Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-03-05 @ 7:58 PM
Study NCT ID:
NCT05015959
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2021-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 859}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-14', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-14', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality outcomes', 'timeFrame': 'study period (Jan 2017 to Dec 2018)', 'description': 'in-hospital mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complication of Surgical and Medical Care, Unspecified']}, 'descriptionModule': {'briefSummary': 'Retrospective data analysis of mortalities and the evaluation of the quality of care offered, using the Fishbone method.', 'detailedDescription': 'Evaluation of mortalities seen between 01 January 2017 and 31 December 2018. Analysis of the mortality decision into preventable, non-preventable and potentially preventable categories. Identifying the associated risk factors and co-morbidities in a single centre study in Johannesburg. Further analysing was performed on the subset of preventable mortalities and further do the fishbone model of quality of care. RedCap data was utilized for all data points. A further comparison was done to the MNM classification based on the team and an independent senior surgeon.'}, 'eligibilityModule': {'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all adults 18 years or older that presented to our institution and died withing the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: All mortality of patients seen in the Department who were 18yrs or older\n\n\\-\n\nExclusion Criteria:\n\n* incomplete data death in the Emergency department'}, 'identificationModule': {'nctId': 'NCT05015959', 'briefTitle': 'Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement', 'organization': {'class': 'OTHER', 'fullName': 'University of Witwatersrand, South Africa'}, 'officialTitle': 'Analysis of Surgical Mortalities Using the Fishbone Model for Quality Improvement', 'orgStudyIdInfo': {'id': 'M190122'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mortality outcomes', 'description': 'mortality classification into preventable, potentially preventable and non-prevenatable', 'interventionNames': ['Other: observation']}], 'interventions': [{'name': 'observation', 'type': 'OTHER', 'otherNames': ['mortality outcomes'], 'description': 'quality', 'armGroupLabels': ['mortality outcomes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2123', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Charlotte Maxeke Johannesburg Academic Hospital', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Maeyane Moeng, MBBCH, FCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Witwatersrand, South Africa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Witwatersrand, South Africa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Maeyane Stephens Moeng', 'investigatorAffiliation': 'University of Witwatersrand, South Africa'}}}}