Assessment of Implementation Methods in Sepsis and Respiratory Failure

项目摘要 脓毒症是美国重症监护病房(ICU)入院的主要原因，也是 ICU中的呼吸衰竭和死亡。大多数合并败血症或感染性休克的ICU患者要么有呼吸系统 感染是败血症的源头，或有呼吸衰竭需要机械通气。在认识到负担的同时 在美国，脓毒症“捆绑”被引入，以促进指南在临床实践中的实施(已知 作为3小时捆绑包)。自从脓毒症束被引入以来，多项观察性研究表明 实施脓毒症捆绑包与改善存活率之间存在一致的、强烈的关联。这些数据导致了 纽约州(NYS)脓毒症倡议，该倡议表明坚持与脓毒症之间存在显著关联 捆绑和提高存活率，以及医疗保险和医疗补助服务中心(CMS)强制公开报告 败血症措施(SEP-1)。对NYS数据库的分析显示，完成3小时的捆绑在 呼吸衰竭患者的死亡率绝对降低8.6%(18.5RRR)。对于那些 在1小时内完成3小时捆绑的患者，死亡率下降更高，为9.8%(RRR 21.7%)。 2018年，出版了1小时捆绑包，以强调脓毒症患者治疗的紧迫性。我们 相信1小时和3小时捆绑疗法的主要益处都是在呼吸衰竭患者中。它是 不知道实施1小时捆绑是否比3小时捆绑更能降低死亡率。虽然坚持 对于CMS强制要求的3小时捆绑包(SEP-1)，合规性为中等(60%)，表明 3小时捆绑包的实施流程是比较1小时捆绑包和3小时捆绑包所必需的。这个 目前的建议是一项实用的、整群随机的临床试验，使用的是混合型2型有效性-实施 急诊室中评估死亡率和基于呼吸衰竭的结局和捆绑依从性的方法 脓毒症患者。我们将比较1小时捆绑包和3小时捆绑包。结果衡量标准包括医院 死亡率、住院时间、无呼吸机天数和呼吸衰竭发生率。一项临床试验的有效性 使用严格的实施策略实施干预(1小时捆绑)(探索、 1小时和3小时的采用/准备、实施、可持续-EPIS-多层次概念模型 捆绑在一起。在这项研究中，我们还将评估一种可能的基于精度的方法。有关常规临床信息，请访问 医院报告将确定4个离散的脓毒症表型，我们假设其中2个确定了 在未来的研究中，更有可能从1小时的捆绑中受益。我们的团队有丰富的经验 在实施科学有效模型的指导下进行脓毒症的多中心试验。我们已经开发出 自动筛查工具识别脓毒症患者，并指导全州范围内实施脓毒症 绩效衡量标准。我们还使用自动电子病历方法来筛查和登记败血症患者。 学习。这一新颖的混合类型2有效性实施方法解决了关键差距，以促进 实施循证策略以改善脓毒症和急性呼吸衰竭患者的预后。

Project Summary Sepsis is the leading cause of admission to intensive care units (ICUs) in the U.S., and the leading cause of respiratory failure and death in ICUs. The majority of ICU patients with sepsis or septic shock have either respiratory infection as the source of sepsis, or have respiratory failure requiring mechanical ventilation. In recognition of the burden of sepsis in the U.S., sepsis “bundles” were introduced to facilitate guideline implementation in clinical practice (known as the 3-Hour bundle). Since the introduction of sepsis bundles, multiple observational studies have demonstrated a consistent, strong association between implementation of sepsis bundles and improved survival. These data led to the New York State (NYS) Sepsis initiative, which demonstrated a significant association between adherence with sepsis bundles and improved survival, and the Centers for Medicare and Medicaid Services (CMS) mandated public reporting of sepsis measures (SEP-1). Analysis of the NYS database has revealed that completion of the 3-Hour bundle in patients with respiratory failure was associated with an 8.6% absolute reduction in mortality (18.5 RRR). For those patients who completed the 3-Hour bundle within 1 hour, the mortality reduction was even higher, 9.8% (RRR 21.7%). In 2018, the Hour-1 bundle was published to underscore the need for urgency in the treatment of septic patients. We believe that the primary beneficial effect of both the Hour-1 and 3-Hour bundle is in patients with respiratory failure. It is not known if implementation of the Hour-1 bundle reduces mortality more than the 3 Hour bundle. Although adherence with the 3-Hour bundle (SEP-1) is mandated by CMS, compliance is moderate (60%), suggesting an active implementation process for the 3-hour bundle is necessary to compare the Hour-1 bundle to the 3-Hour bundle. The current proposal is a pragmatic, cluster-randomized clinical trial using a hybrid type 2 effectiveness-implementation approach to evaluate mortality and respiratory failure-based outcomes and bundle adherence, in emergency room patients with sepsis. We will compare the hour-1 bundle to the 3-hour bundle. The outcome measures include hospital mortality, hospital length of stay, ventilator-free days, and incidence of respiratory failure. The effectiveness of a clinical intervention (Hour-1 bundle) is implemented using a rigorous implementation strategy (the Exploration, adoption/Preparation, Implementation, Sustainment – EPIS – multi-level conceptual model) for both the 1- and 3-Hour bundles. We will also evaluate a possible precision-based approach in this study. Routine clinical information available at hospital presentation will identify 4 discrete, sepsis phenotypes and we hypothesize that 2 of these identify patients who are significantly more likely to benefit from the 1-Hour bundle in future studies. Our team has extensive experience conducting multi-center trials in sepsis guided by effective models of implementation science. We have developed automated screening tools to identify patients with sepsis and have guided state-wide implementation of sepsis performance measures. We have also used automated EHR methods to screen for and enroll septic patients into these studies. This novel, hybrid type 2 effectiveness-implementation approach addresses key gaps to facilitate the implementation of evidence-based strategies to improve patient outcomes from sepsis and acute respiratory failure.