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| Name | Class |
|---|---|
| Rutgers University | OTHER |
| University of California, San Francisco | OTHER |
| Carnegie Mellon University | OTHER |
| Lancaster General Hospital |
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In a 4-arm, randomized controlled trial, we will evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence. The primary outcome will be change in LDL cholesterol over 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | No Intervention | Arm 1 will be the Control arm, in which participants receive electronic pill bottles for their statin medication but are not enrolled in the sweepstakes. | |
| Process Arm | Experimental | Arm 2 will be a Process incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication. |
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| Outcome Arm | Experimental | Arm 3 will be an Outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group may receive incentives if they lower their LDL. |
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| Process Plus Outcome Arm | Experimental | Arm 4 will be a process plus outcome incentive arm where participants receive electronic pill bottles for their statin medication. In addition, this group is enrolled in a sweepstakes, in which participants may win money if they remember to take their medication and receive additional incentives for lowering their LDL cholesterol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Process Incentive | Behavioral | Daily sweepstake conditional on daily medication adherence |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL cholesterol from baseline to 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Statin Adherence | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Volpp, MD, PhD | University of Pennsylvania | Principal Investigator |
| Peter Reese, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Iwan Barankay, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34605920 | Derived | Reese PP, Barankay I, Putt M, Russell LB, Yan J, Zhu J, Huang Q, Loewenstein G, Andersen R, Testa H, Mussell AS, Pagnotti D, Wesby LE, Hoffer K, Volpp KG. Effect of Financial Incentives for Process, Outcomes, or Both on Cholesterol Level Change: A Randomized Clinical Trial. JAMA Netw Open. 2021 Oct 1;4(10):e2121908. doi: 10.1001/jamanetworkopen.2021.21908. | |
| 33218296 | Derived | Russell LB, Norton LA, Pagnotti D, Sevinc C, Anderson S, Finnerty Bigelow D, Iannotte LG, Josephs M, McGilloway R, Barankay I, Putt ME, Reese PP, Asch DA, Goldberg LR, Mehta SJ, Tanna MS, Troxel AB, Volpp KG. Using Clinical Trial Data to Estimate the Costs of Behavioral Interventions for Potential Adopters: A Guide for Trialists. Med Decis Making. 2021 Jan;41(1):9-20. doi: 10.1177/0272989X20973160. Epub 2020 Nov 20. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OTHER |
In a 4-arm, randomized controlled trial, we propose to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD and who have elevated LDL cholesterol levels by testing process versus outcomes financial incentives. Participants will use electronic pill bottles that continuously monitor statin adherence.
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| Outcome Incentive | Behavioral | Incentives conditional on LDL cholesterol reduction |
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