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

Not Applicable

Completed

• Conditions: Streptococcus Pneumoniae Infection
• Interventions: Other: Structured medico-pharmaceutical collaboration

• Registration Number: NCT05060146
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-29
• Study Start: 2022-09-19
• Primary Completion: 2023-09-13
• Study Completion: 2024-05-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 646

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Structured medico-pharmaceutical collaboration	Structured medico-pharmaceutical collaboration	-

Primary Outcome Measures

Name	Time	Method
Full vaccination coverage (2 doses) between groups	6 months after discharge	Yes/No, confirmed by the administrator

Secondary Outcome Measures

Name	Time	Method
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)	6 months after last follow-up visit	Yes/No according to Système national d'information inter-régimes de l'Assurance maladie (SNIIRAM) database
Full vaccination coverage (2 doses) between groups, stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	6 months after discharge	Yes/No, confirmed by the administrator
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)	6 months after discharge	Yes/No
Notification of requirement for vaccine between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	at discharge (average 5 days after hospitlization)	Yes/No
Partial vaccination coverage (1st dose only) between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)	6 months after discharge	Yes/No, confirmed by the administrator
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)	at discharge (average 5 days after hospitlization)	Yes/No
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)	at discharge (average 5 days after hospitlization)	Yes/No

Trial Locations

Locations (9)

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, France