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

Официальное название

"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""

Обзор

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).

Подробное описание

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).

Вмешательства

• Другое Questionnaires for patients
  Questionnaires for patients
• Другое Questionnaires for healthcare providers
  Questionnaires for healthcare providers

Первичные конечные точки

• Number of subjects vaccinated against pneumococcal infections [Срок оценки: Month 3]
• Number of subjects vaccinated against pneumococcal infections [Срок оценки: Month 18]
• Number of subjects vaccinated against pertussis [Срок оценки: Month 3]
• Number of subjects vaccinated against pertussis [Срок оценки: Month 18]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 6 центров

• 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

Публикации

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• 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
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• 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

Идентификаторы

NCT: NCT07243236 · APHP251228 · 2025-A01886-43

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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