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

NCT ID: NCT01346189

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1503 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-08-31

Brief 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.

Detailed 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 [2] Are results sustained after incentives and other interventions are withdrawn?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?

Conditions

Cardiovascular Disease

Keywords

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Physician Incentives

(with adherence feedback)

Quarterly payments to physician combined based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL with daily patient statin adherence information made available.

Group Type: ACTIVE_COMPARATOR

Behavioral Economic Intervention

Intervention Type: BEHAVIORAL

Various combinations of financial incentives to patients and providers.

Patient Incentives

(with adherence feedback)

Quarterly payments to patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL.

Group Type: ACTIVE_COMPARATOR

Behavioral Economic Intervention

Intervention Type: BEHAVIORAL

Various combinations of financial incentives to patients and providers.

Physician and Patient Combined Incentives

(with adherence feedback)

Quarterly payments shared evenly by physician and patient based on patient achieving an LDL reduction of at least 10 mg/dl relative to baseline LDL or the last quarter's target LDL. Physicians will receive daily information about patients' statin adherence.

Group Type: ACTIVE_COMPARATOR

Behavioral Economic Intervention

Intervention Type: BEHAVIORAL

Various combinations of financial incentives to patients and providers.

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Behavioral Economic Intervention

Various combinations of financial incentives to patients and providers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Geisinger Clinic

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Carnegie Mellon University

OTHER

Sponsor Role: collaborator

Harvard Vanguard Medical Associates

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Volpp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

David Asch, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

Harvard Vanguard Medical Associates

Boston, Massachusetts, United States

Geisinger Health System

Danville, Pennsylvania, United States

Unversity of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

Rosenthal MB, Troxel AB, Volpp KG, Stewart WF, Sequist TD, Jones JB, Hirsch AG, Hoffer K, Zhu J, Wang W, Hodlofski A, Finnerty D, Huang JJ, Asch DA. Moderating Effects of Patient Characteristics on the Impact of Financial Incentives. Med Care Res Rev. 2019 Feb;76(1):56-72. doi: 10.1177/1077558717707313. Epub 2017 May 8.

Reference Type: DERIVED

PMID: 29148344 (View on PubMed)

Asch DA, Troxel AB, Stewart WF, Sequist TD, Jones JB, Hirsch AG, Hoffer K, Zhu J, Wang W, Hodlofski A, Frasch AB, Weiner MG, Finnerty DD, Rosenthal MB, Gangemi K, Volpp KG. Effect of Financial Incentives to Physicians, Patients, or Both on Lipid Levels: A Randomized Clinical Trial. JAMA. 2015 Nov 10;314(18):1926-35. doi: 10.1001/jama.2015.14850.

Reference Type: DERIVED

PMID: 26547464 (View on PubMed)

Other Identifiers

RC4AG039114

Identifier Type: NIH

Identifier Source: secondary_id

View Link

812701

Identifier Type: -

Identifier Source: org_study_id