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

April 26, 2011
May 22, 2014
September 2011
August 2014   (final data collection date for primary outcome measure)
Change in LDL from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01346189 on ClinicalTrials.gov Archive Site
  • 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
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
A Randomized Trial of Behavioral Economic Interventions to Reduce CVD Risk

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.

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?

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Cardiovascular Disease
Behavioral: Behavioral Economic Intervention
Various combinations of financial incentives to patients and providers.
  • 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.

    Intervention: Behavioral: Behavioral Economic Intervention
  • 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.

    Intervention: Behavioral: Behavioral Economic Intervention
  • 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.

    Intervention: Behavioral: Behavioral Economic Intervention
  • No Intervention: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1400
August 2014
August 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01346189
812701, RC4AG039114
Yes
University of Pennsylvania
University of Pennsylvania
  • National Institute on Aging (NIA)
  • Geisinger Clinic
  • Brigham and Women's Hospital
  • Harvard School of Public Health
  • Carnegie Mellon University
  • Harvard Vanguard Medical Associates
Principal Investigator: Kevin Volpp, MD, PhD University of Pennsylvania
Principal Investigator: David Asch, MD, MBA University of Pennsylvania
University of Pennsylvania
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP