Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 764
- Locations
- 1
- Primary Endpoint
- Change in LDL cholesterol from baseline to 12 months
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Control Arm
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.
Process Arm
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.
Intervention: Process Incentive (Behavioral)
Outcome Arm
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.
Intervention: Outcome Incentive (Behavioral)
Process Plus Outcome Arm
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.
Intervention: Process Incentive (Behavioral)
Process Plus Outcome Arm
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.
Intervention: Outcome Incentive (Behavioral)
Outcomes
Primary Outcomes
Change in LDL cholesterol from baseline to 12 months
Time Frame: 12 months
Secondary Outcomes
- Statin Adherence(18 months)