Process Versus Outcomes Incentives for Lipid Management

University of Pennsylvania

Status: Completed

Conditions: Diabetes; Cardiovascular Disease

Treatments: Behavioral: Outcome Incentive; Behavioral: Process Incentive

Study type: Interventional

Funder types: Other

Identifiers

NCT02246959

1R01HL118195-01A1

Details and patient eligibility

About

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.

Enrollment: 764 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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764 participants in 4 patient groups

Control Arm

No Intervention group

Description:

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

Experimental group

Description:

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.

Treatment:

Behavioral: Process Incentive

Outcome Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Outcome Incentive

Process Plus Outcome Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Outcome Incentive

Behavioral: Process Incentive