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

Official title

"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""

Overview

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).

Detailed description

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).

Interventions

• Other Questionnaires for patients
  Questionnaires for patients
• Other Questionnaires for healthcare providers
  Questionnaires for healthcare providers

Primary outcome measures

• Number of subjects vaccinated against pneumococcal infections [Time frame: Month 3]
• Number of subjects vaccinated against pneumococcal infections [Time frame: Month 18]
• Number of subjects vaccinated against pertussis [Time frame: Month 3]
• Number of subjects vaccinated against pertussis [Time frame: Month 18]

Secondary outcome measures (8)

• Associated factors [Time frame: Month 3]
• Associated factors [Time frame: Month 18]
• Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations [Time frame: Month 3]
• Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations [Time frame: Month 18]
• Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination [Time frame: Month 3]
• Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination [Time frame: Month 18]
• Proportion of vaccinating healthcare providers [Time frame: Month 3]
• Proportion of vaccinating healthcare providers [Time frame: Month 18]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

France · 6 centers

• COCHIN HOSPITAL - Assistance Publique-Hôpitaux de Paris (APHP) — Paris
• Sud Seine Et Marne Hospital — Fontainebleau
• Sud Seine Et Marne Hospital — Montereau-Fault-Yonne
• Sud Seine Et Marne Hospital — Nemours
• Rambouillet Hospital — Rambouillet
• Delafontaine Hospital — Saint-Denis

Publications

• Chen H, Matsumoto H, Horita N, Hara Y, Kobayashi N, Kaneko T. Prognostic factors for mortality in invasive pneumococcal disease in adult: a system review and meta-analysis. Sci Rep. 2021 Jun 4;11(1):11865. doi: 10.1038/s41598-021-91234-y. PMID 34088948
• Schnell D, Mayaux J, de Bazelaire C, Legoff J, Feuillet S, Scieux C, Andreu-Gallien J, Darmon M, Baruchel A, Schlemmer B, Azoulay E. Risk factors for pneumonia in immunocompromised patients with influenza. Respir Med. 2010 Jul;104(7):1050-6. doi: 10.1016/j.rmed.2010.01.021. Epub 2010 Feb 24. PMID 20181467
• Belsky JA, Tullius BP, Lamb MG, Sayegh R, Stanek JR, Auletta JJ. COVID-19 in immunocompromised patients: A systematic review of cancer, hematopoietic cell and solid organ transplant patients. J Infect. 2021 Mar;82(3):329-338. doi: 10.1016/j.jinf.2021.01.022. Epub 2021 Feb 4. PMID 33549624
• Garcia Garrido HM, Knol MJ, Heijmans J, van Sorge NM, Sanders EAM, Klumpen HJ, Grobusch MP, Goorhuis A. Invasive pneumococcal disease among adults with hematological and solid organ malignancies: A population-based cohort study. Int J Infect Dis. 2021 May;106:237-245. doi: 10.1016/j.ijid.2021.03.072. Epub 2021 Mar 26. PMID 33781907
• Marijam A, Vroom N, Bhavsar A, Posiuniene I, Lecrenier N, Vroling H. Systematic Literature Review on the Incidence of Herpes Zoster in Populations at Increased Risk of Disease in the EU/EEA, Switzerland, and the UK. Infect Dis Ther. 2024 May;13(5):1083-1104. doi: 10.1007/s40121-024-00963-w. Epub 2024 Apr 24. PMID 38656653
• Ellington S, Strid P, Tong VT, Woodworth K, Galang RR, Zambrano LD, Nahabedian J, Anderson K, Gilboa SM. Characteristics of Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-June 7, 2020. MMWR Morb Mortal Wkly Rep. 2020 Jun 26;69(25):769-775. doi: 10.15585/mmwr.mm6925a1. PMID 32584795
• Mertz D, Geraci J, Winkup J, Gessner BD, Ortiz JR, Loeb M. Pregnancy as a risk factor for severe outcomes from influenza virus infection: A systematic review and meta-analysis of observational studies. Vaccine. 2017 Jan 23;35(4):521-528. doi: 10.1016/j.vaccine.2016.12.012. Epub 2016 Dec 23. PMID 28024955
• Tubiana S, Belchior E, Guillot S, Guiso N, Levy-Bruhl D; Renacoq Participants. Monitoring the Impact of Vaccination on Pertussis in Infants Using an Active Hospital-based Pediatric Surveillance Network: Results from 17 Years' Experience, 1996-2012, France. Pediatr Infect Dis J. 2015 Aug;34(8):814-20. doi: 10.1097/INF.0000000000000739. PMID 25955837

Identifiers

NCT: NCT07243236 · APHP251228 · 2025-A01886-43

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗