Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial.
Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial.
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作者：
脓毒症是重症监护病房（ICU）入院和ICU死亡的主要原因。认识到脓毒症的负担，生存脓毒症运动（SSC）和医疗保健改善研究所开发了脓毒症“捆绑包”（在特定时间段内完成的目标），以促进SSC指南在临床实践中的实施。使用SSC 3-h捆绑包作为基础，医疗保险和医疗补助服务中心开发了3-h脓毒症捆绑包，该捆绑包已成为脓毒症早期管理的国家标准。来自AIMS赠款申请分析的新观察数据表明，更早实施3小时捆绑治疗可能会带来额外的死亡率益处，即，1-h束。这项随机对照试验的主要目的是：（1）检查急诊科在传统的3小时内启动3小时捆绑治疗与在脓毒症识别后1小时内启动3小时捆绑治疗对临床结局的影响;（2）检查严格的实施策略将在多大程度上改善1小时捆绑治疗和3小时捆绑治疗的实施和依从性。本研究将全部在18家研究中心的急诊室进行。次要目的是确定临床脓毒症表型及其对治疗结果的影响。这项采用实施科学方法的随机分组试验对该领域来说是及时和重要的。混合有效性-实施设计可能会对脓毒症管理的临床实践产生影响，因为它提供了1小时和3小时束的严格评价。NHLBI R01HL162954。ClinicalTrials.gov NCT05491941。于2022年8月8日注册。在线版本包含补充材料，可通过10.1186/s13063-023-07644-y获得。
Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis “bundles” (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle. The primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes. This cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles. NHLBI R01HL162954. ClinicalTrials.gov NCT05491941. Registered on August 8, 2022. The online version contains supplementary material available at 10.1186/s13063-023-07644-y.
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影响因子：
3.2
作者：
Hsieh, HF;Shannon, SE
通讯作者：
Shannon, SE
幸存的败血症运动：严重败血症和化粪池冲击管理的国际指南，2012年。
影响因子：
38.9
作者：
Dellinger RP;Levy MM;Rhodes A;Annane D;Gerlach H;Opal SM;Sevransky JE;Sprung CL;Douglas IS;Jaeschke R;Osborn TM;Nunnally ME;Townsend SR;Reinhart K;Kleinpell RM;Angus DC;Deutschman CS;Machado FR;Rubenfeld GD;Webb S;Beale RJ;Vincent JL;Moreno R;Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup
通讯作者：
Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup
DOI：
10.1023/b:mhsr.0000024351.12294.65
发表时间：
2004-06-01
期刊：
Mental health services research
影响因子：
--
作者：
Aarons, Gregory A
通讯作者：
Aarons, Gregory A
影响因子：
120.7
作者：
Ferrer, Ricard;Artigas, Antonio;de la Torre-Prados, Maria Victoria
通讯作者：
de la Torre-Prados, Maria Victoria
DOI：
10.1007/s10488-015-0672-7
发表时间：
2017-07
期刊：
Administration and policy in mental health
影响因子：
--
作者：
Aarons GA;Ehrhart MG;Farahnak LR;Sklar M;Horowitz J
通讯作者：
Horowitz J