Clinical trial NCT05060146: Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients At Risk.
Official title: Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients At Risk.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Streptococcus Pneumoniae Infection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 646
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Step wedge
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Full vaccination coverage (2 doses) between groups
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Full vaccination coverage (2 doses) between groups, stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)
timeFrame: 6 months after discharge
measure: Partial vaccination coverage (1st dose only) between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)
timeFrame: 6 months after discharge
measure: 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)
timeFrame: 6 months after last follow-up visit
measure: 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)
timeFrame: 6 months after discharge
measure: 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)
timeFrame: at discharge (average 5 days after hospitlization)
measure: Notification of requirement for vaccine between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)
timeFrame: at discharge (average 5 days after hospitlization)
measure: 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)
timeFrame: at discharge (average 5 days after hospitlization)
Other outcomes:
Locations:
city: Alès
country: France
facility: CH Alès Cévennes
city: Bagnols-sur-Cèze
country: France
facility: CH de Bagnols sur Cèze
city: Montauban
country: France
facility: CH de Montauban
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nîmes
country: France
facility: CHU de Nimes
city: Perpignan
country: France
facility: CH de Perpignan
city: Saint-Gaudens
country: France
facility: CH Comminges Pyrénées
city: Sète
country: France
facility: CH du Bassin de Thau
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Florent Dubois
role: PRINCIPAL_INVESTIGATOR
References: