Abstract
Financial incentives may improve health behaviors. It is unknown whether incentives are more effective if they target a key process (eg, medication adherence), an outcome (eg, low-density lipoprotein cholesterol [LDL-C] levels), or both. To determine whether financial incentives awarded daily for process (adherence to statins), awarded quarterly for outcomes (personalized LDL-C level targets), or awarded for process plus outcomes induce reductions in LDL-C levels compared with control. A randomized clinical trial was conducted from February 12, 2015, to October 3, 2018; data analysis was performed from October 4, 2018, to May 27, 2021, at the University of Pennsylvania Health System, Philadelphia. Participants included 764 adults with an active statin prescription, elevated risk of atherosclerotic cardiovascular disease, suboptimal LDL-C level, and evidence of imperfect adherence to statin medication. Interventions lasted 12 months. All participants received a smart pill bottle to measure adherence and underwent LDL-C measurement every 3 months. In the process group, daily financial incentives were awarded for statin adherence. In the outcomes group, participants received incentives for achieving or sustaining at least a quarterly 10-mg/dL LDL-C level reduction. The process plus outcomes group participants were eligible for incentives split between statin adherence and quarterly LDL-C level targets. Change in LDL-C level from baseline to 12 months, determined using intention-to-treat analysis. Of the 764 participants, 390 were women (51.2%); mean (SD) age was 62.4 (10.0) years, 310 (40.6%) had diabetes, 298 (39.0%) had hypertension, and mean (SD) baseline LDL-C level was 138.8 (37.6) mg/dL. Mean LDL-C level reductions from baseline to 12 months were -36.9 mg/dL (95% CI, -42.0 to -31.9 mg/dL) among control participants, -40.0 mg/dL (95% CI, -44.7 to -35.4 mg/dL) among process participants, -41.6 mg/dL (95% CI, -46.3 to -37.0 mg/dL) among outcomes participants, and -42.8 mg/dL (95% CI, -47.4 to -38.1 mg/dL) among process plus outcomes participants. In exploratory analysis among participants with diabetes and hypertension, no spillover effects of incentives were detected compared with the control group on hemoglobin A1c level and blood pressure over 12 months. In this randomized clinical trial, process-, outcomes-, or process plus outcomes-based financial incentives did not improve LDL-C levels vs control. ClinicalTrials.gov Identifier: NCT02246959.
Highlights
Atherosclerotic cardiovascular disease (ASCVD) remains the number 1 cause of death globally.[1]
Mean low-density lipoprotein cholesterol (LDL-C) level reductions from baseline to 12 months were −36.9 mg/dL among control participants, −40.0 mg/dL among process participants, −41.6 mg/dL among outcomes participants, and −42.8 mg/dL among process plus outcomes participants
In exploratory analysis among participants with diabetes and hypertension, no spillover effects of incentives were detected compared with the control group on hemoglobin A1c level and blood pressure over 12 months
Summary
Atherosclerotic cardiovascular disease (ASCVD) remains the number 1 cause of death globally.[1] Use of statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) has improved cholesterol levels and lowered ASCVD mortality in clinical trials.[2,3] Statins are inexpensive and generally have manageable adverse effects.[4,5] Nonadherence is common, even among patients who previously experienced a myocardial infarction, and contributes to worse health outcomes.[6,7] Statin nonadherence is a serious barrier to realizing public health gains in the treatment of patients at risk for ASCVD-associated events. Incentives focused only on statin adherence might cause patients to neglect other important health behaviors, such as diet or exercise, or signal to patients that statins should take priority over other important medications,[28] causing unintended spillover effects on nontargeted health conditions.[29]
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