Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT04532658
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2020-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Coaching Impact on Surgical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20791}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of major adverse event', 'timeFrame': 'During surgery or within 30 days after the operation'}, {'measure': 'Occurrence of death', 'timeFrame': 'During surgery or within 30 days after the operation'}, {'measure': 'Occurrence of unplanned stay in critical/intensive care unit', 'timeFrame': 'Within 30 days after the operation'}, {'measure': 'Occurrence of unplanned reoperation', 'timeFrame': 'Within 30 days after the operation'}, {'measure': 'Occurrence of intraoperative and postoperative complications', 'timeFrame': 'During surgery or within 30 days after the operation'}, {'measure': ': Occurrence of avoidable hospital readmission for complication', 'timeFrame': 'Within 30 days after the operation'}, {'measure': 'Operative time', 'timeFrame': 'From skin incision to wound closure'}, {'measure': 'Length of stay', 'timeFrame': 'From hospital admission to discharge, within 30 days after operation'}, {'measure': 'Hospitalization costs', 'timeFrame': 'Within 30 days after the operation'}, {'measure': 'Surgeon well-being', 'timeFrame': 'Throughout the study, Through study completion, an average of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://topsurgeons.univ-lyon1.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This two arms parallel cluster-randomized trial will evaluate the impact of a customized coaching program for surgeons on the occurrence of patient major adverse events. Trends in surgical outcomes before and after the intervention will be compared between surgeons randomly assigned to the coaching program against non-exposed surgeons.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adults needing a surgery who are operated by one of the participating surgeons\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Absence of surgical procedure\n* Palliative care\n* Organ transplantation\n* Refusal for personal data sharing'}, 'identificationModule': {'nctId': 'NCT04532658', 'acronym': 'TopSurgeons', 'briefTitle': 'Evaluation of Coaching Impact on Surgical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Understanding the Influence of Human and Organizational Factors on Surgeon Performance to Enhance Patient Outcomes: Experimental Evaluation of a Customized Coaching Program', 'orgStudyIdInfo': {'id': 'TOPSURGEONS_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Surgeons randomly assigned to the intervention arm', 'interventionNames': ['Behavioral: Coaching program']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Surgeons randomly assigned to the control arm'}], 'interventions': [{'name': 'Coaching program', 'type': 'BEHAVIORAL', 'description': '* Charting system for outcomes feedback\n* Profiling of individual surgeon\n* Modules of improvement', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}