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An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department

NCT01899365 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1475

Last updated 2020-01-23

No results posted yet for this study

Summary

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).

Conditions

  • Pneumococcal Infections

Sponsors & Collaborators

  • Centre Scientifique de Monaco

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • Centre Hospitalier Princesse Grace

    lead OTHER

Principal Investigators

  • Yann-Erick CLAESSENS, MD-PHD · Centre Hospitalier Princesse Grace

  • Xavier DUVAL, MD-PHD · Groupe Hospitalier Bichat Claude-Bernard

  • José LABARERE, MD · University Hospital, Grenoble

  • Jocelyn RAUDE, PHD · Ecole des Hautes Etudes en Santé Publique

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-10-31
Completion
2017-10-31

Countries

  • France
  • Monaco

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01899365 on ClinicalTrials.gov