UH3 Project: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)

UH3 Project: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (Nudge)

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

Study Snapshot

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).

NIH Project Information

Data and Resource Sharing

VIEW ALL Resources

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

Publications

Presentations

Back to top