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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01899365
First Posted: July 15, 2013
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Centre Scientifique de Monaco
Pfizer
Information provided by (Responsible Party):
Centre Hospitalier Princesse Grace
  Purpose

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).

Condition
Pneumococcal Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Princesse Grace:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 month ]

Secondary Outcome Measures:
  • On Flu vaccination at 6-month Δ percentage (%) [ Time Frame: 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

  • On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events) [ Time Frame: 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

  • On death at 6- and 12-month (absolute number of events) [ Time Frame: 6 month ]
  • On death related to infection at 6- and 12-month (absolute number of events) [ Time Frame: 6 month ]
  • Psychosocial evaluation of patients and acceptance / refusal of vaccination [ Time Frame: 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.


Enrollment: 1475
Actual Study Start Date: November 2015
Estimated Study Completion Date: October 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899365


Locations
France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-ferrand, France, 63003
Centre Hospitalier Paul Ardier
Issoire, France, 63503
AP-HM - Hôpital Nord
Marseille, France, 13015
AP-HM - La Timone
Marseille, France, 13385
HIA Laveran
Marseille, France, 13915
Centre Hospitalier La Palmosa
Menton, France, 06507
Centre Hospitalier Universitaire de Nice
Nice, France, 06003
Centre Hospitalier Louis Giorgi
Orange, France, 84106
Hôpital Lariboisière
Paris, France, 75010
Hôpital Pitié-Salpêtrière
Paris, France, 75013
Hôpital Bichat-Claude Bernard
Paris, France, 75018
Hôpital Tenon
Paris, France, 75020
Hôpital Cochin
Paris, France, 75679
Centre hospitalier de Saint-Denis
Saint-denis, France, 93200
Centre Hospitalier de Vaison-la-Romaine
Vaison-la-romaine, France, 84110
Centre Hospitalier Jules Niel
Valreas, France, 84600
Centre Hospitalier Jacques Lacarin
Vichy, France, 03207
Monaco
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000
Sponsors and Collaborators
Centre Hospitalier Princesse Grace
Centre Scientifique de Monaco
Pfizer
Investigators
Study Director: Yann-Erick CLAESSENS, MD-PHD Centre Hospitalier Princesse Grace
Study Director: Xavier DUVAL, MD-PHD Groupe Hospitalier Bichat Claude-Bernard
Study Director: José LABARERE, MD University Hospital, Grenoble
Study Director: Jocelyn RAUDE, PHD Ecole des Hautes Etudes en Santé Publique
  More Information

Responsible Party: Centre Hospitalier Princesse Grace
ClinicalTrials.gov Identifier: NCT01899365     History of Changes
Other Study ID Numbers: 12-09
2013-A00943-42 ( Other Identifier: ANSM )
First Submitted: July 4, 2013
First Posted: July 15, 2013
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Princesse Grace:
anti-pneumococcal vaccination
information
emergency department

Additional relevant MeSH terms:
Emergencies
Pneumococcal Infections
Disease Attributes
Pathologic Processes
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs