Childhood Influenza Immunisation Invitation Trial in Schools

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Influenza, Human
• Intervention / Treatment: Other: Intervention letter; Other: Reminder; Other: Control letter

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Public Health England

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: July 22, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Children; Immunization; Behavioural insights
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: 2016_FluInvSch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No