Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units

Study Overview
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Brief Summary
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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
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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.

Official Title
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Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial

Conditions
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Critical Care

Intervention / Treatment
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* Behavioral: Daily checklist and clinician prompting


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daily checklist and clinician prompting<br>Checklist during multidisciplinary daily visits + clinician prompting + audit & feedback | Behavioral: Daily checklist and clinician prompting<br>* 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.<br>|
| No Intervention: Usual care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Hospital discharge; average of 20 days; follow-up limited to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | ICU discharge; follow-up limited to 60 days | 
| 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 | Daily from ICU day 2 to 17 | 
| 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 | 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. | 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. | 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. | Day 28 after ICU admission | 
| Safety Attitudes Questionnaire Score | Survey | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care, quality improvement, checklist