Integrating Costs Into Shared Decision-Making for Heart Failure with Reduced Ejection Fraction

项目总结 有效的共享决策是以患者为中心的护理的核心。然而，自付成本已经 被排除在促进共同决策的大多数努力之外。尽管这些成本会影响到 关键问题，如服药依从性和患者负担其他药物或非医疗药物的能力 费用。财务毒性是一个真正的考虑因素，特别是对有财务困难的个人来说。 在心血管疾病的许多决策中，自掏腰包的费用占了很大的比例。他们最近 在慢性心力衰竭伴射血分数降低(HFrEF)的背景下上升为突出。这是 主要是由于新药萨库布曲尔的批准和随后的指南建议- 伐沙坦。这种药物显著提高了死亡率(全因死亡率比27%降低2.8% 几个月)，而不是血管紧张素转换酶抑制剂和血管紧张素受体阻滞剂等标准治疗。然而，它是 价格昂贵，费用可变，但自付费用往往很高。相比之下，替代药物非常便宜。 萨库布曲尔-伐沙坦的有效共享决策需要解决成本和参与 讨论成本和死亡风险等考虑因素之间的权衡。开发的方法 有效地做到这一点对低收入和固定收入患者尤其关键，对他们来说，经济上的毒害或副作用 效果可能是最大的。对于非洲裔美国人来说，这也是具有挑战性和重要的，对他们来说，临床证据 是有限的，并指出了初步试验中没有报告的另一种药物。两者都有 人们还面临与健康、识字和算术有关的障碍。与成本相关的决策 因此，对于装备最少的患者来说，萨库布曲尔-valsartan是最具挑战性的。 拟议的项目将汇集心力衰竭、决策科学和伦理学方面的专业知识。它 解决成本整合的多重障碍。最重要的是，它既解决了利益的沟通 与萨舒布曲尔-valsartan相关，并将患者特定成本整合到临床中。这 很重要，因为这种药物是一种指南推荐的治疗方法。前两个发展目标 涉及系统研究：a)如何以及多久一次在患者与提供者的会面中解决成本问题 关于萨舒布曲尔-valsartan(使用商业上可获得的接触记录数据)；和b) 构建药物及其替代品信息的不同方式，以及不同水平的 患者关于是否启动它的可能选择的成本(使用HFrEF患者和。第三个目标 包括进行阶梯式楔形初步疗效试验，以评估将患者- HFrEF患者临床就诊的特定成本。 这个项目是创新的，是为产生影响而设计的。它将直接影响心力衰竭社区。会的 还提供了新的和有价值的数据，可以应用于许多其他心血管疾病。

PROJECT SUMMARY Effective shared decision-making is central to patient-centered care. However, out-of-pocket costs have been left out of most efforts to promote shared decision-making. This is despite the fact that these costs affect critical issues such as medication adherence and patients' ability to afford other medications or non-medical expenses. Financial toxicity is a real consideration, particularly for individuals with financial constraints. Out of pocket costs figure prominently into many decisions in cardiovascular disease. They have recently risen to prominence in the context of chronic heart failure with reduced ejection fraction (HFrEF). This is principally due to the approval and subsequent guideline recommendation for the novel drug sacubutril- valsartan. This drug improves mortality appreciably (absolute all-cause mortality reduction of 2.8% over 27 months) over standard therapy such as ACE-inhibitors and Angiotensin Receptor Blockers. However, it is expensive, with variable but often high co-pays. In contrast, alternative drugs are very inexpensive. Effective shared decision-making for sacubutril-valsartan requires addressing cost and engaging in discussions about tradeoffs between cost and considerations such as mortality risk. Developing methods for doing this effectively is particularly critical for low and fixed income patients, for whom financial toxicity or side effects may be greatest. It is also challenging and important for African-Americans, for whom clinical evidence is limited and for whom an additional drug is indicated that was not reported in the primary trial. Both populations also face barriers related to health literacy and numeracy. Cost-related decision-making regarding sacubutril-valsartan is thus most challenging for patients least-equipped to do it. The proposed project will bring together expertise in heart failure, decision science, and ethics. It addresses multiple barriers to cost integration. Most importantly, it addresses both communication of benefits associated with sacubutril-valsartan and the integration of patient-specific cost into the clinical encounter. This is important because this medication is a guideline-recommended therapy. The first two developmental aims involve systematically studying: a) how and how often cost is addressed in patient-provider encounters regarding sacubutril-valsartan (using commercially-available data of recorded encounters); and b) the impact of different ways of framing information about the drug and its alternatives and the impact of different levels of cost on patients' likely choices about whether to initiate it (using a mix of HFreF patients and. The third aim involves conducting a stepped-wedge preliminary efficacy trial to assess the impact of integrating patient- specific cost into clinical encounters for patients with HFrEF. This project is innovative and designed for impact. It will directly impact the heart failure community. It will also provide novel and valuable data that can be applied to numerous other cardiovascular conditions.