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Clinical Trials/NCT01899365
NCT01899365
Completed
Not Applicable

An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project

Centre Hospitalier Princesse Grace18 sites in 2 countries1,475 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pneumococcal Infections
Sponsor
Centre Hospitalier Princesse Grace
Enrollment
1475
Locations
18
Primary Endpoint
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
Status
Completed
Last Updated
6 years ago

Overview

Brief 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).
Registry
clinicaltrials.gov
Start Date
November 2015
End Date
October 2017
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • On death at 6- and 12-month (absolute number of events)(6 month)
  • On death related to infection at 6- and 12-month (absolute number of events)(6 month)
  • On Flu vaccination at 6-month Δ percentage (%)(6 month)
  • On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)(6 month)
  • Psychosocial evaluation of patients and acceptance / refusal of vaccination(6 month)

Study Sites (18)

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