Clinical trial NCT02490423: Improvement in Medication Adherence Through the Implementation of Personalized Nudges: the ENCOURAGE Trial
Official title: Improvement in Medication Adherence Through the Implementation of Personalized Nudges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: Intermountain Research and Medical Foundation
name: CareCentra
First posted: 2015-07-03
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Adherence with taking prescribed statin medications.
timeFrame: 12 (±1) months
Secondary outcomes:
measure: Adherence with taking other individual cardiovascular medications.
timeFrame: 12 (±1) months
measure: Adherence with taking all cardiovascular medications.
timeFrame: 12 (±1) months
measure: Proportion of adherent subjects per group
timeFrame: 12 (±1) months
measure: Clinical Endpoints
timeFrame: 12 (±1) months
measure: Adherence with taking individual medications at interim timepoints
timeFrame: 3 months, 6 months, 9 months
measure: Adherence with taking the composite of all CV medications at interim timepoints
timeFrame: 3 months, 6 months, 9 months
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Heart Institute
state: Utah
Study officials:
affiliation: Intermountain Medical Center
name: Benjamin D Horne, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermountain Medical Center
name: Joseph B Muhlestein, MD
role: PRINCIPAL_INVESTIGATOR
References: