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Ethical approval was withdrawn by the National Research Ethics Service as they were unable to make contact with the research team despite trying many times.
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This study will investigate whether influenza vaccine uptake by school-age children (in school-based clinics) can be increased by making behavioural-insight informed changes to the invitation process which encourage parents to return consent forms.
Previous research has shown that small changes to the invitation phrasing and/or process informed by understanding and insights into behaviour can be used to increase a desired behaviour (e.g. uptake of health checks, reducing primary care antibiotic prescribing).
This trial will determine whether a behaviour-insight informed invitation letter and/or reminder Short Message Service (SMS)/email message can increase return of consent forms and thereby increase uptake of childhood flu vaccine in schools.
The trial will take place within the existing national childhood immunisation programme in participating areas in England. Randomisation will be at the school-level (stratified by local authority). All eligible children within a school will therefore be in the same arm of the trial and be subject to the same invitation process. Outcome data will be routinely collected, school-level influenza vaccine uptake data. Data will also be collected on the implementation of email/SMS reminders in all schools.
The analysis will investigate the main effects of the interventions and their interactions, take into account provider, local authority and school effects and explore the impact of other factors such as deprivation indicators.
An analysis of letters used by providers of childhood influenza immunisation in schools not involved in the trial will also be conducted. All providers will be asked to submit a copy of their invitation letter for the 2016/17 programme and these will be analysed using the Theoretical Domains Framework.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention letter and reminder | Experimental | Behavioural insights informed invitation letter and SMS/email reminder message |
|
| Intervention letter | Experimental | Behavioural insights informed invitation letter only |
|
| Control letter and reminder | Experimental | Control invitation letter and SMS/email reminder message |
|
| Control letter | Active Comparator | Control invitation letter only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention letter | Other | Behavioural-insight informed letter template |
|
| Measure | Description | Time Frame |
|---|---|---|
| Influenza immunisation uptake in school years 1-3 | Proportion of children in school years 1-3 who receive influenza immunisation as part of the national childhood immunisation programme | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Influenza immunisation uptake in school years 4-6 | Proportion of children in school years 4-6 who receive influenza immunisation | 5 months |
| Influenza immunisation uptake in Reception school year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Chadborn, BSc MSc PhD | Public Health England | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36670376 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 5, 2016 | Sep 29, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Control letter | Other | Invitation letter used by local area last year (updated as required) |
|
| Reminder | Other | Behavioural-insight informed SMS/email reminder message to return consent form |
|
Proportion of children in Reception school year who receive influenza immunisation
| 5 months |
| Influenza immunisation uptake in each school year | Proportion of children in each school year who receive influenza immunisation | 5 months |
| Influenza immunisation consent in school years 1-3 | Proportion of children in school years 1-3 for who consent is neither given nor withheld (i.e. non-responders) | 5 months |
| Influenza immunisation consent in school years 4-6 | Proportion of children in school years 4-6 for who consent is neither given nor withheld (i.e. non-responders) | 5 months |
| Influenza immunisation consent in Reception school year | Proportion of children in Reception school year for who consent is neither given nor withheld (i.e. non-responders) | 5 months |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |