The Grand Rounds session will be held on Friday, November 17, 2023, at 1:00 pm eastern.
Nudge is an NIH Collaboratory Trial. Ho is a professor of medicine and Bull is a professor of community and behavioral health at the University of Colorado. They are the co–principal investigators of Nudge.
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
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.
NIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.
So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:
More than half of patients with prescriptions for cardiovascular medications do not take their medications as prescribed. These patients are at greater risk of death and comorbid conditions and have higher healthcare costs. Strategies to improve medication adherence have had mixed results. Meanwhile, advances in mobile and digital technologies for health promotion and disease self-management offer new opportunities to influence patients’ health behaviors and improve health outcomes.
“One of the real benefits of using technology is that it can be widely disseminated. Studying that dissemination process is really where we are in the field. So a pragmatic trial makes a lot of sense.” — Sheana Bull, PhD, MPH
The NIH Collaboratory is pleased to welcome the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) study to its portfolio of NIH Collaboratory Trials. The Nudge study will use mobile phone text messages and an artificial intelligence chatbot to deliver behavioral “nudges” to patients to improve medication adherence. The study will access population-level pharmacy data in 3 integrated healthcare delivery systems to test the effectiveness of the nudges on adherence and outcomes among patients with chronic cardiovascular conditions who take medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes, or hyperlipidemia.
The Nudge study is led by co–principal investigators Drs. Sheana Bull and Michael Ho of the University of Colorado with support from the National Heart, Lung, and Blood Institute. Watch a video interview with Drs. Bull and Ho, and read more about Nudge.
In this Friday's PCT Grand Rounds, Michael Ho and Sheana Bull of the University of Colorado will present "Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results From the Nudge Study."
NIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and