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

Sponsor

Monroe County Department of Public Health (Other)

Overall Status

Completed

CT.gov ID

NCT01224301

Collaborator

University of Rochester (Other)

25,366

Enrollment

Location

Arms

Duration (Months)

1585.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immunizations Vaccination Influenza School Health	Behavioral: School based flu vaccine: Low intensity Behavioral: School based flu vaccine: High intensity	N/A

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

Actual Enrollment :

25366 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Monroe COunty School Kids Influenza Prevention Project

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

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). [Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010]
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). [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 Outcome Measures

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]
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. [Year 2: Influenza vaccine delivery season: August 1, 2010 to January 15, 2011]
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: (FDAAA) Year 1 Influenza vaccine delivery season: August 15 2009 to January 15, 2010]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.