June 13, 2022: Nudge Trial Overcomes Challenges, Completes Enrollment

Michael Ho, MD, PhD
Michael Ho, MD, PhD

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, we asked Drs. Sheana Bull and Michael Ho to update us on the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) NIH Collaboratory Trial. Nudge is using population-level pharmacy data to deliver nudges via cell phone text messaging and artificially intelligent interactive chat to improve medication adherence and patient outcomes in 3 integrated healthcare delivery systems.

What is the current status of the Nudge trial?
The Nudge study has completed enrollment at all 3 of its participating healthcare systems (VA Eastern Colorado Health Care System, Denver Health, and UCHealth, Aurora, Colorado). Follow-up has been completed for the VA, Denver Health follow-up was completed on May 27, and UCHealth follow-up will continue until April 11, 2023. A pharmacist and research staff continue to engage with questions from participants at UCHealth. Data for final analysis will be pulled for the VA and Denver Health sites in fall 2022.

What challenges have you faced, and how have you dealt with them?

Sheana Bull, PhD, MPH
Sheana Bull, PhD, MPH

The onset of COVID-19 greatly delayed enrolling at the UCHealth site since there were not enough resources to devote to implementing the intervention. Additionally, there were administrative difficulties at UCHealth in adding participants via SureScripts due to concerns about time management and payment for IT professionals.

What impact do you hope your trial will have on real-world healthcare?
Text messaging is increasingly becoming part of standard of care for many health care systems. We hope our trial will encourage more healthcare systems to integrate text messaging and chatbots specifically for medication adherence and other health behaviors. Participants have engaged more with messages that are more personalized and include a chatbot, which may mean patients feel more empowered to discuss their medication needs when a mechanism seems more invested in their well-being.

How has being part of the NIH Pragmatic Trials Collaboratory shaped your project?
It was very helpful to have the NIH Pragmatic Trials Collaboratory weigh in on our IRB and statistical plan during the UG3 [planning] year. In the UH3 [implementation] phase, it has been helpful to participate in the various NIH Pragmatic Trials Collaboratory Core calls and share our experiences and learn from others.