Influenza Vaccination in the Emergency Department

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influenza Vaccination in the Emergency Department

Conditions
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Influenza

Intervention / Treatment
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* Drug: Influenza Vaccination
* Behavioral: Education and referral


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccination group<br>Vaccination group | Drug: Influenza Vaccination<br>* 0.5 mL Sanofi-Pasteur intramuscular influenza vaccination<br>|
| Experimental: Education/referral<br>Education/referral | Behavioral: Education and referral<br>* Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccination status |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza rate |  | 4 months | 
| Influenza-like illness rate |  | 4 months | 
| Visits to medical providers |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, vaccination, Emergency Department