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

NCT07243236 | Recruiting

• 2 other identifiers: APHP2512282025-A01886-43
• Study Type: observational
• Target: 2,920
• Locations: 1 country
• Sites: 6

Brief Summary

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).

Conditions

Healthcare Providers; Postpartum

Keywords

Vaccine coverage; Vaccine funding within healthcare institutions; Outpatient consultations

Outcome Measures

Primary Outcomes (4)

• Number of subjects vaccinated against pneumococcal infections

  Variation in the number of subjects vaccinated against pneumococcal infections (eligible subjects according to current recommendations) before (according to the usual intra-hospital organization) and after the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations across four healthcare institutions in the Ile-de-France region

  Month 3

• Number of subjects vaccinated against pneumococcal infections

  Number of subjects vaccinated against pneumococcal infections (eligible subjects according to current recommendations), before (according to the usual intra-hospital organization) the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations

  Month 18

• Number of subjects vaccinated against pertussis

  Variation in the number of subjects vaccinated against pertussis during pregnancy, before (according to the usual intra-hospital organization) and after the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations

  Month 3

• Number of subjects vaccinated against pertussis

  Variation in the number of subjects vaccinated against pertussis during pregnancy, before (according to the usual intra-hospital organization) and after the implementation of the National Health Insurance funding for vaccines made available during outpatient consultations for the target populations

  Month 18

Secondary Outcomes (8)

• Associated factors

  Month 3

• Associated factors

  Month 18

• Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations

  Month 3

• Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations

  Month 18

• Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination

  Month 3

Study Arms (3)

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

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

Other: Questionnaires for patients

Healthcare providers

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

Other: Questionnaires for healthcare providers

Interventions

Questionnaires for patients OTHER

Questionnaires for patients

Patients eligible for pneumococcal vaccination; Women in the immediate postpartum period

Questionnaires for healthcare providers OTHER

Questionnaires for healthcare providers

Healthcare providers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

During a follow-up hospital consultation, for patients eligible for pneumococcal vaccination or for postpartum women eligible for pertussis vaccination during pregnancy, the healthcare professional proposes and completes a questionnaire with the patient during the consultation.

You may qualify if:

• For patients:
• 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).
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead
• Agence régionale de santé Ile de France: collaborator
• Institut de Recherche en Santé Publique, France: collaborator

Study Sites (6)

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

Paris, IDF, 75014, France

RECRUITING

Sud Seine Et Marne Hospital

Fontainebleau, 77300, France

NOT YET RECRUITING

Sud Seine Et Marne Hospital

Montereau-Fault-Yonne, 77130, France

NOT YET RECRUITING

Sud Seine Et Marne Hospital

Nemours, 77140, France

NOT YET RECRUITING

Rambouillet Hospital

Rambouillet, 78120, France

NOT YET RECRUITING

Delafontaine Hospital

Saint-Denis, 93200, France

NOT YET RECRUITING

Related Publications (16)

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MeSH Terms

Interventions

Surveys and Questionnaires; Health Personnel

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Care Facilities Workforce and Services

Study Officials

• Marie LACHATRE, MD

  Hôpital Cochin - APHP

  STUDY DIRECTOR

• Muriel BELIAH-NAPPEZ, MD

  Agence régionale de santé Ile de France

  STUDY CHAIR

Central Study Contacts

Marie LACHATRE, MD

CONTACT

0033158412093; marie.lachatre@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

0033158411190; marie.godard@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

FR (6)