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
About this trial
This is an interventional prevention trial for Influenza, Human focused on measuring Immunization, Behavioural insights, Children
Eligibility Criteria
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
NCT ID
NCT02921633
First Posted
September 27, 2016
Last Updated
August 27, 2019
Sponsor
Public Health England
Collaborators
National Health Service, United Kingdom
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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