Improving Adherence with Statins Through Use of the Statin Choice Decision Aid

项目摘要 动脉粥样硬化性心血管疾病（ASCVD）是美国的主要死亡原因，HMG- CoA还原酶抑制剂（他汀类药物）是降低ASCVD风险的最有效药物治疗。 近一半的美国成年人可以从服用他汀类药物中获益。然而，即使在那些风险最高的人中， ASCVD，许多人从来没有提供他们的医生，和一半的人谁开始停止他汀类药物内 一年共享决策（SDM）帮助患者根据他们的个性化需求做出明智的决定。 预测不同治疗策略的益处和危害。决策辅助工具（DA）是促进 SDM。他汀选择是一种电子健康记录（EHR）嵌入式DA，旨在由医生使用， 协助SDM与患者进行他汀类药物治疗。他汀类药物的选择是免费的史诗，最 在小型试验环境中，他汀类药物的使用中度 与原发性和继发性他汀类药物依从性相关。然而，这些研究有一些重要的 局限性使得他汀类药物选择对依从性的影响仍然未知。2015年，克利夫兰诊所 卫生系统启用他汀类药物选择作为EHR中的选项，供医生在讨论他汀类药物时使用 和病人一起。我们发现，在初级保健访问期间查看他汀类药物选择的患者的 与未使用他汀类药物的患者相比，使用他汀类药物处方离开访视的几率。因为这是必要的第一步 他汀类药物的选择可能是一个强大的和可扩展的工具，以改善他汀类药物的依从性 坚持。我们的总体目标是通过扩大他汀类药物的使用来提高他汀类药物的依从性， ASCVD事件风险最高的患者。在目标1中，我们将进行一项观察性研究， 180，000名初级保健患者和700名医生描述了使用他汀类药物的医生差异， 患者因素，包括种族/民族和社会经济地位，并评估他汀类药物选择的影响 主要和次要粘附的暴露。决策辅助工具只有在医生使用时才有用。我们 将使用真实的医生在使用他汀类药物选择方面的差异，对医生进行抽样，以参与半 对他们使用该工具的经历进行了结构化访谈。目标1将产生重要的新信息， 在真实的世界条件下使用他汀类药物选择。在目标2中，我们将进行一项群集随机对照试验 他汀类药物选择对主要和次要依从性的临床决策支持。我们的随机试验设计 这将使我们能够建立因果关系，并确定他汀类药物的扩大使用是否会产生 对他汀类药物依从性的影响。许多卫生系统已将他汀类药物选择纳入其EHR， 然而，还有更多的人可以这样做。我们在一个主要卫生系统的研究将产生两个关键的知识， 支持这一努力：1）我们将确定通过临床决策支持提供的他汀类药物选择的真正影响 在大型初级保健人群中对他汀类药物依从性的影响，2）我们将了解他汀类药物的选择如何起作用 在真实的世界中，为其他主要卫生系统更广泛地采用他汀类药物提供信息。

Project Summary Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the United States, and HMG- CoA reductase inhibitors (statins) are the most effective pharmacotherapy for reducing the risk of ASCVD. Nearly half of U.S. adults could benefit from taking a statin. Yet even among those at the highest risk of ASCVD, many are never offered them by their physician, and half of those who start discontinue statins within one year. Shared decision making (SDM) helps patients make informed decisions based on their individualized predicted benefits and harms of different treatment strategies. Decision aids (DAs) are tools that facilitate SDM. Statin Choice is an electronic health record (EHR)-embedded DA designed to be used by physicians to facilitate SDM with patients for statin therapy. Statin Choice is available free of charge in Epic, the most commonly used EHR platform in the U.S. In small trial settings, use of Statin Choice was moderately associated with primary and secondary statin adherence. Yet these studies had a number of important limitations such that the impact of Statin Choice on adherence remains unknown. In 2015 the Cleveland Clinic Health System enabled Statin Choice as an option in the EHR for physicians to use when discussing statins with patients. We found patients who viewed Statin Choice during a primary care visit had three times higher odds of leaving the visit with a statin prescriptions compared to those who did not. As this is the necessary first step on the pathway to adherence, Statin Choice may represent a powerful and scalable tool to improve statin adherence. Our overall goal is to improve statin adherence through expanded use of Statin Choice, particularly among patients at highest risk for ASCVD events. In Aim 1 we will conduct an observational study on over 180,000 primary care patients and 700 physicians to describe physician variation in use of Statin Choice by patient factors, including race/ethnicity and socioeconomic position, and assess the impact of Statin Choice exposure on primary and secondary adherence. Decision aids can only be useful if physicians use them. We will use real world physician variation in use of Statin Choice to sample physicians to participate in semi- structured interviews about their experiences using the tool. Aim 1 will generate important new information on use of Statin Choice under real world conditions. In Aim 2 we will conduct a cluster randomized controlled trial of clinical decision support for Statin Choice on primary and secondary adherence. Our randomized trial design will allow us to establish causality and determine whether expanded use of Statin Choice can have a meaningful impact on statin adherence. Numerous health systems have integrated Statin Choice in their EHR, yet far more could do so. Our study in a major health system will generate two crucial pieces of knowledge to support this effort: 1) we will determine the true impact of Statin Choice delivered via clinical decision support on statin adherence in a large primary care population, and 2) we will understand how Statin Choice use works in the real world, to inform wider adoption of Statin Choice by other major health systems.