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

Princess Grace Hospital Center (CHPG)

Status: Completed

Conditions: Pneumococcal Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01899365

12-09

2013-A00943-42 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 1,475 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,475 participants in 2 patient groups

Multifaceted

Description:

* 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

Description:

* information sheet delivered to patients with explanation about the aim of the study, * brief interview with the physician about study.