Prevention of pneumococcal infections: Impact of structured medico-pharmaceutical collaborative management to improve vaccination coverage of at-risk patients (OPTIVACC study): Protocol for a multicenter randomized stepped -wedge study

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2025-02-15 DOI:10.1016/j.conctc.2025.101462

Florent Dubois , Emilie Champiot-Bayard , Bogdan Cireașă , Paul Loubet , Jérôme Vallat , Julie Bonnet , Valérie Jacob , Pauline Puyo , Ioana Pînzar , Sarah Théret , Emmanuelle Dubois , Elisabeth Peus , Laurent Giraudon , Clarisse Roux-Marson , Pascale Fabbro-Peray , Géraldine Leguelinel-Blache , Jean-Marie Kinowski

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引用次数: 0

Abstract

Background

Streptococcus pneumoniae causes infections especially in patients with immunodeficiency or specific comorbidities. Most could be avoided through pneumococcal vaccination (PV), but PV coverage is only 20 % in France. Many studies assess methods on vaccination coverage improvement, but none evaluates pharmacist-physician collaboration in hospital on PV coverage of inpatients at-risk of invasive pneumococcal disease (IPD).

Methods

This study is a multicentric stepped-wedged randomized trial involving 12 units in 9 French hospitals (3 university and 6 local) during 4 periods of 90 days each. Three clusters will be made, each composed randomly of clinical and surgical units from one university hospital and clinical and surgical units of 2 local hospitals. For each period, one unit will have to include 16 non-vaccinated inpatients at risk of IPD. Patients in the control phase will receive usual care. During the interventional phase, the pharmacist will inform the physician on PV necessity, who will report recommendation and prescribe it at discharge. The pharmacist will perform a consultation and send a discharge letter to the patient's community pharmacist. The primary outcome will assess the impact of intervention on PV coverage after 6 months. Secondary outcomes will evaluate vaccines dispensing, uncompleted protocol rate and intervention process. A subgroup analysis between university and local hospitals and clinical and surgical units, respectively will be made.

Discussion

This study will assess the impact of medico-pharmaceutical collaboration in hospital on PV coverage in inpatients at risk of IPD. Hospitalization could be a way to promote vaccination and enhance healthcare system performance.

Trial registration

Clinicaltrials.gov, NCT05060146. Registered on September 16th, 2021.

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.