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An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department (IMPROVED)

2020年1月22日 更新者：Centre Hospitalier Princesse Grace

An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project

Background :

Community-acquired pneumonia (CAP) is a threat in industrialized countries. It represents the 6th cause of death. CAP also frequently associates with other disorders responsible for admission and death. Among bacteria responsible for CAP, Streptococcus pneumonia is a major pathogen that is commonly involved and frequently leads to severe infection and admission. Categories at risk for this pathogen have been determined, and can be proposed anti-pneumococcal vaccination (APV) that efficiently and safely protects from this microorganism.

In the context of US health services, monocenter pilot experiences have reported improvement of pneumococcal prophylaxis implementing vaccination procedure at ED. A study that set in New Mexico (2003) reported a significant increase in APV (from 18% to 84%) when patients at risk were proposed vaccination at ED. To obtain these results, medical students were specifically trained and dedicated to screen and vaccinate against St. pneumoniae. Another single center trial (Tennessee, 2007) for APV at ED obtained an improvement (from 38.8 to 45.4%) when physicians were alerted for pneumococcal risk by the software they usually utilized at bedside. However these experiences remain sparse as additional dedicated resources are required or patients and attending ED physicians can be reluctant to proceed to vaccination at ED.

Mobile phone and derived communication modalities are current vectors to deliver information in several fields including education and medicine. Initially used in developing countries, short-message services (SMS) have improved behaviour of patients in various medical areas. In France, the investigators have observed that most patients above 50 years of age admitted after ED visit are equipped with mobile phone and can receive alerts by SMS.

These observations prompt us to propose a multifaceted procedure to improve APV after ED visit in at-risk patients, combining structured oral interview, written information and SMS as reminders.

Purpose : The investigators hypothesized that

  • a multifaceted intervention to promote anti-pneumococcal vaccination combining a structured oral interview, a written information to patient and his/her general practitioner, and a series of 3 SMS,
  • improves anti-pneumococcal vaccination at 6 months,
  • in at-risk patients (65+ years) visiting the emergency department. In order to answer this question, the investigators designed an interventional prospective multicenter randomized study (cluster).

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

1475

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 摩纳哥
      • Monaco、摩纳哥、98000
        • Centre Hospitalier Princesse Grace
  • 法国
      • Clermont-ferrand、法国、63003
        • Centre Hospitalier Universitaire de Clermont-Ferrand
      • Issoire、法国、63503
        • Centre Hospitalier Paul Ardier
      • Marseille、法国、13015
        • AP-HM - Hôpital Nord
      • Marseille、法国、13385
        • AP-HM - La Timone
      • Marseille、法国、13915
        • Hia Laveran
      • Menton、法国、06507
        • Centre Hospitalier La Palmosa
      • Nice、法国、06003
        • Centre Hospitalier Universitaire De Nice
      • Orange、法国、84106
        • Centre Hospitalier Louis Giorgi
      • Paris、法国、75010
        • Hôpital Lariboisière
      • Paris、法国、75679
        • Hôpital Cochin
      • Paris、法国、75020
        • Hôpital Tenon
      • Paris、法国、75018
        • Hôpital Bichat-Claude Bernard
      • Paris、法国、75013
        • Hôpital Pitié-Salpêtrière
      • Saint-denis、法国、93200
        • Centre Hospitalier de Saint-Denis
      • Vaison-la-romaine、法国、84110
        • Centre Hospitalier de Vaison-la-Romaine
      • Valreas、法国、84600
        • Centre Hospitalier Jules Niel
      • Vichy、法国、03207
        • Centre Hospitalier Jacques Lacarin

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies

描述

Inclusion Criteria:

  • patients 65-year old and above,
  • benefit from French or Monaco social security a social security.

Exclusion Criteria:

  • refuse to participate,
  • no possibility to receive SMS,
  • impaired cognitive functions and mental status precluding understanding of the study,
  • anticipated barriers precluding adequate follow-up (ex. homeless),
  • previous APV,
  • contraindication to APV,
  • do not understand/read French.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Multifaceted
  • brief structured interview with the physician about pneumococcal risk and vaccination,
  • information sheet delivered to patients with explanation about risk and benefit of APV,
  • letter given to patient for his/her general practitioner stating that the patient is at-risk for pneumococcal infection and could benefit of APV,
  • 3 SMS every 2 weeks to remind patients talking of pneumococcal risk with general practitioner.
Control
  • information sheet delivered to patients with explanation about the aim of the study,
  • brief interview with the physician about study.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Impact of a multifaceted procedure at ED visit on anti-pneumococcal vaccination. (APV) at 6-month. Evaluation criteria : Δ percentage (%) of APV vaccination at 6-month
大体时间：6 month
6 month

次要结果测量

结果测量
措施说明
大体时间
On Flu vaccination at 6-month Δ percentage (%)
大体时间：6 month
number of patients receiving vaccination against flu at 6-month. This issue will be collected by phone (patient, relative or general practioner). This will be a declarative data
6 month
On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)
大体时间：6 month
number of patients who experienced respiratiory tract infection requiring antibiotics or admission. This issue will be collected by phone at 6-month (patient, relative or general practioner). This will be a declarative data
6 month
On death at 6- and 12-month (absolute number of events)
大体时间：6 month
6 month
On death related to infection at 6- and 12-month (absolute number of events)
大体时间：6 month
6 month
Psychosocial evaluation of patients and acceptance / refusal of vaccination
大体时间：6 month
The patient will fil a Psychosocial evaluation questionnaire during the ED visit. To achieve this issue, we will use the socio-economic indicators mobilized in investigations in social epidemiology: sex, age, education, occupation, housing, income and household size. This composite questionnaire will be used for qualitative analysis.
6 month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centre Hospitalier Princesse Grace

合作者

Pfizer
Centre Scientifique de Monaco

调查人员

  • 研究主任：Yann-Erick CLAESSENS, MD-PhD、Centre Hospitalier Princesse Grace
  • 研究主任：Xavier DUVAL, MD-PHD、Groupe Hospitalier Bichat Claude-Bernard
  • 研究主任：José LABARERE, MD、University Hospital, Grenoble
  • 研究主任：Jocelyn RAUDE, PHD、Ecole des Hautes Etudes en Santé Publique

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年11月1日

初级完成 (实际的)

2016年10月1日

研究完成 (实际的)

2017年10月1日

研究注册日期

首次提交

2013年7月4日

首先提交符合 QC 标准的

2013年7月11日

首次发布 (估计)

2013年7月15日

研究记录更新

最后更新发布 (实际的)

2020年1月23日

上次提交的符合 QC 标准的更新

2020年1月22日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 12-09
  • 2013-A00943-42 (其他标识符：ANSM)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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