Influenza Vaccination in the Emergency Department

This study has been completed.
Sponsor:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00822627
First received: January 12, 2009
Last updated: January 13, 2009
Last verified: January 2009

January 12, 2009
January 13, 2009
November 2007
April 2008   (final data collection date for primary outcome measure)
Vaccination status [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822627 on ClinicalTrials.gov Archive Site
  • Influenza rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Influenza-like illness rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
  • Visits to medical providers [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influenza Vaccination in the Emergency Department
Influenza Vaccination in the Emergency Department

Randomized controlled trial of influenza vaccination versus referral for vaccination in the Emergency department. Is the Emergency Department an effective venue for vaccination for influenza? Does vaccination for influenza in the Emergency Department change the rates of influenza, influenza-like-illness or medical provider visits when compared with patient referred for vaccination in the community?

This study is a prospective randomized, controlled trial of influenza vaccination vs referral for influenza vaccination in the Emergency Department. Subjects are either offered vaccination or education regarding vaccination and a list of community providers. At a four-month follow up, rates of influenza, influenza-like illness and number of medical provider visits are determined.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Influenza
  • Drug: Influenza Vaccination
    0.5 mL Sanofi-Pasteur intramuscular influenza vaccination
  • Behavioral: Education and referral
    Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination
  • Experimental: Vaccination group
    Vaccination group
    Intervention: Drug: Influenza Vaccination
  • Experimental: Education/referral
    Education/referral
    Intervention: Behavioral: Education and referral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute:
  • Age 6-59 months or >50 years
  • Pregnant
  • Health care worker
  • Aged 6 months-18 years on chronic aspirin therapy
  • Comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year)
  • Household contact or caregiver of someone with at least one high risk attribute

Exclusion Criteria:

  • Prior vaccination
  • History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination
  • Allergy to influenza vaccination or eggs
  • Age < 6 months old
  • Fever with more than minor illness
  • Hospitalization
Both
6 Months and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00822627
1
No
Katherine M Hiller, MD, Department of Emergency Medicine
University of Arizona
Not Provided
Principal Investigator: Katherine M Hiller, MD University of Arizona Department of Emergency Medicine
University of Arizona
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP