NCT03307421

Brief Summary

Comparison between a team debriefing with an instructor and a team debriefing without an instructor, on improving non-technical skills (TEAM score) after simulating a vital emergency in a multidisciplinary team as part of the initial training

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

September 28, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

October 12, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

1.2 years

First QC Date

September 28, 2017

Last Update Submit

December 22, 2017

Conditions

Keywords

simulationdebriefingteam scoremultidisciplinarityDEBRIEF sim II

Outcome Measures

Primary Outcomes (1)

  • TEAM SCORE

    TEAM Score is a non-technical skills assessment score. This score consists of four items (leadership, teamwork, task management, overall score). Each of these items is rated from 0 to 4, which is a score of 44, to which is added an overall score of 10 points. This score is validated and reflects teamwork skills \[30\] \[31\] \[32\] \[33\]. The scoring of the TEAM score will be carried out by a pair composed of a doctor in anesthesia-resuscitation and a nurse anesthetist trained and trained beforehand. This notation will be done afterwards simulations thanks to the registration of passage of the binomials on simulators.

    6 months

Secondary Outcomes (2)

  • technical score

    6 months

  • sense of self-efficacy (SEP)

    6 months

Study Arms (2)

debriefing without instructor

OTHER

Team debriefing without an instructor will be organized as follows. The pairs of participants will be placed in a room with direct access to the video recording of their passage on the simulator. Two documents will be made available to help participants structure their debriefing: one targeting non-technical skills, based on the TEAM Score, and one recalling recommendations on ACR care. Despite its absence at the time of the debriefing, the instructor will be present during the briefing and during the simulation.

Other: debriefing without instructor

debriefing with instructor

OTHER

The team debriefing with an instructor will begin immediately after the simulator run and will be governed by the principle of "no judgment" described by Rudolph . A portion of the video of the participants' pass may be reviewed and used to support the debriefing (depending on the utility judged by the debrief). Each center will use its own team of trainers, but it will have a predefined plan and predefined objectives, which are provided in advance in order to obtain a standardized debriefing. Moreover, these trainers will not be beginners but will have some expertise in the pedagogy of simulation. They will have to have a DU in a simulation or pedagogy trainer (recommendations from SofraSim) and will have to carry out 15 debriefings per year

Other: debriefing with instructor

Interventions

The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital. The sequence of scenarios for each binomial will also be determined by randomization.

Also known as: video assisted
debriefing without instructor

The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.

debriefing with instructor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women of full age (\> 18 years)
  • Informed consent signed
  • Affiliation to or a beneficiary of a French social security scheme.
  • Internal from 3rd to 10th semester anesthesia resuscitation of the CHU of Besançon, Dijon, Lyon or Strasbourg.
  • IADE students from the nursing school of Besançon, Dijon Lyon or Strasbourg.

You may not qualify if:

  • Subject without health insurance
  • Pregnant woman
  • Subject refusing to sign the confidentiality clause
  • Internal first-year anesthesia-resuscitation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de besançon

Besançon, 25000, France

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 2 parallel groups, stratified by center, randomized by center
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

October 11, 2017

Study Start

October 12, 2017

Primary Completion

December 12, 2018

Study Completion

December 12, 2018

Last Updated

December 26, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations