A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol.
A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol.
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DOI：
10.1186/s13012-014-0190-0
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发表时间：
2015-01-13
期刊：
影响因子：
--
通讯作者：
Berwanger O
中科院分区：
文献类型：
--
作者：
CHECKLIST-ICU Investigators and BRICNet;Machado F;Bozza F;Ibrain J;Salluh F;Campagnucci VP;Guimarães HP;Normilio-Silva K;Chiattone VC;Vendramim P;Carrara F;Lubarino J;da Silva AR;Viana G;Damiani LP;Romano E;Teixeira C;da Silva NB;Chang CC;Angus DC;Berwanger O
在重症监护环境中采用循证疗法的情况并不理想，特别是在资源有限的国家。清单、每日目标评估和临床医生提示可以提高对最佳护理实践流程的依从性，从而改善临床结果。然而，关于核对表有效性的现有证据不可靠，也不确定，而且人们对核对表的机制知之甚少。我们的目的是评估是否使用多方面的质量改进干预措施，包括使用检查表和多学科日常查房和临床医生提示期间的日常护理目标的定义，可以改善入住重症监护病房（ICU）的患者的院内死亡率。我们的次要目的是评估研究干预对特定护理过程、临床结局和安全文化的影响，并确定哪些因素（护理过程和/或安全文化）介导研究干预对死亡率的影响。这是一项涉及巴西118个ICU的群集随机试验，分两个阶段进行。在观察准备阶段，我们收集了60名ICU住院时间超过48小时的连续患者的护理过程和临床结局的基线数据，并对每个ICU中75%或更多的医护人员进行了安全态度问卷（SAQ）。在随机化阶段，我们将ICU分配到实验组或对照组，并重复数据收集。实验组ICU接受多方面的质量改进干预，包括在日常多学科查房期间的日常护理目标的清单和定义，临床医生提示，以及对选定护理过程依从率的反馈。控制臂ICU维持常规护理。主要结局是住院死亡率，截短为60天。次要结果包括遵守适当护理流程的比率、其他临床结果的比率和SAQ领域的评分。分析遵循意向治疗原则，主要结局采用混合效应logistic回归分析。这是一项大规模、实用的随机分组试验，旨在评估多方面的质量改善干预措施（包括在多学科日常查房和临床医生提示期间应用的检查表）是否可以提高已证实疗法的采用率并降低危重患者的死亡率。如果这项研究发现干预措施降低了死亡率，它可能会被广泛采用的重症监护病房，即使是在资源有限的环境。ClinicalTrials.gov NCT 01785966本文的在线版本（doi：10.1186/s13012-014-0190-0）包含补充材料，授权用户可使用。
The uptake of evidence-based therapies in the intensive care environment is suboptimal, particularly in limited-resource countries. Checklists, daily goal assessments, and clinician prompts may improve compliance with best practice processes of care and, in turn, improve clinical outcomes. However, the available evidence on the effectiveness of checklists is unreliable and inconclusive, and the mechanisms are poorly understood. We aim to evaluate whether the use of a multifaceted quality improvement intervention, including the use of a checklist and the definition of daily care goals during multidisciplinary daily rounds and clinician prompts, can improve the in-hospital mortality of patients admitted to intensive care units (ICUs). Our secondary objectives are to assess the effects of the study intervention on specific processes of care, clinical outcomes, and the safety culture and to determine which factors (the processes of care and/or safety culture) mediate the effect of the study intervention on mortality. This is a cluster randomized trial involving 118 ICUs in Brazil conducted in two phases. In the observational preparatory phase, we collect baseline data on processes of care and clinical outcomes from 60 consecutive patients with lengths of ICU stay longer than 48 h and apply the Safety Attitudes Questionnaire (SAQ) to 75% or more of the health care staff in each ICU. In the randomized phase, we assign ICUs to the experimental or control arm and repeat data collection. Experimental arm ICUs receive the multifaceted quality improvement intervention, including a checklist and definition of daily care goals during daily multidisciplinary rounds, clinician prompting, and feedback on rates of adherence to selected care processes. Control arm ICUs maintain usual care. The primary outcome is in-hospital mortality, truncated at 60 days. Secondary outcomes include the rates of adherence to appropriate care processes, rates of other clinical outcomes, and scores on the SAQ domains. Analysis follows the intention-to-treat principle, and the primary outcome is analyzed using mixed effects logistic regression. This is a large scale, pragmatic cluster-randomized trial evaluating whether a multifaceted quality improvement intervention, including checklists applied during the multidisciplinary daily rounds and clinician prompting, can improve the adoption of proven therapies and decrease the mortality of critically ill patients. If this study finds that the intervention reduces mortality, it may be widely adopted in intensive care units, even those in limited-resource settings. ClinicalTrials.gov NCT01785966 The online version of this article (doi:10.1186/s13012-014-0190-0) contains supplementary material, which is available to authorized users.
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影响因子：
39
作者：
Klompas, Michael;Speck, Kathleen;Berenholtz, Sean M.
通讯作者：
Berenholtz, Sean M.
影响因子：
--
作者：
Pronovost, P;Sexton, B
通讯作者：
Sexton, B
影响因子：
56.3
作者：
Levy, Mitchell M.;Artigas, Antonio;Dellinger, R. Phillip
通讯作者：
Dellinger, R. Phillip
影响因子：
4.9
作者：
Horan, Teresa C.;Andrus, Mary;Dudeck, Margaret A.
通讯作者：
Dudeck, Margaret A.
选择性消化或口咽净化和局部口咽氯己定用于预防一般重症监护中的死亡：系统评价和网络荟萃分析。
DOI：
10.1136/bmj.g2197
发表时间：
2014-03-31
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Price R;MacLennan G;Glen J;SuDDICU Collaboration
通讯作者：
SuDDICU Collaboration