An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department
NCT ID: NCT01899365
Last Updated: 2020-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1475 participants
OBSERVATIONAL
2015-11-30
2017-10-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Control
* information sheet delivered to patients with explanation about the aim of the study,
* brief interview with the physician about study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* benefit from French or Monaco social security a social security.
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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Centre Scientifique de Monaco
OTHER
Pfizer
INDUSTRY
Centre Hospitalier Princesse Grace
OTHER
Responsible Party
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Principal Investigators
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Yann-Erick CLAESSENS, MD-PHD
Role: STUDY_DIRECTOR
Centre Hospitalier Princesse Grace
Xavier DUVAL, MD-PHD
Role: STUDY_DIRECTOR
Groupe Hospitalier Bichat Claude-Bernard
José LABARERE, MD
Role: STUDY_DIRECTOR
University Hospital, Grenoble
Jocelyn RAUDE, PHD
Role: STUDY_DIRECTOR
Ecole des Hautes Etudes en Santé Publique
Locations
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Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
Centre Hospitalier Paul Ardier
Issoire, , France
AP-HM - Hôpital Nord
Marseille, , France
AP-HM - La Timone
Marseille, , France
HIA Laveran
Marseille, , France
Centre Hospitalier La Palmosa
Menton, , France
Centre Hospitalier Universitaire de Nice
Nice, , France
Centre Hospitalier Louis Giorgi
Orange, , France
Hôpital Lariboisière
Paris, , France
Hôpital Pitié-Salpêtrière
Paris, , France
Hôpital Bichat-Claude Bernard
Paris, , France
Hôpital Tenon
Paris, , France
Hôpital Cochin
Paris, , France
Centre hospitalier de Saint-Denis
Saint-Denis, , France
Centre Hospitalier de Vaison-la-Romaine
Vaison-la-Romaine, , France
Centre Hospitalier Jules Niel
Valréas, , France
Centre Hospitalier Jacques Lacarin
Vichy, , France
Centre Hospitalier Princesse Grace
Monaco, , Monaco
Countries
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Other Identifiers
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2013-A00943-42
Identifier Type: OTHER
Identifier Source: secondary_id
12-09
Identifier Type: -
Identifier Source: org_study_id
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