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

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: Behavioral Economic Intervention

• Registration Number: NCT01346189
• Lead Sponsor: University of Pennsylvania

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 \[2\] Are results sustained after incentives and other interventions are withdrawn?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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-04-26
• Study First Submitted QC: 2011-04-29
• Study First Posted: 2011-05-02
• Study Start: 2011-09
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Results First Submitted: 2017-09-21
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-31
• Last Update Submitted: 2017-10-31
• Results First Posted: 2017-12-06
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1503

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Physician Incentives	Behavioral Economic Intervention	(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.
Patient Incentives	Behavioral Economic Intervention	(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.
Physician and Patient Combined Incentives	Behavioral Economic Intervention	(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.

Primary Outcome Measures

Name	Time	Method
Change in LDL From Baseline to 12 Months	12 months	Change in LDL-C levels (mg/dL)

Secondary Outcome Measures

Name	Time	Method
Change in LDL From Baseline to 15 Months	15 months	Change in LDL-C levels (mg/dL) from baseline to 15 months

Trial Locations

Locations (3)

Geisinger Health System; 🇺🇸 Danville, Pennsylvania, United States

Harvard Vanguard Medical Associates; 🇺🇸 Boston, Massachusetts, United States

Unversity of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States