UH3 Project: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)
Overview
Principal Investigators:
Sponsoring Institution: University of Colorado
Collaborators:
- UCHealth, Aurora, Colorado
- VA Eastern Colorado Health Care System, Aurora, Colorado
- Denver Health, Denver, Colorado
NIH Institute Providing Oversight: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT03973931
Trial Status: Completed
Trial Summary
Study question and significance: Poor medication adherence is common among patients with chronic conditions, and poor adherence to cardiovascular medications is associated with higher rates of adverse health outcomes, including hospitalization and mortality.
Design and setting: Patient-level randomized trial embedded in 3 healthcare systems testing a variety of text messaging strategies to encourage patients to refill their cardiovascular medications from October 2019 to April 2022. The study enrolled 9051 patients who were aged 18 years to less than 90 years, had a diagnosis of 1 or more cardiovascular conditions, had a 7-day refill gap for any cardiovascular medication they had been prescribed, and did not opt out of the study.
Intervention and methods: Patients were randomly assigned to receive either usual care or 1 of 3 text message interventions: (1) a generic text message reminder to refill medication; (2) a text message reminder that incorporated "behavioral nudges"; and (3) a behavioral nudge text message reminder plus a chatbot that used preprogrammed algorithms to assess common barriers to medication adherence. The primary outcome was the proportion of days covered in the 365 days after randomization for all cardiovascular medication classes for which the patient had a refill gap at baseline.
Findings: There were no statistically significant differences in the proportion of days covered with medication between the study groups. There were also no differences in emergency department visits, hospitalizations, and mortality. In a post hoc analysis exploring medication adherence in the first 3 months after a refill gap, there was a modest improvement in refill adherence with the text messaging strategies compared with usual care.
Conclusions and relevance: Text messaging reminders to patients who delayed refilling their cardiovascular medications did not improve medication adherence compared with usual care. Because poor medication adherence may be due to multiple factors, future interventions may need to be designed to address these multiple factors.
Data and Resource Sharing
- Stamped_The Nudge Project_Flyer for patients_05222019
Nudge Flyer for Patients
- Stamped_Info sheet_DH_12.1.20_Clean
Nudge Information Sheet
- Nudge_Protocol_Clean_v11.12.2024
Nudge Protocol
- Nudge-2019-UH3 Follow-up
Nudge-Ethics and Regulatory UH3 Follow-up
- Nudge Ethics and Regulatory Discussion
Nudge Ethics and Regulatory Discussion
Featured Interviews
Drs. Bull and Ho discuss the progress and challenges of the Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge) NIH Collaboratory Trial.
News and Interviews
- News_A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
- News_NIH Collaboratory Researchers Consider Posttrial Responsibilities
August 25, 2025: NIH Collaboratory Researchers Consider Posttrial Responsibilities
- News_New Report Highlights Value of Informing Participants About Research Conducted Under a Waiver of Consent
April 22, 2025: New Report Highlights Value of Informing Participants About Research Conducted Under a Waiver of Consent
- News_Texting for Behavior Change to Improve Chronic Care Management, in This Week’s PCT Grand Rounds
February 19, 2025: Texting for Behavior Change to Improve Chronic Care Management, in This Week’s PCT Grand Rounds
- News_A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2024: A Year of Innovations and Insights From the NIH Pragmatic Trials Collaboratory
- News_Nudge Pragmatic Trial Finds No Improvement in Adherence to Cardiovascular Medications at 12 Months
December 5, 2024: Nudge Pragmatic Trial Finds No Improvement in Adherence to Cardiovascular Medications at 12 Months
- News_Seasoned Collaboratory PIs Give Tips to New PRISM Pragmatic Trials
November 19, 2020: Seasoned Collaboratory PIs Give Tips to New PRISM Pragmatic Trials
- News_A Year of New Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory
- News_In This Friday’s PCT Grand Rounds, Results From the Nudge Demonstration Project
November 15, 2023: In This Friday’s PCT Grand Rounds, Results From the Nudge Trial
- News_Nudge Trial Overcomes Challenges
June 13, 2022: Nudge Trial Overcomes Challenges, Completes Enrollment
Publications
- O'Rourke et al Learn Health Syst 2025
Disentangling informing participants from obtaining their consent
- Ho et al JAMA 2024
Nudge Main Outcome Paper
- Waughtal et al Cardiovasc Digit Health J 2023
Patient engagement with prescription refill text reminders across time and major societal events
- Marrs et al Am J Health Syst Pharm 2023
Description of patient questions received by clinical pharmacists in the Nudge Study
- Gupta et al Am Heart J 2023
Secondary analysis of electronic opt-out consent in pragmatic research: A study design method to diversify clinical trials?
- Boyd et al J Am Med Inform Assoc 2023
Potential bias and lack of generalizability in electronic health record data: reflections on health equity from the National Institutes of Health Pragmatic Trials Collaboratory
- Sandy et al Medicine (Baltimore) 2021
Leave me out: patients' characteristics and reasons for opting out of a pragmatic clinical trial involving medication adherence
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Glasgow et al Trials 2021
Nudge Study Design Paper
- Luong et al Circ Cardiovasc Qual Outcomes 2021
Text message medication adherence reminders automated and delivered at scale across two institutions: testing the Nudge system: pilot study
- Waughtal et al Transl Behav Med 2021
Nudge me: tailoring text messages for prescription adherence through N-of-1 interviews
- Living Textbook Chapter_mHealth_Case Example from Nudge
Living Textbook Chapter: Mobile Health: Case Example from the Nudge Study
- Living Textbook Chapter_Which PCTs Should Have a DMC
Living Textbook Chapter: Which Pragmatic Trials Should Have a DSMB?
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- Living Textbook Chapter_Monitoring Intervention and Fidelity Adaptions
Living Textbook Chapter: Monitoring Intervention and Fidelity Adaptions: Intervention Adaptation Strategies and Examples
- Nudge Study Snapshot
Nudge Study Snapshot
Presentations
- MA AHA poster MAsmuth 16Nov20241
Association Between Prescription Fill Rates and Adverse Outcomes within an mHealth Clinical Trial Designed to Improve Medication Adherence
- 00_George_Improving Implementation of Digital Tools_Final_Includes all slides
Improving Implementation of Digital Tools Developed in ePCTs
- SC-Mtg-2024-Day2-Platt
How to Transition to the Next Research Opportunity
- AcademyHealth D&I Workshop 2023_Nudge-Slides
AcademyHealth D&I Workshop 2023 - Nudge
- AcademyHealth D&I Workshop 2023_ePCTs in Context_Panel-2_Slides
AcademyHealth D&I Workshop 2023 - Panel 2
- AcademyHealth D&I Workshop 2023_ePCTs in Context_Panel-1_Slides
AcademyHealth D&I Workshop 2023 - Panel 1
- GR-Video-11-17-23
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (GR Video 2023)
- GR-Slides-11-17-23
Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications: Results from the Nudge Study (GR Slides 2023)
- SC-Mtg-2023-Day1-Ho-Bull-Nudge
Michael Ho & Sheana Bull Presentation 2023 Steering Committee Meeting
- SC-Mtg-2023-Day1-Ho
Michael Ho Panel Presentation at 2023 Steering Committee Meeting
- 2022 NIH Workshop_Ho
2022 NIH Workshop: Nudge Presentation
- SC-Mtg-2022-Day-2-Bull
Nudge Presentation at 2022 Steering Committee Meeting
- Reaching out in Real Time_Identifying patients at imminent risk for nonadherence (APHA 2020)
Reaching out in Real Time: Identifying patients at imminent risk for nonadherence (APHA 2020)
- Delivery of automated text message reminders _Nudge Pilot Study (APHA 2020)
Delivery of automated text message reminders: Nudge Pilot Study (APHA 2020)
- Ho_Novel_Nudge_Collaboratory_SC_23APR20
Utilizing Text Message Technology in a Pragmatic Clinical Trial - The Experience of the Nudge Study
- Presentations at the April 2020 SC Meeting
Presentations at the April 2020 SC Meeting
- Poster_Nudge_SBM_2020_c
Nudge Me: Tailoring Text Messages for Prescription Adherence Through N of 1 Interview (SBM 2020)
- GR-Video-02-21-20
Nudge Study Updates (GR Video 2020)
- GR-Slides-02-21-20
Nudge Study Updates (GR Slides 2020)
- Presentation_Nudge_AHA_2019_c
Medication Adherence: Proportion of Days Covered at Point-of-Care and Automated Reminders (AHA 2019)
- SC-2019-UG3-Nudge
UG3 Updates-Nudge
- GR-Video-01-11-19
Nudge: Text Messaging at Scale in Diverse Health Systems to Support Adherence to Cardiac Medication (GR Video 2019)
- GR-Slides-01-11-19
Nudge: Text Messaging at Scale in Diverse Health Systems to Support Adherence to Cardiac Medication (GR Slides 2019)
- 14.-HoBull_15min_FINAL
The Nudge Project: Overview and Status