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Completed

NCT Number: NCT02921633

Childhood Influenza Immunisation in General Practice Invitation Trial

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.

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Key information

Age range

2 year–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Intervention letter

Other

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Public Health England

Other Gov

Collaborators

  • National Health Service, United Kingdom

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2016
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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