COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035826
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : December 10, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Harvard Vanguard Medical Associates
Geisinger Clinic
Information provided by (Responsible Party):
University of Pennsylvania

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 [3] Are results sustained after incentives and other interventions are withdrawn?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


Condition or disease Intervention/treatment Phase
Cardiovascular Disease (CVD) Behavioral: Behavioral Economics Intervention Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1
Arm (Expected Value) 2 Digit Match 1st Digit Match 2nd Digit Match Arm 1 ($2.80) $100 $10 $10
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.

Active Comparator: Arm 2
Arm (Expected Value) 2 Digit Match 1st Digit Match 2nd Digit Match Arm 2 ($1.40) $50 $5 $5
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.

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

No Intervention: Arm 4
Control Arm



Primary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: Baseline and 3 months ]
    The primary outcome will be change in LDL between baseline (prior to randomization) and 3 months.


Secondary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: Baseline to 6 months ]
    We will measure change in LDL from baseline to 6 months.


Other Outcome Measures:
  1. Hemoglobin A1c [ Time Frame: Baseline and 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035826


Locations
Layout table for location information
United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
University of Pennsylvania
National Institutes of Health (NIH)
Harvard Vanguard Medical Associates
Geisinger Clinic
Investigators
Layout table for investigator information
Principal Investigator: Thomas Issac, MD, MPH Harvard Vanguard Medical Associates
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02035826    
Other Study ID Numbers: 2013P001902/BWH
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: November 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases