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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01785966
Recruitment Status : Completed
First Posted : February 7, 2013
Last Update Posted : March 4, 2015
Sponsor:
Collaborators:
Sociedade Hospital Samaritano
D'Or Institute for Research and Education
Information provided by (Responsible Party):
Hospital do Coracao

Tracking Information
First Submitted Date  ICMJE February 1, 2013
First Posted Date  ICMJE February 7, 2013
Last Update Posted Date March 4, 2015
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2014)
In-hospital mortality truncated at 60 days [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
In-hospital mortality after 48 hours of ICU admission [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2015)
  • 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 [ Time Frame: 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 [ Time Frame: 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
  • 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 [ Time Frame: 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.
  • Length of hospital stay [ Time Frame: 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 [ Time Frame: 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.
  • 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). ]
    Survey
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
  • Head of the bed elevated >=30° [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
  • Oral hygiene with chlorhexidine [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
  • Adequate prophylaxis for venous-thromboembolism [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
  • Excessive sedation [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
    We will consider patients who do not arouse after voice stimulus as deeply sedated, unless there is contra-indication to keep the patient alert or lightly sedated.
  • In-hospital mortality [ Time Frame: 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.
  • Intensive care unit mortality [ Time Frame: ICU discharge; average of 10 days; 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.
  • Catheter-related bloodstream infection [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
    Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2008
  • Ventilator-associated pneumonia [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
    Ventilator-associated pneumonia as the CDC 2013 definitions for possible or probable ventilator-associated pneumonia
  • Mechanical ventilator use rate [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
  • Central venous catheter use rate [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ]
  • Length of ICU stay [ Time Frame: ICU discharge; average of 10 days; 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.
  • Length of hospital stay [ Time Frame: 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.
  • Ventilator-free days from day 1 to day 28 [ Time Frame: Day 28 after ICU admission ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units
Official Title  ICMJE Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial
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".
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Critical Care
Intervention  ICMJE 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.

Study Arms  ICMJE
  • Experimental: Daily checklist and clinician prompting
    Checklist during multidisciplinary daily visits + clinician prompting + audit & feedback
    Intervention: Behavioral: Daily checklist and clinician prompting
  • No Intervention: Usual care
    Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2014)
13637
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2013)
12700
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01785966
Other Study ID Numbers  ICMJE 11673812310010060
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hospital do Coracao
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hospital do Coracao
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Sociedade Hospital Samaritano
  • D'Or Institute for Research and Education
Investigators  ICMJE
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
PRS Account Hospital do Coracao
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP