Monroe COunty School Kids Influenza Prevention Project
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 25,366
- Locations
- 2
- Primary Endpoint
- 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).
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 13 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
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.
Intervention: School based flu vaccine: High intensity (Behavioral)
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.
Intervention: School based flu vaccine: Low intensity (Behavioral)
Outcomes
Primary Outcomes
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
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 Outcomes
- Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification.(Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010)
- Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification.(Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011)
- Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice.(Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010)
Investigators
Sharon G. Humiston, M.D., M.P.H.
Principal Investigator
University of Rochester