Clinical trial NCT02035826: A Randomized Trial of Patient Financial Incentives to Reduce CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease (CVD)
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Harvard Vanguard Medical Associates
name: Geisinger Clinic
First posted: 2014-01-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 \[3\] Are results sustained after incentives and other interventions are withdrawn?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


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.

Primary outcomes:
measure: LDL Cholesterol
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: LDL Cholesterol
timeFrame: Baseline to 6 months
Other outcomes:
measure: Hemoglobin A1c
timeFrame: Baseline and 3 months
Locations:
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
Study officials:
affiliation: Harvard Vanguard Medical Associates
name: Thomas Issac, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: