Process Versus Outcomes Incentives for Lipid Management

Study Overview
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Brief Summary
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In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12 months.

Official Title
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Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management

Conditions
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Diabetes, Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Process Incentive
* Behavioral: Outcome Incentive


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 ASCVD (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 ASCVD or diabetes with LDLC with an LDL greater than or equal to 100 mg/dl and estimated 10-year ASCVD risk 7.5%; Individuals without clinical ASCVD or diabetes with LDL cholesterol 190 mg/dl A prescription filled for a statin medication within the last 12 months (derived from pharmacy records); Low medication adherence on self-report completed during enrollment Exclusion Criteria: Under 18 years old A contraindication to further statin use or have suffered statin side effects, such as myopathy Will not or cannot give consent A history of active or progressive liver disease Participating in another clinical trial with related aims Co-morbidities likely to lead to death within a short period (e.g. metastatic cancer)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Interventional Model Description: In a 4-arm, randomized controlled trial, we propose to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence.
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 electronic pill bottles for their statin medication but are not enrolled in the sweepstakes. | |
| Experimental: Process Arm<br>Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication. | Behavioral: Process Incentive<br>* Daily sweepstake conditional on daily medication adherence<br>|
| Experimental: Outcome Arm<br>Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL. | Behavioral: Outcome Incentive<br>* Incentives conditional on LDL cholesterol reduction<br>|
| Experimental: Process Plus Outcome Arm<br>Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol. | Behavioral: Process Incentive<br>* Daily sweepstake conditional on daily medication adherence<br>Behavioral: Outcome Incentive<br>* Incentives conditional on LDL cholesterol reduction<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statin Adherence |  | 18 months |