure

Abstract

Modernized approaches to multi-site randomized controlled trials (RCT) include the use of electronic medical records (EMR) for recruitment, remote data capture (RDC) for multisite data collection, and strategies to reduce the need for research infrastructure. These features facilitate the conduct of pragmatic trials, or trials conducted in ‘real life’ settings. This study describes the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma. Using encounter and prescription databases, a list of potentially-eligible patients was linked to the Epic appointment scheduling system. Patients were enrolled during a scheduled visit and then electronically randomized to a tailored vs generic online intervention. In total, 1146 appointments for 580 eligible patients visiting five clinics were identified, of which 45.9% (266/580) were randomized to reach targeted enrollment (n = 250). RDC facilitated multisite enrollment. Intervention content was further personalized through real-time entry of asthma medications prescribed at the clinic visit. EMR monitoring helped with recruitment trouble-shooting. Systemic challenges included a system-wide EMR transition and a system-wide reorganization of clinic staffing. In conclusion, modernized RCTs can accelerate translation of research findings. Electronic initiatives facilitated implementation of this RCT; however, adaptations to recruitment strategies resulted in a more ‘explanatory’ framework.

Keywords:

• Intervention
• patient enrollment
• CONSORT checklist
• explanatory trials

Acknowledgements

We’d like to acknowledge and thank our research support staff, the participating clinics, and the patients who gave of their valuable time to be in the study.

Disclosure statement

This work was supported by the National Institutes of Health (NIH)/National Heart, Lung and Blood Institute grant R01HL114981. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.