HealthyNCT04898660
The Embedded Participant During High-fidelity Simulation
An observational study of Healthy, run by Claude Bernard University at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Healthy
- How many people
- 340 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 4 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Anaesthesia residents in postgraduate years 1-5 at Edouard Herriot Hospital, Lyon
Who may be able to join
- Resident physicians in anesthesia/intensive care- postgraduate year 1-5 participating in HFS training sessions from 2015 to 2021
- Consent for recording
Who cannot join
- Denial to be recorded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Embedded Participant on Learners' Performance During High- Fidelity Simulation
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.
Read more
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.
Read the detailed 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.
- Conditions
- Healthy
- Keywords
- High Fidelity Simulation, Simulation Training/methods, Task Performance and Analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Skills Performance
technical performance on a scale pre-established according to each scenario rated from 0 to 100.
Measured: 1 month (review video)
Non-technical skills performance
Ottawa Crisis Resource Management Global Rating Scale rated from 6 to 42.
Measured: 1 month (review video)
Secondary outcomes (1)
Demographic characteristics
demographic data related to the instructors (embedded participants) through a questionary
Measured: 1 month (collect data)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Sep 2021
- Primary completion30 Oct 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claude Bernard University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lilot Marc, Claude Bernard University
- Investigators
- thomas rimmele, PhD, Study chair, Claude Bernard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898660
- Sponsor's protocol ID
- FAC1
- Status last verified
- Nov 2022
- First submitted
- 10 May 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29273177Paige 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.
PubMed 32218086Lewis KL, Bohnert CA, Gammon WL, Holzer 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.
PubMed 29450011Boyer TJ, Mitchell SA. Utilization of Embedded Simulation Personnel in Medical Simulation. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562294/
PubMed 32965965
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Embedded Participant on Learners' Performance During High- Fidelity Simulation
- ClinicalTrials.gov ID
- NCT04898660
- Acronym / sponsor ID
- FAC1
- Conditions
- Healthy
- Keywords
- High Fidelity Simulation, Simulation Training/methods, Task Performance and Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Claude Bernard UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Anaesthesia residents in postgraduate years 1-5 at Edouard Herriot Hospital, Lyon
Key inclusion criteria (2 listed)
- Resident physicians in anesthesia/intensive care- postgraduate year 1-5 participating in HFS training sessions from 2015 to 2021
- Consent for recording
Key exclusion criteria (1 listed)
- Denial to be recorded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical Skills Performance
Time frame: 1 month (review video)
technical performance on a scale pre-established according to each scenario rated from 0 to 100.
Non-technical skills performance
Time frame: 1 month (review video)
Ottawa Crisis Resource Management Global Rating Scale rated from 6 to 42.
1 secondary outcome
Demographic characteristics
Time frame: 1 month (collect data)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 29273177Cooke 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.
- Background: PubMed 32218086Paige 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.
- Background: PubMed 29450011Lewis KL, Bohnert CA, Gammon WL, Holzer 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.
- Background: PubMed 32965965Boyer TJ, Mitchell SA. Utilization of Embedded Simulation Personnel in Medical Simulation. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562294/
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
thomas rimmele, PhD study chair
Claude Bernard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Claude Bernard University at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Skills Performance (time frame: 1 month (review video)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898660, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022; AzTrials last refreshed its copy on 28 Oct 2026.