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Childhood Influenza Immunisation in General Practice Invitation Trial

Primary Purpose

Influenza, Human

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention letter
Sponsored by
Public Health England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Immunization, Behavioural insights, Children

Eligibility Criteria

2 Years - 3 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention letter

    Control

    Arm Description

    Centrally-sent behavioural-insight informed invitation letter.

    No centrally-sent invitation letter.

    Outcomes

    Primary Outcome Measures

    Influenza immunisation uptake
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2016
    Last Updated
    August 27, 2019
    Sponsor
    Public Health England
    Collaborators
    National Health Service, United Kingdom
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02921633
    Brief Title
    Childhood Influenza Immunisation in General Practice Invitation Trial
    Official Title
    Can Uptake of Childhood Influenza Immunisation in GP Practices be Increased Through Behavioural-insight Informed Changes to the Invitation Process?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Public Health England
    Collaborators
    National Health Service, United Kingdom

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza, Human
    Keywords
    Immunization, Behavioural insights, Children

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    21786 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention letter
    Arm Type
    Experimental
    Arm Description
    Centrally-sent behavioural-insight informed invitation letter.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No centrally-sent invitation letter.
    Intervention Type
    Other
    Intervention Name(s)
    Intervention letter
    Primary Outcome Measure Information:
    Title
    Influenza immunisation uptake
    Description
    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.
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 2 years or 3 year olds at 31st August 2016 Registered with a primary care practice in the participating area
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tim Chadborn, BSc MSc PhD
    Organizational Affiliation
    Public Health England
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Childhood Influenza Immunisation in General Practice Invitation Trial

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