Clinical trial NCT01346189: A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
Official title: A Randomized Trial of Behavioral Economic Interventions to Reduce CVD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Cardiovascular Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Geisinger Clinic
name: Brigham and Women's Hospital
name: Harvard School of Public Health (HSPH)
name: Carnegie Mellon University
name: Harvard Vanguard Medical Associates
First posted: 2011-05-02
Enrollment: 1503
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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?

Eligibility 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).

Primary outcomes:
measure: Change in LDL From Baseline to 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Change in LDL From Baseline to 15 Months
timeFrame: 15 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Unversity of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Kevin Volpp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: David Asch, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.