Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk. (OPTIVACC)
Primary Purpose
Streptococcus Pneumoniae Infection
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Structured medico-pharmaceutical collaboration
Sponsored by
About this trial
This is an interventional other trial for Streptococcus Pneumoniae Infection
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.
- The patient will return home following discharge
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
Sites / Locations
- CH Alès CévennesRecruiting
- CH de Bagnols sur CèzeRecruiting
- CH de MontaubanRecruiting
- CHU de MontpellierRecruiting
- CHU de NimesRecruiting
- CH de PerpignanRecruiting
- CH Comminges PyrénéesRecruiting
- CH du Bassin de ThauRecruiting
- CHU de ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
Structured medico-pharmaceutical collaboration
Arm Description
Outcomes
Primary Outcome Measures
Full vaccination coverage (2 doses) between groups
Yes/No, confirmed by the administrator
Secondary Outcome Measures
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
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
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
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
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
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
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
Full Information
NCT ID
NCT05060146
First Posted
September 7, 2021
Last Updated
June 8, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT05060146
Brief Title
Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.
Acronym
OPTIVACC
Official Title
Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcus Pneumoniae Infection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Step wedge
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
768 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Title
Structured medico-pharmaceutical collaboration
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Structured medico-pharmaceutical collaboration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Full vaccination coverage (2 doses) between groups
Description
Yes/No, confirmed by the administrator
Time Frame
6 months after discharge
Secondary Outcome Measure Information:
Title
Full vaccination coverage (2 doses) between groups, stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)
Description
Yes/No, confirmed by the administrator
Time Frame
6 months after discharge
Title
Partial vaccination coverage (1st dose only) between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)
Description
Yes/No, confirmed by the administrator
Time Frame
6 months after discharge
Title
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)
Description
Yes/No according to Système national d'information inter-régimes de l'Assurance maladie (SNIIRAM) database
Time Frame
6 months after last follow-up visit
Title
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)
Description
Yes/No
Time Frame
6 months after discharge
Title
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)
Description
Yes/No
Time Frame
at discharge (average 5 days after hospitlization)
Title
Notification of requirement for vaccine between groups and stratified by type of establishment (University hospital vs hospital) and by service (Medicine vs Surgery)
Description
Yes/No
Time Frame
at discharge (average 5 days after hospitlization)
Title
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)
Description
Yes/No
Time Frame
at discharge (average 5 days after hospitlization)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florent Dubois
Phone
04 66 68 38 44
Email
florent.dubois@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florent Dubois
Organizational Affiliation
Centre Hospitalier Universitaire de Nīmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH Alès Cévennes
City
Alès
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Bouix
Phone
04 66 78 33 33
Email
dr.bouix@ch-ales.fr
First Name & Middle Initial & Last Name & Degree
Vincent Bouix
Facility Name
CH de Bagnols sur Cèze
City
Bagnols-sur-Cèze
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Dubois
Phone
04 66 79 10 11
Email
edelage@chbagnolssurceze.fr
First Name & Middle Initial & Last Name & Degree
Emmanuelle Dubois
Facility Name
CH de Montauban
City
Montauban
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Seree de Roch
Phone
05 63 92 80 94
Email
x.sereederoch@ch-montauban.fr
First Name & Middle Initial & Last Name & Degree
Xavier Seree de Roch
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxime Villiet
Phone
04.67.33.85.62
Email
m-villiet@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Maxime Villiet
Facility Name
CHU de Nimes
City
Nîmes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.42.36
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Florent Dubois
First Name & Middle Initial & Last Name & Degree
Jean-Marie Kinowski
First Name & Middle Initial & Last Name & Degree
Geraldine Leguelinel Balche
First Name & Middle Initial & Last Name & Degree
Paul Loubet
Facility Name
CH de Perpignan
City
Perpignan
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Heran
Phone
04 68 61 66 41
Email
isabelle.heran@ch-perpignan.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Heran
Facility Name
CH Comminges Pyrénées
City
Saint-Gaudens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Bonnet
Phone
05 62 00 40 00
Email
Julie.bonnet@ch-saintgaudens.fr
First Name & Middle Initial & Last Name & Degree
Julie Bonnet
Facility Name
CH du Bassin de Thau
City
Sète
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Giraudon
Phone
04 67 46 57 70
Email
lgiraudon@ch-bassindethau.fr
First Name & Middle Initial & Last Name & Degree
Laurent Giraudon
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Cestac
Phone
05 61 32 28 85
Email
cestac.p@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Philippe Cestac
12. IPD Sharing Statement
Learn more about this trial
Prevention of Pneumococcal Infections: Impact Collaborative Medico-pharmaceutical Care Structured to Improve Vaccination Coverage of Patients at Risk.
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