The effects of state sepsis mandates on hospital mortality, health care utilization, and costs

摘要 脓毒症是美国发病率和死亡率的主要原因，影响超过750，000 美国人每年花费超过200亿美元。几种医学治疗方法已被证明 有效性，包括及时给予抗生素和早期复苏 静脉输液然而，这些治疗方法的应用并不一致， 质量差距。早期识别和治疗方案可以帮助缩小这一差距，挽救生命。 因此，政策制定者越来越多地使用法律的机制来激励 败血症治疗方案的使用其中一项举措是一套前所未有的纽约州法规 该法规于2013年6月实施，统称为“Rory法规”。以罗里命名 斯汤顿，一个12岁的男孩谁死于败血症在纽约医院，罗里的条例规定， 该州的所有医院都实施基于证据的脓毒症管理方案，并报告 向州政府提供脓毒症方案遵守情况和结果的数据。Rory的规则是 以政策为基础改进质量的创新战略，因为它们将传统的质量报告联系起来 有具体的任务，以证据为基础的做法。他们也是一个领先的先行者， 在其他国家和国家一级制定脓毒症法规， 我们了解其临床和财务影响。本提案的总体目标是系统地 评估纽约州败血症法规的影响。我们计划一种新的混合方法 一种方法，旨在产生决策者不仅可以用来完善现有政策的信息， 也是设计和实施未来政策的关键。首先，我们将使用医院急诊科， 来自纽约和八个对照州的住院患者数据，以评估2013年法规对 死亡率、护理并发症、卫生保健利用率和成本，控制病例组合， 时间趋势。第二，我们将用理论驱动的 定性分析，我们将执行和分析半结构化访谈的关键 纽约州的利益相关者，包括临床医生、政策制定者和患者倡导者。这 定性分析将有助于解释整体政策效果，并提供可操作的 为寻求制定类似脓毒症相关法规的政策制定者提供指导。总之，这些目标 将包括对全州范围内具有里程碑意义的脓毒症法规的首次严格评估。更 总的来说，他们将是第一次评估一个新的战略，为全国范围内的质量改善，通过 具体循证做法的政策任务，直接为今后改进 护理质量不仅在败血症，而且在医院医学的其他方面。

ABSTRACT Sepsis is a leading cause of morbidity and mortality in the United States, affecting over 750,000 Americans each year at an annual cost of over $20 billion. Several medical treatments are of proven effectiveness in this population, including timely administration of antibiotics and early resuscitation with intravenous fluids. However these treatments are inconsistently applied, creating an important quality gap. Protocols for early recognition and treatment can help close this gap and save lives in patients with sepsis, and in turn policy makers are increasingly using legal mechanisms to incentivize the use of sepsis protocols. One such initiative is an unprecedented set of New York State regulations implemented in June of 2013 and collectively known as “Rory's Regulations”. Named after Rory Staunton, a 12-year-old boy who died of sepsis at a New York hospital, Rory's Regulations mandate that all hospitals in the state implement evidence-based protocols for sepsis management and report data on sepsis protocol adherence and outcomes to the state government. Rory's Regulations are an innovative strategy for policy-based quality improvement in that they link traditional quality reporting with specific mandates for evidence-based practice. They are also a leading-edge forerunner to sepsis regulations in development in other states and at the national level, making it imperative that we understand their clinical and financial impact. The overall goal of this proposal is to systematically evaluate the impact of the New York state sepsis regulations. We plan a novel mixed methods approach designed to yield information that policy makers can use not only to refine the existing policy but also to design and implement future polices. First, we will use hospital emergency department and inpatient data from New York and eight control states to assess the effects of the 2013 regulations on mortality, complications of care, health care utilization and costs, controlling for case-mix and temporal trends. Second, we will complement our quantitative analyses with a theory-driven qualitative analysis in which we will perform and analyze semi-structured interviews with key stakeholders in New York State, including clinicians, policy-makers, and patient advocates. This qualitative analysis will serve to help interpret the overall policy effects and provide actionable guidance to policy makers seeking to develop similar sepsis-related regulations. Together, these aims will comprise the first rigorous evaluation of a landmark set of state-wide sepsis regulations. More broadly, they will be the first evaluation of a novel strategy for state-wide quality improvement through policy mandates for specific evidence-based practices, directly informing future efforts to improve the quality of care not only in sepsis but also in other aspects of hospital medicine.