Clinical trial NCT02883972: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Influenza, Human
Keywords: Immunization
Behavioural insights
Children
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2016-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Influenza immunisation uptake in school years 1-3
timeFrame: 5 months
Secondary outcomes:
measure: Influenza immunisation uptake in school years 4-6
timeFrame: 5 months
measure: Influenza immunisation uptake in Reception school year
timeFrame: 5 months
measure: Influenza immunisation uptake in each school year
timeFrame: 5 months
measure: Influenza immunisation consent in school years 1-3
timeFrame: 5 months
measure: Influenza immunisation consent in school years 4-6
timeFrame: 5 months
measure: Influenza immunisation consent in Reception school year
timeFrame: 5 months
Other outcomes:
Locations:
Study officials:
affiliation: Public Health England
name: Tim Chadborn, BSc MSc PhD
role: PRINCIPAL_INVESTIGATOR
References: