Childhood Influenza Immunisation Invitation Trial in Schools

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can Uptake of Childhood Influenza Immunisation Through Schools be Increased Through Behavioural-insight Informed Changes to the Invitation Process?

Conditions
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Influenza, Human

Intervention / Treatment
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* Other: Intervention letter
* Other: Control letter
* Other: Reminder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention letter and reminder<br>Behavioural insights informed invitation letter and SMS/email reminder message | Other: Intervention letter<br>* Behavioural-insight informed letter template<br>Other: Reminder<br>* Behavioural-insight informed SMS/email reminder message to return consent form<br>|
| Experimental: Intervention letter<br>Behavioural insights informed invitation letter only | Other: Intervention letter<br>* Behavioural-insight informed letter template<br>|
| Experimental: Control letter and reminder<br>Control invitation letter and SMS/email reminder message | Other: Control letter<br>* Invitation letter used by local area last year (updated as required)<br>Other: Reminder<br>* Behavioural-insight informed SMS/email reminder message to return consent form<br>|
| Active Comparator: Control letter<br>Control invitation letter only | Other: Control letter<br>* Invitation letter used by local area last year (updated as required)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza immunisation uptake in school years 4-6 | Proportion of children in school years 4-6 who receive influenza immunisation | 5 months | 
| Influenza immunisation uptake in Reception school year | Proportion of children in Reception school year who receive influenza immunisation | 5 months | 
| Influenza immunisation uptake in each school year | Proportion of children in each school year who receive influenza immunisation | 5 months | 
| 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) | 5 months | 
| 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) | 5 months | 
| 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) | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunization, Behavioural insights, Children