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This multicenter randomized controlled study aims to evaluate the impact of temporary visual deprivation of the medical team leader on non-technical skills and team performance during high-fidelity simulated medical emergencies. The intervention is based on principles of crisis resource management and cognitive load theory. Team performance will be assessed using validated scoring tools immediately after the intervention and at three months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visual deprivation | Experimental | the designated team leader performs the simulated scenario while wearing visual deprivation mask. |
|
| No visual deprivation | No Intervention | Control group leaders perform the scenario without visual deprivation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual deprivation | Behavioral | The designated team leader performs the simulated scenario while wearing visual deprivation mask |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of team performance on non-technicals skills | Team performance on non-technicals skills measured using the validated Team emergency Assessment Measure (TEAM) score assessed by blinded independent evaluators based on video recordings. TEAM score goes from 0 to 54 : 0 being the lowest level of non-technical competence (worst outcome) and 54 being the highest (better outcome) | Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of team's clinical performance | Rating with objective markers of quality of care. Five objective and measurable criteria for each scenario are defined by a panel of three experts in anaesthesia and intensive care using the DELPHI method. | Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month |
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The teams participating in the simulation sessions are composed as follows:
Inclusion Criteria:
Participants with at least two years' experience in the specialty.
a. For interns, an additional requirement is that they must have completed a semester in intensive care.
Recruited via simulation trainers at their respective hospitals or university hospitals.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas LEBOUVIER, M.D. | Contact | 33 (0)2 99 28 24 22 | thomas.lebouvier@chu-rennes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Recruiting | Rennes | 35000 | France |
Data from participant questionnaires will be provided upon request (subject to anonymity).
Video recordings will not be provided, as they will be deleted immediately after analysis by experts, as indicated in the information notice to participants.
Available after the publication of the report and for 5 years after the publication date.
The data will be shared with other researchers under the cover of a research project and a plan of the planned analyses submitted to the corresponding author.
A data sharing agreement will be signed between the study sponsor and the researchers who wish to access the data.
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| Evolution of medical leadership skills | the change in the score for items 1 and 2 of the TEAM grid obtained by the medical leader of each team | Before intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 month |
| Clinical transferability of soft skills training in clinical practice | self-assessment questionnaire on perceived transfer to clinical practice and an open-ended narrative question completed individually by study participants. | Immediately after the intervention at day 1 and at 3 month |
| Evolution of theoretical knowledge of soft skills | scores obtained by participants in the pre- and post-training questionnaires developed for this training course in accordance with the HAS (High Health Authority) recommendations for good practice in health simulation | At the end of the intervention at day 1 and at 3 month |
| Assessment of anxiety induced by the intervention | Anxiety is assessed for all participants using a visual analogue scale and the State-Trait Anxiety Inventory-Form Y (STAI-Y) questionnaire. STAI-Y score ranges from 20 to 80 :
| At the end of the intervention at day 1 |