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).
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Clermont-ferrand, Frankrijk, 63003
- Centre Hospitalier Universitaire de Clermont-Ferrand
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Issoire, Frankrijk, 63503
- Centre Hospitalier Paul Ardier
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Marseille, Frankrijk, 13015
- AP-HM - Hôpital Nord
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Marseille, Frankrijk, 13385
- AP-HM - La Timone
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Marseille, Frankrijk, 13915
- Hia Laveran
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Menton, Frankrijk, 06507
- Centre Hospitalier La Palmosa
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Nice, Frankrijk, 06003
- Centre Hospitalier Universitaire De Nice
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Orange, Frankrijk, 84106
- Centre Hospitalier Louis Giorgi
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Paris, Frankrijk, 75010
- Hôpital Lariboisière
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Paris, Frankrijk, 75679
- Hôpital Cochin
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Paris, Frankrijk, 75020
- Hôpital Tenon
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Paris, Frankrijk, 75018
- Hôpital Bichat-Claude Bernard
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Paris, Frankrijk, 75013
- Hôpital Pitié-Salpêtrière
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Saint-denis, Frankrijk, 93200
- Centre Hospitalier de Saint-Denis
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Vaison-la-romaine, Frankrijk, 84110
- Centre Hospitalier de Vaison-la-Romaine
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Valreas, Frankrijk, 84600
- Centre Hospitalier Jules Niel
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Vichy, Frankrijk, 03207
- Centre Hospitalier Jacques Lacarin
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Monaco, Monaco, 98000
- Centre Hospitalier Princesse Grace
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Multifaceted
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Control
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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
Tijdsspanne: 6 month
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6 month
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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On Flu vaccination at 6-month Δ percentage (%)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 6 month
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6 month
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Psychosocial evaluation of patients and acceptance / refusal of vaccination
Tijdsspanne: 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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Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Yann-Erick CLAESSENS, MD-PhD, Centre Hospitalier Princesse Grace
- Studie directeur: Xavier DUVAL, MD-PHD, Groupe Hospitalier Bichat Claude-Bernard
- Studie directeur: José LABARERE, MD, University Hospital, Grenoble
- Studie directeur: Jocelyn RAUDE, PHD, Ecole des Hautes Etudes en Santé Publique
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12-09
- 2013-A00943-42 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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