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临床试验/NCT01899365
NCT01899365已完成不适用

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

Centre Hospitalier Princesse Grace18 个研究点 分布在 2 个国家目标入组 1,475 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,475
试验地点
18
主要终点
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

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 6 month

次要结局

  • On death at 6- and 12-month (absolute number of events)(6 month)
  • On death related to infection at 6- and 12-month (absolute number of events)(6 month)
  • On Flu vaccination at 6-month Δ percentage (%)(6 month)
  • On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)(6 month)
  • Psychosocial evaluation of patients and acceptance / refusal of vaccination(6 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (18)

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