Machado Flavia, Bozza Fernando, Ibrain Jorge, Salluh Figueira, Campagnucci Valquiria Pelisser, Guimarães Helio Penna, Normilio-Silva Karina, Chiattone Viviane Caetano, Vendramim Patricia, Carrara Fernanda, Lubarino Juliana, da Silva Aline Reis, Viana Grazielle, Damiani Lucas Petri, Romano Edson, Teixeira Cassiano, da Silva Nilton Brandão, Chang Chung-Chou H, Angus Derek C, Berwanger Otavio
Implement Sci. 2015 Jan 13;10:8. doi: 10.1186/s13012-014-0190-0.
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.
METHODS/DESIGN: 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.
在重症监护环境中，循证疗法的应用并不理想，在资源有限的国家尤其如此。检查表、每日目标评估和临床医生提示可能会提高对最佳护理实践流程的依从性，进而改善临床结局。然而，关于检查表有效性的现有证据不可靠且尚无定论，其作用机制也知之甚少。我们旨在评估多方面质量改进干预措施的使用，包括在多学科每日查房期间使用检查表、定义每日护理目标以及临床医生提示，是否能降低入住重症监护病房（ICU）患者的院内死亡率。我们的次要目标是评估研究干预措施对特定护理流程、临床结局和安全文化的影响，并确定哪些因素（护理流程和/或安全文化）介导了研究干预措施对死亡率的影响。
方法/设计：这是一项在巴西118个ICU中分两个阶段进行的整群随机试验。在观察性准备阶段，我们从60例连续入住ICU且住院时间超过48小时的患者中收集护理流程和临床结局的基线数据，并对每个ICU中75%或更多的医护人员应用安全态度问卷（SAQ）。在随机阶段，我们将ICU分配到试验组或对照组，并重复数据收集。试验组ICU接受多方面质量改进干预措施，包括在每日多学科查房期间使用检查表、定义每日护理目标、临床医生提示以及关于选定护理流程依从率的反馈。对照组ICU维持常规护理。主要结局是60天内的院内死亡率。次要结局包括对适当护理流程的依从率、其他临床结局的发生率以及SAQ各领域的得分。分析遵循意向性分析原则，主要结局使用混合效应逻辑回归进行分析。
这是一项大规模、实用的整群随机试验，旨在评估多方面质量改进干预措施，包括在多学科每日查房期间应用检查表和临床医生提示，是否能提高已证实疗法的采用率并降低危重症患者的死亡率。如果本研究发现该干预措施能降低死亡率，它可能会在重症监护病房中广泛应用，甚至在资源有限的环境中也是如此。
ClinicalTrials.gov NCT01785966。
