Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (CHECKLIST-ICU)

H

Hospital do Coracao

Status

Completed

Conditions

Critical Care

Treatments

Behavioral: Daily checklist and clinician prompting

Study type

Interventional

Funder types

Other

Identifiers

NCT01785966
11673812310010060

Details and patient eligibility

About

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).

Full 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".

Enrollment

13,637 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

13,637 participants in 2 patient groups

Daily checklist and clinician prompting
Experimental group
Description:
Checklist during multidisciplinary daily visits + clinician prompting + audit & feedback
Treatment:
Behavioral: Daily checklist and clinician prompting
Usual care
No Intervention group
Description:
Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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