Comparative effectiveness of process and outcomes incentives for lipid management

一、项目总结 心血管疾病(CVD)是美国的主要死亡原因，并使美国 医疗系统每年5000亿美元。他汀类药物，也被称为HMG-CoA还原酶抑制剂，一直以来 在多项临床试验中显示可改善胆固醇和降低心血管疾病的死亡率。大多数患者 患有心血管疾病或具有同等心血管风险的疾病，如糖尿病，需要他汀类药物来达到低- 临床实践指南中的密度胆固醇(LDL)目标。尽管有实质性的好处和合理的 与他汀类药物相关的风险，依从性非常差，一年内的依从率通常约为50% 在心脏病发作后。因此，减少与心血管疾病有关的发病率、死亡率和保健费用将取决于 在很大程度上是关于帮助患者提高服药依从性的有效策略。 财政激励已被证明在改善患者健康行为方面是有效的，包括 在各种情况下的用药依从性。这些激励措施的实施得到了加强， 促进日常用药测量的新无线技术的最新发展 以自动方式遵守和提供激励措施。然而，这种方法的相对有效性 基于过程(例如，他汀类药物的依从性)与结果(例如，低密度脂蛋白胆固醇的改善)的激励是 未知。随着《平价医疗法案》第2705条的实施，这一成果的政策相关性将会增强 2014年的CARE法案，允许雇主使用高达30%的保费(如果计划包括 吸烟)，以结果为基础的指标，如低密度脂蛋白胆固醇。 我们提出了一项随机对照试验来评估阿司匹林的相对有效性和成本效益。 改善心血管疾病高危参与者(目标低密度脂蛋白100 mg/dl)和世卫组织的胆固醇水平 通过测试过程和结果来提高低密度脂蛋白水平(&gt；130毫克/分升)。 参与者将使用电子药瓶，持续监测他汀类药物的依从性。主要结果将是 在12个月内低密度脂蛋白胆固醇的变化。低密度脂蛋白胆固醇将在18个月或6个月后再次测量 在干预结束几个月后，评估财政激励对结果的持久性。这个 试验将采用2x2析因设计，其中624名参与者将获得以下其中一项：1)基于彩票的财务 对他汀类药物依从性的激励--参与者每天都有资格正确服药 (“过程”奖励组)；2)每3个月将低密度脂蛋白降低10毫克/分升的财政奖励 (“结果”激励组)；3)每日彩票激励和降低低密度脂蛋白的激励相结合 胆固醇(“过程加结果”)；或4)常规护理(“对照”)。 研究将达到以下具体目标：1)评估以过程为基础的 降低低密度脂蛋白的激励；2)评估以结果为基础的降低激励的有效性 低密度脂蛋白胆固醇；3)评估降低低密度脂蛋白的联合过程和结果激励的有效性 4)评估每种干预措施的成本效益。

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.