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

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ClinicalTrials.gov Identifier: NCT02490423
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : July 17, 2020
Sponsor:
Collaborators:
Intermountain Research and Medical Foundation
CareCentra
Information provided by (Responsible Party):
Intermountain Health Care, Inc.

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.

Condition or disease Intervention/treatment Phase
Medication Adherence Other: Nudges Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improvement in Medication Adherence Through the Implementation of Personalized Nudges
Actual Study Start Date : March 2016
Actual Primary Completion Date : February 16, 2019
Actual Study Completion Date : February 16, 2019

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.



Primary Outcome Measures :
  1. Adherence with taking prescribed statin medications. [ Time Frame: 12 (±1) months ]
    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).


Secondary Outcome Measures :
  1. Adherence with taking other individual cardiovascular medications. [ Time Frame: 12 (±1) months ]
    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).

  2. Adherence with taking all cardiovascular medications. [ Time Frame: 12 (±1) months ]
    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).

  3. Adherence with prescribed lifestyle changes. [ Time Frame: 12 (±1) months ]
    Adherence with prescribed lifestyle changes (i.e., smoking cessation, physical activity, and heart-healthy diet) will be obtained through electronic medical record review.

  4. Adherence with standard follow-up physician visits and cardiac rehabilitation. [ Time Frame: 12 (±1) months ]
    Adherence with standard follow-up physician visits and cardiac rehabilitation will be obtained through electronic medical record review.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490423


Locations
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United States, Utah
Intermountain Heart Institute
Murray, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
Intermountain Research and Medical Foundation
CareCentra
Investigators
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Principal Investigator: Benjamin D Horne, PhD, MPH Intermountain Medical Center
Principal Investigator: Joseph B Muhlestein, MD Intermountain Medical Center
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Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT02490423    
Other Study ID Numbers: 1040522
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020