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

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

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).

Study Overview

• Status: Completed
• Conditions: Pneumococcal Infections

• Study Type: Observational
• Enrollment (Actual): 1475

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63003
    • Centre Hospitalier Universitaire de Clermont-Ferrand
  • Issoire, France, 63503
    • Centre Hospitalier Paul Ardier
  • Marseille, France, 13015
    • AP-HM - Hôpital Nord
  • Marseille, France, 13385
    • AP-HM - La Timone
  • Marseille, France, 13915
    • Hia Laveran
  • Menton, France, 06507
    • Centre Hospitalier La Palmosa
  • Nice, France, 06003
    • Centre Hospitalier Universitaire de Nice
  • Orange, France, 84106
    • Centre Hospitalier Louis Giorgi
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Paris, France, 75679
    • Hôpital Cochin
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75018
    • Hopital Bichat-Claude Bernard
  • Paris, France, 75013
    • Hopital Pitie-Salpetriere
  • Saint-denis, France, 93200
    • Centre Hospitalier de Saint-Denis
  • Vaison-la-romaine, France, 84110
    • Centre Hospitalier de Vaison-la-Romaine
  • Valreas, France, 84600
    • Centre Hospitalier Jules Niel
  • Vichy, France, 03207
    • Centre Hospitalier Jacques Lacarin
• Monaco
  • Monaco, Monaco, 98000
    • Centre Hospitalier Princesse Grace

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
On Flu vaccination at 6-month Δ percentage (%)	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	6 month
On episodes of respiratory tract infections requiring antibiotics or admission at 6-month Δ (absolute number of events)	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	6 month
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
Psychosocial evaluation of patients and acceptance / refusal of vaccination	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.	6 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Princesse Grace
• Collaborators: Pfizer; Centre Scientifique de Monaco
• 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: July 4, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: emergency department; information; anti-pneumococcal vaccination
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Emergencies; Pneumococcal Infections
• Other Study ID Numbers: 12-09; 2013-A00943-42 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO