Patient engagement in a pragmatic trial: Insights from the FM-TIPS trial
Elizabeth M. Johnson, Dana L. Dailey, Carol G.T. Vance, Barbara J. Van Gorp, Andrew A. Post, Ruth L. Chimenti, Kari G. Vance, David-Erick Lafontant, Dixie Ecklund, Kristin R. Archer, Bridget M. Zimmerman, Emine Bayman, Kathleen A. Sluka, Leslie J. CroffordAbstract
Introduction:
Pragmatic trials are designed to test the effectiveness of an intervention in a real-world setting, which requires decentralized enrollment and data collection methods. Communication strategies may play an important role in supporting participant engagement, though evidence describing their implementation and impact in pragmatic trials is limited. The purpose of this study was to describe the impact of various communication strategies with participants on the rate of enrollment, baseline data completion, and retention rates in the Fibromyalgia TENS in Physical Therapy Study (FM-TIPS).
Methods:
We evaluated enrollment, baseline data completion, and retention in relation to implementation of different communication strategies for FM-TIPS, a cluster randomized pragmatic clinical trial. Communication strategies evolved iteratively over the course of the trial, ranging from automated reminders to reactive and proactive personalized contact by study staff.
Results:
Following implementation of the reactive communication plan, enrollment increased from 83% to 92%, and completion of Day 1 research homework increased from 67% to 81%. Following implementation of the proactive participant onboarding approach, including a welcome phone call and email, completion of Day 1 research homework increased to 89%. Retention at later time points improved following the introduction of automated reminders combined with targeted, personalized contact. Additional communication unrelated to enrollment and completion of research homework, such as troubleshooting technical issues, may have contributed to participant retention in the study.
Conclusion:
The addition of personalized communication strategies to regular automated reminders was associated with higher enrollment, baseline data completion, and participant retention in a decentralized pragmatic trial.