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: 10665714
• 负责人: Mitchell M Levy
• 金额: $ 72.26万
• 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/10665714
• 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; Education; 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 Admission; Patient Care; Patient-Focused Outcomes; Patients; Performance; Phase; Phenotype; Population Heterogeneity; Preparation; Publishing; Randomized; Relative Risks; Reporting; Research; Respiratory Disease; Respiratory Failure; Respiratory Tract Infections; Resuscitation; Risk Reduction; Screening procedure; Sepsis; Septic Shock; Societies; Source; Structure; Surveys; United States; United States Centers for Medicare and Medicaid Services; Ventilator; Work; arm; clinical phenotype; clinical practice; cohort; comparative effectiveness; compare effectiveness; effectiveness evaluation; effectiveness outcome; effectiveness/implementation hybrid; effectiveness/implementation trial; evidence base; experience; implementation evaluation; implementation facilitation; implementation facilitators; implementation intervention; implementation process; implementation science; implementation strategy; implementation/effectiveness; improved; improved outcome; individualized medicine; meetings; mortality; novel; organizational readiness; pragmatic trial; precision medicine; primary outcome; programs; randomized trial; randomized, clinical trials; respiratory; response; secondary outcome; septic patients; standard of care; 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.

项目概要 脓毒症是美国重症监护病房 (ICU) 入住的主要原因，也是 ICU 中的呼吸衰竭和死亡。大多数 ICU 脓毒症或脓毒性休克患者患有呼吸道疾病 感染是败血症的根源，或有呼吸衰竭需要机械通气。认识到负担 在美国，脓毒症“捆绑包”被引入以促进临床实践中的指南实施（已知 作为 3 小时捆绑包）。自从引入脓毒症集束以来，多项观察性研究表明 实施脓毒症捆绑治疗与提高生存率之间存在一致、强烈的关联。这些数据导致 纽约州 (NYS) 脓毒症倡议，表明坚持与脓毒症之间存在显着关联 捆绑并提高生存率，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)。对纽约州数据库的分析显示，完成 3 小时捆绑课程的时间为 呼吸衰竭患者的死亡率绝对降低了 8.6%（18.5 RRR）。对于那些 在 1 小时内完成 3 小时捆绑的患者，死亡率降低甚至更高，为 9.8%（RRR 21.7%）。 2018 年，Hour-1 捆绑包的发布强调了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有益效果是对呼吸衰竭患者。这是 尚不清楚实施 1 小时捆绑方案是否比 3 小时捆绑方案更能降低死亡率。虽然坚持 CMS 强制要求 3 小时捆绑包 (SEP-1)，依从性中等 (60%)，表明积极 3 小时捆绑的实施过程对于将 1 小时捆绑与 3 小时捆绑进行比较是必要的。这 目前的提案是一项实用的整群随机临床试验，使用混合 2 型有效性实施 在急诊室评估基于死亡率和呼吸衰竭的结果以及捆绑依从性的方法 败血症患者。我们将比较 1 小时捆绑和 3 小时捆绑。结果测量包括医院 死亡率、住院时间、不使用呼吸机的天数和呼吸衰竭的发生率。临床效果 干预（Hour-1 捆绑）是使用严格的实施策略（探索、 1 小时和 3 小时的采用/准备、实施、维持 – EPIS – 多层次概念模型） 捆绑。我们还将在本研究中评估一种可能的基于精度的方法。常规临床信息可在 医院报告将识别出 4 种离散的脓毒症表型，我们假设其中 2 种识别出以下患者： 在未来的研究中，他们更有可能从 1 小时捆绑中受益。我们的团队拥有丰富的经验 在有效的实施科学模型的指导下开展脓毒症多中心试验。我们开发了 自动筛查工具可识别败血症患者并指导全州范围内败血症的实施 绩效衡量标准。我们还使用自动化 EHR 方法来筛选脓毒症患者并将其纳入其中 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，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治疗结果。

项目成果

Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial.

• DOI: 10.1186/s13063-023-07644-y
• 发表时间: 2023-09-29
• 期刊: Trials
• 影响因子: 2.5