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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05060146
Acronym
OPTIVACC
Enrollment
646
Registered
2021-09-29
Start date
2022-09-19
Completion date
2024-06-12
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Streptococcus Pneumoniae Infection

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

Interventions

OTHERStructured 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Step wedge

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Full vaccination coverage (2 doses) between groups6 months after dischargeYes/No, confirmed by the administrator

Secondary

MeasureTime frameDescription
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 dischargeYes/No, confirmed by the administrator
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 visitYes/No according to Système national d'information inter-régimes de l'Assurance maladie (SNIIRAM) database
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 dischargeYes/No
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 dischargeYes/No, confirmed by the administrator
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
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
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026