NCT01384474

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23,056

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 18, 2013

Status Verified

July 1, 2013

Enrollment Period

1.5 years

First QC Date

June 21, 2011

Last Update Submit

July 17, 2013

Conditions

Surgery

Keywords

Crew Resource ManagementSurgical safety checklistPostoperative complications

Outcome Measures

Primary Outcomes (1)

  • Occurrence of any major postoperative complication during hospitalization

    during the two phases of the study : 18 months

Secondary Outcomes (3)

  • Team's adherence to the items of surgical safety checklist

    During the two phases of the study : 18 months

  • Occurrence of any postoperative death during hospitalization

    During the two phases of the study : 18 months

  • Healthcare workers' attitude regarding the patient safety culture

    Twice during the study : the 4th and the 17th month after the beginning of the study

Study Arms (2)

CRM training of surgical teams

CRM : Crew resource Management

Other: Diffusion of a surgical safety checklist

No CRM training of surgical teams

CRM : Crew resource Management

Interventions

Diffusion of a surgical safety checklistOTHER

* 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

CRM training of surgical teams

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69003, France

Location

Related Publications (2)

  • 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.

    PMID: 35948294DERIVED

  • 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.

    PMID: 27642053DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Cyrille COLIN

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 29, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2013

Study Completion

July 1, 2013

Last Updated

July 18, 2013

Record last verified: 2013-07

Locations

FR(1)