Clinical trial NCT01785966: Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units
Official title: Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Care
Keywords: Critical care
quality improvement
checklist
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Sociedade Hospital Samaritano
name: D'Or Institute for Research and Education
First posted: 2013-02-07
Enrollment: 13637
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: CHECKLIST-ICU will be a cluster randomized trial to ascertain whether the use of an intervention including 1) checklists with assessment of daily goals during the multidisciplinary visit, and 2) clinician prompting can reduce in-hospital mortality of patients admitted to intensive care units (ICUs).

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).

Detailed description: Cluster randomized trial involving ICUs in Brazil. ICU is the unit of randomization.

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".

Eligibility criteria: Inclusion criteria for clusters:

* Intensive care units, except dedicated coronary care units/cardiac intensive care units and step-down units;
* 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.

Exclusion criteria for clusters:

• We will exclude ICUs that systematically apply checklists in the multiprofessional daily visit. We define systematically applied checklist when all the following criteria are met:

* 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

Patient inclusion criteria:

• Adult patients (≥18 years-old) with anticipated ICU length of stay \> 24 hours.

Patient exclusion criteria;

* High probability of death within 24 hours or patients admitted in ICU for palliative care only;
* Suspected or confirmed brain death.

Primary outcomes:
measure: In-hospital mortality truncated at 60 days
timeFrame: Hospital discharge; average of 20 days; follow-up limited to 60 days
Secondary outcomes:
measure: Head of the bed elevated at 30°
timeFrame: Every 3 three days, from ICU day 2 to 17
measure: Adequate prophylaxis for venous thromboembolism
timeFrame: Every 3 three days, from ICU day 2 to 17
measure: Patient-days under light sedation or alert and calm (RASS - 3 to 0)
timeFrame: Every 3 three days, from ICU day 2 to 17
measure: Rate of central-line catheter use
timeFrame: Daily from ICU day 2 to 17
measure: Indwelling urinary catheter use rate
timeFrame: Daily from ICU day 2 to 17
measure: Rate of patients receiving enteral or parenteral feeding
timeFrame: Every 3 three days, from ICU day 2 to 17
measure: Tidal volume <=8mL/kg of predicted body weight in patients on mechanical
timeFrame: Every 3 three days, from ICU day 2 to 17
measure: ICU mortality
timeFrame: ICU discharge; follow-up limited to 60 days
measure: Central line-associated bloodstream infection (CLABSI) rate
timeFrame: Daily from ICU day 2 to 17
measure: Urinary tract infection associated with catheter rate
timeFrame: Daily from ICU day 2 to 17
measure: Ventilator-associated pneumonia (VAP)
timeFrame: Daily from ICU day 2 to 17
measure: Length of ICU stay
timeFrame: Hospital discharge; follow-up limited to 60 days
measure: Length of hospital stay
timeFrame: Hospital discharge; average of 20 days; follow-up limited to 60 days
measure: Mechanical ventilation-free days at 28 days
timeFrame: Day 28 after ICU admission
measure: Safety Attitudes Questionnaire Score
timeFrame: In phase 1, between sept/2013 and january/2014 each ICU staff answered the questionnaire once. In phase 2, between july/2014 and december/2014 the questionnaire was applied again (once for each ICU staff).
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Alexandre Biasi Cavalcanti
state: SP
Study officials:
affiliation: Research Institute - Hospital do Coracao
name: Alexandre B Cavalcanti, MD, PhD
role: STUDY_CHAIR
affiliation: D'Or Institute for Research and Education
name: Fernando Bozza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: D'Or Institute for Research and Education
name: Jorge I Salluh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of São Paulo
name: Flávia Machado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coracao
name: Edson R Romano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coração
name: Karina Normilio-Silva
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coracao
name: Otavio Berwanger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Samaritano
name: Patricia Vendramim, R.N.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coracao
name: Viviane C Chiattone, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coracao
name: Helio P Guimaraes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coracao
name: Valquiria P Campagnucci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Critical Care Medicine and CRISMA Center. University of Pittsburgh School of Medicine
name: Derek C Angus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Latin American Sepsis Institute (LASI)
name: Fernanda Carrara, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Latin American Sepsis Institute (LASI)
name: Juliana Lubarino, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: D'Or Institute for Research and Education
name: Aline R Sila, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: D'Or Institute for Research and Education
name: Grazielle Viana, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute - Hospital do Coracao
name: Lucas P Damiani, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of General Internal Medicine at University of Pittsburgh
name: Chung C Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.