Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-01 @ 10:16 AM
Study NCT ID:
NCT05952193
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2023-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-11', 'studyFirstSubmitDate': '2023-07-11', 'studyFirstSubmitQcDate': '2023-07-11', 'lastUpdatePostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the proportion of overall correct responses in each groups', 'timeFrame': '5 minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Iatrogenesis', 'Clinical vignettes', 'Diagnostic performance study', 'Medical Information Search', 'Artificial Intelligence'], 'conditions': ['Iatrogenesis', 'Clinical Vignettes', 'Diagnostic Performance Study', 'Medical Information Search', 'Artificial Intelligence']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter evaluation of diagnostic performance using simulated clinical vignettes. It aims to test the effectiveness of the POSOS app in detecting drug-induced iatrogenesis in urgent medical situations, an issue of public health importance. Participating physicians, who are randomly assigned to either use or not use POSOS, are categorized based on their years of experience. Vignettes, including a mixture of complex, simple, and non-iatrogenesis cases, are assigned to these doctors. During the simulation, physicians respond to their respective vignettes on the YgheniVi platform, with responses recorded at two intervals (5 min and 15 min). The supervising physicians subsequently fill out an e-CRF, providing further data on the time spent, the number of medical research applications used, and the overall user experience of POSOS. A doctor/pharmacist pair then corrects the answers to the vignettes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The physicians included are emergency physicians, selected by convenience so as to have as many physicians (seniority of practice 3 years after thesis) as (seniority of practice less).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not applicable as the study population is made up of clinical vignettes, there is no inclusion of patients.\n* The physicians included are emergency physicians, selected by convenience so as to have as many physicians (seniority of practice 3 years after thesis) as (seniority of practice less).\n\nExclusion Criteria:\n\n* Not applicable.\n* Simulations with technical faults will be excluded: (absence of the test doctor, internet access not working, PC malfunction, serious disruptions during the simulation).'}, 'identificationModule': {'nctId': 'NCT05952193', 'acronym': 'YGenHiVi', 'briefTitle': 'Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Evaluation of the POSOS Device for Iatrogenesis Detection in Clinical History? A Vignettes Study', 'orgStudyIdInfo': {'id': 'PI2023_843_0070'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'seniority ≥3 years + POSOS'}, {'label': 'seniority ≥3 years without POSOS'}, {'label': 'seniority <3 years with POSOS'}, {'label': 'seniority <3 years without POSOS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80480', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurélien Mary, Pr', 'role': 'CONTACT', 'email': 'mary.aurelien@chu-amiens.fr', 'phone': '03.22.08.83.71'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Aurélien MARY, Dr', 'role': 'CONTACT', 'email': 'Mary.aurelien@chu-amiens.fr', 'phone': '03 22 08 71 40'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre Hospitalier de Bourg en Bresse', 'class': 'OTHER'}, {'name': 'Saint Antoine University Hospital', 'class': 'OTHER'}, {'name': 'CHU de Rouen - Accueil', 'class': 'OTHER'}, {'name': 'CHU de Créteil', 'class': 'UNKNOWN'}, {'name': 'Médipôle Lyon-Villeurbanne', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, {'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de Niort', 'class': 'OTHER'}, {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, {'name': 'CHU de Reims', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}