Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT03412032
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2017-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Two Summative Assessment Methods in Advanced Life Support Courses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-03', 'studyFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2018-01-25', 'lastUpdatePostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Team leadership', 'timeFrame': '1 minute after the assessment is completed', 'description': 'Subjective rating of team leadership'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Self-Assessment']}, 'descriptionModule': {'briefSummary': 'Several approaches for summative assessment during Advanced Life Support courses are used. The most commonly used method during European Resuscitation (ERC) Council Life Support Courses is that 1 instructor is miming a whole team, and the candidate has to lead this "team" through a scenario; another variant of the summative assessment (mainly used by American Heart Association (AHA) Courses) is with a group of students, where one student is the team leader to be assessed and the others are his team not being assessed. The second approach might be more realistic; however there is no evidence around with regard to effectiveness (pass/fail rate, ability to test non-technical skills (NTS)) or participant/assessor satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All medical students at the University of Bern, study year 2017/2018, 5th and 6th study year\n\nExclusion Criteria:\n\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT03412032', 'briefTitle': 'Comparison of Two Summative Assessment Methods in Advanced Life Support Courses', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Comparison of Two Summative Assessment Methods in Advanced Life Support Courses - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ILS_2017/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ERC', 'description': 'Assessment as used by the European Resuscitation Council', 'interventionNames': ['Other: assessment']}, {'type': 'OTHER', 'label': 'AHA', 'description': 'Assessment as used by the American Heart Association', 'interventionNames': ['Other: assessment']}], 'interventions': [{'name': 'assessment', 'type': 'OTHER', 'description': 'different assessments in both arms', 'armGroupLabels': ['AHA', 'ERC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bern', 'country': 'Switzerland', 'facility': 'University of Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Robert Greif', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bern, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}