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

This study has been completed.
Sponsor:
Collaborators:
Sociedade Hospital Samaritano
D'Or Institute for Research and Education
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01785966
First received: February 1, 2013
Last updated: March 2, 2015
Last verified: November 2014
  Purpose

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).


Condition Intervention
Critical Care
Behavioral: Daily checklist and clinician prompting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • In-hospital mortality truncated at 60 days [ Time Frame: Hospital discharge; average of 20 days; follow-up limited to 60 days ] [ Designated as safety issue: No ]
    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:
  • Head of the bed elevated at 30° [ Time Frame: Every 3 three days, from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • Adequate prophylaxis for venous thromboembolism [ Time Frame: Every 3 three days, from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rate of central-line catheter use [ Time Frame: Daily from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • Indwelling urinary catheter use rate [ Time Frame: Daily from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • Rate of patients receiving enteral or parenteral feeding [ Time Frame: Every 3 three days, from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • Tidal volume <=8mL/kg of predicted body weight in patients on mechanical [ Time Frame: Every 3 three days, from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • ICU mortality [ Time Frame: ICU discharge; follow-up limited to 60 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Daily from ICU day 2 to 17 ] [ Designated as safety issue: No ]
    Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2008

  • Urinary tract infection associated with catheter rate [ Time Frame: Daily from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • Ventilator-associated pneumonia (VAP) [ Time Frame: Daily from ICU day 2 to 17 ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: Hospital discharge; follow-up limited to 60 days ] [ Designated as safety issue: No ]
    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.

  • Length of hospital stay [ Time Frame: Hospital discharge; average of 20 days; follow-up limited to 60 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 28 after ICU admission ] [ Designated as safety issue: No ]

    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.


  • Safety Attitudes Questionnaire Score [ 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). ] [ Designated as safety issue: No ]
    Survey


Enrollment: 13637
Study Start Date: August 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily checklist and clinician prompting
Checklist during multidisciplinary daily visits + clinician prompting + audit & feedback
Behavioral: Daily checklist and clinician prompting

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.

No Intervention: Usual care
Usual care

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785966

Locations
Brazil
Alexandre Biasi Cavalcanti
São Paulo, SP, Brazil, 04005000
Sponsors and Collaborators
Hospital do Coracao
Sociedade Hospital Samaritano
D'Or Institute for Research and Education
Investigators
Study Chair: Alexandre B Cavalcanti, MD, PhD Research Institute - Hospital do Coracao
Principal Investigator: Fernando Bozza, MD, PhD D'Or Institute for Research and Education
Principal Investigator: Jorge I Salluh, MD, PhD D'Or Institute for Research and Education
Principal Investigator: Flávia Machado, MD, PhD Federal University of Sao Paulo
Principal Investigator: Edson R Romano, MD Hospital do Coracao
Principal Investigator: Karina Normilio-Silva Research Institute - Hospital do Coração
Principal Investigator: Otavio Berwanger, MD, PhD Research Institute - Hospital do Coracao
Principal Investigator: Patricia Vendramim, R.N. Hospital Samaritano
Principal Investigator: Viviane C Chiattone, RN Research Institute - Hospital do Coracao
Principal Investigator: Helio P Guimaraes, MD, PhD Research Institute - Hospital do Coracao
Principal Investigator: Valquiria P Campagnucci, MD Research Institute - Hospital do Coracao
Principal Investigator: Derek C Angus, MD, PhD Department of Critical Care Medicine and CRISMA Center. University of Pittsburgh School of Medicine
Principal Investigator: Fernanda Carrara, RN Latin American Sepsis Institute (LASI)
Principal Investigator: Juliana Lubarino, RN Latin American Sepsis Institute (LASI)
Principal Investigator: Aline R Sila, RN D'Or Institute for Research and Education
Principal Investigator: Grazielle Viana, RN D'Or Institute for Research and Education
Principal Investigator: Lucas P Damiani, MSc Research Institute - Hospital do Coracao
Principal Investigator: Chung C Chang, PhD Division of General Internal Medicine at University of Pittsburgh
  More Information

No publications provided

Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01785966     History of Changes
Other Study ID Numbers: 11673812310010060
Study First Received: February 1, 2013
Last Updated: March 2, 2015
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital do Coracao:
Critical care
quality improvement
checklist

ClinicalTrials.gov processed this record on May 29, 2015