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

Christine L.M. Joseph, Dennis Randall Ownby, Edward Zoratti, Dayna Johnson, Shannon Considine, Renee Bourgeois, Christina Melkonian, Cheryl Miree, Christine Cole Johnson, Mei Lu

Research output: Contribution to journalArticle

5 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)25-32
Number of pages8
JournalClinical Research and Regulatory Affairs
Volume33
Issue number2-4
DOIs
StatePublished - Oct 1 2016

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Keywords

  • CONSORT checklist
  • Intervention
  • explanatory trials
  • patient enrollment

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science
  • Pharmacology (medical)

Cite this

Joseph, C. L. M., Ownby, D. R., Zoratti, E., Johnson, D., Considine, S., Bourgeois, R., Melkonian, C., Miree, C., Cole Johnson, C., & Lu, M. (2016). Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure. Clinical Research and Regulatory Affairs, 33(2-4), 25-32. https://doi.org/10.1080/10601333.2016.1182693