A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/7/2015 |
| Start Date: | January 2014 |
| End Date: | August 2014 |
| Contact: | Amy Marston |
| Email: | Amy_Marston@AtriusHealth.org |
| Phone: | 617-559-8085 |
Cardiovascular disease (CVD) is the leading cause of death in the United States. Despite
strong evidence that reducing low-density lipoproteins (LDL) with statins successfully
lowers CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment
when indicated, and more than 50% of patients stop taking statins within one year of first
prescription though such therapy typically should be life-long. In this study, we will test
the effectiveness of different financial incentives in increasing statin use and reducing
LDL cholesterol among patients with poor cholesterol control who are at very high risk for
CVD. The application of conceptual approaches from behavioral economics offers considerable
promise in advancing health and health care. We will test these approaches among patients at
very high risk of CVD at Harvard Vanguard Medical Associates. Using a 4-arm,
cluster-randomized controlled trial, we aim to answer these questions: [1] How does the
provision of patient incentives compare to no incentives at all? [2] Is success with patient
incentives improved by increasing the financial amounts? [3] Are results sustained after
incentives and other interventions are withdrawn?
Study Objectives and Hypothesis
Aim 1: To evaluate the effectiveness of varying patient incentives on improvement in LDL
cholesterol relative to usual care during a 3-month intervention among patients at high risk
of CVD. H1: Each of the incentives will be more effective than usual care in reducing LDL
cholesterol.
Aim 2: To evaluate the relative effectiveness of those intervention arms superior to control
in reducing LDL cholesterol. H2: Higher incentive amounts for patients will be more
effective than lower incentive amounts.
Aim 3: To evaluate the impact of each effective intervention in sustaining adherence and
reduced LDL after the 3-month intervention period.
Aim 4: To conduct a rigorous process evaluation to examine why some incentives were more
effective than others and to address other factors relevant to broader implementation.
strong evidence that reducing low-density lipoproteins (LDL) with statins successfully
lowers CVD risk, physicians under-prescribe statins, physicians fail to intensify treatment
when indicated, and more than 50% of patients stop taking statins within one year of first
prescription though such therapy typically should be life-long. In this study, we will test
the effectiveness of different financial incentives in increasing statin use and reducing
LDL cholesterol among patients with poor cholesterol control who are at very high risk for
CVD. The application of conceptual approaches from behavioral economics offers considerable
promise in advancing health and health care. We will test these approaches among patients at
very high risk of CVD at Harvard Vanguard Medical Associates. Using a 4-arm,
cluster-randomized controlled trial, we aim to answer these questions: [1] How does the
provision of patient incentives compare to no incentives at all? [2] Is success with patient
incentives improved by increasing the financial amounts? [3] Are results sustained after
incentives and other interventions are withdrawn?
Study Objectives and Hypothesis
Aim 1: To evaluate the effectiveness of varying patient incentives on improvement in LDL
cholesterol relative to usual care during a 3-month intervention among patients at high risk
of CVD. H1: Each of the incentives will be more effective than usual care in reducing LDL
cholesterol.
Aim 2: To evaluate the relative effectiveness of those intervention arms superior to control
in reducing LDL cholesterol. H2: Higher incentive amounts for patients will be more
effective than lower incentive amounts.
Aim 3: To evaluate the impact of each effective intervention in sustaining adherence and
reduced LDL after the 3-month intervention period.
Aim 4: To conduct a rigorous process evaluation to examine why some incentives were more
effective than others and to address other factors relevant to broader implementation.
Inclusion Criteria:
- Between the ages of 18-80 yrs
- FRS of > 20% with LDL > 120, or FRS = 10-20% with LDL > 140, or a coronary artery
disease equivalent (diabetes, peripheral artery disease, ischemic CVD,
arteriosclerotic CVD, stroke/TIA, CABG, coronary stenting, or coronary bypass
anastomosis) with LDL > 120.
Exclusion Criteria:
- Patients with a history of side effects to statins. Patients with a history of side
effects to statins will be forwarded to the study's medical monitor (a physician
aligned with the study) and may still participate in the study if, after the medical
monitor reviews the patient's medical record, he/she determines that the patient may
safely participate in the study;
- Patients who will not or cannot give consent;
- Patients with terminal illness who are no longer suitable candidates for aggressive
lipid management as determined by the patient's primary care physician;
- Patients with ALT values detected at greater than 80 U/L;
- Patients with active or progressive liver disease.
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