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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Geisinger Clinic
Brigham and Women's Hospital
Harvard School of Public Health
Carnegie Mellon University
Harvard Vanguard Medical Associates
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01346189
First received: April 26, 2011
Last updated: May 22, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Behavioral: Behavioral Economic Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Trial of Behavioral Economic Interventions to Reduce CVD Risk

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in LDL from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in LDL from baseline to 15 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • To assess the cost-effectiveness of each of the interventions relative to usual care. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Incentive payments, administrative costs, GlowCap costs, computer support fees and healthcare utilization costs will be compared to usual care costs (arm 6).

  • To conduct a rigorous qualitative process evaluation to examine why some interventions were more effective than others and to address other factors relevant to broader implementation. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    The process evaluation will consider patient and provider demographics. The evaluation will employ patient and provider interviews, patient focus groups, and a patient and provider exit survey


Estimated Enrollment: 1400
Study Start Date: September 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.

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

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

Behavioral: Behavioral Economic Intervention
Various combinations of financial incentives to patients and providers.
No Intervention: Usual Care

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?

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346189

Locations
United States, Massachusetts
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States, 02120
United States, Pennsylvania
Geisinger Health System
Danville, Pennsylvania, United States, 17822
Unversity of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Geisinger Clinic
Brigham and Women's Hospital
Harvard School of Public Health
Carnegie Mellon University
Harvard Vanguard Medical Associates
Investigators
Principal Investigator: Kevin Volpp, MD, PhD University of Pennsylvania
Principal Investigator: David Asch, MD, MBA University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01346189     History of Changes
Other Study ID Numbers: 812701, RC4AG039114
Study First Received: April 26, 2011
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Cardiovascular Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 19, 2014