Alexandre Biasi Cavalcanti
São Paulo, 04005000, Brazil
NCT Number: NCT01785966
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
São Paulo, 04005000, Brazil
Cluster randomized trial involving ICUs in Brazil. ICU is the unit of randomization.
The trial will have two stages:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for clusters:
Exclusion criteria
for clusters:
Patient inclusion criteria:
Patient exclusion criteria;
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.
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.
Time frame: Every 3 three days, from ICU day 2 to 17
Time frame: Every 3 three days, from ICU day 2 to 17
Time frame: Every 3 three days, from ICU day 2 to 17
Time frame: Daily from ICU day 2 to 17
Time frame: Daily from ICU day 2 to 17
Time frame: Every 3 three days, from ICU day 2 to 17
Time frame: Every 3 three days, from ICU day 2 to 17
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.
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
Time frame: Daily from ICU day 2 to 17
Time frame: Daily from ICU day 2 to 17
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.
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.
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.
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
Hospital do Coracao
Other
Checklist During Multidisciplinary Daily Visits and Clinician Prompting for Reduction of Mortality in Intensive Care Units: A Cluster Randomized Trial
Acronym: CHECKLIST-ICU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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