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 败血症是美国接受重症监护病房（ICU）的主要原因，是 ICU中的呼吸衰竭和死亡。大多数ICU患有败血症或败血性休克患者的呼吸道 负担作为败血症的来源或​​需要机械通气的呼吸衰竭时的反应。 引入了败血症的败血症，引入了败血症的“束”，以促进临床实践中的准则实施（已知 作为3小时的捆绑包）。自引入败血症束以来，多次观察性研究表明 一致性，实施败血症束与改善生存之间的牢固关联。这些数据导致 纽约州（NYS）败血症倡议 捆绑和改善的生存，以及医疗保险和医疗补助服务中心（CMS）授权的公开报告 败血症测量值（SEP-1）。对NYS数据库的分析表明，在3小时内完成 呼吸衰竭的患者与死亡率的绝对降低8.6％有关（18.5 RRR）。对于那些 在1小时内完成3小时束的患者，死亡率降低甚至更高，9.8％（RRR 21.7％）。 2018年，发布了1小时捆绑包，以强调化粪池患者的迫切需要。我们 相信小时1和3小时束的主要有益作用是呼吸衰竭患者。这是 不知道实施小时1捆绑会比3小时捆绑降低死亡率。虽然坚持 CMS要求使用3小时捆绑包（SEP-1），合规性是中等的（60％），表明有效 需要进行3小时捆绑包的实现过程，以将小时1捆绑包与3小时捆绑包进行比较。这 当前的建议是使用混合2型有效性实现的务实的，聚类的临床试验 在急诊室评估死亡率和呼吸衰竭的结果和捆绑依从性的方法 败血症患者。我们将将小时1捆绑包与3小时的捆绑包进行比较。结果措施包括医院 死亡率，住院时间，无通风天和呼吸衰竭的发生。临床的有效性 使用严格的实施策略（探索， 1小时和3小时 捆。我们还将评估本研究中可能的基于精确的方法。常规临床信息可用 医院介绍将确定4种离散，败血症表型，我们假设其中2个识别患者 在以后的研究中，从1小时的捆绑包中受益更大的可能性。我们的团队有丰富的经验 在有效的实施科学模型的指导下进行败血症的多中心试验。我们已经发展了 自动筛查工具以识别败血症患者，并具有全州范围内的败血症实施 绩效指标。我们还使用自动EHR方法来筛选和注册化粪池患者 研究。这种小说，混合2型有效性实施方法解决了关键差距，以促进 实施基于证据的策略，以改善败血症和急性呼吸衰竭的患者预后。