Influenza, HumanNCT02921633
Childhood Influenza Immunisation in General Practice Invitation Trial
A study testing Intervention letter in people with Influenza, Human, run by Public Health England.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Intervention letter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,786 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2 years or 3 year olds at 31st August 2016
- Registered with a primary care practice in the participating area
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Influenza, Human
- Being tested
- Intervention letter
- Keywords
- Immunization, Behavioural insights, Children
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention letterOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention letter | Experimental | Centrally-sent behavioural-insight informed invitation letter. Receives: Other: Intervention letter |
| Control | No intervention | No centrally-sent invitation letter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,786 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Tim Chadborn, BSc MSc PhD, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921633
- Sponsor's protocol ID
- 2016_FluInvGP
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2016
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.
PubMed 36670376
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Uptake of Childhood Influenza Immunisation in GP Practices be Increased Through Behavioural-insight Informed Changes to the Invitation Process?
- ClinicalTrials.gov ID
- NCT02921633
- Acronym / sponsor ID
- 2016_FluInvGP
- Conditions
- Influenza, Human
- Keywords
- Immunization, Behavioural insights, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,786 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Collaborators
- National Health Service, United Kingdom
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 3 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention letter | Experimental | Other: Intervention letterCentrally-sent behavioural-insight informed invitation letter. |
| Control | No intervention | –No centrally-sent invitation letter. |
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2 years or 3 year olds at 31st August 2016
- Registered with a primary care practice in the participating area
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention letter | Other | Intervention letter |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Derived from this study: PubMed 36670376Howell-Jones R, Gold N, Bowen S, Bunten A, Tan K, Saei A, Jones S, MacDonald P, Watson R, Bennett KF, Chadborn T. Can uptake of childhood influenza immunisation through schools and GP practices be increased through behaviourally-informed invitation letters and reminders: two pragmatic randomized controlled trials. BMC Public Health. 2023 Jan 20;23(1):143. doi: 10.1186/s12889-022-14439-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Chadborn, BSc MSc PhD principal investigator
Public Health England
Questions about this trial
What is this clinical trial studying?
A study testing Intervention letter in people with Influenza, Human, run by Public Health England.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza immunisation uptake (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02921633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.