Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
- Conditions
- Diabetes MellitusHypertensionCoronary Artery DiseaseAtrial FibrillationAdherence, MedicationMedication AdherenceCardiovascular DiseasesHyperlipidemias
- Interventions
- Behavioral: Nudge
- Registration Number
- NCT03973931
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.
- Detailed Description
Background: Up to fifty percent of patients do not take their cardiovascular medications as prescribed resulting in increased morbidity, mortality, and healthcare costs. Mobile and digital technologies for health promotion and disease self-management offer an intriguing and as of yet untested opportunity to adapt behavioral 'nudges' using ubiquitous cell phone technology to facilitate medication adherence.
Objectives: Aim 1: Conduct a pragmatic patient-level randomized intervention across three health care systems (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 include clinical events (e.g., event times for stroke, MI, mortality), utilization of care (e.g., hospitalizations or clinic visits for CV-related reasons), and costs of healthcare utilization. Aim 2: Evaluate the intervention using a mixed methods approach and applying the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. In addition, 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.
Setting: The study will be conducted within three HCS in metro Denver: VA Eastern Colorado Health Care System (VA), Denver Health and Hospital Authority, and UCHealth.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9501
- Patients with the following cardiovascular conditions and respective medication classes:
- Hypertension (Beta-blockers [B-blockers)], Calcium Channel Blocker [CCB], Angiotensin converting enzyme inhibitors (ACEi), Angiotensin Receptor Blockers [ARB], or Thiazide diuretic)
- Hyperlipidemia (HMG CoA reductase inhibitor [Statins])
- Diabetes (Alpha-glucosidase inhibitors, Biguanides, DPP-4 inhibitors, Sodium glucose transport inhibitor, Meglitinides, Sulfonylureas, Thiazolidinediones, or statins Coronary artery disease P2Y12 inhibitor [Clopidogrel, Ticagrelor, Prasugrel, Ticlopidine], B-blockers, ACEi or ARB or statins)
- Atrial fibrillation (Direct oral anticoagulants, B-blockers, CCB)
- Patients who do not have a mailing address listed in EHR;
- Patients who do not have a landline or cellphone listed in EHR;
- Currently pregnant if denoted in the EHR at the time of the data pull;
- Patients with a mailing address outside of the state of Colorado;
- Patients that do not speak either English or Spanish.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Optimized nudge Nudge An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1, 3, 5, 7 and 10 after they have been labeled as non-adherent. Optimized nudge plus AI Chat Bot Nudge An optimized nudge text will be delivered to patients to remind them to refill their medications at days 1 and 3 after they have been labeled as non-adherent. If the patient has not filled their medication on days 5 and 7, in addition to receiving an optimized nudge text, an AI will conduct interactive chat via a chat bot to assess barriers filling the medication as described in Aim 1 above. If they still have not filled the medication, they will receive another message on day 10. Generic Nudge Nudge A generic reminder text will be delivered to patients to refill their medication at days 1, 3, 5, 7 and 10 after they been labeled as non-adherent.
- Primary Outcome Measures
Name Time Method Medication Adherence 12 months after intervention The primary outcome was medication adherence defined by the proportion of days covered (PDC) using pharmacy refill data adjusted difference from usual care.
Mean Proportion of Days Covered Relative to Usual Care 12 months We analyzed this longitudinal data (up to 12 observations per patient) and estimated absolute differences in PDC between treatment arms and usual care using a Generalized Estimating Equation (GEE) model with an identity link and independence with unequal variances for the covariance structure of the 12 observations .A multistage gatekeeper approach was used to account for multiple treatment comparisons by comparing each of the 3 treatment arms to the control in stage 1 using significance levels of 0.05/3, and if any test was significant, a significance level of (R/3)\*(0.05/3) using the Holm method was used for the 3 pairwise comparisons, where R is the number of significant stage 1 tests.
- Secondary Outcome Measures
Name Time Method Hospitalization one year estimated probability of hospitalization at one year
Death one year estimated probability of death at one year
Emergency Department Visit one year estimated probability of emergency department visit at one year
Trial Locations
- Locations (4)
Denver Health and Hospital Authority
🇺🇸Denver, Colorado, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
VA Eastern Colorado Health Care System
🇺🇸Aurora, Colorado, United States
UCHealth
🇺🇸Aurora, Colorado, United States