Evaluation of the School Kids Influenza Prevention Project (SKIPP)
Primary Purpose
Childhood Influenza Vaccination, School-located Influenza Vaccination
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text message notification
Sponsored by
About this trial
This is an interventional health services research trial for Childhood Influenza Vaccination focused on measuring Influenza vaccination rates, Respiratory Tract Diseases
Eligibility Criteria
Inclusion Criteria:
- Enrolled in the urban school district
Exclusion Criteria:
- Attends a school in the urban district containing a school-based health center
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
SLIV + usual communication
SLIV + usual communication + text
Arm Description
Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV
Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV plus a series of text messages informing them about the usual communication for SLIV
Outcomes
Primary Outcome Measures
Influenza vaccination status
Vaccination status for the 2017/2018 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
NCT03307642
First Posted
October 5, 2017
Last Updated
March 9, 2018
Sponsor
University of Rochester
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT03307642
Brief Title
Evaluation of the School Kids Influenza Prevention Project
Acronym
SKIPP
Official Title
Evaluation of a Text Based Reminder Recall System to Increase Utilization of the School Kids Influenza Prevention Project and Increase Influenza Vaccination Rates in Monroe County, NY
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 4, 2017 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Children whose parents receive text reminders are more likely to be consented to participate in the school located influenza vaccination clinic than children whose parents do not receive text reminders.
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, Respiratory Tract Diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
SLIV will be offered at all schools in an urban school district. Students will be randomized into either SLIV + standard communication about SLIV or SLIV + standard communication + text message reminders.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18540 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLIV + usual communication
Arm Type
No Intervention
Arm Description
Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV
Arm Title
SLIV + usual communication + text
Arm Type
Active Comparator
Arm Description
Parents receive usual communication from school (paper consent packets & automated voice mails) about SLIV plus a series of text messages informing them about the usual communication for SLIV
Intervention Type
Other
Intervention Name(s)
Text message notification
Intervention Description
Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication
Primary Outcome Measure Information:
Title
Influenza vaccination status
Description
Vaccination status for the 2017/2018 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
Through January, 2018
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Enrolled in the urban school district
Exclusion Criteria:
- Attends a school in the urban district containing a school-based health center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley Schaffer, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the School Kids Influenza Prevention Project
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