Improvement in Medication Adherence Through the Implementation of Personalized Nudges: the ENCOURAGE Trial (ENCOURAGE)

Improvement in Medication Adherence Through the Implementation of Personalized Nudges

This study will determine whether a complex, data-driven protocol for assessing patient needs and providing "nudges" (reminders to be adherent with medication prescriptions) improves adherence with cardiovascular medications. This will be accomplished by performing a 12-month clinical trial of patients with an indication for statin therapy. Participants will be randomized to either an intervention or standard-of-care arm and will be followed via passive electronic means to determine if they are adherent with medication prescriptions.

Study Overview

• Status: Completed
• Conditions: Medication Adherence
• Intervention / Treatment: Other: Nudges Intervention

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84143
      • Intermountain Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Indication for statin therapy (regardless of statin use history), either: 1) the presence of coronary artery disease (CAD) (either a new diagnosis or prior diagnosis), 2) low-density lipoprotein cholesterol (LDL-C) ≥190 mg/dL, 3) the presence of diabetes and LDL-C of 70-189 mg/dL in patients aged 40- 75 years, or 4) CAD-free and diabetes-free patients aged 40-75 years who have LDL-C 70-189 mg/dL and an estimated 10-year risk of CAD ≥7.5% based on the Pooled Cohort Risk Equations (http://my.americanheart.org/professional/StatementsGuidelines/Prevention Guidelines/Prevention-Guidelines_UCM_457698_SubHomePage.jsp)
• Enrollment in a SelectHealth insurance plan
• Age ≥18 years
• Planned discharge to home

Exclusion Criteria:

• Age <18 years
• Alzheimers/Dementia
• Receipt of or expected receipt of palliative care or discharge to hospice, skilled nursing facility, inpatient rehabilitation, or long-term care facility
• Any contraindication to statin agents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nudges Intervention; The intervention arm will employ standard cardiovascular clinical care plus the combination of the MoBe Maps Patient Activation Platform with the Intermountain Risk Score to personalize and deliver motivational nudges to each participant.	Other: Nudges Intervention; The intervention arm will employ standard cardiovascular clinical care plus the combination of the MoBe Maps Patient Activation Platform with the Intermountain Risk Score to personalize and deliver motivational nudges to each participant.
No Intervention: Standard of Care; The standard of care arm will utilize Intermountain cardiovascular clinical program care processes as they are in place today for treatment of the study subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence with taking prescribed statin medications.	Adherence will be measured by examining the passively-collected data regarding the filling and refilling of the subject's prescriptions that are available electronically through SelectHealth data and calculating the proportion of time during the followup period that each subject had medication (number of days in which the medication was available after a prescription was filled divided by the total length of the follow-up period).	12 (±1) months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence with taking other individual cardiovascular medications.	Adherence with other individual cardiovascular medications (including beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants). Adherence will be measured by examining the passively-collected data regarding the filling and refilling of the subject's prescriptions that are available electronically through SelectHealth data and calculating the proportion of time during the followup period that each subject had medication (number of days in which the medication was available after a prescription was filled divided by the total length of the follow-up period).	12 (±1) months
Adherence with taking all cardiovascular medications.	Adherence will be measured as a composite of cardiovascular medications including statins, beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants. Adherence will be measured by examining the passively-collected data regarding the filling and refilling of the subject's prescriptions that are available electronically through SelectHealth data and calculating the proportion of time during the followup period that each subject had medication (number of days in which the medication was available after a prescription was filled divided by the total length of the follow-up period).	12 (±1) months
Proportion of adherent subjects per group	Number of patients in each group who were adherent. Adherence will be measured by examining the passively-collected data regarding the filling and refilling of the subject's prescriptions that are available electronically through SelectHealth data and calculating the proportion of time during the follow-up period that each subject had medication (number of days in which the medication was available after a prescription was filled divided by the total length of the follow-up period).	12 (±1) months
Clinical Endpoints	A composite of major adverse cardiovascular events and its components, including mortality, myocardial infarction, stroke, and revascularization.	12 (±1) months
Adherence with taking individual medications at interim timepoints	Adherence will be measured for individual cardiovascular medications including statins, beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants. Adherence will be measured by examining the passively-collected data regarding the filling and refilling of the subject's prescriptions that are available electronically through SelectHealth data and calculating the proportion of time during the followup period that each subject had medication (number of days in which the medication was available after a prescription was filled divided by the total length of the follow-up period).	3 months, 6 months, 9 months
Adherence with taking the composite of all CV medications at interim timepoints	Adherence will be measured for a composite of cardiovascular medications including statins, beta-blockers, ACE inhibitors, P2Y12 inhibitors/antiplatelets, diuretics, angiotensin receptor blockers, angiotensin-receptor neprilysin inhibitors, calcium channel blockers, vasodilators, anti-arrhythmia medications, niacin, cholesterol absorption inhibitors (ezetimibe), fibrates, digoxin, and warfarin/anticoagulants. Adherence will be measured by examining the passively-collected data regarding the filling and refilling of the subject's prescriptions that are available electronically through SelectHealth data and calculating the proportion of time during the followup period that each subject had medication (number of days in which the medication was available after a prescription was filled divided by the total length of the follow-up period).	3 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: Intermountain Research and Medical Foundation; CareCentra
• Investigators: Principal Investigator: Benjamin D Horne, PhD, MPH, Intermountain Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): February 16, 2019
• Study Completion (Actual): February 16, 2019

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 1040522