Process Versus Outcomes Incentives for Lipid Management
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 2/28/2019 |
| Start Date: | February 2015 |
| End Date: | October 2018 |
Comparative Effectiveness of Process and Outcomes Incentives for Lipid Management
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.
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.
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)
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