Influenza Vaccination in the Emergency Department

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Drug: Influenza Vaccination; Behavioral: Education and referral

• Registration Number: NCT00822627
• Lead Sponsor: University of Arizona

Brief Summary

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?

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.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2009-01
• Study First Submitted: 2009-01-12
• Study First Submitted QC: 2009-01-13
• Last Update Submitted: 2009-01-13
• Study First Posted: 2009-01-14
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccination group	Influenza Vaccination	Vaccination group
Education/referral	Education and referral	Education/referral

Primary Outcome Measures

Name	Time	Method
Vaccination status	4 months

Secondary Outcome Measures

Name	Time	Method
Influenza rate	4 months
Influenza-like illness rate	4 months
Visits to medical providers	4 months

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States