Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-05 @ 1:46 AM
Study NCT ID:
NCT02569450
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Control Chart Impact on Surgical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 157594}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2015-10-05', 'studyFirstSubmitQcDate': '2015-10-05', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of any major adverse event during hospitalization', 'timeFrame': 'within 30 days following surgical procedure', 'description': 'Major adverse events include postoperative death, complication, unplanned intensive care stay or reoperation within 30 days of surgery.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of any death during hospitalization within 30 days of surgery', 'timeFrame': 'within 30 days following surgical procedure'}, {'measure': 'Occurrence of any complication during hospitalization within 30 days of surgery', 'timeFrame': 'at the end of hospitalization'}, {'measure': 'Occurrence of unplanned intensive care stay during hospitalization within 30 days of surgery', 'timeFrame': 'within 30 days following surgical procedure'}, {'measure': 'Occurrence of reoperation during hospitalization within 30 days of surgery', 'timeFrame': 'within 30 days following surgical procedure'}, {'measure': 'Number of hospital bed-days consumed', 'timeFrame': 'within 30 days following surgical procedure'}, {'measure': 'Hospitalization costs from a health insurance perspective', 'timeFrame': 'within 30 days following surgical procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Surgery', 'Performance', 'Outcome', 'Control chart'], 'conditions': ['Digestive Surgery']}, 'referencesModule': {'references': [{'pmid': '37553238', 'type': 'DERIVED', 'citation': 'Skinner S, Pascal L, Polazzi S, Chollet F, Lifante JC, Duclos A; SHEWHART Trial Group. Economic analysis of surgical outcome monitoring using control charts: the SHEWHART cluster randomised trial. BMJ Qual Saf. 2024 Apr 24;33(5):284-292. doi: 10.1136/bmjqs-2022-015390.'}, {'pmid': '33148601', 'type': 'DERIVED', 'citation': 'Duclos A, Chollet F, Pascal L, Ormando H, Carty MJ, Polazzi S, Lifante JC; SHEWHART Trial Group. Effect of monitoring surgical outcomes using control charts to reduce major adverse events in patients: cluster randomised trial. BMJ. 2020 Nov 4;371:m3840. doi: 10.1136/bmj.m3840.'}]}, 'descriptionModule': {'briefSummary': 'This two arms parallel cluster-randomized trial will evaluate the impact of monitoring surgical outcomes using Shewhart control chart (intervention) on the occurence of major adverse events, among a large sample of French surgical departments. Trends in surgical outcomes before and after the intervention will be compared between arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients operated in participating French public and private hospitals (cluster)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All adults needing a digestive surgery who are hospitalized in one of the 40 departments\n\nExclusion Criteria:\n\n* Age \\< 18 years old\n* Hospitalization \\<24 hours\n* Absence of surgical procedure\n* Ambulatory care\n* Palliative care\n* Organ transplantation'}, 'identificationModule': {'nctId': 'NCT02569450', 'acronym': 'SHEWHART', 'briefTitle': 'Evaluation of Control Chart Impact on Surgical Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'The Impact of Surgical Outcomes Monitoring Using Control Chart on Surgical Performance: A Cluster Randomized Trial', 'orgStudyIdInfo': {'id': '69HCL14_0282'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Intervention arm', 'description': 'Hospitals randomly assigned to the intervention arm with surgical outcomes monitoring', 'interventionNames': ['Behavioral: Surgical outcomes monitoring using Shewhart control chart']}, {'label': 'Hospitals in control arm', 'description': 'Hospitals randomly assigned to the control arm without surgical outcome monitoring'}], 'interventions': [{'name': 'Surgical outcomes monitoring using Shewhart control chart', 'type': 'BEHAVIORAL', 'description': '* Assistance by a local surgeon responsible for the implementation of intervention within his/her department\n* Quarterly team meeting to interpret variations in observed outcomes on the control charts\n* Restitution of surgical outcomes based on wall posters in operating room\n* Training sessions provided to local surgeon for appropriate control chart utilization', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon, Pôle IMER', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}