Critical CareCHECKLIST-ICUNCT01785966
Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units
A study testing Daily checklist and clinician prompting in people with Critical Care, run by Hospital do Coracao at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care
- What is being tested?
- Daily checklist and clinician prompting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,637 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial
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).
Read the 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".
- Conditions
- Critical Care
- Being tested
- Daily checklist and clinician prompting
- Keywords
- Critical care, quality improvement, checklist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily checklist and clinician promptingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Daily checklist and clinician prompting | Experimental | Checklist during multidisciplinary daily visits + clinician prompting + audit \& feedback Receives: Behavioral: Daily checklist and clinician prompting |
| Usual care | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Hospital discharge; average of 20 days; follow-up limited to 60 days
Secondary outcomes (15)
Head of the bed elevated at 30°
Measured: Every 3 three days, from ICU day 2 to 17
Adequate prophylaxis for venous thromboembolism
Measured: Every 3 three days, from ICU day 2 to 17
Patient-days under light sedation or alert and calm (RASS - 3 to 0)
Measured: Every 3 three days, from ICU day 2 to 17
Rate of central-line catheter use
Measured: Daily from ICU day 2 to 17
Indwelling urinary catheter use rate
Measured: Daily from ICU day 2 to 17
Rate of patients receiving enteral or parenteral feeding
Measured: Every 3 three days, from ICU day 2 to 17
Tidal volume <=8mL/kg of predicted body weight in patients on mechanical
Measured: Every 3 three days, from ICU day 2 to 17
ICU mortality
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.
Measured: ICU discharge; follow-up limited to 60 days
Central line-associated bloodstream infection (CLABSI) rate
Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2008
Measured: Daily from ICU day 2 to 17
Urinary tract infection associated with catheter rate
Measured: Daily from ICU day 2 to 17
Ventilator-associated pneumonia (VAP)
Measured: Daily from ICU day 2 to 17
Length of ICU stay
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.
Measured: Hospital discharge; follow-up limited to 60 days
Length of hospital stay
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.
Measured: Hospital discharge; average of 20 days; follow-up limited to 60 days
Mechanical ventilation-free days at 28 days
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.
Measured: Day 28 after ICU admission
Safety Attitudes Questionnaire Score
Survey
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13,637 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Sociedade Hospital Samaritano, D'Or Institute for Research and Education
- Responsible party
- Sponsor
- Investigators
- Alexandre B Cavalcanti, MD, PhD, Study chair, Research Institute - Hospital do CoracaoFernando Bozza, MD, PhD, Principal investigator, D'Or Institute for Research and EducationJorge I Salluh, MD, PhD, Principal investigator, D'Or Institute for Research and EducationFlávia Machado, MD, PhD, Principal investigator, Federal University of São PauloEdson R Romano, MD, Principal investigator, Hospital do CoracaoKarina Normilio-Silva, Principal investigator, Research Institute - Hospital do CoraçãoOtavio Berwanger, MD, PhD, Principal investigator, Research Institute - Hospital do CoracaoPatricia Vendramim, R.N., Principal investigator, Hospital Samaritano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785966
- Sponsor's protocol ID
- 11673812310010060
- Acronym
- CHECKLIST-ICU
- Status last verified
- Nov 2014
- First submitted
- 1 Feb 2013
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27115264Damiani 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.
PubMed 26017129CHECKLIST-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.
PubMed 25928627
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01785966
- Acronym / sponsor ID
- CHECKLIST-ICU / 11673812310010060
- Conditions
- Critical Care
- Keywords
- Critical care, quality improvement, checklist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,637 participants (actual)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Sociedade Hospital Samaritano, D'Or Institute for Research and Education
- Study start
- Aug 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily checklist and clinician prompting | Experimental | Behavioral: Daily checklist and clinician promptingChecklist during multidisciplinary daily visits + clinician prompting + audit \& feedback |
| Usual care | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily checklist and clinician promptingInterventions 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. | Behavioural | Daily checklist and clinician prompting |
Primary outcome
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.
15 secondary outcomes
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
Central line-associated bloodstream infection (CLABSI) rate
Time frame: Daily from ICU day 2 to 17
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
Length of hospital stay
Time frame: Hospital discharge; average of 20 days; follow-up limited to 60 days
Mechanical ventilation-free days at 28 days
Time frame: Day 28 after ICU admission
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Derived from this study: PubMed 27115264Writing 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.
- Derived from this study: PubMed 26017129Damiani 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.
- Derived from this study: PubMed 25928627CHECKLIST-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre B Cavalcanti, MD, PhD study chair
Research Institute - Hospital do Coracao
Fernando Bozza, MD, PhD principal investigator
D'Or Institute for Research and Education
Jorge I Salluh, MD, PhD principal investigator
D'Or Institute for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily checklist and clinician prompting in people with Critical Care, run by Hospital do Coracao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality truncated at 60 days (time frame: Hospital discharge; average of 20 days; follow-up limited to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785966, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.