An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department

NCT01899365 | Completed DMC

• 2 other identifiers: 12-092013-A00943-42
• Study Type: observational
• Target: 1,475
• Locations: 2 countries
• Sites: 18

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).

Conditions

Pneumococcal Infections

Keywords

anti-pneumococcal vaccination; information; emergency department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

  6 month

Study Arms (2)

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 Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• patients 65-year old and above,
• benefit from French or Monaco social security a social security.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead
• Centre Scientifique de Monaco: collaborator
• Pfizer: collaborator

Study Sites (18)

Centre Hospitalier Universitaire de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Centre Hospitalier Paul Ardier

Issoire, 63503, France

Location

AP-HM - Hôpital Nord

Marseille, 13015, France

Location

AP-HM - La Timone

Marseille, 13385, France

Location

HIA Laveran

Marseille, 13915, France

Location

Centre Hospitalier La Palmosa

Menton, 06507, France

Location

Centre Hospitalier Universitaire de Nice

Nice, 06003, France

Location

Centre Hospitalier Louis Giorgi

Orange, 84106, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

Location

Hôpital Bichat-Claude Bernard

Paris, 75018, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Centre hospitalier de Saint-Denis

Saint-Denis, 93200, France

Location

Centre Hospitalier de Vaison-la-Romaine

Vaison-la-Romaine, 84110, France

Location

Centre Hospitalier Jules Niel

Valréas, 84600, France

Location

Centre Hospitalier Jacques Lacarin

Vichy, 03207, France

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Pneumococcal Infections; Emergencies

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: July 15, 2013
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2017
• Last Updated: January 23, 2020

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (17); MO (1)