Childhood Influenza Immunisation Invitation Trial in Schools

NCT ID: NCT02883972

Last Updated: 2023-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-04-30

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.

Conditions

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Influenza, Human

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention letter and reminder

Behavioural insights informed invitation letter and SMS/email reminder message

Group Type EXPERIMENTAL

Intervention letter

Intervention Type OTHER

Behavioural-insight informed letter template

Reminder

Intervention Type OTHER

Behavioural-insight informed SMS/email reminder message to return consent form

Intervention letter

Behavioural insights informed invitation letter only

Group Type EXPERIMENTAL

Intervention letter

Intervention Type OTHER

Behavioural-insight informed letter template

Control letter and reminder

Control invitation letter and SMS/email reminder message

Group Type EXPERIMENTAL

Control letter

Intervention Type OTHER

Invitation letter used by local area last year (updated as required)

Reminder

Intervention Type OTHER

Behavioural-insight informed SMS/email reminder message to return consent form

Control letter

Control invitation letter only

Group Type ACTIVE_COMPARATOR

Control letter

Intervention Type OTHER

Invitation letter used by local area last year (updated as required)

Interventions

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Intervention letter

Behavioural-insight informed letter template

Intervention Type OTHER

Control letter

Invitation letter used by local area last year (updated as required)

Intervention Type OTHER

Reminder

Behavioural-insight informed SMS/email reminder message to return consent form

Intervention Type OTHER

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Public Health England

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Chadborn, BSc MSc PhD

Role: PRINCIPAL_INVESTIGATOR

Public Health England

References

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Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.

Reference Type DERIVED
PMID: 36670376 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016_FluInvSch

Identifier Type: -

Identifier Source: org_study_id

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