An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department (IMPROVED)
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).
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Clermont-ferrand、フランス、63003
- Centre Hospitalier Universitaire de Clermont-Ferrand
-
Issoire、フランス、63503
- Centre Hospitalier Paul Ardier
-
Marseille、フランス、13015
- AP-HM - Hôpital Nord
-
Marseille、フランス、13385
- AP-HM - La Timone
-
Marseille、フランス、13915
- Hia Laveran
-
Menton、フランス、06507
- Centre Hospitalier La Palmosa
-
Nice、フランス、06003
- Centre Hospitalier Universitaire De Nice
-
Orange、フランス、84106
- Centre Hospitalier Louis Giorgi
-
Paris、フランス、75010
- Hôpital Lariboisière
-
Paris、フランス、75679
- Hôpital Cochin
-
Paris、フランス、75020
- Hôpital Tenon
-
Paris、フランス、75018
- Hôpital Bichat-Claude Bernard
-
Paris、フランス、75013
- Hôpital Pitié-Salpêtrière
-
Saint-denis、フランス、93200
- Centre Hospitalier de Saint-Denis
-
Vaison-la-romaine、フランス、84110
- Centre Hospitalier de Vaison-la-Romaine
-
Valreas、フランス、84600
- Centre Hospitalier Jules Niel
-
Vichy、フランス、03207
- Centre Hospitalier Jacques Lacarin
-
-
-
-
-
Monaco、モナコ、98000
- Centre Hospitalier Princesse Grace
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
|
Multifaceted
|
|
Control
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠：6 month
|
6 month
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
On Flu vaccination at 6-month Δ percentage (%)
時間枠：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)
時間枠：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)
時間枠：6 month
|
6 month
|
|
|
On death related to infection at 6- and 12-month (absolute number of events)
時間枠：6 month
|
6 month
|
|
|
Psychosocial evaluation of patients and acceptance / refusal of vaccination
時間枠：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
|
協力者と研究者
捜査官
- スタディディレクター：Yann-Erick CLAESSENS, MD-PhD、Centre Hospitalier Princesse Grace
- スタディディレクター：Xavier DUVAL, MD-PHD、Groupe Hospitalier Bichat Claude-Bernard
- スタディディレクター：José LABARERE, MD、University Hospital, Grenoble
- スタディディレクター：Jocelyn RAUDE, PHD、Ecole des Hautes Etudes en Santé Publique
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。