A Trial of Behavioral Economic Interventions to Reduce Cardiovascular Disease (CVD) Risk
A Randomized Trial of Behavioral Economic Interventions to Reduce CVD Risk
2 other identifiers
interventional
1,503
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2011
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 2, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
December 6, 2017
CompletedDecember 6, 2017
October 1, 2017
2.9 years
April 26, 2011
September 21, 2017
October 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in LDL From Baseline to 12 Months
Change in LDL-C levels (mg/dL)
12 months
Secondary Outcomes (1)
Change in LDL From Baseline to 15 Months
15 months
Study Arms (4)
Physician Incentives
ACTIVE COMPARATOR(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
ACTIVE COMPARATOR(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
ACTIVE COMPARATOR(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.
Usual Care
NO INTERVENTIONInterventions
Various combinations of financial incentives to patients and providers.
Eligibility Criteria
You may qualify if:
- Physicians: All primary care providers who have at least 5 patients who meet eligibility criteria will be eligible.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- National Institute on Aging (NIA)collaborator
- Geisinger Cliniccollaborator
- Brigham and Women's Hospitalcollaborator
- Harvard School of Public Health (HSPH)collaborator
- Carnegie Mellon Universitycollaborator
- Harvard Vanguard Medical Associatescollaborator
Study Sites (3)
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02120, United States
Geisinger Health System
Danville, Pennsylvania, 17822, United States
Unversity of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
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.
PMID: 29148344DERIVEDAsch 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.
PMID: 26547464DERIVED
MeSH Terms
Conditions
Limitations and Caveats
Patients in the control group received electronic pill bottles and may have been more adherent than is typical; Mean of about 6 patients per physician enrolled, limiting total size of potential reward; Adherence info came from pill bottle opening
Results Point of Contact
- Title
- Dr. Kevin G. Volpp
- Organization
- University of Pennsylvania and Department of Veteran Affairs
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Volpp, MD, PhD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
David Asch, MD, MBA
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2011
First Posted
May 2, 2011
Study Start
September 1, 2011
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 6, 2017
Results First Posted
December 6, 2017
Record last verified: 2017-10