Impact of Vaccine Funding by the National Health Insurance on Vaccination Coverage Among Patients Targeted by Current Vaccination Recommendations and Followed in Outpatient Consultations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2920 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-19

Study Completion Date

2027-07-31

Brief Summary

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The objective of our study is to evaluate the impact of vaccine funding for patients seen in outpatient consultations within four healthcare institutions in the Ile-de-France region in France, made possible through the establishment of a tripartite agreement between the hospital group, the Île-de-France Regional Health Agency (ARS IDF), and the Primary Health Insurance Fund (CPAM).

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Detailed Description

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The aim of this project is to highlight whether dedicated funding for vaccine procurement in healthcare institutions can generate both individual and collective benefits in terms of improved vaccination coverage among vulnerable patients at infectious risk.

Should the data analysis demonstrate a positive impact on vaccination coverage among patients who attended outpatient consultations in the participating institutions during the study period, it is planned to approach the Directorate General for Health with a view to generalizing such agreements between healthcare institutions and local health insurance organizations, thereby enabling reimbursement of vaccines included in the national immunization schedule administered within these institutions.

Primary objective: To assess the impact of National Health Insurance (NHI) funding for vaccines made available in outpatient consultations on pertussis vaccination coverage among pregnant women and pneumococcal vaccination coverage among eligible patients, in accordance with current French recommendations and fully covered by NHI, across four healthcare institutions in the Île-de-France region.

Secondary objectives:

To evaluate:

* The influence of socio-economic determinants on patients' vaccination coverage;
* Changes in the practices of hospital healthcare professionals in outpatient consultations regarding the monitoring of their patients' vaccination status;
* Changes in practices related to the documentation of patient vaccinations to facilitate communication between healthcare institutions and primary care practitioners through the use of existing digital tools (hospital software, electronic vaccination record (CVE) in MonEspaceSanté).

Conditions

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Healthcare Providers Postpartum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women in the immediate postpartum period

Women in the immediate postpartum period (during their stay in the maternity ward) who have declared their pregnancy to the National Health Insurance, covered under maternity benefits up to the 12th day following delivery

Questionnaires for patients

Intervention Type OTHER

Questionnaires for patients

Patients eligible for pneumococcal vaccination

Patients eligible for pneumococcal vaccination who benefit from long-term illness coverage (ALD), state medical aid (AME), or complementary universal health coverage C2S

Questionnaires for patients

Intervention Type OTHER

Questionnaires for patients

Healthcare providers

Vaccinating healthcare providers + Other healthcare providers involved in the operational aspects of the project (excluding health data)

Questionnaires for healthcare providers

Intervention Type OTHER

Questionnaires for healthcare providers

Interventions

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Questionnaires for patients

Intervention Type OTHER

Questionnaires for healthcare providers

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

For patients:

1. For the assessment of pneumococcal coverage among patients eligible for this vaccination:

* Individuals aged 18 years or older,
* Individuals followed in outpatient consultations within a department and healthcare institution participating in the project;
* Individuals eligible for pneumococcal vaccination against according to current French recommendations,
* Individuals meeting the eligibility conditions and receiving care under long-term illness coverage (ALD) or benefiting from complementary universal health coverage (C2S) or state medical aid (AME).
2. For the assessment of pertussis vaccination among pregnant women:

* Women aged 18 years or older,
* Women who have had at least one follow-up outpatient consultation from 20 weeks of gestation in a maternity ward participating in the project,
* Women in the immediate postpartum period (during their maternity stay) who have given birth to one or more live children and delivered after 36 weeks of gestation,
* Women who have declared their pregnancy and are covered under maternity insurance (i.e., from the first day of the sixth month of pregnancy until the 12th day after delivery).

For healthcare professionals: all vaccinating healthcare providers working in a participating department or center.

Exclusion Criteria

* Individuals seen in settings other than outpatient consultations (day hospital, week hospital, conventional hospitalization, International Vaccination Center).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie LACHATRE, MD

Role: STUDY_DIRECTOR

Hôpital Cochin - APHP

Muriel BELIAH-NAPPEZ, MD

Role: STUDY_CHAIR

Agence régionale de santé Ile de France

Locations

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COCHIN HOSPITAL - Assistance Publique-Hôpitaux de Paris (APHP)

Paris, IDF, France

Site Status RECRUITING