A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk

Cardiovascular Disease Clinical Trial

Official title:

A Randomized Trial of Behavioral Economic Interventions to Reduce CVD Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346189
• Other study ID #: 812701
• Secondary ID: RC4AG039114
• Status: Completed
• Phase: N/A
• First received: April 26, 2011
• Last updated: October 31, 2017
• Start date: September 2011
• Est. completion date: August 2014

Study information

• Verified date: October 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Using a 4-arm, cluster-randomized controlled trial, the investigators will test the effectiveness of different behavioral economic interventions in increasing statin use and reducing LDL cholesterol among patients with poor cholesterol control who are at very high risk for CVD. The investigators will test these approaches among primary care physicians and their patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania outpatient clinics.

Description:

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 behavioral economic interventions 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. Pay for performance initiatives represent one such potential application, but one in which incorporating the underlying psychology of decision makers has not generally been done, and experimental tests have not been conducted. We will test these approaches among primary care physicians and their patients at very high risk of CVD at Geisinger Health System and University of Pennsylvania outpatient clinics. Using a 4-arm, cluster-randomized controlled trial, we aim to answer these questions: [1] How does the provision of provider incentives compare to the provision of patient incentives, to a combination of patient and provider incentives, or to no incentives at all? [2] Are results sustained after incentives and other interventions are withdrawn? [3] How do these approaches compare in implementation, acceptability, cost, and cost-effectiveness?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1503
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Physicians: All primary care providers who have at least 5 patients who meet eligibility criteria will be eligible.

• Patients: 10-year CVD risk of between 10-20% who do not have an LDL below 140 mg/dl or 10-year CVD risk of at least 20% (including those with preexisting CHD) who do not have an LDL below 120 mg/dl will be the primary inclusion criteria. We have chosen to include all patients meeting these inclusion criteria regardless of their reported adherence to statins, as there clearly is room for improvement in the LDL through a combination of physician and patient actions.

Exclusion Criteria:

• Patients will be excluded if they have a known allergy or history of side effects to statins, will not or cannot give consent, or have a markedly shortened life expectancy (diagnosis of metastatic cancer, end-stage renal disease on dialysis, or dementia).

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Behavioral Economic Intervention
Various combinations of financial incentives to patients and providers.

Locations

Country	Name	City	State
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts
United States	Geisinger Health System	Danville	Pennsylvania
United States	Unversity of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
University of Pennsylvania	Brigham and Women's Hospital, Carnegie Mellon University, Geisinger Clinic, Harvard School of Public Health, Harvard Vanguard Medical Associates, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL From Baseline to 12 Months	Change in LDL-C levels (mg/dL)	12 months
Secondary	Change in LDL From Baseline to 15 Months	Change in LDL-C levels (mg/dL) from baseline to 15 months	15 months