Cardiovascular Disease (CVD) Clinical Trial
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incentives and other interventions are withdrawn?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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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