Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.

Streptococcus Pneumoniae Infection Clinical Trial

— OPTIVACC  

Official title:

Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060146
• Other study ID #: PHRC-I/2019/FD-01
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Florent Dubois
• Phone: 04 66 68 38 44
• Email: florent.dubois[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In France, Streptococcus pneumoniae is the leading agent bacterial involved in community lung disease and meningitis. The frequency of these infections and their mortality increase significantly in those at risk such as patients with certain chronic diseases, immunocompromised or on immunosuppressive therapy. This population, despite regular monitoring, has a limited pneumococcal vaccine coverage of around 20%. By carrying out a reconciliation of treatments upon admission to hospital, the clinical pharmacist can detect those without up to date pneumococcal vaccination status. The goal of this management is to make the patient aware of the need for vaccination and organization upon return home. Thus, this limited pneumococcal vaccination coverage would benefit from intervention by regional clinical pharmacy activities. The study investigators want to study the impact of a structured medico-pharmaceutical collaboration on pneumococcal vaccination of patients with risk on discharge from hospital. The investigators hypothesize that this collaboration in patients at risk of infection with pneumococcus could significantly increase their anti-pneumococcal vaccination coverage

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 768
• Est. completion date: September 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patient must have given their free and informed oral consent
• The patient must be a member or beneficiary of a health insurance plan
• The patient is admitted to full hospitalization in a surgical or medical department.
• The patient will benefit from a reconciliation of drug treatments.
• The patient is considered at risk of pneumococcal infection according to the recommendations of March 2017 of the High Council of Public Health (HCSP)
• Pneumococcal vaccination is not up to date according to the HCSP 2017 recommendations.

Exclusion Criteria:

• The subject is participating in a category 1 interventional study
• The patient has participated in a category 1 trial within the previous 3 months or is in a period of exclusion determined by a previous study
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• The patient is not in a fit state to express consent
• The patient is pregnant, parturient or breast feeding

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pneumococcal Infections
• Pneumonia, Pneumococcal
• Streptococcus Pneumoniae Infection

Intervention

Other:
• Structured medico-pharmaceutical collaboration
Reconciliation of drug treatments; Writing of the prescription for discharge from hospital for the pneumococcal vaccine; Pharmaceutical interview at discharge; Drafting of the discharge letter and transmission to the attending physician; Writing of the pharmaceutical discharge letter and transmission to the pharmacist; Pharmaceutical dispensing in the pharmacy; Administration of the vaccine by the attending physician or a nurse at home.

Locations

Country	Name	City	State
France	CH Alès Cévennes	Alès
France	CH de Bagnols sur Cèze	Bagnols-sur-Cèze
France	CH de Montauban	Montauban
France	CHU de Montpellier	Montpellier
France	CHU de Nimes	Nîmes
France	CH de Perpignan	Perpignan
France	CH Comminges Pyrénées	Saint-Gaudens
France	CH du Bassin de Thau	Sète
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full vaccination coverage (2 doses) between groups	Yes/No, confirmed by the administrator	6 months after discharge
Secondary	Full vaccination coverage (2 doses) between groups, stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No, confirmed by the administrator	6 months after discharge
Secondary	Partial vaccination coverage (1st dose only) between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No, confirmed by the administrator	6 months after discharge
Secondary	Record of both vaccines being dispensed by the pharmacy between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No according to Système national d'information inter-régimes de l'Assurance maladie (SNIIRAM) database	6 months after last follow-up visit
Secondary	Concordance between vaccines dispensed and vaccines recorded in the SNIRRAM database between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No	6 months after discharge
Secondary	Prescription of vaccines at discharge by the doctor between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No	at discharge (average 5 days after hospitlization)
Secondary	Notification of requirement for vaccine between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No	at discharge (average 5 days after hospitlization)
Secondary	Transmission of letter highlighting the absence of vaccination by the pharmacy to the patient's doctor between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	Yes/No	at discharge (average 5 days after hospitlization)