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

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

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

View abstract on PubMed

Summary

This study used electronic health records for a pragmatic clinical trial in urban youth with asthma. Modernized recruitment accelerated research translation, though adaptations led to a more explanatory trial design.

Area of Science:

Clinical Trials
Public Health Research
Digital Health

Background:

Modern multisite randomized controlled trials (RCTs) leverage electronic medical records (EMR) and remote data capture (RDC) for efficiency.
These advancements support pragmatic trials conducted in real-world clinical settings.

Purpose of the Study:

To describe the recruitment process of an RCT evaluating a clinic-based intervention for urban youth with asthma.
To assess the feasibility of using EMR and RDC for multisite recruitment and enrollment.

Main Methods:

A list of potentially eligible patients was generated from EMR encounter and prescription databases.
Patients were enrolled during scheduled visits and electronically randomized to tailored or generic online interventions.
Remote data capture facilitated multisite enrollment and real-time intervention personalization.

Main Results:

580 eligible patients across 5 clinics were identified, with 45.9% randomized, achieving target enrollment.
Electronic medical record monitoring aided in troubleshooting recruitment issues.
System-wide EMR transitions and staffing changes presented challenges.

Conclusions:

Modernized RCT approaches, including electronic initiatives, can expedite research translation.
While electronic tools facilitated implementation, recruitment strategy adaptations shifted the trial towards an explanatory framework.
This highlights the need for adaptable recruitment strategies in pragmatic trials.