Childhood Influenza Immunisation Invitation Trial in Schools

Influenza, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02883972
• Other study ID #: 2016_FluInvSch
• Status: Withdrawn
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 2017

Study information

• Verified date: July 2016
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Other:
• Intervention letter
Behavioural-insight informed letter template
• Control letter
Invitation letter used by local area last year (updated as required)
• Reminder
Behavioural-insight informed SMS/email reminder message to return consent form

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Public Health England

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Influenza immunisation uptake in school years 4-6	Proportion of children in school years 4-6 who receive influenza immunisation	5 months
Secondary	Influenza immunisation uptake in Reception school year	Proportion of children in Reception school year who receive influenza immunisation	5 months
Secondary	Influenza immunisation uptake in each school year	Proportion of children in each school year who receive influenza immunisation	5 months
Secondary	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
Secondary	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
Secondary	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