- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484933
Risk Management in Primary Care (eGERISSEP)
Assessing Risk Management in Primary Care Teams
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 :
- 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)
- 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)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: HAESEBAERT Julie, PU-PH
- Phone Number: +33 (0)4 72 11 51 65
- Email: julie.haesebaert01@chu-lyon.fr
Study Contact Backup
- Name: POYAU Karine, PhD
- Phone Number: +33 (0)4 72 11 53 81
- Email: karine.poyau@chu-lyon.fr
Study Locations
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Oullins, France, 69600
- Cabinet Médical
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Contact:
- Julie HAESEBAERT, MD
- Phone Number: +33 04 72 68 49 05
- Email: julie.haesebaert@chu-lyon.fr
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Principal Investigator:
- Julie HAESEBAERT, MD
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Contact:
- Marc CHANELIERE, MD,PhD
- Phone Number: +33 04 27 85 63 18
- Email: marc.chaneliere@univ-lyon1.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Healthcare professional
- 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.
- Most care provided on an outpatient basis
- Care activity in the AURA region
- Agreement to participate in the focus group Users
- Any user of the healthcare system over the age of 18
- Consulting a healthcare professional from a team included in the research
- Agreement to participate in the focus group
Exclusion Criteria:
Healthcare professional
- 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
- Persons deprived of their liberty by a judicial or administrative decision
- Adults under legal protection (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Healthcare professionals and users of primary care
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.
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2 phases of Focus Group will be organized :
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Operational definition of the notion of a professional team in primary care in the France, by means of focus groups and validation by consensus.
Time Frame: up to 23 months
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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.
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up to 23 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL24_0010
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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