An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department

NCT ID: NCT01899365

Last Updated: 2020-01-23

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1475 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Scientifique de Monaco

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role collaborator

Centre Hospitalier Princesse Grace

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Centre Hospitalier Paul Ardier

Issoire, , France

Site Status

AP-HM - Hôpital Nord

Marseille, , France

Site Status

AP-HM - La Timone

Marseille, , France

Site Status

HIA Laveran

Marseille, , France

Site Status

Centre Hospitalier La Palmosa

Menton, , France

Site Status

Centre Hospitalier Universitaire de Nice

Nice, , France

Site Status

Centre Hospitalier Louis Giorgi

Orange, , France

Site Status

Hôpital Lariboisière

Paris, , France

Site Status

Hôpital Pitié-Salpêtrière

Paris, , France

Site Status

Hôpital Bichat-Claude Bernard

Paris, , France

Site Status

Hôpital Tenon

Paris, , France

Site Status

Hôpital Cochin

Paris, , France

Site Status

Centre hospitalier de Saint-Denis

Saint-Denis, , France

Site Status

Centre Hospitalier de Vaison-la-Romaine

Vaison-la-Romaine, , France

Site Status

Centre Hospitalier Jules Niel

Valréas, , France

Site Status

Centre Hospitalier Jacques Lacarin

Vichy, , France

Site Status

Centre Hospitalier Princesse Grace

Monaco, , Monaco

Site Status

Countries

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France Monaco

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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