A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk

NCT ID: NCT02035826

Last Updated: 2014-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-10-31

Brief 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 [3] Are results sustained after incentives and other interventions are withdrawn?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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1

Arm (Expected Value) 2 Digit Match 1st Digit Match 2nd Digit Match Arm 1 ($2.80) $100 $10 $10

Group Type: ACTIVE_COMPARATOR

Behavioral Economics Intervention

Intervention Type: BEHAVIORAL

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.

Arm 2

Arm (Expected Value) 2 Digit Match 1st Digit Match 2nd Digit Match Arm 2 ($1.40) $50 $5 $5

Group Type: ACTIVE_COMPARATOR

Behavioral Economics Intervention

Intervention Type: BEHAVIORAL

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.

Arm 3

Arm (Expected Value) 2 Digit Match 1st Digit Match 2nd Digit Match Arm 3 ($0.70) $25 $5 $0

Group Type: ACTIVE_COMPARATOR

Behavioral Economics Intervention

Intervention Type: BEHAVIORAL

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.

Arm 4

Control Arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Harvard Vanguard Medical Associates

OTHER

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Issac, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard Vanguard Medical Associates

Locations

Harvard Vanguard Medical Associates

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2013P001902/BWH

Identifier Type: -

Identifier Source: org_study_id