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

Study Overview
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Brief Summary
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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

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

Conditions
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Streptococcus Pneumoniae Infection

Intervention / Treatment
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* Other: Structured medico-pharmaceutical collaboration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Step wedge
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br> | |
| Experimental: Structured medico-pharmaceutical collaboration<br> | Other: Structured medico-pharmaceutical collaboration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Full vaccination coverage (2 doses) between groups | Yes/No, confirmed by the administrator | 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 
| 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) |