- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05250089
Physicians Performance After Night Shifts (URGENCE24)
Performance of Emergency Physicians in the Management of Critical Situations Twenty-four Hours After the End of a Night Shift
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).
Study Overview
Detailed Description
The study compare the post-recovery performance (PRP) and the usual performance (UP) of emergency physicians in the management of a critical situation. The PRP corresponds to the performance twenty-four hours after the end of a minimum 12 hours night shift, which corresponds to the usual time when a physician go back to work. The UP is defined as the performance achieved in the absence of night shifts during the three previous nights.
Each participants realises 2 complex simulations, each simulation will focus on a trauma case 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 interview on the simulation scenario, and the time for the simulated practice.The simulation environment of the study is as close as possible to a reception room for vital emergencies (SAUV), in order to be as close as possible to the usual professional environment of the participants.
During the simulated practice, a technician manages the progress of the scenario under the supervision of an emergency doctor controlling it. In the room, each participant is accompanied by two trained paramedics, whose roles will depend on the scenarios.
The performance is assessed via the Ottawa Crisis Resource Management Global Rating Scale (Ottawa GRS), questionnaires and an electrocardiogram (ECG).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Charles-Henri HOUZE-CERFON, MD
- Phone Number: 05-61-77-21-47
- Email: houze-cerfon.ch@chu-toulouse.fr
Study Locations
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-
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Toulouse, France
- Recruiting
- CHU Toulouse
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Contact:
- Charles-Henri HOUZE CERFON, PHD - MD
- Phone Number: 05-61-77-21-47
- Email: houze-cerfon.ch@chu-toulouse.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Emergency physicians
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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
non-technical efficiency via the Ottawa GRS
Time Frame: 24 hours after a night shift
|
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:
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
Time Frame: after a minimum of 3 nights free of night work
|
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:
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physiologic stress
Time Frame: 24 hours after a night shift
|
Comparison of the psychological stress of emergency physicians during a simulated critical situation, between post-recovery time frame and usual time frame. Physiological stress will be assessed via the measurement of heart rate variability, thanks to the analysis of data from a Holter ECG worn by the participant during each simulated practice (Post Recovery Performance and Usual Performance). |
24 hours after a night shift
|
Physiologic stress
Time Frame: after a minimum of 3 nights free of night work
|
Comparison of the psychological stress of emergency physicians during a simulated critical situation, between post-recovery time frame and usual time frame. Physiological stress will be assessed via the measurement of heart rate variability, thanks to the analysis of data from a Holter ECG worn by the participant during each simulated practice (Post Recovery Performance and Usual Performance). |
after a minimum of 3 nights free of night work
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Charles-Henri HOUZE-CERFON, MD, University Hospital, Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RC31/21/0241
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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