Clinical trial NCT01224301: School Influenza Vaccine vs Standard of Care With Nested Trial of 2 Parent Notification Intensities
Official title: Monroe COunty School Kids Influenza Prevention Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immunizations
Vaccination
Influenza
School Health
Keywords: seasonal influenza vaccine
school-based clinics
economic analysis of school based influenza vaccine delivery
pediatric influenza vaccine rates
Influenza vaccine information for parents
Lead sponsor: Monroe County Department of Public Health
Sponsor class: OTHER
Collaborators: name: University of Rochester
First posted: 2010-10-20
Enrollment: 25366
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

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Primary outcomes:
measure: 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).
timeFrame: Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010
measure: 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).
timeFrame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011
Secondary outcomes:
measure: Number of seasonal influenza vaccines received by children enrolled in schools with high vs. low vs. no parental notification.
timeFrame: Year 1 Influenza vaccine delivery season: August 15, 2009 to January 15, 2010
measure: Number of seasonal influenza vaccines received by children enrolled in schools with high vs low vs no parental notification.
timeFrame: Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011
measure: Costs and incremental cost effectiveness of seasonal influenza vaccines delivered in schools compared to cost of influenza vaccines delivered in private practice.
timeFrame: Time Frame: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Monroe County Department of Public Health
state: New York
Study officials:
affiliation: University of Rochester
name: Sharon G. Humiston, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Humiston SG, Schaffer SJ, Szilagyi PG, Long CE, Chappel TR, Blumkin AK, Szydlowski J, Kolasa MS. Seasonal influenza vaccination at school: a randomized controlled trial. Am J Prev Med. 2014 Jan;46(1):1-9. doi: 10.1016/j.amepre.2013.08.021.