NCT01785966

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,637

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 4, 2015

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

February 1, 2013

Last Update Submit

March 2, 2015

Conditions

Critical Care

Keywords

Critical carequality improvementchecklist

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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

  • +10 more secondary outcomes

Study Arms (2)

Daily checklist and clinician prompting

EXPERIMENTAL

Checklist during multidisciplinary daily visits + clinician prompting + audit \& feedback

Behavioral: Daily checklist and clinician prompting

Usual care

NO INTERVENTION

Usual care

Interventions

Daily checklist and clinician promptingBEHAVIORAL

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.

Daily checklist and clinician prompting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • Adult patients (≥18 years-old) with anticipated ICU length of stay \> 24 hours.
  • High probability of death within 24 hours or patients admitted in ICU for palliative care only;
  • Suspected or confirmed brain death.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandre Biasi Cavalcanti

São Paulo, São Paulo, 04005000, Brazil

Location

Related Publications (3)

  • Writing Group for the CHECKLIST-ICU Investigators and the Brazilian Research in Intensive Care Network (BRICNet); Cavalcanti AB, Bozza FA, Machado FR, Salluh JI, Campagnucci VP, Vendramim P, Guimaraes HP, Normilio-Silva K, Damiani LP, Romano E, Carrara F, Lubarino Diniz de Souza J, Silva AR, Ramos GV, Teixeira C, Brandao da Silva N, Chang CC, Angus DC, Berwanger O. Effect of a Quality Improvement Intervention With Daily Round Checklists, Goal Setting, and Clinician Prompting on Mortality of Critically Ill Patients: A Randomized Clinical Trial. JAMA. 2016 Apr 12;315(14):1480-90. doi: 10.1001/jama.2016.3463.

    PMID: 27115264DERIVED

  • Damiani LP, Cavalcanti AB, Moreira FR, Machado F, Bozza FA, Salluh JI, Campagnucci VP, Normilio-Silva K, Chiattone VC, Angus DC, Berwanger O, Chou H Chang C. A cluster-randomised trial of a multifaceted quality improvement intervention in Brazilian intensive care units (Checklist-ICU trial): statistical analysis plan. Crit Care Resusc. 2015 Jun;17(2):113-21.

    PMID: 26017129DERIVED

  • CHECKLIST-ICU Investigators and BRICNet; Machado F, Bozza F, Ibrain J, Salluh F, Campagnucci VP, Guimaraes HP, Normilio-Silva K, Chiattone VC, Vendramim P, Carrara F, Lubarino J, da Silva AR, Viana G, Damiani LP, Romano E, Teixeira C, da Silva NB, Chang CC, Angus DC, Berwanger O. A cluster randomized trial of a multifaceted quality improvement intervention in Brazilian intensive care units: study protocol. Implement Sci. 2015 Jan 13;10:8. doi: 10.1186/s13012-014-0190-0.

    PMID: 25928627DERIVED

Study Officials

  • Alexandre B Cavalcanti, MD, PhD

    Research Institute - Hospital do Coracao

    STUDY CHAIR

  • 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 São 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

February 7, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 4, 2015

Record last verified: 2014-11

Locations

BR(1)