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Recruitment experience for a pragmatic randomized controlled trial: Using EMR initiatives and minimizing research
Christine Lm Joseph1, Dennis R Ownby2, Edward Zoratti3
1Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.
Clinical Research and Regulatory Affairs
|May 9, 2017
Summary
Recruiting urban youth for asthma trials using electronic health records and remote data capture accelerated research. Despite challenges, modernized randomized controlled trials (RCTs) enhance real-world evidence generation.
Area of Science:
- Clinical Trials
- Public Health
- Digital Health
Background:
- Modernized multisite randomized controlled trials (RCTs) leverage electronic medical records (EMR) and remote data capture (RDC).
- These approaches support pragmatic trials conducted in real-world clinical settings.
- Streamlined infrastructure reduces the need for extensive research support.
Purpose of the Study:
- To describe the recruitment process of an RCT for an asthma intervention in urban youth.
- To evaluate the effectiveness of clinic-based interventions targeting pediatric asthma.
Main Methods:
- Utilized EMR encounter and prescription data to identify eligible patients.
- Linked patient data to scheduling systems for enrollment during clinic visits.
- Employed electronic randomization to tailor or generic online interventions.
- Used RDC for multisite data collection and EMR monitoring for recruitment oversight.
Main Results:
- Identified 1146 appointments for 580 eligible patients across 5 clinics.
- Achieved 45.9% randomization rate (266/580 patients), nearing the target enrollment of 250.
- RDC facilitated efficient multisite enrollment and real-time intervention personalization.
- EMR monitoring aided in troubleshooting recruitment issues.
Conclusions:
- Modernized RCTs, utilizing electronic initiatives, can expedite research translation.
- Adaptations in recruitment strategies shifted the trial towards a more explanatory framework.
- Systemic challenges like EMR transitions and staffing changes impacted implementation.
