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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01384474
First Posted: June 29, 2011
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  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:


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 ]

Secondary Outcome Measures:
  • Team's adherence to the items of surgical safety checklist [ Time Frame: 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 ]
  • 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 ]

Enrollment: 23056
Study Start Date: September 2011
Study Completion Date: July 2013
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384474


Locations
France
Hospices Civils de Lyon
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01384474     History of Changes
Other Study ID Numbers: D50737
PHRC National 2010 ( Other Identifier: government )
First Submitted: June 21, 2011
First Posted: June 29, 2011
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by Hospices Civils de Lyon:
Crew Resource Management
Surgical safety checklist
Postoperative complications