Influenza Vaccination in the Emergency Department

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-04-30

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?

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Vaccination group

Group Type EXPERIMENTAL

Influenza Vaccination

Intervention Type DRUG

0.5 mL Sanofi-Pasteur intramuscular influenza vaccination

Education/referral

Group Type EXPERIMENTAL

Education and referral

Intervention Type BEHAVIORAL

Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination

Interventions

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Influenza Vaccination

0.5 mL Sanofi-Pasteur intramuscular influenza vaccination

Intervention Type DRUG

Education and referral

Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes