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 i nvolves 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.

Public Health Relevance

The proposed project addresses a critical barrier in achieving patient-centered, shared decision-making regarding treatment of congestive heart failure: incorporation of out of pocket costs. The project focuses on the particular clinical decision about use of sacubutril-valsartan, a novel drug for heart failure that is effective and guideline-recommended but has highly variable and often significant out-of-pocket costs. Capitalizing on the strengths of an experienced multi-disciplinary team, we will: 1) observe the way that this decision is discussed and the extent to which cost is incorporated in practice; 2) assess the impact of both how the decision is framed and the amount of out of pocket cost on patient preferences regarding this drug; and 3) conduct a trial to examine the impact of providing point-of-care patient-specific cost estimates on cost-sensitive shared decision-making.

National Institute of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Research Project (R01)
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Healthcare Systems and Values Research (HSVR)
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James, Marian
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Emory University
Internal Medicine/Medicine
Schools of Medicine
United States
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