Habit Formation for Adherence to Statin Use and LDL Reduction

Study Overview
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Brief Summary
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In a 4-arm, Randomized Control Trial among members of CVS Caremark or Penn Medicine Patients with suboptimal cholesterol control who are at high risk for CVD, the study investigators propose to test the effectiveness of different behavioral economic techniques in inducing habit formation for adherence to statin use and sustained reductions in LDL cholesterol after financial incentives are discontinued. Primary outcome is changes in LDL from enrollment to 12 months (6 months after cessation of financial incentives).

Official Title
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Testing Behavioral Economic Interventions to Improve Statin Use and Reduce CVD Risk

Conditions
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Medication Adherence

Intervention / Treatment
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* Behavioral: Sweepstake Incentive 1
* Behavioral: Sweepstake Incentive 2
* Behavioral: Sweepstake Incentive 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals at high risk of a cardiac event, specifically one of the following: Individuals with clinical CVD (defined as diagnosis with myocardial infarction, stroke, or peripheral vascular disease) with an LDL greater than or equal to 100 mg/dl ; Individuals with Diabetes (between the ages of 40-75) with an LDL greater than or equal to 100 mg/dl; Individuals without clinical CVD or diabetes with LDL greater than or equal to 100 mg/dl and estimated 10-year CVD risk 7.5%; Individuals without clinical CVD or diabetes with LDL cholesterol greater than or equal to 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records); Medication Possession Ratio (MPR) less than or equal to 80% Low medication adherence on self-report completed during enrollment Exclusion Criteria: Less than 18 years old Contraindication to further statin use or have suffered side effects from statins, such as myopathy Will not or cannot give consent History of active or progressive liver disease or abnormal liver function tests on baseline screening when applicable Currently participating in another clinical trial with related aims Co-morbidities likely to lead to death within a short-period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>Arm 1 will be the Control arm, in which participants receive an electronic pill container and are provided with daily reminders to take their medication but are not enrolled in the sweepstakes. | |
| Experimental: Sweepstakes Incentive 1<br>Arm 2 will be a sweepstakes incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication. | Behavioral: Sweepstake Incentive 1<br>* Daily sweepstake conditional on daily medication adherence<br>|
| Experimental: Sweepstake Incentive 2<br>Arm 3 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which monetary prizes may be awarded if participants take their medication prior to receiving a reminder. | Behavioral: Sweepstake Incentive 2<br>* Daily sweepstake conditional on daily medication adherence<br>|
| Experimental: Sweepstake Incentive 3<br>Arm 4 will be a sweepstake incentive arm where participants receive an electronic pill container and daily reminders to take their medication. In addition, this group is enrolled in a sweepstakes, in which each participant maintains an account that will accumulate money based on their medication adherence throughout the study. | Behavioral: Sweepstake Incentive 3<br>* Daily sweepstake conditional on daily medication adherence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LDL from baseline to 12 months |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin Adherence 6 months after active phase of intervention |  | 6 months |