Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 9:37 AM
Study NCT ID:
NCT04898660
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2021-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Embedded Participant During High-fidelity Simulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-06', 'studyFirstSubmitDate': '2021-05-10', 'studyFirstSubmitQcDate': '2021-05-19', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Skills Performance', 'timeFrame': '1 month (review video)', 'description': 'technical performance on a scale pre-established according to each scenario rated from 0 to 100.'}, {'measure': 'Non-technical skills performance', 'timeFrame': '1 month (review video)', 'description': 'Ottawa Crisis Resource Management Global Rating Scale rated from 6 to 42.'}], 'secondaryOutcomes': [{'measure': 'Demographic characteristics', 'timeFrame': '1 month (collect data)', 'description': 'demographic data related to the instructors (embedded participants) through a questionary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['High Fidelity Simulation', 'Simulation Training/methods', 'Task Performance and Analysis'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29273177', 'type': 'BACKGROUND', '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."}, {'pmid': '32218086', 'type': 'BACKGROUND', '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.'}, {'pmid': '29450011', 'type': 'BACKGROUND', 'citation': 'Lewis 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.'}, {'pmid': '32965965', 'type': 'BACKGROUND', 'citation': 'Boyer TJ, Mitchell SA. Utilization of Embedded Simulation Personnel in Medical Simulation. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562294/'}]}, 'descriptionModule': {'briefSummary': "Simulation in medicine is a powerful and effective teaching tool that has become essential for the training of students and health professionals.\n\nIn 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.\n\nHowever, 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.\n\nAll 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.\n\nIn 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.", 'detailedDescription': '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.\n\nTwo investigators will independently evaluate the performance of HFS by video record:\n\n* technical performance on tables pre-established by experienced instructors and based on international recommendations,\n* non-technical performances, assessed using the Ottawa Global Rating Scale.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Anaesthesia residents in postgraduate years 1-5 at Edouard Herriot Hospital, Lyon', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Resident physicians in anesthesia/intensive care- postgraduate year 1-5 participating in HFS training sessions from 2015 to 2021\n* Consent for recording\n\nExclusion Criteria:\n\n* Denial to be recorded'}, 'identificationModule': {'nctId': 'NCT04898660', 'briefTitle': 'The Embedded Participant During High-fidelity Simulation', 'organization': {'class': 'OTHER', 'fullName': 'Claude Bernard University'}, 'officialTitle': "The Role of the Embedded Participant on Learners' Performance During High- Fidelity Simulation", 'orgStudyIdInfo': {'id': 'FAC1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Claude Bernard University', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'thomas rimmele, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Claude Bernard University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Claude Bernard University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lilot Marc', 'investigatorAffiliation': 'Claude Bernard University'}}}}