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).
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Clermont-ferrand, France, 63003
- Centre Hospitalier Universitaire de Clermont-Ferrand
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Issoire, France, 63503
- Centre Hospitalier Paul Ardier
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Marseille, France, 13015
- AP-HM - Hôpital Nord
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Marseille, France, 13385
- AP-HM - La Timone
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Marseille, France, 13915
- Hia Laveran
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Menton, France, 06507
- Centre Hospitalier La Palmosa
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Nice, France, 06003
- Centre Hospitalier Universitaire De Nice
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Orange, France, 84106
- Centre Hospitalier Louis Giorgi
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Paris, France, 75010
- Hôpital Lariboisière
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Paris, France, 75679
- Hôpital Cochin
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Paris, France, 75020
- Hôpital Tenon
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Paris, France, 75018
- Hôpital Bichat-Claude Bernard
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Paris, France, 75013
- Hôpital Pitié-Salpêtrière
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Saint-denis, France, 93200
- Centre Hospitalier de Saint-Denis
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Vaison-la-romaine, France, 84110
- Centre Hospitalier de Vaison-la-Romaine
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Valreas, France, 84600
- Centre Hospitalier Jules Niel
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Vichy, France, 03207
- Centre Hospitalier Jacques Lacarin
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Monaco, Monaco, 98000
- Centre Hospitalier Princesse Grace
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Multifaceted
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Control
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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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
Délai: 6 month
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6 month
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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On Flu vaccination at 6-month Δ percentage (%)
Délai: 6 month
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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
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6 month
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On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)
Délai: 6 month
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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
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6 month
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On death at 6- and 12-month (absolute number of events)
Délai: 6 month
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6 month
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On death related to infection at 6- and 12-month (absolute number of events)
Délai: 6 month
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6 month
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Psychosocial evaluation of patients and acceptance / refusal of vaccination
Délai: 6 month
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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.
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6 month
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Yann-Erick CLAESSENS, MD-PhD, Centre Hospitalier Princesse Grace
- Directeur d'études: Xavier DUVAL, MD-PHD, Groupe Hospitalier Bichat Claude-Bernard
- Directeur d'études: José LABARERE, MD, University Hospital, Grenoble
- Directeur d'études: Jocelyn RAUDE, PHD, Ecole des Hautes Etudes en Santé Publique
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 12-09
- 2013-A00943-42 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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