Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-08 @ 3:42 PM
Study NCT ID:
NCT06484933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Management in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operational definition of the notion of a professional team in primary care in the France, by means of focus groups and validation by consensus.', 'timeFrame': 'up to 23 months', 'description': 'This definition will be based on data from a literature review adapted to the context of French primary care and the practices/experience of professionals and users by means of focus groups including professionals and users from the primary care teams.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary care', 'Risk management', 'Teamwork'], 'conditions': ['Primary Care']}, 'descriptionModule': {'briefSummary': 'The proposed research is a prospective, non-comparative study based on a qualitative method, comprising a literature review followed by 2 successive series of Focus Groups with users and healthcare professionals of primary care in the French AURA region. The 2 Focus Group phases will make it possible to :\n\n* propose an operational definition of the notion of a professional team in primary care (validation by consensus between the participants of the first 4 Focus Groups based on the definitions in the literature)\n* describe the ways in which risks are managed in primary care teams (qualitative analysis of the contributions made by the participants in the next 12 Focus Groups organized in 12 primary care teams)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary care organizations in France', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthcare professional\n\n* Healthcare professional over 18 years of age, registered with the professional association on which he/she depends and holding an RPPS identification number with care activity as part of a coordinated practice, within a legally formalised care team working on a territorial health project, or care activity within a care team that is not legally formalized but defined as an entity bringing together ≥ 4 different professionals to care for the same patient.\n* Most care provided on an outpatient basis\n* Care activity in the AURA region\n* Agreement to participate in the focus group Users\n* Any user of the healthcare system over the age of 18\n* Consulting a healthcare professional from a team included in the research\n* Agreement to participate in the focus group\n\nExclusion Criteria:\n\nHealthcare professional\n\n* Primary care healthcare professional with a specific exclusive practice that does not form part of the overall management of a patient (e.g. homeopathy, mesotherapy, acupuncture, etc.) Users\n* Persons deprived of their liberty by a judicial or administrative decision\n* Adults under legal protection (guardianship, curatorship)\n* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme'}, 'identificationModule': {'nctId': 'NCT06484933', 'acronym': 'eGERISSEP', 'briefTitle': 'Risk Management in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Assessing Risk Management in Primary Care Teams', 'orgStudyIdInfo': {'id': '69HCL24_0010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthcare professionals and users of primary care', 'description': 'Health professionals and users of primary care will be asked during focus groups on the definition of the professional team in primary care and on the risk management procedures put in place in primary care organisations.', 'interventionNames': ['Behavioral: Focus groups of health professionals and users of primary care']}], 'interventions': [{'name': 'Focus groups of health professionals and users of primary care', 'type': 'BEHAVIORAL', 'description': '2 phases of Focus Group will be organized :\n\n* the participants of the first 4 Focus Groups will propose an operational definition of the notion of a professional team in primary care (validation by consensus based on the definitions in the literature)\n* 12 subsequent Focus Groups will be organized in 12 primary care teams to describe the ways in which risks are managed in primary care', 'armGroupLabels': ['Healthcare professionals and users of primary care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69600', 'city': 'Oullins', 'country': 'France', 'contacts': [{'name': 'Julie HAESEBAERT, MD', 'role': 'CONTACT', 'email': 'julie.haesebaert@chu-lyon.fr', 'phone': '04 72 68 49 05', 'phoneExt': '+33'}, {'name': 'Marc CHANELIERE, MD,PhD', 'role': 'CONTACT', 'email': 'marc.chaneliere@univ-lyon1.fr', 'phone': '04 27 85 63 18', 'phoneExt': '+33'}, {'name': 'Julie HAESEBAERT, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cabinet Medical', 'geoPoint': {'lat': 45.71404, 'lon': 4.80755}}], 'centralContacts': [{'name': 'HAESEBAERT Julie, PU-PH', 'role': 'CONTACT', 'email': 'julie.haesebaert01@chu-lyon.fr', 'phone': '+33 (0)4 72 11 51 65'}, {'name': 'POYAU Karine, PhD', 'role': 'CONTACT', 'email': 'karine.poyau@chu-lyon.fr', 'phone': '+33 (0)4 72 11 53 81'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}