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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 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: August 6, 2013
Last verified: August 2013
  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 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (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
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, PU-PH +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, PU-PH         
Principal Investigator: Jeannot SCHMIDT, PU-PH         
Centre Hospitalier Paul Ardier Not yet recruiting
Issoire, France, 63503
Contact: Laure JAINSKY, Doctor         
Principal Investigator: Laure JAINSKY, Doctor         
AP-HM - La Timone Not yet recruiting
Marseille, France, 13385
Contact: Pierre MICHELET, PU-PH         
Principal Investigator: Pierre MICHELET, PU-PH         
AP-HM - La Conception Not yet recruiting
Marseille, France, 13915
Contact: Pierre MICHELET, PU-PH         
Principal Investigator: Pierre MICHELET, PU-PH         
Centre Hospitalier La Palmosa Not yet recruiting
Menton, France, 06507
Contact: Véronique MATTEI, Doctor         
Principal Investigator: Véronique MATTEI, Doctor         
Centre Hospitalier Universitaire de Nice Not yet recruiting
Nice, France, 06003
Contact: Jacques LEVRAUT, PU-PH         
Principal Investigator: Jacques LEVRAUT, PU-PH         
Centre Hospitalier Louis Giorgi Not yet recruiting
Orange, France, 84106
Contact: Guillaume DER SAHAKIAN, Doctor         
Principal Investigator: Guillaume DER SAHAKIAN, Doctor         
Hôpital Lariboisière Not yet recruiting
Paris, France, 75010
Contact: Patrick PLAISANCE, PU-PH         
Principal Investigator: Patrick PLAISANCE, PU-PH         
Hôpital Cochin Not yet recruiting
Paris, France, 75014
Contact: Bertrand RENAUD, PU-PH         
Principal Investigator: Bertrand RENAUD, PU-PH         
Hôpital Bichat-Claude Bernard Not yet recruiting
Paris, France, 75018
Contact: Christophe CHOQUET, Doctor         
Principal Investigator: Christophe CHOQUET, Doctor         
Hôpital Tenon Not yet recruiting
Paris, France, 75020
Contact: Patrick RAY, PU-PH         
Principal Investigator: Patrick RAY, PU-PH         
Hôpital Pitié-Salpêtrière Not yet recruiting
Paris, France, 75013
Contact: Pierre HAUSFATER, PU-PH         
Principal Investigator: Pierre HAUSFATER, PU-PH         
Centre hospitalier de Saint-Denis Not yet recruiting
Saint-denis, France, 93200
Contact: Benoit DOUMENC, Doctor         
Principal Investigator: Benoit DOUMENC, Doctor         
Centre Hospitalier intercommunal de Toulon - La Seyne sur mer Not yet recruiting
Toulon, France, 83056
Contact: Vincent CARRET, Doctor         
Principal Investigator: Vincent CARRET, Doctor         
Centre Hospitalier de Vaison-la-Romaine Not yet recruiting
Vaison-la-romaine, France, 84110
Contact: Guillaume DER SAHAKIAN, Doctor         
Principal Investigator: Guillaume DER SAHAKIAN, Doctor         
Centre Hospitalier Jules Niel
Valreas, France, 84600
Centre Hospitalier Jacques Lacarin Not yet recruiting
Vichy, France, 03207
Contact: Didier STORME, Doctor         
Principal Investigator: Didier STORME, Doctor         
Monaco
Centre Hospitalier Princesse Grace Not yet recruiting
Monaco, Monaco, 98000
Contact: Nicolas RIJO, ARC    37797988445    recherche.clinique@chpg.mc   
Principal Investigator: Yann-Erick CLAESSENS, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Princesse Grace
Centre Scientifique de Monaco
Pfizer
Investigators
Study Director: Yann-Erick CLAESSENS, PU-PH Centre Hospitalier Princesse Grace
Study Director: Xavier DUVAL, PU-PH Groupe Hospitalier Bichat Claude-Bernard
Study Director: José LABARERE, Doctor University Hospital, Grenoble
Study Director: Jocelyn RAUDE, PhD EHESP School of Public Health
  More Information

No publications provided

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: August 6, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Monaco : Comité Consultatif d'Ethique en Matière de Recherche Biomédicale

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

Additional relevant MeSH terms:
Emergencies
Pneumococcal Infections
Bacterial Infections
Disease Attributes
Gram-Positive Bacterial Infections
Pathologic Processes
Streptococcal Infections

ClinicalTrials.gov processed this record on October 23, 2014