Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units
NCT ID: NCT01785966
Last Updated: 2015-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13637 participants
INTERVENTIONAL
2013-08-31
2014-11-30
Brief Summary
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The investigators also aim to describe participant ICUs in terms of the standards for intensive care units proposed by the Brazilian National Health Agency (ANVISA).
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Detailed Description
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The trial will have two stages:
* Stage I - Baseline data.In this stage we will:
* Apply "Safety Attitudes Questionnaire" for the employees of the participating ICU.
* Characterize participant ICUs in terms of the standards (RDC nº7/2010, RDC nº26/2012 e RDC nº 63/2011) for intensive care units proposed by the Brazilian National Health Agency (ANVISA)
* Characterize patients: we will collect data from 60 consecutive critically ill patients from each participant ICU to describe adherence to measures aimed at avoiding ICU complications and clinical outcome measures.
* Stage II - Intervention: This is the main stage for data analysis. ICUs will be randomly assigned to an experimental or control group. The experimental group should use a multi-item verbal checklist including assessment of daily goals during the multidisciplinary visits plus clinician prompting. We will collect data from 60 additional patients for each ICU in both study groups and apply "Safety Attitudes Questionnaire".
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Daily checklist and clinician prompting
Checklist during multidisciplinary daily visits + clinician prompting + audit \& feedback
Daily checklist and clinician prompting
Interventions are:
Checklists: The checklists are arranged in a paper notebook (one per patient) with a daily list on each page, as most ICUs do not have electronic health record systems. During the multidisciplinary visit, the checklist items are read aloud by the nurse and answered by participants of the visit. The checklist is applied at least once on all week days preferably in the mornings, although we strongly suggest applying it also on weekend days.
Daily Goals and Clinician Prompting: During the clinical discussion of each patient and the application of the checklist, the intensivists write down the daily goals in a standardized form and read them aloud to the team. Every afternoon between 3 and 5 PM, a nurse reviews the daily goals and takes note of any pending items. Subsequently, the nurse prompts the on-call physician, requesting solutions for these pending items.
Usual care
Usual care
No interventions assigned to this group
Interventions
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Daily checklist and clinician prompting
Interventions are:
Checklists: The checklists are arranged in a paper notebook (one per patient) with a daily list on each page, as most ICUs do not have electronic health record systems. During the multidisciplinary visit, the checklist items are read aloud by the nurse and answered by participants of the visit. The checklist is applied at least once on all week days preferably in the mornings, although we strongly suggest applying it also on weekend days.
Daily Goals and Clinician Prompting: During the clinical discussion of each patient and the application of the checklist, the intensivists write down the daily goals in a standardized form and read them aloud to the team. Every afternoon between 3 and 5 PM, a nurse reviews the daily goals and takes note of any pending items. Subsequently, the nurse prompts the on-call physician, requesting solutions for these pending items.
Eligibility Criteria
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Inclusion Criteria
* Must have multidisciplinary daily rounds or coordinators agree to implement daily rounds, including at least one physician and one nurse, conducted at least on week days.
• Adult patients (≥18 years-old) with anticipated ICU length of stay \> 24 hours.
Exclusion Criteria
* Content: structured evaluation following a digital or printed document of multiple items focused on prevention of common ICU complications (eg. ventilator-associated pneumonia, stress ulcer, venous thromboembolism and/or catheter-associated bloodstream infection) and/or explicit assessment of daily goals;
* Time frame: daily application of checklist for at least 30 days
* Periodicity: at least 3 days per week
* How is applied: verbal, observational (1 professional check all items), with or without written register
* High probability of death within 24 hours or patients admitted in ICU for palliative care only;
* Suspected or confirmed brain death.
18 Years
ALL
No
Sponsors
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Sociedade Hospital Samaritano
OTHER
D'Or Institute for Research and Education
OTHER
Hospital do Coracao
OTHER
Responsible Party
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Principal Investigators
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Alexandre B Cavalcanti, MD, PhD
Role: STUDY_CHAIR
Research Institute - Hospital do Coracao
Fernando Bozza, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
D'Or Institute for Research and Education
Jorge I Salluh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
D'Or Institute for Research and Education
Flávia Machado, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Edson R Romano, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital do Coracao
Karina Normilio-Silva
Role: PRINCIPAL_INVESTIGATOR
Research Institute - Hospital do Coração
Otavio Berwanger, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Institute - Hospital do Coracao
Patricia Vendramim, R.N.
Role: PRINCIPAL_INVESTIGATOR
Hospital Samaritano
Viviane C Chiattone, RN
Role: PRINCIPAL_INVESTIGATOR
Research Institute - Hospital do Coracao
Helio P Guimaraes, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Research Institute - Hospital do Coracao
Valquiria P Campagnucci, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute - Hospital do Coracao
Derek C Angus, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Critical Care Medicine and CRISMA Center. University of Pittsburgh School of Medicine
Fernanda Carrara, RN
Role: PRINCIPAL_INVESTIGATOR
Latin American Sepsis Institute (LASI)
Juliana Lubarino, RN
Role: PRINCIPAL_INVESTIGATOR
Latin American Sepsis Institute (LASI)
Aline R Sila, RN
Role: PRINCIPAL_INVESTIGATOR
D'Or Institute for Research and Education
Grazielle Viana, RN
Role: PRINCIPAL_INVESTIGATOR
D'Or Institute for Research and Education
Lucas P Damiani, MSc
Role: PRINCIPAL_INVESTIGATOR
Research Institute - Hospital do Coracao
Chung C Chang, PhD
Role: PRINCIPAL_INVESTIGATOR
Division of General Internal Medicine at University of Pittsburgh
Locations
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Alexandre Biasi Cavalcanti
São Paulo, São Paulo, Brazil
Countries
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References
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Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet); Cavalcanti AB, Bozza FA, Machado FR, Salluh JI, Campagnucci VP, Vendramim P, Guimaraes HP, Normilio-Silva K, Damiani LP, Romano E, Carrara F, Lubarino Diniz de Souza J, Silva AR, Ramos GV, Teixeira C, Brandao da Silva N, Chang CC, Angus DC, Berwanger O. Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 12;315(14):1480-90. doi: 10.1001/jama.2016.3463.
Damiani LP, Cavalcanti AB, Moreira FR, Machado F, Bozza FA, Salluh JI, Campagnucci VP, Normilio-Silva K, Chiattone VC, Angus DC, Berwanger O, Chou H Chang C. A cluster-randomised trial of a multifaceted quality improvement intervention in Brazilian intensive care units (Checklist-ICU trial): statistical analysis plan. Crit Care Resusc. 2015 Jun;17(2):113-21.
CHECKLIST-ICU Investigators and BRICNet; Machado F, Bozza F, Ibrain J, Salluh F, Campagnucci VP, Guimaraes 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. A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol. Implement Sci. 2015 Jan 13;10:8. doi: 10.1186/s13012-014-0190-0.
Other Identifiers
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11673812310010060
Identifier Type: -
Identifier Source: org_study_id
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