肺炎球菌感染的预防：结构化医药协同管理对提高高危患者疫苗接种覆盖率的影响（OPTIVACC研究）：一项多中心随机阶梯楔形研究方案

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

摘要

背景肺炎链球菌引起感染，特别是免疫缺陷或特定合并症患者。大多数可以通过肺炎球菌疫苗（PV）来避免，但法国的PV覆盖率仅为20%。许多研究评估了提高疫苗接种覆盖率的方法，但没有一项研究评估了医院中药剂师和医生在侵袭性肺炎球菌病（IPD）风险住院患者的PV覆盖率方面的合作。方法采用多中心楔式随机试验，在法国9家医院（3家大学医院和6家地方医院）的12个单位进行，每期90天，共4期。将组成三个分组，每个分组随机由一所大学医院的临床和外科单位和两所地方医院的临床和外科单位组成。在每个时期，一个单位必须包括16名有IPD风险的未接种疫苗的住院患者。处于控制期的患者将接受常规护理。在介入阶段，药剂师将告知医生PV的必要性，医生将报告建议并在出院时开处方。药剂师将进行会诊，并向患者的社区药剂师发送出院信。主要结果将在6个月后评估干预对PV覆盖率的影响。次要结果将评估疫苗分配、未完成方案率和干预过程。将分别对大学和地方医院以及临床和外科单位进行亚组分析。本研究将评估医院医药合作对IPD风险住院患者PV覆盖率的影响。住院治疗可能是促进疫苗接种和提高卫生保健系统绩效的一种方式。临床试验注册：clinicaltrials .gov, NCT05060146。注册于2021年9月16日。

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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

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.