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

  • Christine L.M. Joseph(corresponding author)
    ,
  • Dennis Randall Ownby
    ,
  • Edward Zoratti
    ,
  • Dayna Johnson
    ,
  • Shannon Considine
    ,
  • Renee Bourgeois
*Corresponding author for this work
Scholary Output:
Contribution to journal
Article
Peer-review

Open access

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.

Publication Information

Output type

Scholary Output:
Contribution to journal
Article
Peer-review

Original language

English (US)

Pages from-to (Number of pages)

Pages 25-32 (8 pages)

Journal (Volume, Issue Number)

Clinical Research and Regulatory Affairs (Volume 33, Issue 2-4)

Publication milestones

  • Published - 10/01/2016

Publication status

Published - 10/01/2016

ISSN

1060-1333

Publication IDs

  • Scopus: 84973160653

Publication metrics

Metrics

SciVal
FWCI
0.62
SciVal
Author count
10
SciVal
citations
7
SciVal
Paper percentile
64
Scopus
citations
Fractional count
1
Fractional count
0.10
Fractional count
9
Fractional count
0.90
Fractional count
1
Fractional count
1

PlumX, opens in new tab

Captures
46
Citation count
10