NCT05250089

Brief Summary

Emergency medicine is one of the professional activities integrating a night activity into working time. Concerns about the sleep deprivation that this activity generates have been growing for the past thirty years. However, at present, the pace - duration and repetition - of this activity does not yet seem to be optimized, and therefore continues to be the subject of questions in terms of safety of care and quality of life at work. One of the peculiarities of emergency medicine is that doctors have to work in a crisis situation. A situation is qualified as critical for a patient when his state of health is unstable, and with an evolution which can be rapidly pejorative. Crisis situations are at the heart of the emergency room profession, and due to their potential seriousness for the patients, it must be managed in all circumstances. To cope with a crisis situation, a doctor needs to be efficient. However, performance calls for two types of skills: technical skills on one hand, and non-technical skills on the other. This study therefore aims to answer the following question: are the non-technical skills of emergency physicians in the management of a crisis situation affected twenty-four hours after the end of a night shift? The study assesses the performance of emergency physicians via complex simulations at two time frames : 24h after a night shift (the post recovery performance simulation) and another time were the participant did not have night shifts in less than 3 nights (usual performance simulation).

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

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

January 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 16, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

1.9 years

First QC Date

January 11, 2022

Last Update Submit

January 29, 2024

Conditions

Keywords

emergencynight shiftefficiencyphysicians

Outcome Measures

Primary Outcomes (2)

  • non-technical efficiency via the Ottawa GRS

    Overall non-technical skill score assessed using the Ottawa Crisis Resource Management Global Rating Scale (Ottawa GRS). The Ottawa GRS scale assesses the following five criteria: * leadership skills * situational awareness * communication skills * problem solving * resource management For each of the criteria, a score between 1 and 7 is attributed. The scoring is made as follows: a score of 1 corresponds to a novice performance, a score of 3 corresponds to a performance of a novice with experience in Crisis Resource Management (CRM) and resuscitation, a score of 5 corresponds to the performance of a physician with sufficient experience in CRM and resuscitation to properly manage a crisis situation, finally a score of 7 corresponds to the performance of a physician expert in CRM and resuscitation. An average score of the five scores is taken to obtain an overall proficiency score, also out of 7, which will be used to compare Post Recovery Performance and Usual Performance

    24 hours after a night shift

  • non-technical efficiency via the Ottawa GRS

    Overall non-technical skill score assessed using the Ottawa Crisis Resource Management Global Rating Scale (Ottawa GRS). The Ottawa GRS scale assesses the following five criteria: * leadership skills * situational awareness * communication skills * problem solving * resource management For each of the criteria, a score between 1 and 7 is attributed. The scoring is made as follows: a score of 1 corresponds to a performance judged to be that of a novice, a score of 3 corresponds to a performance of a novice with experience in CRM and resuscitation, a score of 5 corresponds to the performance of a physician with sufficient experience in CRM and resuscitation to properly manage a crisis situation, finally a score of 7 corresponds to the performance of a physician expert in CRM and resuscitation. An average score of the five scores is taken to obtain an overall proficiency score, also out of 7, which will be used to compare Post Recovery Performance and Usual Performance

    after a minimum of 3 nights free of night work

Secondary Outcomes (2)

  • Physiologic stress

    24 hours after a night shift

  • Physiologic stress

    after a minimum of 3 nights free of night work

Study Arms (1)

Emergency physicians

EXPERIMENTAL

Each participant will have to carry out two simulation sessions. The first simulation will correspond to the "usual" evaluation, that is to say it will take place on a day that will not be preceded by night duty during the three previous nights. The second simulation will correspond to the assessment twenty-four hours after the end of a call, in the "post-recovery" period. The participant must therefore have performed a night shift the day before the day when the simulation takes place. This call must have a minimum duration of twelve hours on night shifts.

Other: Simulation

Interventions

Each simulation will focus on a trauma case deemed to be complex, that is to say one involving difficult decision-making. Each simulation session lasts approximately thirty minutes. It includes a time to complete the questionnaires necessary for carrying out the study, before and / or after the simulated practice depending on the type of questionnaire, a brief briefing on the simulation scenario, and the time for the simulated practice.

Emergency physicians

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • be an emergency doctor with an emergency medicine capacity,
  • work full time in the emergency medicine center of the Toulouse University Hospital
  • on call in at least one of the emergency reception services of the Toulouse University Hospital
  • to have given his non-opposition to participate and his authorization of right to his image and his voice within the framework of the research

You may not qualify if:

  • non-emergency doctor
  • emergency doctor not on call in at least one of the emergency services of the Toulouse University Hospital
  • professional with a declared personal or professional conflict with one of the members of the group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charles-Henri HOUZE-CERFON, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles-Henri HOUZE-CERFON, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The time frame of the simulation (post recovery or usual) will be unknown to the evaluator
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: single site prospective pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 22, 2022

Study Start

January 16, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations