Childhood Influenza Immunisation Invitation Trial in Schools
Primary Purpose
Influenza, Human
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention letter
Control letter
Reminder
Sponsored by
About this trial
This is an interventional other trial for Influenza, Human focused on measuring Immunization, Behavioural insights, Children
Eligibility Criteria
Inclusion Criteria:
- Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial
- Eligible for influenza immunisation
Exclusion Criteria:
- Ineligible for influenza immunisation
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Intervention letter and reminder
Intervention letter
Control letter and reminder
Control letter
Arm Description
Behavioural insights informed invitation letter and SMS/email reminder message
Behavioural insights informed invitation letter only
Control invitation letter and SMS/email reminder message
Control invitation letter only
Outcomes
Primary Outcome Measures
Influenza immunisation uptake in school years 1-3
Proportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme
Secondary Outcome Measures
Influenza immunisation uptake in school years 4-6
Proportion of children in school years 4-6 who receive influenza immunisation
Influenza immunisation uptake in Reception school year
Proportion of children in Reception school year who receive influenza immunisation
Influenza immunisation uptake in each school year
Proportion of children in each school year who receive influenza immunisation
Influenza immunisation consent in school years 1-3
Proportion of children in school years 1-3 for who consent is neither given nor withheld (i.e. non-responders)
Influenza immunisation consent in school years 4-6
Proportion of children in school years 4-6 for who consent is neither given nor withheld (i.e. non-responders)
Influenza immunisation consent in Reception school year
Proportion of children in Reception school year for who consent is neither given nor withheld (i.e. non-responders)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02883972
Brief Title
Childhood Influenza Immunisation Invitation Trial in Schools
Official Title
Can Uptake of Childhood Influenza Immunisation Through Schools be Increased Through Behavioural-insight Informed Changes to the Invitation Process?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Ethical approval was withdrawn by the National Research Ethics Service as they were unable to make contact with the research team despite trying many times.
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health England
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
This study will investigate whether influenza vaccine uptake by school-age children (in school-based clinics) can be increased by making behavioural-insight informed changes to the invitation process which encourage parents to return consent forms.
Detailed Description
Previous research has shown that small changes to the invitation phrasing and/or process informed by understanding and insights into behaviour can be used to increase a desired behaviour (e.g. uptake of health checks, reducing primary care antibiotic prescribing).
This trial will determine whether a behaviour-insight informed invitation letter and/or reminder Short Message Service (SMS)/email message can increase return of consent forms and thereby increase uptake of childhood flu vaccine in schools.
The trial will take place within the existing national childhood immunisation programme in participating areas in England. Randomisation will be at the school-level (stratified by local authority). All eligible children within a school will therefore be in the same arm of the trial and be subject to the same invitation process. Outcome data will be routinely collected, school-level influenza vaccine uptake data. Data will also be collected on the implementation of email/SMS reminders in all schools.
The analysis will investigate the main effects of the interventions and their interactions, take into account provider, local authority and school effects and explore the impact of other factors such as deprivation indicators.
An analysis of letters used by providers of childhood influenza immunisation in schools not involved in the trial will also be conducted. All providers will be asked to submit a copy of their invitation letter for the 2016/17 programme and these will be analysed using the Theoretical Domains Framework.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Immunization, Behavioural insights, Children
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention letter and reminder
Arm Type
Experimental
Arm Description
Behavioural insights informed invitation letter and SMS/email reminder message
Arm Title
Intervention letter
Arm Type
Experimental
Arm Description
Behavioural insights informed invitation letter only
Arm Title
Control letter and reminder
Arm Type
Experimental
Arm Description
Control invitation letter and SMS/email reminder message
Arm Title
Control letter
Arm Type
Active Comparator
Arm Description
Control invitation letter only
Intervention Type
Other
Intervention Name(s)
Intervention letter
Intervention Description
Behavioural-insight informed letter template
Intervention Type
Other
Intervention Name(s)
Control letter
Intervention Description
Invitation letter used by local area last year (updated as required)
Intervention Type
Other
Intervention Name(s)
Reminder
Intervention Description
Behavioural-insight informed SMS/email reminder message to return consent form
Primary Outcome Measure Information:
Title
Influenza immunisation uptake in school years 1-3
Description
Proportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Influenza immunisation uptake in school years 4-6
Description
Proportion of children in school years 4-6 who receive influenza immunisation
Time Frame
5 months
Title
Influenza immunisation uptake in Reception school year
Description
Proportion of children in Reception school year who receive influenza immunisation
Time Frame
5 months
Title
Influenza immunisation uptake in each school year
Description
Proportion of children in each school year who receive influenza immunisation
Time Frame
5 months
Title
Influenza immunisation consent in school years 1-3
Description
Proportion of children in school years 1-3 for who consent is neither given nor withheld (i.e. non-responders)
Time Frame
5 months
Title
Influenza immunisation consent in school years 4-6
Description
Proportion of children in school years 4-6 for who consent is neither given nor withheld (i.e. non-responders)
Time Frame
5 months
Title
Influenza immunisation consent in Reception school year
Description
Proportion of children in Reception school year for who consent is neither given nor withheld (i.e. non-responders)
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Attendance at a school where national childhood influenza immunisation programme is delivered by a provider participating in the trial
Eligible for influenza immunisation
Exclusion Criteria:
Ineligible for influenza immunisation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Chadborn, BSc MSc PhD
Organizational Affiliation
Public Health England
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Childhood Influenza Immunisation Invitation Trial in Schools
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