Cardiovascular Disease
Conditions
Keywords
Cardiovascular Disease
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 \[2\] Are results sustained after incentives and other interventions are withdrawn?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?
Interventions
BEHAVIORALBehavioral Economic Intervention
Various combinations of financial incentives to patients and providers.
Sponsors
National Institute on Aging (NIA)
Geisinger Clinic
Brigham and Women's Hospital
Harvard School of Public Health (HSPH)
Carnegie Mellon University
Harvard Vanguard Medical Associates
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL From Baseline to 12 Months | 12 months | Change in LDL-C levels (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL From Baseline to 15 Months | 15 months | Change in LDL-C levels (mg/dL) from baseline to 15 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 433 |
| 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. | 358 |
| 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. | 346 |
| Usual Care No Intervention | 366 |
| Total | 1,503 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 3 | 0 | 0 |
| Overall Study | Moved | 3 | 0 | 4 | 0 |
| Overall Study | Non-health system primary care physician | 0 | 5 | 0 | 0 |
| Overall Study | Other | 2 | 4 | 7 | 3 |
| Overall Study | Physician Decision | 4 | 0 | 0 | 0 |
| Overall Study | Travel | 0 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 5 | 3 | 5 |
Baseline characteristics
| Characteristic | Physician Incentives | Patient Incentives | Physician and Patient Combined Incentives | Usual Care | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.68 years STANDARD_DEVIATION 8.67 | 62.41 years STANDARD_DEVIATION 8.63 | 62.03 years STANDARD_DEVIATION 8.64 | 61.70 years STANDARD_DEVIATION 8.89 | 61.99 years STANDARD_DEVIATION 8.7 |
| Annual Household Income, No., $ >100,000 | 85 Participants | 76 Participants | 68 Participants | 68 Participants | 297 Participants |
| Annual Household Income, No., $ <50,000 | 193 Participants | 145 Participants | 134 Participants | 163 Participants | 635 Participants |
| Annual Household Income, No., $ 50,000 to 100,000 | 144 Participants | 129 Participants | 126 Participants | 124 Participants | 523 Participants |
| Education <College | 148 Participants | 107 Participants | 102 Participants | 129 Participants | 486 Participants |
| Education College and postcollege graduate | 165 Participants | 148 Participants | 133 Participants | 131 Participants | 577 Participants |
| Education Some college | 118 Participants | 102 Participants | 108 Participants | 105 Participants | 433 Participants |
| Framingham Risk Score (FRS) | 20.1 % STANDARD_DEVIATION 9 | 19.7 % STANDARD_DEVIATION 8.6 | 19.1 % STANDARD_DEVIATION 8.7 | 20.1 % STANDARD_DEVIATION 8.7 | 19.8 % STANDARD_DEVIATION 8.7 |
| Marital Status Married | 286 Participants | 236 Participants | 239 Participants | 231 Participants | 992 Participants |
| Marital Status Other | 81 Participants | 62 Participants | 60 Participants | 75 Participants | 278 Participants |
| Marital Status Single | 64 Participants | 59 Participants | 43 Participants | 59 Participants | 225 Participants |
| Pre-existing coronary artery disease (CAD) | 143 Participants | 110 Participants | 115 Participants | 148 Participants | 516 Participants |
| Race/Ethnicity African American, non-Hispanic | 57 Participants | 72 Participants | 42 Participants | 61 Participants | 232 Participants |
| Race/Ethnicity Hispanic | 6 Participants | 10 Participants | 7 Participants | 7 Participants | 30 Participants |
| Race/Ethnicity Missing | 2 Participants | 1 Participants | 6 Participants | 2 Participants | 11 Participants |
| Race/Ethnicity Other non-Hispanic | 8 Participants | 10 Participants | 6 Participants | 7 Participants | 31 Participants |
| Race/Ethnicity White, non-Hispanic | 360 Participants | 265 Participants | 285 Participants | 289 Participants | 1199 Participants |
| Sex: Female, Male Female | 179 Participants | 164 Participants | 135 Participants | 161 Participants | 639 Participants |
| Sex: Female, Male Male | 254 Participants | 194 Participants | 211 Participants | 205 Participants | 864 Participants |
| Taking cholesterol-reducing medications at baseline | 166 Participants | 180 Participants | 200 Participants | 166 Participants | 712 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 433 | 3 / 358 | 0 / 346 | 1 / 366 |
| other Total, other adverse events | 0 / 433 | 0 / 358 | 0 / 346 | 1 / 366 |
| serious Total, serious adverse events | 0 / 433 | 0 / 358 | 1 / 346 | 0 / 366 |
Outcome results
Primary
Change in LDL From Baseline to 12 Months
Change in LDL-C levels (mg/dL)
Time frame: 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Physician Incentives | Change in LDL From Baseline to 12 Months | Mean Reduction | 27.9 mg/dL |
| Physician Incentives | Change in LDL From Baseline to 12 Months | 12 Months | 132 mg/dL |
| Physician Incentives | Change in LDL From Baseline to 12 Months | Baseline | 159.9 mg/dL |
| Patient Incentives | Change in LDL From Baseline to 12 Months | Mean Reduction | 25.1 mg/dL |
| Patient Incentives | Change in LDL From Baseline to 12 Months | 12 Months | 135.5 mg/dL |
| Patient Incentives | Change in LDL From Baseline to 12 Months | Baseline | 160.6 mg/dL |
| Physician and Patient Combined Incentives | Change in LDL From Baseline to 12 Months | Baseline | 160.1 mg/dL |
| Physician and Patient Combined Incentives | Change in LDL From Baseline to 12 Months | Mean Reduction | 33.6 mg/dL |
| Physician and Patient Combined Incentives | Change in LDL From Baseline to 12 Months | 12 Months | 126.4 mg/dL |
| Usual Care | Change in LDL From Baseline to 12 Months | Mean Reduction | 25.1 mg/dL |
| Usual Care | Change in LDL From Baseline to 12 Months | 12 Months | 136.4 mg/dL |
| Usual Care | Change in LDL From Baseline to 12 Months | Baseline | 161.5 mg/dL |
Secondary
Change in LDL From Baseline to 15 Months
Change in LDL-C levels (mg/dL) from baseline to 15 months
Time frame: 15 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Physician Incentives | Change in LDL From Baseline to 15 Months | 29.1 mg/dL |
| Patient Incentives | Change in LDL From Baseline to 15 Months | 23.9 mg/dL |
| Physician and Patient Combined Incentives | Change in LDL From Baseline to 15 Months | 32.8 mg/dL |
| Usual Care | Change in LDL From Baseline to 15 Months | 25.8 mg/dL |