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).
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".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
13,637
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.
Alexandre Biasi Cavalcanti
São Paulo, São Paulo, Brazil
In-hospital mortality truncated at 60 days
Follow-up will be limited to 60 days after ICU admission. Patients who are still in the hospital after 60 days of ICU admission will be considered as discharged alive.
Time frame: Hospital discharge; average of 20 days; follow-up limited to 60 days
Head of the bed elevated at 30°
Time frame: Every 3 three days, from ICU day 2 to 17
Adequate prophylaxis for venous thromboembolism
Time frame: Every 3 three days, from ICU day 2 to 17
Patient-days under light sedation or alert and calm (RASS - 3 to 0)
Time frame: Every 3 three days, from ICU day 2 to 17
Rate of central-line catheter use
Time frame: Daily from ICU day 2 to 17
Indwelling urinary catheter use rate
Time frame: Daily from ICU day 2 to 17
Rate of patients receiving enteral or parenteral feeding
Time frame: Every 3 three days, from ICU day 2 to 17
Tidal volume <=8mL/kg of predicted body weight in patients on mechanical
Time frame: Every 3 three days, from ICU day 2 to 17
ICU mortality
Follow-up will be limited to 60 days after ICU admission. Patients who are still in the ICU after 60 days of ICU admission will be considered as discharged alive.
Time frame: ICU discharge; follow-up limited to 60 days
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Central line-associated bloodstream infection (CLABSI) rate
Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2008
Time frame: Daily from ICU day 2 to 17
Urinary tract infection associated with catheter rate
Time frame: Daily from ICU day 2 to 17
Ventilator-associated pneumonia (VAP)
Time frame: Daily from ICU day 2 to 17
Length of ICU stay
Follow-up will be limited to 60 days after ICU admission. Patients who are still in the hospital after 60 days of ICU admission will be considered as discharged alive.
Time frame: Hospital discharge; follow-up limited to 60 days
Length of hospital stay
Follow-up will be limited to 60 days after ICU admission. Patients who are still in the hospital after 60 days of ICU admission will be considered as discharged alive.
Time frame: Hospital discharge; average of 20 days; follow-up limited to 60 days
Mechanical ventilation-free days at 28 days
Survival time free of invasive mechanical ventilation from ICU admission to day 28. Patients who were discharged from hospital alive before 28 days are considered to be alive and free of mechanical ventilation until the 28th day.
Time frame: Day 28 after ICU admission
Safety Attitudes Questionnaire Score
Survey
Time frame: 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).