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Joseph CL, Ownby DR, Zoratti E, et al. Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure. Clin Res Regul Aff. 2016;33(2):25-32doi: 10.1080/10601333.2016.1182693.
Joseph, C. L., Ownby, D. R., Zoratti, E., Johnson, D., Considine, S., Bourgeois, R., Melkonian, C., Miree, C., Johnson, C. 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), 25-32. https://doi.org/10.1080/10601333.2016.1182693
Joseph, Christine Lm, et al. "Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure." Clinical research and regulatory affairs vol. 33,2 (2016): 25-32. doi: https://doi.org/10.1080/10601333.2016.1182693
Joseph CL, Ownby DR, Zoratti E, Johnson D, Considine S, Bourgeois R, Melkonian C, Miree C, Johnson CC, Lu M. Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research infrastructure. Clin Res Regul Aff. 2016;33(2):25-32. doi: 10.1080/10601333.2016.1182693. Epub 2016 Jun 01. PMID: 28479846; PMCID: PMC5417689.
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Clin Res Regul Aff. 2016;33(2):25-32. doi: 10.1080/10601333.2016.1182693. Epub 2016 Jun 01.

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

Clinical research and regulatory affairs

Christine Lm Joseph, Dennis R Ownby, Edward Zoratti, Dayna Johnson, Shannon Considine, Renee Bourgeois, Christina Melkonian, Cheryl Miree, Christine Cole Johnson, Mei Lu

Affiliations

  1. Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.
  2. Department of Pediatrics, Georgia Regents University, Augusta, GA, USA.
  3. Department of Internal Medicine, Division of Allergy, Henry Ford Hospital, Detroit, MI, USA.

PMID: 28479846 PMCID: PMC5417689 DOI: 10.1080/10601333.2016.1182693

Abstract

CONTEXT: Modernized approaches to multisite 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.

OBJECTIVE: We describe the recruitment experience of an RCT to evaluate a clinic-based intervention targeting urban youth with asthma.

MATERIALS AND METHODS: 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 versus generic online intervention.

RESULTS AND DISCUSSION: 1146 appointments for 580 eligible patients visiting 5 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.

CONCLUSIONS: 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: CONSORT checklist; explanatory trials; intervention; patient enrollment

Conflict of interest statement

Declaration of Interest 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

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