Comparative effectiveness of process and outcomes incentives for lipid management

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I. PROJECT SUMMARY Cardiovascular disease (CVD) is the leading cause of death in the United States (US) and costs the US healthcare system $500 billion annually. Statins, also known as HMG-CoA reductase inhibitors, have been shown to improve cholesterol and lower mortality from CVD in multiple clinical trials. The majority of patients with CVD or diseases with equivalent cardiovascular risk, such as diabetes, require a statin to achieve the low- density cholesterol (LDL) targets in clinical practice guidelines. Despite the substantial benefits and reasonable risks associated with statins, adherence is strikingly poor with adherence rates often about 50% within the year following a heart attack. Therefore, reducing CVD-related morbidity, mortality and health care costs will depend to a great degree on effective strategies to help patients improve medication adherence. Financial incentives have been shown to be effective at improving patient health behaviors including medication adherence in a wide variety of contexts. The delivery of such incentives has been enhanced by the recent development of new wireless technologies that facilitate the measurement of daily medication adherence and the provision of incentives in an automated fashion. However, the relative effectiveness of incentives based on process (e.g. statin adherence) versus outcome (e.g. improvements in LDL cholesterol) is unknown. The results will grow in policy relevance with the implementation of Section 2705 of the Affordable Care Act in 2014, which allows employers to utilize as much as 30% of premiums (50% if programs include smoking) for outcome-based incentives for metrics like LDL cholesterol. We propose a randomized controlled trial to evaluate the relative effectiveness and cost-effectiveness of improving cholesterol levels among participants who are at high risk of CVD (goal LDL <100 mg/dl) and who have elevated LDL cholesterol levels (>130 mg/dl) 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. LDL cholesterol will be measured again at 18 months, six months after the intervention has ended, to assess the durability of financial incentives on the outcome. The trial will have a 2 x 2 factorial design in which the 624 participants receive either: 1) lottery-based financial incentives for statin adherence -- with participants eligible each day they take their medication correctly ("process" incentive group); 2) financial incentives for lowering LDL cholesterol by >10 mg/dl every 3 months ("outcome" incentive group); 3) a combination of daily lottery incentives and incentives for lowering LDL cholesterol ("process plus outcomes"); or 4) usual care (the "control"). The study will achieve the following Specific Aims: 1) Assess the effectiveness of a process-based incentive on lowering LDL cholesterol; 2) Assess the effectiveness of an outcome-based incentive on lowering LDL cholesterol; 3) Assess the effectiveness of a combined process plus outcomes incentive on lowering LDL cholesterol; 4) Assess the cost-effectiveness of each of the interventions.