Risk Management in Primary Care (eGERISSEP)

July 1, 2024 updated by: Hospices Civils de Lyon

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

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary care organizations in France

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

2 phases of Focus Group will be organized :

  • 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)
  • 12 subsequent Focus Groups will be organized in 12 primary care teams to describe the ways in which risks are managed in primary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
up to 23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 5, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

July 1, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 1, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 69HCL24_0010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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