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An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department (IMPROVED)

22. januar 2020 opdateret af: Centre Hospitalier Princesse Grace

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).

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1475

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Clermont-ferrand, Frankrig, 63003
        • Centre Hospitalier Universitaire de Clermont-Ferrand
      • Issoire, Frankrig, 63503
        • Centre Hospitalier Paul Ardier
      • Marseille, Frankrig, 13015
        • AP-HM - Hôpital Nord
      • Marseille, Frankrig, 13385
        • AP-HM - La Timone
      • Marseille, Frankrig, 13915
        • Hia Laveran
      • Menton, Frankrig, 06507
        • Centre Hospitalier La Palmosa
      • Nice, Frankrig, 06003
        • Centre Hospitalier Universitaire de Nice
      • Orange, Frankrig, 84106
        • Centre Hospitalier Louis Giorgi
      • Paris, Frankrig, 75010
        • Hôpital Lariboisière
      • Paris, Frankrig, 75679
        • Hôpital Cochin
      • Paris, Frankrig, 75020
        • Hopital Tenon
      • Paris, Frankrig, 75018
        • Hopital Bichat-Claude Bernard
      • Paris, Frankrig, 75013
        • Hopital Pitie-Salpetriere
      • Saint-denis, Frankrig, 93200
        • Centre Hospitalier de Saint-Denis
      • Vaison-la-romaine, Frankrig, 84110
        • Centre Hospitalier de Vaison-la-Romaine
      • Valreas, Frankrig, 84600
        • Centre Hospitalier Jules Niel
      • Vichy, Frankrig, 03207
        • Centre Hospitalier Jacques Lacarin
  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Multifaceted
  • brief structured interview with the physician about pneumococcal risk and vaccination,
  • information sheet delivered to patients with explanation about risk and benefit of APV,
  • letter given to patient for his/her general practitioner stating that the patient is at-risk for pneumococcal infection and could benefit of APV,
  • 3 SMS every 2 weeks to remind patients talking of pneumococcal risk with general practitioner.
Control
  • information sheet delivered to patients with explanation about the aim of the study,
  • brief interview with the physician about study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 6 month
6 month

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
On Flu vaccination at 6-month Δ percentage (%)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 6 month
6 month
On death related to infection at 6- and 12-month (absolute number of events)
Tidsramme: 6 month
6 month
Psychosocial evaluation of patients and acceptance / refusal of vaccination
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Centre Hospitalier Princesse Grace

Samarbejdspartnere

Pfizer
Centre Scientifique de Monaco

Efterforskere

  • Studieleder: Yann-Erick CLAESSENS, MD-PhD, Centre Hospitalier Princesse Grace
  • Studieleder: Xavier DUVAL, MD-PHD, Groupe Hospitalier Bichat Claude-Bernard
  • Studieleder: José LABARERE, MD, University Hospital, Grenoble
  • Studieleder: Jocelyn RAUDE, PHD, Ecole des Hautes Etudes en Santé Publique

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2015

Primær færdiggørelse (Faktiske)

1. oktober 2016

Studieafslutning (Faktiske)

1. oktober 2017

Datoer for studieregistrering

Først indsendt

4. juli 2013

Først indsendt, der opfyldte QC-kriterier

11. juli 2013

Først opslået (Skøn)

15. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. januar 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2020

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12-09
  • 2013-A00943-42 (Anden identifikator: ANSM)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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