NCT00822627

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2009

Completed
Last Updated

January 14, 2009

Status Verified

January 1, 2009

Enrollment Period

5 months

First QC Date

January 12, 2009

Last Update Submit

January 13, 2009

Conditions

Keywords

InfluenzavaccinationEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Vaccination status

    4 months

Secondary Outcomes (3)

  • Influenza rate

    4 months

  • Influenza-like illness rate

    4 months

  • Visits to medical providers

    4 months

Study Arms (2)

Vaccination group

EXPERIMENTAL

Vaccination group

Drug: Influenza Vaccination

Education/referral

EXPERIMENTAL

Education/referral

Behavioral: Education and referral

Interventions

0.5 mL Sanofi-Pasteur intramuscular influenza vaccination

Vaccination group

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

Education/referral

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

MeSH Terms

Conditions

Influenza, HumanEmergencies

Interventions

Influenza VaccinesEducational StatusReferral and Consultation

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesSocioeconomic FactorsPopulation CharacteristicsProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Katherine M Hiller, MD

    University of Arizona Department of Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2009

First Posted

January 14, 2009

Study Start

November 1, 2007

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

January 14, 2009

Record last verified: 2009-01

Locations