Clinical trial NCT03973931: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications
Official title: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Adherence, Medication
Medication Adherence
Diabetes Mellitus
Hypertension
Hyperlipidemias
Coronary Artery Disease
Atrial Fibrillation
Keywords: cardiovascular disease
telemedicine
medication adherence
behavioral health
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-06-04
Enrollment: 9501
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a pragmatic, randomized controlled study with four treatment arms. Once patients are identified through pharmacy refill data to have a 7-day gap in any prescribed CV medication refills, they will be randomized to one of four arms, described in Intervention below. Randomization will be stratified within each of the clinics, and within strata defined by number of other CV medication classes that are prescribed at randomization (1-4), using blocks of 4 patients to ensure balance within clinics over time. Thus, within each clinic and number of other medication stratum, each set of 4 consecutively enrolled subjects will be randomized to the four study arms. Treatments will be initiated immediately upon randomization, in response to the 7-day gap.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication Adherence
timeFrame: 12 months after intervention
measure: Mean Proportion of Days Covered Relative to Usual Care
timeFrame: 12 months
Secondary outcomes:
measure: Hospitalization
timeFrame: one year
measure: Death
timeFrame: one year
measure: Emergency Department Visit
timeFrame: one year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: UCHealth
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Aurora
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Michael Ho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Sheana Bull, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ho PM, Spertus JA, Masoudi FA, Reid KJ, Peterson ED, Magid DJ, Krumholz HM, Rumsfeld JS. Impact of medication therapy discontinuation on mortality after myocardial infarction. Arch Intern Med. 2006 Sep 25;166(17):1842-7. doi: 10.1001/archinte.166.17.1842.
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