Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RC4AG039114 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Geisinger Clinic | OTHER |
| Brigham and Women's Hospital | OTHER |
| Harvard School of Public Health (HSPH) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 [2] Are results sustained after incentives and other interventions are withdrawn?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?
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Economic Intervention | Behavioral | Various combinations of financial incentives to patients and providers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL From Baseline to 12 Months | Change in LDL-C levels (mg/dL) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL From Baseline to 15 Months | Change in LDL-C levels (mg/dL) from baseline to 15 months | 15 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin Volpp, MD, PhD | University of Pennsylvania | Principal Investigator |
| David Asch, MD, MBA | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harvard Vanguard Medical Associates | Boston | Massachusetts | 02120 | United States | ||
| Geisinger Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29148344 | Derived | 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. | |
| 26547464 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| FG001 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| FG002 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| FG003 | Usual Care/Control | No Intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in LDL From Baseline to 12 Months | Change in LDL-C levels (mg/dL) | Subjects were lost to follow-up, or withdrawn for other reasons. Thus the number analyzed at the 12 month time point does not equal the number analyzed during baseline. | Posted | Mean | 95% Confidence Interval | mg/dL | 12 months |
|
Adverse event data were collected during the subjects' participation in the study; 15 month time period.
Defining Adverse Events:
In this study, ALT greater than or equal to three times the upper limit of normal was considered an adverse event.
Defining Serious Adverse Events:
A definition for an SAE was assigned as ALT greater than or equal to 400 U/L, or hospitalizations or deaths caused by Myalgia or Rhabdomyolysis or liver toxicity.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatic mass | Surgical and medical procedures | Follow up CT scan revealed a large pancreatic obstructing mass compressing the common bile duct. With this clinical picture, this is the most likely cause for the transaminase elevation, and not statin related, as verified by subject's PCP |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Alanine Aminotransferase (ALT) | Blood and lymphatic system disorders | Elevated ALT lab result. ALT was determined by subject's PCP to not be study related; but rather due to methotrexate medication, which was stopped. |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin G. Volpp | University of Pennsylvania and Department of Veteran Affairs | volpp70@wharton.upenn.edu |
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
| OTHER |
| Carnegie Mellon University | OTHER |
| Harvard Vanguard Medical Associates | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Danville |
| Pennsylvania |
| 17822 |
| United States |
| Unversity of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Physician Decision |
|
| Moved |
|
| Other |
|
| Death |
|
| Non-health system primary care physician |
|
| Travel |
|
| BG001 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| BG002 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| BG003 | Usual Care | No Intervention |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity | Count of Participants | Participants |
|
| Annual Household Income, No., $ | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Framingham Risk Score (FRS) | The Framingham Risk Score is a gender-specific algorithm used to estimate the 10-year cardiovascular risk of an individual. Individuals with low risk have 10% or less CHD risk at 10 years, with intermediate risk 10-20%, and with high risk 20% or more. | Mean | Standard Deviation | % |
|
| Pre-existing coronary artery disease (CAD) | Count of Participants | Participants |
|
| Taking cholesterol-reducing medications at baseline | Count of Participants | Participants |
|
(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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| OG002 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. |
| OG003 | Usual Care |
|
|
| Secondary | Change in LDL From Baseline to 15 Months | Change in LDL-C levels (mg/dL) from baseline to 15 months | Posted | Mean | 95% Confidence Interval | mg/dL | 15 months |
|
|
|
| 2 |
| 433 |
| 0 |
| 433 |
| 0 |
| 433 |
| EG001 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. | 3 | 358 | 0 | 358 | 0 | 358 |
| EG002 | 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. Behavioral Economic Intervention: Various combinations of financial incentives to patients and providers. | 0 | 346 | 1 | 346 | 0 | 346 |
| EG003 | Usual Care/Control | 1 | 366 | 0 | 366 | 1 | 366 |
|
|
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|