Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06092320
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does Teaching Before or After Simulation Improve Learning?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-16', 'size': 1479749, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-11T21:02', 'hasProtocol': True}, {'date': '2023-08-16', 'size': 281157, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-09-11T21:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will not know the specific pediatric resuscitation simulation they will be completing.\n\nSimulation reviewers will not know which arm of the intervention the participants are in.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2023-10-03', 'studyFirstSubmitQcDate': '2023-10-17', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in resuscitation performance retention score 2 months post-initial training assessed using global simulation performance score', 'timeFrame': 'From initial simulation until repeat simulation 2 months later', 'description': 'The scoring sheet used will be the Global Simulation performance score a one to seven scale that assess over medical expertise performance in the simulation with higher values representing increased competence.'}], 'secondaryOutcomes': [{'measure': 'Change in knowledge assessment score at 2 months post-initial training assessed using an MCQ', 'timeFrame': 'From initial knowledge test until repeat testing 2 months later', 'description': 'The knowledge test is a 15 questions multiple choice exam scored from 0 to 15 with higher numbers representing a higher score.'}, {'measure': 'Learner satisfaction measured by Likert scale items after each simulation debrief', 'timeFrame': 'Single time metric completed five minutes after initial simulation session', 'description': 'The Likert scale will be a one to five scale with higher scores representing increased satisfaction'}, {'measure': 'Time to resuscitation metrics', 'timeFrame': 'The time for each metric will be measured once during the second evaluatory simulation 2 months after the initial simulation and participant enrolment.', 'description': 'The following "time to" metrics will be measured from simulation start until completion of each activity within that simulation: glucose check, IV access, first-line anti-epileptic administration, second-line anti-epileptic administration, chemistry panel'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical Education', 'Simulation', 'Pediatrics'], 'conditions': ['Medical Education', 'Simulation']}, 'descriptionModule': {'briefSummary': 'The goal of the randomized educational intervention study is to test whether simulation preceding didactic teaching leads to improved knowledge and performance retention compared to a didactic lecture proceeding simulation for medical students\n\nParticipants will be randomized to one of two different groups with reverse orders for simulation and lectures.\n\nResearchers will compare each group to see which way is better for learning.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Second year medical student at the University of British Columbia\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT06092320', 'briefTitle': 'Does Teaching Before or After Simulation Improve Learning?', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Outcome of a Lecture Before vs After Simulation-based Education on Pediatric Status Epileptics: A Randomized Controlled Pilot Trial', 'orgStudyIdInfo': {'id': 'H22-03760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simulation - Didactic Lecture Group', 'description': 'This group will start with a Simulation and debrief followed by a didactic lecture afterwards. They will then complete a simulation 2 months later.', 'interventionNames': ['Other: Simulation on Pediatric Status Epilepticus', 'Other: Didactic Lecture on Pediatric Status Epilepticus']}, {'type': 'EXPERIMENTAL', 'label': 'Didactic Lecture - Simulation Group', 'description': 'This group will start with a didactic lecture and then complete a simulation and debrief. They will then complete a simulation 2 months later.', 'interventionNames': ['Other: Simulation on Pediatric Status Epilepticus', 'Other: Didactic Lecture on Pediatric Status Epilepticus']}], 'interventions': [{'name': 'Simulation on Pediatric Status Epilepticus', 'type': 'OTHER', 'description': 'The participants will complete a simulation session and debrief lead by a pediatric emergency medicine physician on status epilepticus.', 'armGroupLabels': ['Didactic Lecture - Simulation Group', 'Simulation - Didactic Lecture Group']}, {'name': 'Didactic Lecture on Pediatric Status Epilepticus', 'type': 'OTHER', 'description': 'The participants will complete a lecture on pediatric status epilepticus', 'armGroupLabels': ['Didactic Lecture - Simulation Group', 'Simulation - Didactic Lecture Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'John Ramsay, MD', 'role': 'CONTACT', 'email': 'john.ramsay1@phsa.ca', 'phone': '(604) 875-2345'}], 'facility': "BC Children's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'John Ramsay, MD', 'role': 'CONTACT', 'email': 'john.ramsay1@phsa.ca', 'phone': '(604) 875-2345'}], 'overallOfficials': [{'name': 'Melissa Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Provincial Health Services Authority British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Melissa Chan', 'investigatorAffiliation': 'University of British Columbia'}}}}