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)
Program Official: Lawrence Fine, MD, DrPH (NHLBI)
Project Scientist: Nicole Redmond, MD, PhD, MPH (NHLBI)
ClinicalTrials.gov Identifier: NCT03973931
Trial Status: Enrolling
Trial Summary
Up to 50% of patients do not take their cardiovascular medications as prescribed, resulting in increased morbidity, mortality, and healthcare costs. Interventions to improve adherence - such as patient education, reminders, pharmacist support, and financial incentives - have produced inconsistent results due to limited study designs. Mobile and digital technologies for health promotion and disease self-management offer an untested opportunity to adapt behavioral ‘nudges’ using ubiquitous cell phone technology to facilitate medication adherence.
Our objective is to employ population-level pharmacy data and to deliver nudges via cell phone text messaging and artificially intelligent (AI) interactive chat bot to improve medication adherence and patient outcomes in 3 integrated healthcare delivery systems (HCS): University of Colorado Health System (UCHealth), VA Eastern Colorado Health Care System (VA), and Denver Health Medical Center (DH). In the UG3 Phase of our study, we aim to develop the necessary infrastructure and to pilot the nudge trial in preparation for the implementation of a pragmatic, patient-level randomized intervention across 3 HCS (UH3 Phase/Years 2-5). In the UG3 Phase, we aim to develop and program a theoretically-informed, technology-based (a) nudge message library and (b) chat bot content library using multiple and iterative N of 1 within-subject studies to optimize content for a range of diverse patients (Aim 1). Secondly, applying our findings from Aim 1, we aim to conduct a pilot intervention to demonstrate the feasibility of delivering the nudge messages and their preliminary effects in all 3 HCS (Aim 2). During the process, we will also engage patient, provider and health systems stakeholders in designing, refining, and implementing the pilot intervention. To accomplish Aim 2, our study team will identify patients with chronic cardiovascular (CV) conditions taking medications to treat hypertension, atrial fibrillation, coronary artery disease, diabetes and/or hyperlipidemia. We will also leverage pharmacy refill data to identify episodes of non-adherence through gaps in medication refills and randomize individuals to 1 of 4 study arms when they have a first refill gap: 1) usual care; 2) generic text message reminder; 3) tailored and engaging text messages optimized to facilitate behavior change; or 4) optimized text messages plus a pre-programmed AI interactive chat bot designed to support identification and resolution of barriers to medication refill and adherence. We seek to apply our findings from the UG3 Phase/Year 1 study to accomplish two additional aims in Years 2-5 (UH3): Conduct a pragmatic patient-level randomized intervention across 3 HCS to improve adherence to chronic CV medications. The primary outcome will be medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data. Secondary outcomes will include intermediate clinical measures (e.g., BP control), CV clinical events (e.g., hospitalizations), healthcare utilization, and costs (Aim 3). We will also evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. In addition, we will assess the context and implementation processes to inform local tailoring, adaptations and modifications, and eventual expansion of the intervention within the 3 HCS more broadly and nationally (Aim 4).
Data and Resource Sharing
- 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 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
- News_A Year of New Insights From the NIH Collaboratory
December 14, 2021: A Year of New Insights From the NIH Collaboratory
- News_Nudge Awarded Continuation From Planning to Implementation Phase
July 26, 2019: Nudge Awarded Continuation From Planning to Implementation Phase
- News_Spotlight on a New Demonstration Project_Nudge
August 28, 2018: Spotlight on a New NIH Collaboratory Trial: Nudge
- Drs. Sheana Bull and Michael Ho Introduce Nudge
Drs. Sheana Bull and Michael Ho Introduce Nudge
Publications
- 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?
- 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 PCTs Should Have a DMC?
- 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
- 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