A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk

Cardiovascular Disease (CVD) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035826
• Other study ID #: 2013P001902/BWH
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: December 8, 2014
• Start date: January 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

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 [3] Are results sustained after incentives and other interventions are withdrawn?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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiovascular Disease (CVD)
• Cardiovascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Geisinger Clinic, Harvard Vanguard Medical Associates, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin A1c	We will also measure Hemoglobin A1c, an assessment of intermediate term glycemic control, among patients with diabetes. This measure is related to CVD risk but is not a target of the intervention. We measure it to examine positive or negative spillover effects from targeting LDL cholesterol: a focus on LDL may crowd out attention to other conditions or, alternatively, might stimulate it.	Baseline and 3 months	No
Primary	LDL Cholesterol	The primary outcome will be change in LDL between baseline (prior to randomization) and 3 months.	Baseline and 3 months	No
Secondary	LDL Cholesterol	We will measure change in LDL from baseline to 6 months.	Baseline to 6 months	No