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Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies

LEADE ME: Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies - A Multicenter Randomized Controlled Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07427641
Acronym
LEAD ME
Enrollment
54
Registered
2026-02-23
Start date
2026-02-02
Completion date
2027-04-01
Last updated
2026-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Competency Based Education, Education, Medical, Education, Medical, Continuing, High Fidelity Simulation Training, Randomized Controlled Trials, Teaching Innovation

Brief summary

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.

Interventions

The designated team leader performs the simulated scenario while wearing visual deprivation mask

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

The teams participating in the simulation sessions are composed as follows: * A senior doctor identified as the "medical leader" * An anaesthesia and intensive care intern * A state-registered nurse anaesthetist Inclusion Criteria: 1. 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. 2. Recruited via simulation trainers at their respective hospitals or university hospitals.

Exclusion criteria

* The study cannot be carried out during a safety rest period (i.e. the day after being on call).

Design outcomes

Primary

MeasureTime frameDescription
Evolution of team performance on non-technicals skillsBefore intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 monthTeam 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)

Secondary

MeasureTime frameDescription
Evolution of team's clinical performanceBefore intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 monthRating 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.
Evolution of medical leadership skillsBefore intervention (scenario 1) at day 1, immediately after (scenario 3) at day 1 and after the procedure (scenario 4) at 3 monththe change in the score for items 1 and 2 of the TEAM grid obtained by the medical leader of each team
Clinical transferability of soft skills training in clinical practiceImmediately after the intervention at day 1 and at 3 monthself-assessment questionnaire on perceived transfer to clinical practice and an open-ended narrative question completed individually by study participants.
Evolution of theoretical knowledge of soft skillsAt the end of the intervention at day 1 and at 3 monthscores 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
Assessment of anxiety induced by the interventionAt the end of the intervention at day 1Anxiety 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 : * 20 to 37: low anxiety (better outcome) * 38 to 44: moderate anxiety * 44 to 80: high anxiety (worse outcome)

Countries

France

Contacts

CONTACTThomas LEBOUVIER, M.D.
thomas.lebouvier@chu-rennes.fr33 (0)2 99 28 24 22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026