Back to resultsInfluenza Vaccination in the Emergency Department
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Influenza Vaccination
Education and referral
Sponsored by
About this trial
This is an interventional health services research trial for Influenza focused on measuring Influenza, vaccination, Emergency Department
Eligibility 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
Sites / Locations
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Vaccination group
Education/referral
Arm Description
Vaccination group
Education/referral
Outcomes
Primary Outcome Measures
Vaccination status
Secondary Outcome Measures
Influenza rate
Influenza-like illness rate
Visits to medical providers
Full Information
NCT ID
NCT00822627
First Posted
January 12, 2009
Last Updated
January 13, 2009
Sponsor
University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT00822627
Brief Title
Influenza Vaccination in the Emergency Department
Official Title
Influenza Vaccination in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Arizona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, vaccination, Emergency Department
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccination group
Arm Type
Experimental
Arm Description
Vaccination group
Arm Title
Education/referral
Arm Type
Experimental
Arm Description
Education/referral
Intervention Type
Drug
Intervention Name(s)
Influenza Vaccination
Intervention Description
0.5 mL Sanofi-Pasteur intramuscular influenza vaccination
Intervention Type
Behavioral
Intervention Name(s)
Education and referral
Intervention Description
Patients are given information regarding the inactivated influenza vaccination and a list of community providers who provide influenza vaccination
Primary Outcome Measure Information:
Title
Vaccination status
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Influenza rate
Time Frame
4 months
Title
Influenza-like illness rate
Time Frame
4 months
Title
Visits to medical providers
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine M Hiller, MD
Organizational Affiliation
University of Arizona Department of Emergency Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Influenza Vaccination in the Emergency Department
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