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
  Purpose

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?


Condition Intervention
Influenza
Drug: Influenza Vaccination
Behavioral: Education and referral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Influenza Vaccination in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Vaccination status [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 140
Study Start Date: November 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccination group
Vaccination group
Drug: Influenza Vaccination
0.5 mL Sanofi-Pasteur intramuscular influenza vaccination
Experimental: Education/referral
Education/referral
Behavioral: Education and referral
Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822627

Locations
United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Katherine M Hiller, MD University of Arizona Department of Emergency Medicine
  More Information

No publications provided

Responsible Party: Katherine M Hiller, MD, Department of Emergency Medicine
ClinicalTrials.gov Identifier: NCT00822627     History of Changes
Other Study ID Numbers: 1
Study First Received: January 12, 2009
Last Updated: January 13, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Influenza
vaccination
Emergency Department

Additional relevant MeSH terms:
Influenza, Human
Emergencies
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014