How health centers organize to offer better, more accessible care
| ISRCTN | ISRCTN25187077 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25187077 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | RESPIR-21-003 |
| Sponsor | Institut Jean-François Rey |
| Funder | Direction Générale de l’offre de Soins |
- Submission date
- 06/08/2025
- Registration date
- 02/09/2025
- Last edited
- 08/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In recent years, the way doctors and other healthcare professionals work together in France has been changing. Instead of working alone, many now work as teams in health centers. These teams include general practitioners (GPs), nurses, medical assistants, and even social workers. The goal is to offer patients more complete care that is easier to access and better organized. However, it’s not yet clear which ways of organizing these teams work best, especially for patients who are more vulnerable because of age, poverty, or social situations. This study, called EPIDAURE-2, aims to understand how different health centers organize care, how patients and professionals experience it, and whether this improves access and quality of care.
The study is especially focused on the role of the primary care doctor (known in France as the médecin traitant), who is meant to coordinate each patient's care, and how this role fits into increasingly team-based care models.
Who can participate?
Patients of all ages (adults and accompanied children) who have named a GP at one of the participating health centers, and all professionals working in the selected health centers during the study period, including doctors, nurses, administrative staff, and others.
What does the study involve?
This is an observational study, which means no treatment or care will be changed. Instead, the study will collect information through:
- Questionnaires filled out by patients about their experience and satisfaction with care.
- Questionnaires filled out by healthcare professionals about how their teams are organized and how they feel about their work.
- Social and demographic data, including a measure of patient vulnerability using the EPICES score (a tool used in France to assess social disadvantage).
What are the possible benefits and risks of participating?
Benefits include helping researchers and policymakers better understand what makes care effective and accessible, especially for vulnerable patients. Participating centers may also benefit from feedback on how to improve teamwork and patient satisfaction.
There are no medical risks involved, as the study only collects survey responses and demographic information. All data will be collected anonymously and handled securely.
Where is the study run from?
The study is coordinated by the Institut Jean-François Rey (IJFR), in collaboration with the French Society of General Practice (SFMG) and academic partners such as the École des Hautes Études en Santé Publique (EHESP, Rennes) and the INSERM CEPIA research team.
When is the study starting and how long will it run?
November 2024 to June 2026
Who is funding the study?
The study is funded by the French Ministry of Health, through the Direction Générale de l’Offre de Soins (DGOS), as part of a grant awarded via the RESPIR (Regional Support for Research in Primary Care) for proposals managed by the GIRCI Île-de-France (Interregional Clinical Research and Innovation Group).
Who is the main contact?
Prof. Julien Le Breton, julien.lebreton@u-pec.fr
Contact information
Public, Scientific, Principal investigator
Société Française de Médecine Générale (SFMG)
141, avenue de Verdun
Issy-les-Moulineaux
92040
France
 ORCID ID |
0000-0002-7531-1132 |
|---|---|
| Phone | +33 (0)6 64 00 91 07 |
| julien.lebreton@u-pec.fr |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Exploratory observational study using descriptive epidemiology to analyze organizational models in health centers |
| Secondary study design | Cross sectional study |
| Study type | Participant information sheet |
| Scientific title | Analysis of coordinated care organization in health centers: accessibility and quality of curative and preventive services |
| Study acronym | EPIDAURE-2 |
| Study objectives | Primary Objective To assess the relevance of different organizational models in health centers — including modes of interprofessional cooperation, coordination, and regulation within teams, and the role of general practitioners — in delivering coordinated healthcare. Secondary Objectives - To evaluate the ability of these organizational models to provide care for socially vulnerable populations and to identify the factors associated with this capacity - To assess the perceptions (experience, satisfaction) of healthcare professionals involved in these organizational models and identify associated factors - To assess the perceptions (experience, satisfaction) of patients (those listed with a primary care physician) using these organizational models and identify associated factors |
| Ethics approval(s) |
Approved 18/03/2025, Comité Ethique du CNGE (155 rue de Charonne, Paris, 75011, France; +33 (0)175622290; comite-ethique@cnge.Fr), ref: 740 |
| Health condition(s) or problem(s) studied | Access to and quality of coordinated primary care, including care for socially vulnerable populations |
| Intervention | This is an observational, descriptive epidemiological study conducted in nine community health centers in the Île-de-France region, France. The study involves two participant populations: 1. Healthcare professionals (clinical and non-clinical staff) working in the centers. 2. Patients who consult with a general practitioner (GP) within these centers and have declared a GP at the center. Participant involvement: • Healthcare professionals will complete the SAPHORA-JOB questionnaire, which collects information on their professional characteristics, experience of coordination, and job satisfaction. • Patients will complete the EUROPEP questionnaire, providing data on their healthcare experience and satisfaction, as well as sociodemographic information and social vulnerability (EPICES score). No intervention is delivered as part of this study. All data are collected via self-administered or assisted questionnaires during routine care. Participation does not alter clinical care pathways. Duration of participation: • For patients: A single-point questionnaire during the consultation period. • For professionals: One-time data collection during the study period. Total observation period: March 2025 – March 2026 (12 months total) Total duration of follow-up for each participant: No follow-up; single timepoint only. |
| Intervention type | Other |
| Primary outcome measure(s) |
The relevance of organizational models in health centers will be assessed using the following tools: |
| Key secondary outcome measure(s) |
1. Perception and experience of healthcare professionals measured using the SAPHORA-JOB questionnaire at a single timepoint. |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient, Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 1300 |
| Key inclusion criteria | Health Centers: The study will include a total of 9 health centers in the Île-de-France region, with variation in organizational and remuneration models: 1. 2 centers with activity-based remuneration 2. 7 centers with fixed-salary remuneration Patients: 1. Prospectively and randomly included during consultations. 2. Eligible patients are adults who have declared a primary care physician within the participating health center. Healthcare Professionals: All staff working in the participating centers during the study period will be included, whether medical or non-medical, clinical or non-clinical. |
| Key exclusion criteria | Patients: Patients who have not declared a primary care physician within the participating health center Healthcare Professionals: 1. Professionals not working at the participating health centers during the study period 2. Temporary staff or visiting professionals with no regular activity in the center |
| Date of first enrolment | 27/03/2025 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- France
Study participating centres
La Courneuve
93120
France
Nanterre
92000
France
Malakoff
92240
France
Arcueil
94110
France
Paris
75010
France
Champigny-sur-Marne
94500
France
Saint-Denis
93200
France
Paris
75013
France
Paris
75003
France
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Julien Le Breton, julien.lebreton@u-pec.fr. Type of data that will be shared: De-identified individual-level data from questionnaires completed by patients and healthcare professionals. This includes: - Patient responses on care experience and satisfaction (EUROPEP questionnaire) - Professional responses on team coordination and work experience (SAPHORA-JOB questionnaire) - Social vulnerability data (EPICES score) - Basic demographic characteristics When the data will become available: Within 6 months after publication of the main study results. For how long the data will be available: For a period of 2 years after publication. Access criteria: Data will be shared with qualified researchers affiliated with academic or healthcare institutions, upon submission and approval of a data access request outlining the proposed secondary analysis. Mechanism for data access: Requests should be submitted by email to the study contact. A data-sharing agreement (DSA) will be required to ensure data use complies with ethical, legal, and confidentiality obligations. Consent and anonymisation: All identifiable information will be fully anonymised before sharing. Participants have been informed of potential secondary data use during the consent process. Ethical or legal restrictions: Data sharing is subject to compliance with GDPR and French data protection laws. Any qualitative data will be reviewed to ensure full de-identification prior to release. Additional comments: The data will not be deposited in a public repository due to confidentiality considerations, but access can be granted on a case-by-case basis through controlled procedures. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/08/2025: Study's existence confirmed by the CNGE Ethics Committee.
