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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospital do Coracao
Sponsor:
Collaborators:
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: February 26, 2014
Last verified: February 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
Critically Ill Patients
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

Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • In-hospital mortality after 48 hours of ICU admission [ 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 >=30° [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ] [ Designated as safety issue: No ]
  • Oral hygiene with chlorhexidine [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ] [ Designated as safety issue: No ]
  • Adequate prophylaxis for venous-thromboembolism [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ] [ Designated as safety issue: No ]
  • Excessive sedation [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ] [ Designated as safety issue: No ]
    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 ] [ 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.

  • Intensive care unit mortality [ Time Frame: ICU discharge; average of 10 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Central venous catheter use rate [ Time Frame: Daily assessment during ICU stay; average of 10 days; follow-up limited to 60 days ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: ICU discharge; average of 10 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 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 ] [ 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.

  • Ventilator-free days from day 1 to day 28 [ Time Frame: Day 28 after ICU admission ] [ Designated as safety issue: No ]
  • Safety Attitudes Questionnaire Score [ Time Frame: Will be used at the beginning of the stage one and at the end of the trial ] [ Designated as safety issue: No ]
    Survey


Estimated Enrollment: 12700
Study Start Date: August 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Daily checklist and clinician prompting
Usual care, with multidisciplinary daily rounds plus daily checklist and clinical prompting
Behavioral: Daily checklist and clinician prompting

Interventions are:

Verbal multi-item checklist aimed at preventing common critically ill patient complications to be applied in the multidisciplinary daily round.

Clinician prompting: resident physician or nurse prompts intensivists when checklists items were overlooked in the daily round.

No Intervention: Usual care
Usual care, including multidisciplinary daily rounds.

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:

    • Will be applied "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

Contacts
Contact: Karina N Silva +55 11 3051-6611 ext 8204 knsilva@hcor.com.br
Contact: Alexandre B Cavalcanti, MD, PhD +55 11 3051-6611 ext 8201 abiasi@hcor.com.br

Locations
Brazil
Alexandre Biasi Cavalcanti Recruiting
São Paulo, SP, Brazil, 04005000
Contact: Karina N Silva    55xx1130536611 ext 8204    knsilva@hcor.com.br   
Contact: Alexandre B Cavalcanti, MD,PhD    55xx1130536611 ext 8102    abiasi@hcor.com.br   
Principal Investigator: Alexandre B Cavalcanti, MD.Phd         
Sponsors and Collaborators
Hospital do Coracao
Hospital Samaritano
D'Or Institute for Research and Education
Investigators
Principal Investigator: 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: Jose M Telles, MD, PhD Hospital Santo Amaro
Principal Investigator: Edson R Romano, MD Hospital do Coracao
Principal Investigator: Karina N 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
  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: February 26, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital do Coracao:
critically ill patients
quality improvement
checklist

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014