A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk

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 \[3\] Are results sustained after incentives and other interventions are withdrawn?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.

Conditions

• Cardiovascular Disease (CVD)

Interventions

BEHAVIORAL

Behavioral Economics Intervention

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.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Harvard Vanguard Medical Associates

  collaborator OTHER

• Geisinger Clinic

  collaborator OTHER

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Thomas Issac, MD, MPH · Harvard Vanguard Medical Associates

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2014-10-31

Completion

2014-10-31

Countries

• United States

Study Locations