National insurance funding to increase vaccination in outpatient care
"Assessment of the Impact of Vaccine Funding by the National Health Insurance on Vaccination Coverage Among Patients Targeted by Current Vaccination Recommendations and Followed in Outpatient Consultations in Ile-de-France Region in France""
This project will try giving vaccines paid for by the national health insurance in outpatient visits at several hospitals to see if it raises pertussis vaccination in pregnant women and pneumococcal vaccination in eligible adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2920 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 6 sites (Paris, IDF and 5 other locations) |
| Trial ID | NCT07243236 on ClinicalTrials.gov |
What this trial studies
This observational project follows patients seen in outpatient consultations at four health institutions in Île‑de‑France after a tripartite agreement enabled National Health Insurance funding of recommended vaccines administered on site. Data collection combines patient and provider questionnaires with vaccination records to measure coverage for pertussis in pregnancy and pneumococcal vaccination in eligible adults. Analyses will examine changes in coverage, the influence of socio‑economic factors, and whether hospital clinician practices and documentation of vaccination status change. If coverage improves during the funding period, investigators plan to present results to national health authorities to support broader agreements between hospitals and local insurers.
Who should consider this trial
Good fit: Ideal participants are adults eligible for pneumococcal vaccination who attend outpatient consultations at participating institutions (and meet ALD/C2S/AME criteria) and pregnant women who had at least one outpatient follow‑up from 20 weeks gestation or are in the immediate postpartum stay at participating maternity wards.
Not a fit: Patients who are not eligible under the national immunization schedule, who do not attend the participating outpatient clinics, or who cannot be reached for follow‑up are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the approach could raise vaccine uptake among vulnerable outpatients and support policy changes to reimburse vaccines given in hospitals.
How similar studies have performed: Similar in‑hospital and insurer‑supported vaccination programs have shown mixed but often positive effects on coverage in comparable settings, while broad national rollouts remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Paris, IDF and 5 other locations
- COCHIN HOSPITAL - Assistance Publique-Hôpitaux de Paris (APHP) — Paris, Idf, France (Recruiting)
- Sud Seine Et Marne Hospital — Fontainebleau, France (Not_yet_recruiting)
- Sud Seine Et Marne Hospital — Montereau-Fault-Yonne, France (Not_yet_recruiting)
- Sud Seine Et Marne Hospital — Nemours, France (Not_yet_recruiting)
- Rambouillet Hospital — Rambouillet, France (Not_yet_recruiting)
- Delafontaine Hospital — Saint-Denis, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Marie LACHATRE, MD
- Email: marie.lachatre@aphp.fr
- Phone: 0033158412093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.