School-located Influenza Vaccination Clinics for Adolescents (SKIPP RCT2)
Primary Purpose
Childhood Influenza Vaccination, School-located Influenza Vaccination
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
School-located Influenza Vaccination
Sponsored by
About this trial
This is an interventional health services research trial for Childhood Influenza Vaccination focused on measuring Influenza Vaccination Rates
Eligibility Criteria
Inclusion Criteria:
- Currently enrolled students of a participating school
Exclusion Criteria:
- Not a currently enrolled student of a participating school
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
School-located Influenza Vaccination
Arm Description
No school-located influenza vaccination clinic
Children in intervention schools were offered a chance to receive influenza vaccination at a school-located influenza vaccination clinic, if their parent or legal guardian provided permission
Outcomes
Primary Outcome Measures
Influenza vaccination status as recorded in the NY state registry (NYSIIS)
Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
Secondary Outcome Measures
Full Information
NCT ID
NCT03137667
First Posted
April 28, 2017
Last Updated
May 2, 2017
Sponsor
University of California, Los Angeles
Collaborators
University of Rochester, Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT03137667
Brief Title
School-located Influenza Vaccination Clinics for Adolescents
Acronym
SKIPP RCT2
Official Title
Efficacy Study of School-located Influenza Vaccination Clinics to Increase Influenza Vaccination Rates in Monroe County, New York
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
January 15, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of Rochester, Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics and randomized within pairs to receiving a school-based influenza vaccination clinic or not (control).
Detailed Description
The overarching goal of the study was to evaluate the effectiveness and cost-effectiveness of offering school-based influenza vaccination clinics during school hours on influenza vaccination rates. A cluster-randomized trial (clustering by school) was conducted in Monroe County, NY. Twenty middle and high schools were paired based on several characteristics including urban/suburban,school grade-span (6-8th, 9-12th), school size, percent of students eligible for free or reduced school lunch, and influenza vaccination rates in the previous season among students in the school. School were randomized within pairs, with one school offering a school-based influenza vaccination clinic or and one school not offering the clinic (control).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Influenza Vaccination, School-located Influenza Vaccination
Keywords
Influenza Vaccination Rates
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigator is not aware of the allocation at the level of the patient. In addition, the investigator is not involved in vaccine verification (data collection involving patient-level vaccination status)
Allocation
Randomized
Enrollment
17650 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No school-located influenza vaccination clinic
Arm Title
School-located Influenza Vaccination
Arm Type
Experimental
Arm Description
Children in intervention schools were offered a chance to receive influenza vaccination at a school-located influenza vaccination clinic, if their parent or legal guardian provided permission
Intervention Type
Other
Intervention Name(s)
School-located Influenza Vaccination
Intervention Description
Children in the intervention arm are enrolled in schools in Monroe County, New York that are offering school-located influenza vaccination clinics during school hours
Primary Outcome Measure Information:
Title
Influenza vaccination status as recorded in the NY state registry (NYSIIS)
Description
Vaccination status for the 2014/2015 influenza season will be assessed. The vaccination date will be recorded, as well as the provider name, to determine whether vaccine was received at the school-located influenza clinic
Time Frame
Within one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently enrolled students of a participating school
Exclusion Criteria:
Not a currently enrolled student of a participating school
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31234842
Citation
Yoo BK, Schaffer SJ, Humiston SG, Rand CM, Goldstein NPN, Albertin CS, Concannon C, Szilagyi PG. Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children. BMC Health Serv Res. 2019 Jun 24;19(1):407. doi: 10.1186/s12913-019-4228-5.
Results Reference
derived
PubMed Identifier
30878250
Citation
Schaffer SJ, Rand CM, Humiston SG, Concannon C, Hightower AD, Albertin C, Szilagyi PG. Practical considerations in developing a successful school-located influenza vaccination (SLIV) program. Vaccine. 2019 Apr 10;37(16):2171-2173. doi: 10.1016/j.vaccine.2019.01.088. Epub 2019 Mar 13. No abstract available.
Results Reference
derived
PubMed Identifier
30600690
Citation
Szilagyi PG, Schaffer S, Rand CM, Goldstein NPN, Younge M, Mendoza M, Albertin CS, Concannon C, Graupman E, Hightower AD, Yoo BK, Humiston SG. Text Message Reminders for Child Influenza Vaccination in the Setting of School-Located Influenza Vaccination: A Randomized Clinical Trial. Clin Pediatr (Phila). 2019 Apr;58(4):428-436. doi: 10.1177/0009922818821878. Epub 2019 Jan 2.
Results Reference
derived
Learn more about this trial
School-located Influenza Vaccination Clinics for Adolescents
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