Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-03-11 @ 9:03 PM
Study NCT ID:
NCT01653704
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2012-07-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sboet@toh.on.ca', 'phone': '6137985555', 'title': 'Dr. Sylvain Boet', 'phoneExt': '14775', 'organization': 'The Ottawa Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Duration the simulation session (1 day)', 'eventGroups': [{'id': 'EG000', 'title': 'Active Management of Crises Scenario', 'description': 'participants assigned to actively manage a crisis scenario\n\nactive role: active role in managing crisis scenario', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Observer Role in Crisis Scenario', 'description': 'Observational role in management of crises scenario\n\nobservational role: observational role in crisis scenario', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Ottawa GRS Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Active Management of Crises Scenario', 'description': 'participants assigned to actively manage a crisis scenario\n\nactive role: active role in managing crisis scenario'}, {'id': 'OG001', 'title': 'Observer Role in Crisis Scenario', 'description': 'Observational role in management of crises scenario\n\nobservational role: observational role in crisis scenario'}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '4.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'The Ottawa GRS scale is a reliable and valid scale used to measure CRM performance in high fidelity simulation. The scale assesses five main CRM categories: leadership, problem solving, situational awareness, resource allocation and communication skills. In addition to these five categories, there is a category on overall performance of the participant. Each category is measured on a 7 point Likert scale with descriptive anchors to provide guidelines on alternating points along the scale. The categorical scores will be summed to give a total score of 6 to 42. Higher values represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Active Management of Crises Scenario', 'description': 'participants assigned to actively manage a crisis scenario\n\nactive role: active role in managing crisis scenario'}, {'id': 'FG001', 'title': 'Observer Role in Crisis Scenario', 'description': 'Observational role in management of crises scenario\n\nobservational role: observational role in crisis scenario'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Technical failure during recording', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Performance not reflective of training', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'All emergency medicine residents in postgraduate years 1-5 in both the Royal College of Physicians and Surgeons and College of Family Physician programs at the University of Ottawa were invited to participate in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Active Management of Crises Scenario', 'description': 'participants assigned to actively manage a crisis scenario\n\nactive role: active role in managing crisis scenario'}, {'id': 'BG001', 'title': 'Observer Role in Crisis Scenario', 'description': 'Observational role in management of crises scenario\n\nobservational role: observational role in crisis scenario'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to the manner in which data were recorded for this study, baseline data were not associated with the participant study ID, therefore, it is impossible to provide Baseline data per-Arm/Group.', 'groupId': 'BG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to the manner in which data were recorded for this study, baseline data were not associated with the participant study ID, therefore, it is impossible to provide Baseline data per-Arm/Group.', 'groupId': 'BG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '29.9', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '43'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': "2 participants' data experienced technical failure during video recording of performance.\n\n1 participant's data was excluded from analysis because performance was not reflective of level of training."}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to the manner in which data were recorded for this study, baseline data were not associated with the participant study ID, therefore, it is impossible to provide Baseline data per-Arm/Group.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Due to the manner in which data were recorded for this study, baseline data were not associated with the participant study ID, therefore, it is impossible to provide Baseline data per-Arm/Group.', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to the manner in which data were recorded for this study, baseline data were not associated with the participant study ID, therefore, it is impossible to provide Baseline data per-Arm/Group.', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Due to the manner in which data were recorded for this study, baseline data were not associated with the participant study ID, therefore, it is impossible to provide Baseline data per-Arm/Group.', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': "2 participants' data experienced technical failure during video recording of performance.\n\n1 participant's data was excluded from analysis because performance was not reflective of level of training."}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': "2 participants' data experienced technical failure during video recording of performance.\n\n1 participant's data was excluded from analysis because performance was not reflective of level of training."}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2012-07-16', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-07', 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Ottawa GRS Score', 'timeFrame': '1 day', 'description': 'The Ottawa GRS scale is a reliable and valid scale used to measure CRM performance in high fidelity simulation. The scale assesses five main CRM categories: leadership, problem solving, situational awareness, resource allocation and communication skills. In addition to these five categories, there is a category on overall performance of the participant. Each category is measured on a 7 point Likert scale with descriptive anchors to provide guidelines on alternating points along the scale. The categorical scores will be summed to give a total score of 6 to 42. Higher values represent a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Focus of Study is Teaching Crisis Resource Management']}, 'referencesModule': {'references': [{'pmid': '26987738', 'type': 'RESULT', 'citation': 'Lai A, Haligua A, Dylan Bould M, Everett T, Gale M, Pigford AA, Boet S. Learning crisis resource management: Practicing versus an observational role in simulation training - a randomized controlled trial. Anaesth Crit Care Pain Med. 2016 Aug;35(4):275-81. doi: 10.1016/j.accpm.2015.10.010. Epub 2016 Mar 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effectiveness in learning crisis resource management (CRM) principles when being an active participant in simulation-based education versus being an observer participant. The investigators hypothesize that active participants will improve their CRM skills more than observer participants.', 'detailedDescription': 'This will be a prospective randomized controlled study. Participants will be randomized to one of two groups with stratification according to their level of training: the active group and the observer group. Each participant of the active group will be paired with one of the participants from the observer group. The active participant will manage individually a simulated crisis scenario (pretest) while the paired observer participant will observe the scenario from outside the simulation room using a video transmission system. Immediately after, both participants will be debriefed by a trained instructor focused on CRM principles. The same active and observer participants will then individually manage another simulated crisis scenario (post-test). Two independent raters, blinded to the study design and to the randomization groups, will review the videos of all scenarios in a random order and rate each participant on their CRM performance using a global rating scale (GRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* emergency medicine residents from the University of Ottawa'}, 'identificationModule': {'nctId': 'NCT01653704', 'briefTitle': 'Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Learning Crisis Resource Management: Practicing Versus Observational Role in Simulation Training', 'orgStudyIdInfo': {'id': '20120008-01H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active management of crises scenario', 'description': 'participants assigned to actively manage a crisis scenario', 'interventionNames': ['Behavioral: active role']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Observer role in crisis scenario', 'description': 'Observational role in management of crises scenario', 'interventionNames': ['Behavioral: observational role']}], 'interventions': [{'name': 'observational role', 'type': 'BEHAVIORAL', 'description': 'observational role in crisis scenario', 'armGroupLabels': ['Observer role in crisis scenario']}, {'name': 'active role', 'type': 'BEHAVIORAL', 'description': 'active role in managing crisis scenario', 'armGroupLabels': ['active management of crises scenario']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y3E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Skills and Simulation Centre', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Anita Lai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}, {'name': 'Sylvain Boet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Ottawa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}