School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities (MCSkipp)

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Sharon G. Humiston, M.D., M.P.H., University of Rochester
ClinicalTrials.gov Identifier:
NCT01224301
First received: October 18, 2010
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

Purpose of the study. The purpose of the project is to evaluate the feasibility, acceptability, and cost effectiveness of providing influenza vaccine in schools to children in grades Kindergarten through 6th grade.

Hypothesis 1: School based influenza vaccination (SIV) will increase the overall rate of influenza vaccination in school children.

Hypothesis 2: Higher intensity parent notification about school based influenza vaccination does not increase immunization rates compared to low intensity.

Hypothesis 3: School based vaccination from the perspective of mass vaccinators is cost neutral.


Condition Intervention
Immunizations
Vaccination
Influenza
School Health
Behavioral: School based flu vaccine: Low intensity
Behavioral: School based flu vaccine: High intensity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Monroe COunty School Kids Influenza Prevention Project

Resource links provided by NLM:


Further study details as provided by Monroe County Department of Public Health:

Primary Outcome Measures:
  • Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS). [ Time Frame: Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010 ] [ Designated as safety issue: No ]
    Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.

  • Seasonal influenza vaccine rates for children attending schools with and without school-based influenza vaccine delivery as reported in the New York State Immunization Information System (NYSIIS). [ Time Frame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011 ] [ Designated as safety issue: No ]
    Number of children with at least one seasonal influenza vaccine given in school compared to number of children with influenza vaccine given elsewhere and number of children with no record of influenza vaccine.


Secondary Outcome Measures:
  • Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification. [ Time Frame: Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010 ] [ Designated as safety issue: No ]
    Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.

  • Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification. [ Time Frame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011 ] [ Designated as safety issue: No ]
    Vaccine rates among children offered seasonal influenza vaccine in school whose parents got high intensity notification of the program vs those who got low intensity notification. Notification included educational materials, program description, consent forms, phone messages, and varied by type and frequency for schools with High and Low levels of parental notification.

  • Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice. [ Time Frame: Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010 ] [ Designated as safety issue: No ]
    Economic analysis of costs and revenues associated with school-based seasonal influenza vaccine delivered by a mass vaccinator. The project is based on a business model for purchasing/acquiring vaccine from vendors and vaccines for children, and recovering payment from insurance. Costs associated with vaccines administered in school are derived from this clinical trial, School Influenza Vaccine vs Standard of Care, and private practice data are from the literature.


Enrollment: 25366
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: School based flu vaccine: High intensity
Interventions: Parents in high intensity schools have access to school-based flu vaccine clinics and 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.
Behavioral: School based flu vaccine: High intensity
Interventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.
Other Names:
  • Trivalent injectable influenza vaccine
  • Live Attenuated Influenza vaccine
  • School based vaccines
Experimental: School based flu vaccine: Low intensity
Interventions: Parents in low intensity schools have access to school-based flu vaccine clinics and less than 3 communications from schools about influenza illness, influenza vaccine, and school based clinics.
Behavioral: School based flu vaccine: Low intensity
Interventions: Parents of children in Low Intensity Notification schools got less than 3 communications from schools describing influenza vaccine and the clinics, and consent forms sent home one.
Other Names:
  • Trivalent injectable influenza vaccine
  • Live Attenuated Influenza vaccine
  • School based vaccines
No Intervention: Standard of Care
Control Schools did not have any in school seasonal influenza vaccine clinics. Parents of children in control schools got no notification from the schools and sought seasonal influenza vaccines for their children as they normally would.

Detailed Description:

Background. The ACIP (American Committee on Immunization Practices) has now recommended influenza vaccination for all children 6 months to 18 years of age. While many school-aged children will be vaccinated in the medical home, the large number of children for whom the vaccine is now recommended exceeds the capacity of many primary care settings. Schools have been recommended as potential sites for influenza vaccination, yet little is known about the feasibility, implementation requirements, costs, or effectiveness of school-based influenza vaccination (SIV) programs. This project will implement and rigorously evaluate the feasibility, acceptability, billing and reimbursement components, costs, cost-effectiveness, and overall effectiveness of an SIV program that targets diverse populations and different intensity of interventions.

  Eligibility

Ages Eligible for Study:   4 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Children in grades K through 5 enrolled in schools that agreed to participate in the randomized trial of school based influenza vaccine

Exclusion Criteria:

Children and schools not enrolled in school based influenza vaccine program Children in participating schools in grades other than Kindergarten through 5th grade.

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224301

Locations
United States, New York
Monroe County Department of Public Health
Rochester, New York, United States, 14692
Sponsors and Collaborators
Monroe County Department of Public Health
University of Rochester
Investigators
Principal Investigator: Sharon G. Humiston, M.D., M.P.H. University of Rochester
  More Information

No publications provided by Monroe County Department of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sharon G. Humiston, M.D., M.P.H., Principal Investigator, University of Rochester
ClinicalTrials.gov Identifier: NCT01224301     History of Changes
Other Study ID Numbers: 00439262
Study First Received: October 18, 2010
Last Updated: April 3, 2012
Health Authority: United States: Federal Government

Keywords provided by Monroe County Department of Public Health:
seasonal influenza vaccine
school-based clinics
economic analysis of school based influenza vaccine delivery
pediatric influenza vaccine rates
Influenza vaccine information for parents

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014