Process Versus Outcomes Incentives for Lipid Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

764 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-10-31

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.

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Detailed Description

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Conditions

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Diabetes Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Process Incentive

Intervention Type BEHAVIORAL

Daily sweepstake conditional on daily medication adherence

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.

Group Type EXPERIMENTAL

Outcome Incentive

Intervention Type BEHAVIORAL

Incentives conditional on LDL cholesterol reduction

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.

Group Type EXPERIMENTAL

Process Incentive

Intervention Type BEHAVIORAL

Daily sweepstake conditional on daily medication adherence

Outcome Incentive

Intervention Type BEHAVIORAL

Incentives conditional on LDL cholesterol reduction

Interventions

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Process Incentive

Daily sweepstake conditional on daily medication adherence

Intervention Type BEHAVIORAL

Outcome Incentive

Incentives conditional on LDL cholesterol reduction

Intervention Type BEHAVIORAL

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No