- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384474
Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist (IDILIC) (IDILIC)
July 17, 2013 updated by: Hospices Civils de Lyon
Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist
This multicenter cluster-randomized trial will evaluate the impact of Crew Resource Management training on the occurrence of postoperative complications and the adherence to a surgical safety checklist, among a large sample of French surgical departments.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
23056
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lyon, France, 69003
- Hospices Civils de Lyon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients needing a surgery who are hospitalized in one of the 31 departments.
Description
Inclusion Criteria:
- Age ≥ 18 years old
- Hospitalization ≥ 24 hours
- Available medical file
Exclusion Criteria:
- Patient refusal
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
CRM training of surgical teams
CRM : Crew resource Management
|
|
|
No CRM training of surgical teams
CRM : Crew resource Management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Occurrence of any major postoperative complication during hospitalization
Time Frame: during the two phases of the study : 18 months
|
during the two phases of the study : 18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Team's adherence to the items of surgical safety checklist
Time Frame: During the two phases of the study : 18 months
|
During the two phases of the study : 18 months
|
|
Occurrence of any postoperative death during hospitalization
Time Frame: During the two phases of the study : 18 months
|
During the two phases of the study : 18 months
|
|
Healthcare workers' attitude regarding the patient safety culture
Time Frame: Twice during the study : the 4th and the 17th month after the beginning of the study
|
Twice during the study : the 4th and the 17th month after the beginning of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cyrille COLIN, Hospices Civils de Lyon - Pôle Imer - 162 Avenue Lacassagne - 69003 LYON
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sens F, Viprey M, Piriou V, Peix JL, Herquelot E, Occelli P, Bourdy S, Gawande AA, Carty Mj MJ, Michel P, Lifante JC, Colin C, Duclos A; IDILIC Study Group. Safety Attitude of Operating Room Personnel Associated With Accurate Completion of a Surgical Checklist: A Cross-sectional Observational Study. J Patient Saf. 2022 Aug 1;18(5):449-456. doi: 10.1097/PTS.0000000000000954. Epub 2021 Dec 17.
- Duclos A, Peix JL, Piriou V, Occelli P, Denis A, Bourdy S, Carty MJ, Gawande AA, Debouck F, Vacca C, Lifante JC, Colin C; IDILIC Study Group. Cluster randomized trial to evaluate the impact of team training on surgical outcomes. Br J Surg. 2016 Dec;103(13):1804-1814. doi: 10.1002/bjs.10295. Epub 2016 Sep 19.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
June 21, 2011
First Submitted That Met QC Criteria
June 28, 2011
First Posted (Estimate)
June 29, 2011
Study Record Updates
Last Update Posted (Estimate)
July 18, 2013
Last Update Submitted That Met QC Criteria
July 17, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- D50737
- PHRC National 2010 (Other Identifier: government)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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