Effect of Visual Deprivation of the Team Leader on Team Performance During Simulated Medical Emergencies (LEAD ME)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Education, Medical; High Fidelity Simulation Training; Randomized Controlled Trials; Competency Based Education; Education, Medical, Continuing; Teaching Innovation
• Intervention / Treatment: Behavioral: Visual deprivation

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas LEBOUVIER, M.D.; Phone Number: 33 (0)2 99 28 24 22; Email: thomas.lebouvier@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35000
    • Recruiting
    • Rennes University Hospital
    • Contact: Thomas LEBOUVIER, M.D.; Phone Number: 33 (0)2 99 28 24 22; Email: thomas.lebouvier@chu-rennes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual deprivation; the designated team leader performs the simulated scenario while wearing visual deprivation mask.	Behavioral: Visual deprivation; The designated team leader performs the simulated scenario while wearing visual deprivation mask
No Intervention: No visual deprivation; Control group leaders perform the scenario without visual deprivation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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 : 20 to 37: low anxiety (better outcome); 38 to 44: moderate anxiety; 44 to 80: high anxiety (worse outcome)	At the end of the intervention at day 1

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 35RC25-T4818_LEADME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Available after the publication of the report and for 5 years after the publication date.

IPD Sharing Access Criteria

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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No