An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department

Pneumococcal Infections Clinical Trial

— IMPROVED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899365
• Other study ID #: 12-09
• Secondary ID: 2013-A00943-42
• Status: Completed
• Start date: November 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Princesse Grace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1475
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Pneumococcal Infections

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Clermont-Ferrand	Clermont-ferrand
France	Centre Hospitalier Paul Ardier	Issoire
France	AP-HM - Hôpital Nord	Marseille
France	AP-HM - La Timone	Marseille
France	HIA Laveran	Marseille
France	Centre Hospitalier La Palmosa	Menton
France	Centre Hospitalier Universitaire de Nice	Nice
France	Centre Hospitalier Louis Giorgi	Orange
France	Hôpital Bichat-Claude Bernard	Paris
France	Hôpital Cochin	Paris
France	Hôpital Lariboisière	Paris
France	Hôpital Pitié-Salpêtrière	Paris
France	Hôpital Tenon	Paris
France	Centre hospitalier de Saint-Denis	Saint-denis
France	Centre Hospitalier de Vaison-la-Romaine	Vaison-la-romaine
France	Centre Hospitalier Jules Niel	Valreas
France	Centre Hospitalier Jacques Lacarin	Vichy
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Princesse Grace	Centre Scientifique de Monaco, Pfizer

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of a multifaceted procedure at ED visit on anti-pneumococcal vaccination. (APV) at 6-month. Evaluation criteria : ? percentage (%) of APV vaccination at 6-month		6 month
Secondary	On Flu vaccination at 6-month ? 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
Secondary	On episodes of respiratory tract infections requiring antibiotics or admission at 6-month ? (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
Secondary	On death at 6- and 12-month (absolute number of events)		6 month
Secondary	On death related to infection at 6- and 12-month (absolute number of events)		6 month
Secondary	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