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https://www.arca.fiocruz.br/handle/icict/34872
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ArtigoDireito Autoral
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- INI - Artigos de Periódicos [3460]
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A CLUSTER RANDOMIZED TRIAL OF A MULTIFACETED QUALITY IMPROVEMENT INTERVENTION IN BRAZILIAN INTENSIVE CARE UNITS: STUDY PROTOCOL
Critical illness
Intensive care units
Checklist
Hospital mortality
Outcome and process assessment
Quality improvement
Autor(es)
Cavalcanti, Alexandre Biasi
Machado, Flavia
Bozza, Fernando
Salluh, Jorge Ibrain Figueira
Campagnucci, Valquiria Pelisser
Guimarães, Helio Penna
Normilio-Silva, Karina
Chiattone, Viviane Caetano
Vendramim, Patricia
Carrara, Fernanda
Lubarino, Juliana
Silva, Aline Reis da
Viana, Grazielle
Damiani, Lucas Petri
Romano, Edson
Teixeira, Cassiano
Silva, Nilton Brandão da
Chang, Chung-Chou H.
Angus, Derek C.
Berwanger, Otavio
Machado, Flavia
Bozza, Fernando
Salluh, Jorge Ibrain Figueira
Campagnucci, Valquiria Pelisser
Guimarães, Helio Penna
Normilio-Silva, Karina
Chiattone, Viviane Caetano
Vendramim, Patricia
Carrara, Fernanda
Lubarino, Juliana
Silva, Aline Reis da
Viana, Grazielle
Damiani, Lucas Petri
Romano, Edson
Teixeira, Cassiano
Silva, Nilton Brandão da
Chang, Chung-Chou H.
Angus, Derek C.
Berwanger, Otavio
Afiliação
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Universidade Federal de São Paulo. Hospital Universitário. São Paulo, SP, Brazil / Latin American Sepsis Institute. São Paulo, SP, Brazil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil / Fundação Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil.
Hospital Samaritano. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital Samaritano. São Paulo, SP, Brazil.
Latin American Sepsis Institute. São Paulo, SP, Brazil.
Latin American Sepsis Institute. São Paulo, SP, Brazil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital Moinhos de Vento. Porto Alegre, RS, Brasil.
Hospital Moinhos de Vento. Porto Alegre, RS, Brasil.
University of Pittsburgh. School of Medicine. Division of General Internal Medicine. Pittsburgh, PA, USA.
University of Pittsburgh. School of Medicine. Department of Critical Care Medicine. CRISMA Center. Pittsburgh, PA, USA.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Universidade Federal de São Paulo. Hospital Universitário. São Paulo, SP, Brazil / Latin American Sepsis Institute. São Paulo, SP, Brazil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil / Fundação Oswaldo Cruz. Rio de Janeiro, RJ, Brasil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil.
Hospital Samaritano. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital Samaritano. São Paulo, SP, Brazil.
Latin American Sepsis Institute. São Paulo, SP, Brazil.
Latin American Sepsis Institute. São Paulo, SP, Brazil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil.
D’Or Institute for Research and Education. Rio de Janeiro, RJ, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Hospital Moinhos de Vento. Porto Alegre, RS, Brasil.
Hospital Moinhos de Vento. Porto Alegre, RS, Brasil.
University of Pittsburgh. School of Medicine. Division of General Internal Medicine. Pittsburgh, PA, USA.
University of Pittsburgh. School of Medicine. Department of Critical Care Medicine. CRISMA Center. Pittsburgh, PA, USA.
Hospital do Coração. Research Institute. São Paulo, SP, Brazil.
Resumo em Inglês
Background: 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. Discussion: 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.
Palavras-chave em inglês
Intensive careCritical illness
Intensive care units
Checklist
Hospital mortality
Outcome and process assessment
Quality improvement
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