Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Coronary Artery Disease; Hypertension; Atrial Fibrillation; Medication Adherence; Hyperlipidemias; Adherence, Medication; Diabetes Mellitus; Cardiovascular Diseases

Treatments: Behavioral: Nudge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03973931

18-2779

UH3HL144163 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,501 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9,501 participants in 4 patient groups

Usual Care

No Intervention group

Description:

This group will not receive an intervention. We have included a usual care group to demonstrate the impact of the text messaging interventions above and beyond usual care given that many prior medication adherence interventions have demonstrated small to negligible effects.

Generic Nudge

Experimental group

Description:

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.

Treatment:

Behavioral: Nudge

Optimized nudge

Experimental group

Description:

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.

Treatment:

Behavioral: Nudge

Optimized nudge plus AI Chat Bot

Experimental group

Description:

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.

Treatment:

Behavioral: Nudge