Clinical trial NCT01899365: An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department
Official title: An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Infections
Keywords: anti-pneumococcal vaccination
information
emergency department
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
Collaborators: name: Centre Scientifique de Monaco
name: Pfizer
First posted: 2013-07-15
Enrollment: 1475
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies

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).


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.

Primary outcomes:
measure: 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
timeFrame: 6 month
Secondary outcomes:
measure: On Flu vaccination at 6-month Δ percentage (%)
timeFrame: 6 month
measure: On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)
timeFrame: 6 month
measure: On death at 6- and 12-month (absolute number of events)
timeFrame: 6 month
measure: On death related to infection at 6- and 12-month (absolute number of events)
timeFrame: 6 month
measure: Psychosocial evaluation of patients and acceptance / refusal of vaccination
timeFrame: 6 month
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand
city: Issoire
country: France
facility: Centre Hospitalier Paul Ardier
city: Marseille
country: France
facility: AP-HM - Hôpital Nord
city: Marseille
country: France
facility: AP-HM - La Timone
city: Marseille
country: France
facility: HIA Laveran
city: Menton
country: France
facility: Centre Hospitalier La Palmosa
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Orange
country: France
facility: Centre Hospitalier Louis Giorgi
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière
city: Paris
country: France
facility: Hôpital Bichat-Claude Bernard
city: Paris
country: France
facility: Hôpital Tenon
city: Paris
country: France
facility: Hôpital Cochin
city: Saint-denis
country: France
facility: Centre hospitalier de Saint-Denis
city: Vaison-la-romaine
country: France
facility: Centre Hospitalier de Vaison-la-Romaine
city: Valreas
country: France
facility: Centre Hospitalier Jules Niel
city: Vichy
country: France
facility: Centre Hospitalier Jacques Lacarin
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
affiliation: Centre Hospitalier Princesse Grace
name: Yann-Erick CLAESSENS, MD-PHD
role: STUDY_DIRECTOR
affiliation: Groupe Hospitalier Bichat Claude-Bernard
name: Xavier DUVAL, MD-PHD
role: STUDY_DIRECTOR
affiliation: University Hospital, Grenoble
name: José LABARERE, MD
role: STUDY_DIRECTOR
affiliation: Ecole des Hautes Etudes en Santé Publique
name: Jocelyn RAUDE, PHD
role: STUDY_DIRECTOR
References: