A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk
Condition: Cardiovascular Disease (CVD)
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      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      incentives and other interventions are withdrawn?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.
    


Intervention name(s): Behavioral Economics Intervention
Intervention type(s): Behavioral
Intervention description(s): Patients will receive an active intervention for 3 months followed by 3 months of observation. Incentives will be awarded at the end of the first 3 months, based on an improvement of at least 10 mg/dl in LDL relative to the patient's baseline LDL or achieving or sustaining LDL of 100, depending on baseline LDL and FRS. Adherence in all groups will be measured using Vitality GlowCaps as a recording device. Patients in all arms will be given the GlowCaps and instructions on use. Patients will receive adherence feedback electronically with daily lottery awards to match the timing of their task.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science