Childhood Influenza Immunisation in General Practice Invitation Trial

August 27, 2019 updated by: Public Health England

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

This study will investigate whether behaviourally informed changes to the invitation process can improve uptake of childhood influenza vaccine by two and three year olds at primary care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Previous research has shown that small changes to routine invitations/reminders to attend local health services informed by behavioural science can be used to increase a desired behaviour (e.g. uptake of health checks, reducing missed appointments).

This trial will determine whether an invitation letter, informed by behavioural insights and sent through a central system (Child Health Information System, CHIS), can increase uptake of childhood flu vaccine in primary care.

The trial will take place within the existing national childhood immunisation programme in the participating area in England. Randomisation will be clustered at the primary care practice level. Outcome data will be anonymised, routinely collected, individual-level influenza vaccine uptake data extracted from CHIS. For CHIS data validation purposes, practice-level vaccine uptake data reported through an alternative, routine system will be collected. Data will be collected on additional invitations/communications that primary care practices (in both the intervention and control arms) send to their patients. Cost data for the centralised letter will also be obtained.

The analysis will investigate the main effect of the intervention on uptake of the flu vaccination for all eligible children included in the trial. The model will include primary care practice and Clinical Commissioning Group effects to account for clustering. Secondary analysis will investigate the impact of such individual factors as age, immunisation history and socioeconomic status and practice-level factors (e.g. direct communication from practices) on uptake of the flu vaccination.

Study Type

Interventional

Enrollment (Actual)

21786

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 2 years or 3 year olds at 31st August 2016
  • Registered with a primary care practice in the participating area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention letter
Centrally-sent behavioural-insight informed invitation letter.
Other: Intervention letter
No Intervention: Control
No centrally-sent invitation letter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influenza immunisation uptake
Time Frame: 4 months
Immunisation uptake by eligible children (i.e. those aged 2 and 3 years on 31st August 2016) at primary care. Individual immunisation uptake data are routinely sent by primary care practices to the Child Health Information System. Anonymised uptake data will therefore be extracted for all eligible children from this system.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health England

Collaborators

National Health Service, United Kingdom

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_FluInvGP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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