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Childhood Influenza Immunisation Invitation Trial in Schools

Not Applicable
Withdrawn
Conditions
Influenza, Human
Interventions
Other: Intervention letter
Other: Control letter
Other: Reminder
Registration Number
NCT02883972
Lead Sponsor
Public Health England
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Intervention letterIntervention letterBehavioural insights informed invitation letter only
Intervention letter and reminderIntervention letterBehavioural insights informed invitation letter and SMS/email reminder message
Intervention letter and reminderReminderBehavioural insights informed invitation letter and SMS/email reminder message
Control letter and reminderControl letterControl invitation letter and SMS/email reminder message
Control letter and reminderReminderControl invitation letter and SMS/email reminder message
Control letterControl letterControl invitation letter only
Primary Outcome Measures
NameTimeMethod
Influenza immunisation uptake in school years 1-35 months

Proportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme

Secondary Outcome Measures
NameTimeMethod
Influenza immunisation consent in school years 1-35 months

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 4-65 months

Proportion of children in school years 4-6 for who consent is neither given nor withheld (i.e. non-responders)

Influenza immunisation uptake in Reception school year5 months

Proportion of children in Reception school year who receive influenza immunisation

Influenza immunisation uptake in each school year5 months

Proportion of children in each school year who receive influenza immunisation

Influenza immunisation consent in Reception school year5 months

Proportion of children in Reception school year for who consent is neither given nor withheld (i.e. non-responders)

Influenza immunisation uptake in school years 4-65 months

Proportion of children in school years 4-6 who receive influenza immunisation

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