Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units
- Conditions
- Critical Care
- Interventions
- Behavioral: Daily checklist and clinician prompting
- Registration Number
- NCT01785966
- Lead Sponsor
- Hospital do Coracao
- 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".
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13637
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daily checklist and clinician prompting Daily checklist and clinician prompting Checklist during multidisciplinary daily visits + clinician prompting + audit \& feedback
- Primary Outcome Measures
Name Time Method In-hospital mortality truncated at 60 days Hospital discharge; average of 20 days; follow-up limited to 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.
- Secondary Outcome Measures
Name Time Method Head of the bed elevated at 30° Every 3 three days, from ICU day 2 to 17 Adequate prophylaxis for venous thromboembolism Every 3 three days, from ICU day 2 to 17 Patient-days under light sedation or alert and calm (RASS - 3 to 0) Every 3 three days, from ICU day 2 to 17 Rate of central-line catheter use Daily from ICU day 2 to 17 Indwelling urinary catheter use rate Daily from ICU day 2 to 17 Rate of patients receiving enteral or parenteral feeding Every 3 three days, from ICU day 2 to 17 Tidal volume <=8mL/kg of predicted body weight in patients on mechanical Every 3 three days, from ICU day 2 to 17 ICU mortality ICU discharge; follow-up limited to 60 days 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.
Central line-associated bloodstream infection (CLABSI) rate Daily from ICU day 2 to 17 Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2008
Length of hospital stay Hospital discharge; average of 20 days; follow-up limited to 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.
Mechanical ventilation-free days at 28 days Day 28 after ICU admission 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.Urinary tract infection associated with catheter rate Daily from ICU day 2 to 17 Ventilator-associated pneumonia (VAP) Daily from ICU day 2 to 17 Length of ICU stay Hospital discharge; follow-up limited to 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.
Safety Attitudes Questionnaire Score 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). Survey
Trial Locations
- Locations (1)
Alexandre Biasi Cavalcanti
🇧🇷São Paulo, SP, Brazil