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

项目摘要 有效的共同决策是以病人为中心的护理的核心。然而，自付费用 在促进共同决策的大多数努力中被排除在外。尽管这些成本会影响 关键问题，如药物依从性和患者负担其他药物或非医疗 费用财务毒性是一个真实的考虑因素，特别是对于财务拮据的个人。 自付费用在心血管疾病的许多决策中占据突出地位。他们最近 在慢性心力衰竭伴射血分数降低（HFrEF）的背景下变得突出。这是 主要是由于新药沙库布曲的批准和随后的指南推荐， 缬沙坦该药物可显着降低死亡率（27岁以上绝对全因死亡率降低2.8%） 月）超过标准治疗，如ACE抑制剂和血管紧张素受体阻滞剂。但据 费用昂贵，自付额不一，但往往很高。相比之下，替代药物非常便宜。 沙库布曲-缬沙坦的有效共同决策需要解决成本问题， 讨论成本和死亡风险等因素之间的权衡。制定方法， 有效地做到这一点对于低收入和固定收入的患者尤其重要，对他们来说， 效果可能最大。对于非裔美国人来说，这也是具有挑战性和重要性的，对他们来说， 受限制，并且需要使用一种在主要试验中未报告的其他药物。两 人口还面临与卫生知识和算术有关的障碍。与费用有关的决策， 因此，沙库布曲-缬沙坦对于最不适合的患者来说是最具挑战性的。 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 解决了成本整合的多重障碍。最重要的是，它既涉及利益的沟通， 与沙库布曲-缬沙坦相关，并将患者特定成本纳入临床治疗。这 因为这种药物是指南推荐的治疗方法。前两个发展目标 涉及系统地研究：a）在患者-提供者接触中如何以及多久解决一次费用问题 关于沙库布曲-缬沙坦（使用记录的接触的商业可用数据）;和B） 关于药物及其替代品的不同信息框架方式以及不同水平的 成本取决于患者是否开始治疗的可能选择（使用HFEF患者和。第三个目标 包括进行一个阶梯楔形初步疗效试验，以评估整合患者的影响， HFrEF患者临床就诊的具体成本。 这个项目是创新的，旨在产生影响。它将直接影响心力衰竭社区。它将 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.