Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS).
Protocol for a two-arm pragmatic stepped-wedge hybrid effectiveness-implementation trial evaluating Engagement and Collaborative Management to Proactively Advance Sepsis Survivorship (ENCOMPASS).
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DOI：
10.1186/s12913-021-06521-1
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发表时间：
2021-06-02
影响因子：
2.8
通讯作者：
Taylor SP
中科院分区：
文献类型：
--
作者：
Kowalkowski M;Eaton T;McWilliams A;Tapp H;Rios A;Murphy S;Burns R;Gutnik B;O'Hare K;McCurdy L;Dulin M;Blanchette C;Chou SH;Halpern S;Angus DC;Taylor SP
败血症幸存者的发病率和死亡率很高，医疗保健系统缺乏有效的战略来满足出院后患者的需求。脓毒症过渡和康复(STAR)计划是一项由导航员主导的、基于远程健康的多组件战略，旨在使用证据驱动的败血症后护理任务为高危患者提供主动护理协调和监测。本研究的目的是评估STAR在改善脓毒症患者预后方面的有效性，并检查影响STAR实施的环境因素。这项研究使用了一种混合的I型有效性实施设计来同时测试临床有效性和收集实施数据。有效性评估是在北卡罗来纳州的八家医院进行的一项双臂、务实、阶梯式楔形群随机对照试验，比较了接受常规护理的脓毒症幸存者与通过STAR提供的护理之间的临床结果。每家医院从通常的护理控制阶段开始，过渡到按随机分配的顺序开始(每4个月一次)。在医院被分配到常规护理的几个月内，所有符合条件的患者都将得到常规护理。一旦医院过渡到STAR，所有符合条件的患者在住院期间和出院后90 天内都将获得STAR。STAR包括位于中央的护士导航器，使用电话咨询和基于电子健康记录的支持来促进最佳实践的败血症后护理策略，包括出院后药物审查、新的损伤或症状评估、监测现有的合并症，以及适当时的姑息护理转介。由感染和器官衰竭的临床标准定义的疑似败血症入院的成年人也包括在内。计划在36个月期间招募4032名患者。主要有效结果是所有原因导致的出院90 天内再次入院或死亡的综合结果。将在实施STAR之前、期间和之后进行混合方法实施评估。这项务实的评估将测试STAR在减少住院再入院率和死亡率方面的有效性，同时确定关键的实施因素。结果将提供实用信息，以促进对如何在护理环境中整合败血症后管理的理解，并促进最佳实践败血症后管理战略在其他不同类型的医疗保健提供系统中的实施、传播和持续利用。NCT04495946。2020年7月7日提交；2020年8月3日发布。网上版载有补充材料，可在10.1186/s12913-021-06521-1查阅。
Sepsis survivors experience high morbidity and mortality, and healthcare systems lack effective strategies to address patient needs after hospital discharge. The Sepsis Transition and Recovery (STAR) program is a navigator-led, telehealth-based multicomponent strategy to provide proactive care coordination and monitoring of high-risk patients using evidence-driven, post-sepsis care tasks. The purpose of this study is to evaluate the effectiveness of STAR to improve outcomes for sepsis patients and to examine contextual factors that influence STAR implementation. This study uses a hybrid type I effectiveness-implementation design to concurrently test clinical effectiveness and gather implementation data. The effectiveness evaluation is a two-arm, pragmatic, stepped-wedge cluster randomized controlled trial at eight hospitals in North Carolina comparing clinical outcomes between sepsis survivors who receive Usual Care versus care delivered through STAR. Each hospital begins in a Usual Care control phase and transitions to STAR in a randomly assigned sequence (one every 4 months). During months that a hospital is allocated to Usual Care, all eligible patients will receive usual care. Once a hospital transitions to STAR, all eligible patients will receive STAR during their hospitalization and extending through 90 days from discharge. STAR includes centrally located nurse navigators using telephonic counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted with suspected sepsis, defined by clinical criteria for infection and organ failure, are included. Planned enrollment is 4032 patients during a 36-month period. The primary effectiveness outcome is the composite of all-cause hospital readmission or mortality within 90 days of discharge. A mixed-methods implementation evaluation will be conducted before, during, and after STAR implementation. This pragmatic evaluation will test the effectiveness of STAR to reduce combined hospital readmissions and mortality, while identifying key implementation factors. Results will provide practical information to advance understanding of how to integrate post-sepsis management across care settings and facilitate implementation, dissemination, and sustained utilization of best-practice post-sepsis management strategies in other heterogeneous healthcare delivery systems. NCT04495946. Submitted July 7, 2020; Posted August 3, 2020. The online version contains supplementary material available at 10.1186/s12913-021-06521-1.
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影响因子：
12.7
作者：
Glasgow, RE;Vogt, TM;Boles, SM
通讯作者：
Boles, SM
DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
DOI：
10.1186/s13054-017-1609-1
发表时间：
2017-02-24
期刊：
Critical care (London, England)
影响因子：
--
作者：
de Grooth HJ;Geenen IL;Girbes AR;Vincent JL;Parienti JJ;Oudemans-van Straaten HM
通讯作者：
Oudemans-van Straaten HM
影响因子：
9.7
作者：
Coleman, Katie;Austin, Brian T.;Wagner, Edward H.
通讯作者：
Wagner, Edward H.
影响因子：
2.2
作者：
Freeman, Harold P
通讯作者：
Freeman, Harold P