An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department (IMPROVED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Centre Hospitalier Princesse Grace
Sponsor:
Collaborators:
Centre Scientifique de Monaco
Pfizer
Information provided by (Responsible Party):
Centre Hospitalier Princesse Grace
ClinicalTrials.gov Identifier:
NCT01899365
First received: July 4, 2013
Last updated: March 4, 2016
Last verified: March 2016
  Purpose

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).

Condition
Pneumococcal Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Princesse Grace:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • On Flu vaccination at 6-month Δ percentage (%) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    number of patients receiving vaccination against flu at 6-month. This issue will be collected by phone (patient, relative or general practioner). This will be a declarative data

  • On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    number of patients who experienced respiratiory tract infection requiring antibiotics or admission. This issue will be collected by phone at 6-month (patient, relative or general practioner). This will be a declarative data

  • On death at 6- and 12-month (absolute number of events) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • On death related to infection at 6- and 12-month (absolute number of events) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
  • Psychosocial evaluation of patients and acceptance / refusal of vaccination [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    The patient will fil a Psychosocial evaluation questionnaire during the ED visit. To achieve this issue, we will use the socio-economic indicators mobilized in investigations in social epidemiology: sex, age, education, occupation, housing, income and household size. This composite questionnaire will be used for qualitative analysis.


Estimated Enrollment: 1800
Study Start Date: October 2015
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
Control
  • information sheet delivered to patients with explanation about the aim of the study,
  • brief interview with the physician about study.

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899365

Contacts
Contact: Yann-Erick CLAESSENS, MD-PHD +377 97 98 39 69 yann-erick.claessens@chpg.mc

Locations
France
Centre Hospitalier Universitaire de Clermont-Ferrand Not yet recruiting
Clermont-ferrand, France, 63003
Contact: Jeannot SCHMIDT, MD-PHD         
Principal Investigator: Jeannot SCHMIDT, MD-PHD         
Centre Hospitalier Paul Ardier Not yet recruiting
Issoire, France, 63503
Contact: Laure JAINSKY, MD         
Principal Investigator: Laure JAINSKY, MD         
AP-HM - Hôpital Nord Not yet recruiting
Marseille, France, 13015
Contact: Fleur JOURDA DE VAUX, MD         
Principal Investigator: Fleur JOURDA DE VAUX, MD         
AP-HM - La Timone Not yet recruiting
Marseille, France, 13385
Contact: Pierre MICHELET, MD-PHD         
Principal Investigator: Pierre MICHELET, MD-PHD         
HIA Laveran Not yet recruiting
Marseille, France, 13915
Contact: Olivier GACIA, MD         
Principal Investigator: Olivier GACIA, MD         
Centre Hospitalier La Palmosa Recruiting
Menton, France, 06507
Contact: Véronique MATTEI, MD         
Principal Investigator: Véronique MATTEI, MD         
Centre Hospitalier Universitaire de Nice Active, not recruiting
Nice, France, 06003
Centre Hospitalier Louis Giorgi Not yet recruiting
Orange, France, 84106
Contact: Guillaume DER SAHAKIAN, MD         
Principal Investigator: Guillaume DER SAHAKIAN, MD         
Hôpital Cochin Recruiting
Paris, France, 75679
Contact: Benoit DOUMENC, MD         
Principal Investigator: Benoit DOUMENC, MD         
Hôpital Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Pierre HAUSFATER, MD-PHD         
Principal Investigator: Pierre HAUSFATER, MD-PHD         
Hôpital Bichat-Claude Bernard Recruiting
Paris, France, 75018
Contact: Christophe CHOQUET, MD         
Principal Investigator: Christophe CHOQUET, MD         
Hôpital Lariboisière Recruiting
Paris, France, 75010
Contact: Patrick PLAISANCE, MD-PHD         
Principal Investigator: Patrick PLAISANCE, MD-PHD         
Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Patrick RAY, MD-PHD         
Principal Investigator: Patrick RAY, MD-PHD         
Centre hospitalier de Saint-Denis Recruiting
Saint-denis, France, 93200
Contact: Marie-Clément KOUKA, MD         
Principal Investigator: Marie-Clément KOUKA, MD         
Centre Hospitalier de Vaison-la-Romaine Not yet recruiting
Vaison-la-romaine, France, 84110
Contact: Guillaume DER SAHAKIAN, MD         
Principal Investigator: Guillaume DER SAHAKIAN, MD         
Centre Hospitalier Jules Niel Not yet recruiting
Valreas, France, 84600
Contact: Guillaume DER SAHAKIAN, MD         
Principal Investigator: Guillaume DER SAHAKIAN, MD         
Centre Hospitalier Jacques Lacarin Not yet recruiting
Vichy, France, 03207
Contact: Didier STORME, MD         
Principal Investigator: Didier STORME, MD         
Monaco
Centre Hospitalier Princesse Grace Active, not recruiting
Monaco, Monaco, 98000
Sponsors and Collaborators
Centre Hospitalier Princesse Grace
Centre Scientifique de Monaco
Pfizer
Investigators
Study Director: Yann-Erick CLAESSENS, MD-PHD Centre Hospitalier Princesse Grace
Study Director: Xavier DUVAL, MD-PHD Groupe Hospitalier Bichat Claude-Bernard
Study Director: José LABARERE, MD University Hospital, Grenoble
Study Director: Jocelyn RAUDE, PHD Ecole des Hautes Etudes en Santé Publique
  More Information

Responsible Party: Centre Hospitalier Princesse Grace
ClinicalTrials.gov Identifier: NCT01899365     History of Changes
Other Study ID Numbers: 12-09  2013-A00943-42 
Study First Received: July 4, 2013
Last Updated: March 4, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Monaco : Comité Consultatif d'Ethique en Matière de Recherche Biomédicale
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Princesse Grace:
anti-pneumococcal vaccination
information
emergency department

Additional relevant MeSH terms:
Emergencies
Pneumococcal Infections
Disease Attributes
Pathologic Processes
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2016