Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units

Critical Care Clinical Trial

— CHECKLIST-ICU  

Official title:

Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785966
• Other study ID #: 11673812310010060
• Status: Completed
• Phase: N/A
• First received: February 1, 2013
• Last updated: March 2, 2015
• Start date: August 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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).

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).

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13637
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Critical Care

Intervention

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.

Locations

Country	Name	City	State
Brazil	Alexandre Biasi Cavalcanti	São Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Hospital do Coracao	D'Or Institute for Research and Education, Sociedade Hospital Samaritano

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Head of the bed elevated at 30°		Every 3 three days, from ICU day 2 to 17	No
Secondary	Adequate prophylaxis for venous thromboembolism		Every 3 three days, from ICU day 2 to 17	No
Secondary	Patient-days under light sedation or alert and calm (RASS - 3 to 0)		Every 3 three days, from ICU day 2 to 17	No
Secondary	Rate of central-line catheter use		Daily from ICU day 2 to 17	No
Secondary	Indwelling urinary catheter use rate		Daily from ICU day 2 to 17	No
Secondary	Rate of patients receiving enteral or parenteral feeding		Every 3 three days, from ICU day 2 to 17	No
Secondary	Tidal volume <=8mL/kg of predicted body weight in patients on mechanical		Every 3 three days, from ICU day 2 to 17	No
Secondary	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.	ICU discharge; follow-up limited to 60 days	No
Secondary	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	Daily from ICU day 2 to 17	No
Secondary	Urinary tract infection associated with catheter rate		Daily from ICU day 2 to 17	No
Secondary	Ventilator-associated pneumonia (VAP)		Daily from ICU day 2 to 17	No
Secondary	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.	Hospital discharge; follow-up limited to 60 days	No
Secondary	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.	Hospital discharge; average of 20 days; follow-up limited to 60 days	No
Secondary	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.	Day 28 after ICU admission	No
Secondary	Safety Attitudes Questionnaire Score	Survey	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).	No