An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department

NCT01899365

Last updated date
Study Location
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-ferrand, , 63003, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- patients 65-year old and above,

- benefit from French or Monaco social security a social security.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department
Official Title An Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department; A Multicenter Prospective Randomized Open Trial The IMPROVED Project
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patient aged 65 years or over who is not vaccinated against pneumoccocus virus during consultation with medical emergencies
Condition Pneumococcal Infections
Intervention Not Provided
Study 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2017)
1475
Original Estimated Enrollment
 (submitted: July 11, 2013)
1800
Actual Study Completion Date October 2017
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Monaco
Removed Location Countries  
 
Administrative Information
NCT Number NCT01899365
Other Study ID Numbers 12-09
2013-A00943-42 ( Other Identifier: ANSM )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Responsible Party Centre Hospitalier Princesse Grace
Study Sponsor Centre Hospitalier Princesse Grace
Collaborators
  • Centre Scientifique de Monaco
  • Pfizer
Investigators
Study Director:Yann-Erick CLAESSENS, MD-PHDCentre Hospitalier Princesse Grace
Study Director:Xavier DUVAL, MD-PHDGroupe Hospitalier Bichat Claude-Bernard
Study Director:José LABARERE, MDUniversity Hospital, Grenoble
Study Director:Jocelyn RAUDE, PHDEcole des Hautes Etudes en Santé Publique
PRS Account Centre Hospitalier Princesse Grace
Verification Date October 2017