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).
연구 개요
상태
정황
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Monaco, 모나코, 98000
- Centre Hospitalier Princesse Grace
-
-
-
-
-
Clermont-ferrand, 프랑스, 63003
- Centre Hospitalier Universitaire de Clermont-Ferrand
-
Issoire, 프랑스, 63503
- Centre Hospitalier Paul Ardier
-
Marseille, 프랑스, 13015
- AP-HM - Hôpital Nord
-
Marseille, 프랑스, 13385
- AP-HM - La Timone
-
Marseille, 프랑스, 13915
- Hia Laveran
-
Menton, 프랑스, 06507
- Centre Hospitalier La Palmosa
-
Nice, 프랑스, 06003
- Centre Hospitalier Universitaire De Nice
-
Orange, 프랑스, 84106
- Centre Hospitalier Louis Giorgi
-
Paris, 프랑스, 75010
- Hôpital Lariboisière
-
Paris, 프랑스, 75679
- Hôpital Cochin
-
Paris, 프랑스, 75020
- Hôpital Tenon
-
Paris, 프랑스, 75018
- Hôpital Bichat-Claude Bernard
-
Paris, 프랑스, 75013
- Hôpital Pitié-Salpêtrière
-
Saint-denis, 프랑스, 93200
- Centre Hospitalier de Saint-Denis
-
Vaison-la-romaine, 프랑스, 84110
- Centre Hospitalier de Vaison-la-Romaine
-
Valreas, 프랑스, 84600
- Centre Hospitalier Jules Niel
-
Vichy, 프랑스, 03207
- Centre Hospitalier Jacques Lacarin
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Multifaceted
|
|
Control
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
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
기간: 6 month
|
6 month
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
On Flu vaccination at 6-month Δ percentage (%)
기간: 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)
기간: 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)
기간: 6 month
|
6 month
|
|
|
On death related to infection at 6- and 12-month (absolute number of events)
기간: 6 month
|
6 month
|
|
|
Psychosocial evaluation of patients and acceptance / refusal of vaccination
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Yann-Erick CLAESSENS, MD-PhD, Centre Hospitalier Princesse Grace
- 연구 책임자: Xavier DUVAL, MD-PHD, Groupe Hospitalier Bichat Claude-Bernard
- 연구 책임자: José LABARERE, MD, University Hospital, Grenoble
- 연구 책임자: Jocelyn RAUDE, PHD, Ecole des Hautes Etudes en Santé Publique
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 12-09
- 2013-A00943-42 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .