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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04898660
Other study ID # FAC1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date November 4, 2022

Study information

Verified date November 2022
Source Claude Bernard University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Simulation in medicine is a powerful and effective teaching tool that has become essential for the training of students and health professionals. In this context, simulation instructor training have been implemented in recent years, where many subjects are addressed, such as the main principles of pedagogy, the integration of simulation, the construction of a scenario, briefing and debriefing. However, scenario facilitation, in particular the role of the embedded participant (EP), is only vaguely discussed. The EP of a high-fidelity simulation session plays a very important role in driving the scenario. Indeed, he/she guides the learner in order to achieve all the educational objectives set by the main instructor of the scenario. He/she also manages unexpected behavior and possible technical issues that may arise. Finally, the EP supervises the physical and psychological risks inherent in the simulation in order to maintain a safe environment. All of these key roles suggest that the EP can influence the performance of the learners. Little is known about the relationship between Facilitation and Learner Performance. In this observational study, investigators aim to explore the influence of the embedded participant on learners' technical and non-technical performances during high-fidelity simulation by analysing previously recorded sessions.


Description:

In this observational study, investigators aim to measure performance on high-fidelity simulation scenarios (HFS) used routinely in the current anesthesiology, training curriculum. Age, sex, previous experience of HFS will be noted. All data will be anonymized. Two investigators will independently evaluate the performance of HFS by video record: - technical performance on tables pre-established by experienced instructors and based on international recommendations, - non-technical performances, assessed using the Ottawa Global Rating Scale.


Recruitment information / eligibility

Status Completed
Enrollment 340
Est. completion date November 4, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Resident physicians in anesthesia/intensive care- postgraduate year 1-5 participating in HFS training sessions from 2015 to 2021 - Consent for recording Exclusion Criteria: - Denial to be recorded

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Claude Bernard University Lyon

Sponsors (1)

Lead Sponsor Collaborator
Claude Bernard University

Country where clinical trial is conducted

France, 

References & Publications (4)

Boyer TJ, Mitchell SA. Utilization of Embedded Simulation Personnel in Medical Simulation. 2022 Jul 25. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562294/ — View Citation

Cooke JM, Rooney DM, Fernandez GL, Farley DR. Simulation center best practices: A review of ACS-accredited educational institutes' best practices, 2011 to present. Surgery. 2018 Apr;163(4):916-920. doi: 10.1016/j.surg.2017.11.004. Epub 2017 Dec 19. — View Citation

Lewis KL, Bohnert CA, Gammon WL, Hölzer H, Lyman L, Smith C, Thompson TM, Wallace A, Gliva-McConvey G. The Association of Standardized Patient Educators (ASPE) Standards of Best Practice (SOBP). Adv Simul (Lond). 2017 Jun 27;2:10. doi: 10.1186/s41077-017-0043-4. eCollection 2017. — View Citation

Paige JB, Graham L, Sittner B. Formal Training Efforts to Develop Simulation Educators: An Integrative Review. Simul Healthc. 2020 Aug;15(4):271-281. doi: 10.1097/SIH.0000000000000424. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Technical Skills Performance technical performance on a scale pre-established according to each scenario rated from 0 to 100. 1 month (review video)
Primary Non-technical skills performance Ottawa Crisis Resource Management Global Rating Scale rated from 6 to 42. 1 month (review video)
Secondary Demographic characteristics demographic data related to the instructors (embedded participants) through a questionary 1 month (collect data)
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