Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist (IDILIC)

This study is currently recruiting participants.

Verified January 2013 by Hospices Civils de Lyon

Sponsor:

Information provided by (Responsible Party):

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT01384474

First received: June 21, 2011

Last updated: January 3, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Surgery	Other: Diffusion of a surgical safety checklist

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist

Resource links provided by NLM:

MedlinePlus related topics: Hospice Care

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:

Occurrence of any major postoperative complication during hospitalization [ Time Frame: during the two phases of the study : 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Team's adherence to the items of surgical safety checklist [ Time Frame: During the two phases of the study : 18 months ] [ Designated as safety issue: No ]
Occurrence of any postoperative death during hospitalization [ Time Frame: During the two phases of the study : 18 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	23250
Study Start Date:	September 2011
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
CRM training of surgical teams CRM : Crew resource Management	Other: Diffusion of a surgical safety checklist Assistance by a local caregiver investigator (i.e., surgeon, anaesthetist, nurse,...) responsible for the implementation of surgical safety checklist within the operatory rooms of his department ; A two-step CRM training of surgical teams (i.e., surgeons, anaesthetists, nurses,...) conducted by advisors from the world of air company using video support: First month following randomization: a course about the implementation of surgical safety checklist (using online-available WHO short movies and other videos of surgical teams) and core concepts of CRM adapted to the operating room; Sixth month following randomization: a feedback to surgical teams aiming at identifying and solving barriers related to the checklist implementation and interpersonal communication Written reminders including the systematic presence of an unfilled surgical safety checklist in the patient's medical report, stickers and wall posters in operatory rooms
No CRM training of surgical teams CRM : Crew resource Management

Groups/Cohorts

Assigned Interventions

CRM training of surgical teams

CRM : Crew resource Management

Other: Diffusion of a surgical safety checklist

Assistance by a local caregiver investigator (i.e., surgeon, anaesthetist, nurse,...) responsible for the implementation of surgical safety checklist within the operatory rooms of his department ;
A two-step CRM training of surgical teams (i.e., surgeons, anaesthetists, nurses,...) conducted by advisors from the world of air company using video support:
- First month following randomization: a course about the implementation of surgical safety checklist (using online-available WHO short movies and other videos of surgical teams) and core concepts of CRM adapted to the operating room;
- Sixth month following randomization: a feedback to surgical teams aiming at identifying and solving barriers related to the checklist implementation and interpersonal communication
Written reminders including the systematic presence of an unfilled surgical safety checklist in the patient's medical report, stickers and wall posters in operatory rooms

No CRM training of surgical teams

CRM : Crew resource Management

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All patients needing a surgery who are hospitalized in one of the 31 departments.

Criteria

Inclusion Criteria:

Age ≥ 18 years old
Hospitalization ≥ 24 hours
Available medical file

Exclusion Criteria:

Patient refusal

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384474

Contacts

Contact: Antoine DUCLOS

antoine.duclos@chu-lyon.fr

Locations

France
Hospices Civils de Lyon	Recruiting
Lyon, France, 69003

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

Principal Investigator:

Cyrille COLIN

Hospices Civils de Lyon - Pôle Imer - 162 Avenue Lacassagne - 69003 LYON

More Information

No publications provided

Responsible Party:	Hospices Civils de Lyon
ClinicalTrials.gov Identifier:	NCT01384474 History of Changes
Other Study ID Numbers:	D50737, PHRC National 2010
Study First Received:	June 21, 2011
Last Updated:	January 3, 2013
Health Authority:	France: French Data Protection Authority

Keywords provided by Hospices Civils de Lyon:

Crew Resource Management
Surgical safety checklist
Postoperative complications

ClinicalTrials.gov processed this record on May 23, 2013

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