Influenza Vaccination for Parents and Other Caregivers in the Pediatric Medical Home

We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Drug: Influenzae vaccine

• Study Type: Interventional
• Enrollment (Actual): 336
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents or caregiver adults who accompany at-risk children to a Pediatric Care outpatient clinic appointment. High risk children are defined as those 0 to 5 years of age, or who have any of the following diagnoses:

  • Sickle cell disease
  • Asthma
  • Cystic fibrosis
  • Chronic renal disease
  • Congenital heart disease
  • Cancer
  • Any immunodeficiency

Exclusion Criteria:

• Caregivers of children residing in group homes
• Persons whose children do not meet the Center for Disease Control (CDC) definition of high-risk
• Persons who have had allergic reactions to influenza vaccination or any other vaccination in the past
• Persons who are allergic to eggs or egg products
• Persons who are allergic to thimerosol
• Previous diagnosis of Guillain-Barré syndrome (GBS)
• Persons who are moderately to severely ill at the time the vaccination is to be given

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Received Influenza Vaccine.	Caregivers identified for participation were offered influenza vaccine. This describes the number who accepted vaccination	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Background Rate of Influenza Vaccination in the Parents/Caregivers of High Risk Pediatric Patients in a Low Income Population?	Number of participants who received influenza vaccine the prior year.	16 months

Collaborators and Investigators

• Sponsor: Akron Children's Hospital
• Investigators: Principal Investigator: Peter C White, MD, Akron Children's Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: December 18, 2008
• First Submitted That Met QC Criteria: December 18, 2008
• First Posted (Estimate): December 19, 2008

Study Record Updates

• Last Update Posted (Estimate): January 23, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Influenza prevention
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 081105