TY - JOUR
T1 - Recruitment experience for a pragmatic randomized controlled trial
T2 - Using EMR initiatives and minimizing research infrastructure
AU - Joseph, Christine L.M.
AU - Ownby, Dennis Randall
AU - Zoratti, Edward
AU - Johnson, Dayna
AU - Considine, Shannon
AU - Bourgeois, Renee
AU - Melkonian, Christina
AU - Miree, Cheryl
AU - Cole Johnson, Christine
AU - Lu, Mei
N1 - Publisher Copyright:
© 2016 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
KW - CONSORT checklist
KW - Intervention
KW - explanatory trials
KW - patient enrollment
UR - http://www.scopus.com/inward/record.url?scp=84973160653&partnerID=8YFLogxK
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U2 - 10.1080/10601333.2016.1182693
DO - 10.1080/10601333.2016.1182693
M3 - Article
AN - SCOPUS:84973160653
SN - 1060-1333
VL - 33
SP - 25
EP - 32
JO - Clinical Research and Regulatory Affairs
JF - Clinical Research and Regulatory Affairs
IS - 2-4
ER -