Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-29 @ 6:03 PM
Study NCT ID:
NCT04556604
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2020-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Consent During the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2020-09-18', 'studyFirstSubmitQcDate': '2020-09-18', 'lastUpdatePostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance to consenting practice', 'timeFrame': '3 months', 'description': 'The number of patients being consented for COVID-19 infection in the lead up to surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Consent']}, 'descriptionModule': {'briefSummary': 'Multiloop audit of consenting practice in surgical procedures during the COVID-19 pandemic'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults presenting with general surgical, vascular or breast surgical issues that require surgical intervention', 'healthyVolunteers': True, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* Children (under 18 years old)\n* Participants who lack capacity and therefore cannot be consented appropriately'}, 'identificationModule': {'nctId': 'NCT04556604', 'briefTitle': 'Surgical Consent During the COVID-19 Pandemic', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Medway Primary Care Trust'}, 'officialTitle': 'Consent for Surgery During the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': '2021.016N'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'First cycle of the audit on consenting practice pre intervention'}, {'label': '2', 'description': 'Second cycle of the audit on consenting practice to assess change following intervention', 'interventionNames': ['Behavioral: Educational meetings and visual prompts']}, {'label': '3', 'description': 'Third cycle of the audit on consenting practice to assess long term compliance', 'interventionNames': ['Behavioral: Educational meetings and visual prompts']}], 'interventions': [{'name': 'Educational meetings and visual prompts', 'type': 'BEHAVIORAL', 'description': 'Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts', 'armGroupLabels': ['2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'ME7 5NY', 'city': 'Gillingham', 'country': 'United Kingdom', 'facility': 'Medway NHS Foundation Trust', 'geoPoint': {'lat': 51.38914, 'lon': 0.54863}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'On request, IPD may be shared. This will include anonymised data collected during the study period'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medway Primary Care Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Oloruntobi Rotimi', 'investigatorAffiliation': 'Medway Primary Care Trust'}}}}