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，而HMG- 辅酶A还原酶抑制剂(他汀类)是降低ASCVD风险的最有效的药物治疗。 近一半的美国成年人可以从服用他汀类药物中受益。然而，即使是在那些面临最高风险的人中 ASCVD，许多人从未被他们的医生提供过，一半开始停用他汀类药物的患者在 一年。共享决策(SDM)帮助患者根据他们的个性化情况做出明智的决策 预测不同治疗策略的益处和危害。决策辅助工具(DA)可帮助 SDM。他汀类选择是一种嵌入电子健康记录(EHR)的DA，旨在供医生使用 促进SDM与患者进行他汀类药物治疗。他汀类药物的选择在Epic中是免费的， 在美国常用的EHR平台。在小规模试验设置中，他汀类药物选择的使用程度适中 与原发和继发的他汀类药物依从性有关。然而，这些研究有许多重要的 限制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 医疗系统使他汀类药物选择成为EHR中的一个选项，供医生在讨论他汀类药物时使用 和病人在一起。我们发现，在初级保健就诊期间查看他汀类药物选择的患者的风险是前者的三倍 与那些没有服用他汀类药物的患者相比，携带他汀类药物的患者离开就诊的几率更高。因为这是必要的第一步 踏上坚持的道路，他汀类药物选择可能代表着一种强大且可扩展的工具来改善他汀类药物 坚持不懈。我们的总体目标是通过扩大他汀类药物选择的使用范围来改善他汀类药物的依从性，特别是 在ASCVD事件的高危患者中。在目标1中，我们将对超过 18万名初级保健患者和700名医生描述医生在他汀类药物选择方面的使用差异 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 暴露于原发和继发粘连。决策辅助只有在医生使用的情况下才会有用。我们 将利用现实世界中医生的变异使用他汀类药物选择样本医生参加半决赛 关于他们使用该工具的经验的结构化采访。目标1将产生关于以下方面的重要新信息 在现实世界条件下使用他汀类药物选择。在目标2中，我们将进行整群随机对照试验 他汀类药物对初次和继发性依从性的临床决策支持。我们的随机试验设计 将使我们能够建立因果关系，并确定扩大他汀类药物选择的使用是否会有 对他汀类药物依从性有意义的影响。许多医疗系统在其电子病历中集成了他汀类药物选择， 然而，更多的人可以这样做。我们对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 关于大量初级保健人群中他汀类药物的依从性，以及2)我们将了解他汀类药物选择是如何起作用的 在现实世界中，告知其他主要卫生系统更广泛地采用他汀类药物选择。

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.