Assessment of Implementation Methods in Sepsis and Respiratory Failure

脓毒症和呼吸衰竭实施方法的评估

• 批准号: 10416329
• 负责人: Mitchell M Levy
• 金额: $ 75.69万
• 依托单位: RHODE ISLAND HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-15 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10416329
• 关键词: Academic Detailing; Accident and Emergency department; Acute respiratory failure; Address; Adherence; Admission activity; Adoption; Caring; Cessation of life; Characteristics; Climate; Clinical; Clinical Data; Clinical effectiveness; Cluster randomized trial; Communities; Critical Care; Data; Databases; Effectiveness; Electronic Health Record; Elements; Emergency Department patient; Enrollment; Evaluation; Future; Goals; Guidelines; Heterogeneity; Hospital Mortality; Hospitals; Hour; Hybrids; Incidence; Infection; Intensive Care Units; Intervention; Interview; Leadership; Learning; Length of Stay; Link; Liquid substance; Lung; Measures; Mechanical ventilation; Mediating; Medicine; Methods; Modeling; Multicenter Trials; New York; Observational Study; Outcome; Outcome Measure; Patient Care; Patient-Focused Outcomes; Patients; Performance; Phase; Phenotype; Population Heterogeneity; Preparation; Publishing; Randomized; Randomized Clinical Trials; Relative Risks; Reporting; Research; Respiratory Disease; Respiratory Failure; Respiratory Tract Infections; Resuscitation; Risk Reduction; Screening procedure; Sepsis; Septic Shock; Societies; Source; Structure; Surveys; Time; United States; United States Centers for Medicare and Medicaid Services; Ventilator; Work; arm; base; clinical phenotype; clinical practice; cohort; comparative effectiveness; compare effectiveness; effectiveness evaluation; effectiveness implementation study; effectiveness implementation trial; effectiveness outcome; evidence base; experience; implementation facilitation; implementation facilitators; implementation framework; implementation intervention; implementation process; implementation science; implementation strategy; improved; improved outcome; individualized medicine; meetings; mortality; novel; organizational readiness; pragmatic trial; precision medicine; primary outcome; programs; randomized trial; respiratory; response; secondary outcome; septic patients; standard of care; sustainability framework; treatment effect; uptake

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.

项目摘要 脓毒症是美国重症监护病房（ICU）入院的主要原因，也是导致 呼吸衰竭和ICU死亡。大多数重症监护病房的脓毒症或脓毒性休克患者， 感染是脓毒症的来源，或呼吸衰竭需要机械通气。认识到 脓毒症在美国，脓毒症“束”被引入以促进临床实践中的指南实施（已知的 3小时包）。自脓毒症捆绑治疗引入以来，多项观察性研究表明， 脓毒症捆绑治疗的实施与生存率提高之间存在一致的强相关性。这些数据导致了 纽约州（NYS）脓毒症倡议，该倡议证明了脓毒症依从性与 捆绑和提高生存率，以及医疗保险和医疗补助服务中心（CMS）授权的公共报告 脓毒症指标（SEP-1）。对纽约州数据库的分析显示， 呼吸衰竭患者的死亡率绝对降低8.6%（18.5 RRR）。对于那些 在1小时内完成3小时捆绑治疗的患者，死亡率下降更高，为9.8%（RRR 21.7%）。 2018年，发布了Hour-1捆绑包，以强调脓毒症患者治疗的紧迫性。我们 认为1小时和3小时束的主要有益效果是在呼吸衰竭患者中。是 尚不清楚实施1小时捆绑包是否比3小时捆绑包更能降低死亡率。虽然坚持 3小时捆绑（SEP-1）是CMS强制要求的，依从性中等（60%），这表明 3小时捆绑包的实施过程是必要的，以比较1小时捆绑包和3小时捆绑包。的 目前的建议是一个务实的，集群随机临床试验，使用混合型2有效性-实施 急诊室中基于死亡率和呼吸衰竭的结局及集束治疗依从性的评价方法 脓毒症患者我们将比较1小时捆绑包和3小时捆绑包。结果指标包括医院 死亡率、住院时间、无呼吸机天数和呼吸衰竭发生率。临床的有效性 使用严格的实施策略（探索， 采用/准备、实施、维持- EPIS -多层次概念模型） 捆起来。在本研究中，我们还将评估一种可能的基于精度的方法。常规临床信息， 医院表现将鉴定4种离散脓毒症表型，我们假设这些鉴定的患者中的2个 在未来的研究中，更有可能从1小时套餐中受益。我们的团队拥有丰富的经验 在实施科学的有效模式指导下，开展脓毒症的多中心试验。我们已经开发 自动筛查工具，以识别脓毒症患者，并指导全州范围内实施脓毒症 业绩计量。我们还使用自动化EHR方法来筛选和登记脓毒症患者， 问题研究这种新颖的混合型2型有效性实施方法解决了关键差距， 实施循证策略，改善脓毒症和急性呼吸衰竭患者的预后。