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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01886-43 | Other Identifier | France : Ministry of Health |
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| Name | Class |
|---|---|
| Agence régionale de santé Ile de France | UNKNOWN |
| Institut de Recherche en Santé Publique, France | OTHER |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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 ÃŽle-de-France Regional Health Agency (ARS IDF), and the Primary Health Insurance Fund (CPAM).
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 ÃŽle-de-France region.
Secondary objectives:
To evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
| |
| Healthcare providers | Vaccinating healthcare providers + Other healthcare providers involved in the operational aspects of the project (excluding health data) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires for patients | Other | Questionnaires for patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Associated factors | Factors associated with pertussis vaccination among pregnant women and pneumococcal vaccination among eligible patients (including vaccination pathway, socio-demographic and socio-economic factors, category of healthcare providers involved in pregnancy follow-up, etc.), | Month 3 |
| Associated factors |
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Inclusion Criteria:
For patients:
For the assessment of pneumococcal coverage among patients eligible for this vaccination:
For the assessment of pertussis vaccination among pregnant women:
For healthcare professionals: all vaccinating healthcare providers working in a participating department or center.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie LACHATRE, MD | Contact | 0033158412093 | marie.lachatre@aphp.fr | |
| Marie BENHAMMANI-GODARD | Contact | 0033158411190 | marie.godard@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie LACHATRE, MD | Hôpital Cochin - APHP | Study Director |
| Muriel BELIAH-NAPPEZ, MD | Agence régionale de santé Ile de France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| COCHIN HOSPITAL - Assistance Publique-Hôpitaux de Paris (APHP) | Recruiting | Paris | IDF | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34088948 | Background | 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. | |
| 20181467 | Background | 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. |
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| Questionnaires for healthcare providers | Other | Questionnaires for healthcare providers |
|
Factors associated with pertussis vaccination among pregnant women and pneumococcal vaccination among eligible patients (including vaccination pathway, socio-demographic and socio-economic factors, category of healthcare providers involved in pregnancy follow-up, etc.), |
| Month 18 |
| Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations | Frequency with which vaccination providers offer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for these vaccinations | Month 3 |
| Frequency with which vaccination providers offer vaccinations to eligible patients for these vaccinations | Frequency with which vaccination providers offer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for these vaccinations | Month 18 |
| Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination | Frequency with which vaccinating healthcare providers administer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for this vaccination | Month 3 |
| Frequency with which vaccinating healthcare providers administer vaccinations to eligible patients for this vaccination | Frequency with which vaccinating healthcare providers administer pertussis vaccination to pregnant women and pneumococcal vaccination to eligible patients for this vaccination | Month 18 |
| Proportion of vaccinating healthcare providers | Proportion of vaccinating healthcare providers recording in a digital tool pertussis vaccinations for pregnant women and pneumococcal vaccinations for eligible patients | Month 3 |
| Proportion of vaccinating healthcare providers | Proportion of vaccinating healthcare providers recording in a digital tool pertussis vaccinations for pregnant women and pneumococcal vaccinations for eligible patients | Month 18 |
| Sud Seine Et Marne Hospital | Not yet recruiting | Fontainebleau | 77300 | France |
|
| Sud Seine Et Marne Hospital | Not yet recruiting | Montereau-Fault-Yonne | 77130 | France |
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| Sud Seine Et Marne Hospital | Not yet recruiting | Nemours | 77140 | France |
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| Rambouillet Hospital | Not yet recruiting | Rambouillet | 78120 | France |
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| Delafontaine Hospital | Not yet recruiting | Saint-Denis | 93200 | France |
|
| 33549624 | Background | 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. |
| 33781907 | Background | 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. |
| 38656653 | Background | 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. |
| 32584795 | Background | 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. |
| 28024955 | Background | 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. |
| 25955837 | Background | 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. |
| 28882916 | Background | Fell DB, Johnson J, Mor Z, Katz MA, Skidmore B, Neuzil KM, Ortiz JR, Bhat N. Incidence of laboratory-confirmed influenza disease among infants under 6 months of age: a systematic review. BMJ Open. 2017 Sep 7;7(9):e016526. doi: 10.1136/bmjopen-2017-016526. |
| 37246724 | Background | Del Riccio M, Spreeuwenberg P, Osei-Yeboah R, Johannesen CK, Fernandez LV, Teirlinck AC, Wang X, Heikkinen T, Bangert M, Caini S, Campbell H, Paget J; RESCEU Investigators. Burden of Respiratory Syncytial Virus in the European Union: estimation of RSV-associated hospitalizations in children under 5 years. J Infect Dis. 2023 Nov 28;228(11):1528-1538. doi: 10.1093/infdis/jiad188. |
| 35811205 | Background | Wyplosz B, Fernandes J, Sultan A, Roche N, Roubille F, Loubet P, Fougere B, Moulin B, Duhot D, Vainchtock A, Raguideau F, Lortet-Tieulent J, Blanc E, Moisi J, Goussiaume G. Pneumococcal and influenza vaccination coverage among at-risk adults: A 5-year French national observational study. Vaccine. 2022 Aug 5;40(33):4911-4921. doi: 10.1016/j.vaccine.2022.06.071. Epub 2022 Jul 7. |
| 34835303 | Background | Loubet P, Rouviere J, Merceron A, Launay O, Sotto A, On Behalf Of The Avnir Group. Patients' Perception and Knowledge about Influenza and Pneumococcal Vaccination during the COVID-19 Pandemic: An Online Survey in Patients at Risk of Infections. Vaccines (Basel). 2021 Nov 22;9(11):1372. doi: 10.3390/vaccines9111372. |
| 24850059 | Background | Launay O, Le Strat Y, Tosini W, Kara L, Quelet S, Levy S, Danan J, Reveillon J, Houdayer J, Bouvet E, Levy-Bruhl D; ANRS-FORMVAC Study Group. Impact of free on-site vaccine and/or healthcare workers training on hepatitis B vaccination acceptability in high-risk subjects: a pre-post cluster randomized study. Clin Microbiol Infect. 2014 Oct;20(10):1033-9. doi: 10.1111/1469-0691.12689. Epub 2014 Jul 25. |
| 31369626 | Background | Alessandrini V, Anselem O, Girault A, Mandelbrot L, Luton D, Launay O, Goffinet F. Does the availability of influenza vaccine at prenatal care visits and of immediate vaccination improve vaccination coverage of pregnant women? PLoS One. 2019 Aug 1;14(8):e0220705. doi: 10.1371/journal.pone.0220705. eCollection 2019. |
| 30921421 | Background | Mohammed H, McMillan M, Roberts CT, Marshall HS. A systematic review of interventions to improve uptake of pertussis vaccination in pregnancy. PLoS One. 2019 Mar 28;14(3):e0214538. doi: 10.1371/journal.pone.0214538. eCollection 2019. |
| 38476102 | Background | Du P, Jin S, Lu S, Wang L, Ma X, Wang J, Huang R, Luo Q, Yang S, Feng X. Strategies to increase the coverage of influenza and pneumonia vaccination in older adults: a systematic review and network meta-analysis. Age Ageing. 2024 Mar 1;53(3):afae035. doi: 10.1093/ageing/afae035. |
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D006282 | Health Personnel |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D005159 | Health Care Facilities Workforce and Services |
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