Medication Adherence
Conditions
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.
Interventions
OTHERNudges 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.
Sponsors
Intermountain Research and Medical Foundation
CareCentra
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence with taking prescribed statin medications. | 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
| Measure | Time frame | Description |
|---|---|---|
| Adherence with taking all cardiovascular medications. | 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). |
| Proportion of adherent subjects per group | 12 (±1) months | 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). |
| Adherence with taking other individual cardiovascular medications. | 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). |
| Adherence with taking individual medications at interim timepoints | 3 months, 6 months, 9 months | 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). |
| Adherence with taking the composite of all CV medications at interim timepoints | 3 months, 6 months, 9 months | 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). |
| Clinical Endpoints | 12 (±1) months | A composite of major adverse cardiovascular events and its components, including mortality, myocardial infarction, stroke, and revascularization. |
Countries
United States
Outcome results
None listed