SurgeryIDILICNCT01384474
Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist (IDILIC)
An observational study of Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Diffusion of a surgical safety checklist
- How many people
- 23,056 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients needing a surgery who are hospitalized in one of the 31 departments.
Who may be able to join
- Age ≥ 18 years old
- Hospitalization ≥ 24 hours
- Available medical file
Who cannot join
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Surgery
- Being tested
- Diffusion of a surgical safety checklist
- Keywords
- Crew Resource Management, Surgical safety checklist, Postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| CRM training of surgical teams | CRM : Crew resource Management Receives: Other: Diffusion of a surgical safety checklist | |
| No CRM training of surgical teams | CRM : Crew resource Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any major postoperative complication during hospitalization
Measured: during the two phases of the study : 18 months
Secondary outcomes (3)
Team's adherence to the items of surgical safety checklist
Measured: During the two phases of the study : 18 months
Occurrence of any postoperative death during hospitalization
Measured: During the two phases of the study : 18 months
Healthcare workers' attitude regarding the patient safety culture
Measured: Twice during the study : the 4th and the 17th month after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,056 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyrille COLIN, Principal investigator, Hospices Civils de Lyon - Pôle Imer - 162 Avenue Lacassagne - 69003 LYON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384474
- Sponsor's protocol ID
- D50737
- Other IDs
- PHRC National 2010
- Acronym
- IDILIC
- Status last verified
- Jul 2013
- First submitted
- 21 Jun 2011
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 35948294Duclos 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.
PubMed 27642053
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Crew Resource Management Training to Improve the Effectiveness of Surgical Safety Checklist
- ClinicalTrials.gov ID
- NCT01384474
- Acronym / sponsor ID
- IDILIC / D50737
- Conditions
- Surgery
- Keywords
- Crew Resource Management, Surgical safety checklist, Postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,056 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRM training of surgical teams | – | Other: Diffusion of a surgical safety checklistCRM : Crew resource Management |
| No CRM training of surgical teams | – | –CRM : Crew resource Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients needing a surgery who are hospitalized in one of the 31 departments.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Hospitalization ≥ 24 hours
- Available medical file
Key exclusion criteria (1 listed)
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | CRM training of surgical teams |
Primary outcome
Occurrence of any major postoperative complication during hospitalization
Time frame: during the two phases of the study : 18 months
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
- Derived from this study: PubMed 35948294Sens 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.
- Derived from this study: PubMed 27642053Duclos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyrille COLIN principal investigator
Hospices Civils de Lyon - Pôle Imer - 162 Avenue Lacassagne - 69003 LYON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any major postoperative complication during hospitalization (time frame: during the two phases of the study : 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01384474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2013.