Influenza VaccinationNCT03637036
An Improvement Project Around Staffs' Influenza Vaccine Uptake
A study testing Communication intervention in people with Influenza Vaccination, run by University of Warwick at 1 site in United Kingdom.
Trial summary
To reach seasonal vaccination against influenza targets, University Hospitals Birmingham (UHB) already invites staff to take up the vaccination, and every November reminds staff that have not yet vaccinated to do so. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccination
- What is being tested?
- Communication intervention
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,438 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Sep 2018to 4 Jan 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All UHB staff eligible for the seasonal influenza vaccination are eligible for this study. (no patients are included)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Birmingham NHS Foundation Trust (UHB)
Birmingham, B15 2GW
About this study
Official title: An Improvement Project to Evaluate the Effectiveness of Different Reminders Designed to Increase the University Hospitals Birmingham NHS Foundation Trust's Staff Uptake of the Seasonal Influenza Vaccine
To reach seasonal vaccination against influenza targets, University Hospitals Birmingham (UHB) already invites staff to take up the vaccination, and every November reminds staff that have not yet vaccinated to do so. The current protocol describes a randomized controlled trial (RCT) in which staff will be sent different reminders, and the investigators will compare the proportion of staff that go on to vaccinate after receiving each reminder.
Read the detailed description
Seasonal vaccination against influenza is recommended for NHS staff. , To increase vaccination rates, NHS England put forth a Commissioning for Quality and Innovation goal for the 2018/2019 season of 75%. University Hospitals Birmingham NHS Foundation Trust (UHB) wants its vaccination rate to surpass this target. Since staff get infected outside of the hospital and from patients staff vaccination does not provide significant 'herd immunity'
To reach past targets, every September UHB already invites staff to take up the vaccination, and regularly reminds staff that have not yet vaccinated to do so. The current protocol describes a randomized controlled trial (RCT) in which staff will be sent a different letter when first invited to receive vaccination, and we will compare the proportion of staff that go on to vaccinate after receiving each type of letter..
To conduct the RCT the research team will design four letter styles. One factor will emphasize an authority figure inviting staff to vaccinate (the Chief Executive, who is also a doctor). The other factor will emphasize a competitive social norm describing vaccination rates in peer hospitals, including Addenbrooke's, Cambridge University Hospitals (which has exemplary rates) see appendix A and across American hospitals (which also have high rates). Letters will be sent to staff in the first week in October by UHB's communications team and they will be disseminated in a randomized fashion.
The UoW's role in this study is to advise the study's design and write-up the project for publication. UHB will approve the reminders, send the reminders, retrieve the data, and analyse the data. No individual-level data will be transferred across organizations. All individual-level data will be managed by authorized UHB employees, e.g., a UHB statistician will randomize staff to receive different reminders and analyze the data, and UHB's communication team to disseminate the reminders.
- Conditions
- Influenza Vaccination
- Being tested
- Communication intervention
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication interventionOther
The intervention is a communication inviting staff to take up the influenza vaccination. Different versions of the communication are created, and the investigators will compare uptake rates between staff that received different letters.
| Study group | Role | What they receive |
|---|---|---|
| Control Condition | Other | A general communication intervention will occur inviting staff to take up the influenza vaccination, without a specific authority or social norm designated. Receives: Other: Communication intervention |
| Authority Condition | Other | A communication intervention will occur inviting staff to take up the influenza vaccination with a specific authority but not a social norm designated. Receives: Other: Communication intervention |
| Norms Condition | Other | A communication intervention will occur inviting staff to take up the influenza vaccination with a social norm but not a specific authority designated. Receives: Other: Communication intervention |
| Authority + Norms Condition | Other | A communication intervention will occur inviting staff to take up the influenza vaccination with a specific authority and a social norm designated. Receives: Other: Communication intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination uptake
Whether participants vaccinated (Yes, No)
Measured: 3 months
Secondary outcomes (3)
Vaccination uptake date
The date participants received vaccination (DD-MM-YYYY or blank if not vaccinated)
Measured: 3 months
Vaccination uptake reflusal
Whether participants formally indicated refusal to vaccinate (Yes, No)
Measured: 3 months
Vaccination uptake alternative location
Whether participants formally indicated being vaccinated at another location (Yes, No)
Measured: 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start24 Sep 2018
- Primary completion4 Jan 2019
- Study completion4 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza VaccinationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8,438 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Warwick
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham
- Responsible party
- Principal investigator, Professor Richard Lilford, University of Warwick
- Investigators
- Richard J Lilford, Principal investigator, University of Warwick
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637036
- Sponsor's protocol ID
- RRK6479
- Status last verified
- Jan 2019
- First submitted
- 13 Aug 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Improvement Project to Evaluate the Effectiveness of Different Reminders Designed to Increase the University Hospitals Birmingham NHS Foundation Trust's Staff Uptake of the Seasonal Influenza Vaccine
- ClinicalTrials.gov ID
- NCT03637036
- Acronym / sponsor ID
- RRK6479
- Conditions
- Influenza Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,438 participants (actual)
- Lead sponsor
- University of WarwickUniversity, hospital or other
- Collaborators
- University Hospital Birmingham
- Study start
- 24 Sep 2018 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Jan 2019 (actual)
- First posted
- 17 Aug 2018 (actual)
- 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.
To reach seasonal vaccination against influenza targets, University Hospitals Birmingham (UHB) already invites staff to take up the vaccination, and every November reminds staff that have not yet vaccinated to do so. The current protocol describes a randomized controlled trial (RCT) in which staff will be sent different reminders, and the investigators will compare the proportion of staff that go on to vaccinate after receiving each reminder.
Detailed description
Seasonal vaccination against influenza is recommended for NHS staff. , To increase vaccination rates, NHS England put forth a Commissioning for Quality and Innovation goal for the 2018/2019 season of 75%. University Hospitals Birmingham NHS Foundation Trust (UHB) wants its vaccination rate to surpass this target. Since staff get infected outside of the hospital and from patients staff vaccination does not provide significant 'herd immunity'
To reach past targets, every September UHB already invites staff to take up the vaccination, and regularly reminds staff that have not yet vaccinated to do so. The current protocol describes a randomized controlled trial (RCT) in which staff will be sent a different letter when first invited to receive vaccination, and we will compare the proportion of staff that go on to vaccinate after receiving each type of letter..
To conduct the RCT the research team will design four letter styles. One factor will emphasize an authority figure inviting staff to vaccinate (the Chief Executive, who is also a doctor). The other factor will emphasize a competitive social norm describing vaccination rates in peer hospitals, including Addenbrooke's, Cambridge University Hospitals (which has exemplary rates) see appendix A and across American hospitals (which also have high rates). Letters will be sent to staff in the first week in October by UHB's communications team and they will be disseminated in a randomized fashion.
The UoW's role in this study is to advise the study's design and write-up the project for publication. UHB will approve the reminders, send the reminders, retrieve the data, and analyse the data. No individual-level data will be transferred across organizations. All individual-level data will be managed by authorized UHB employees, e.g., a UHB statistician will randomize staff to receive different reminders and analyze the data, and UHB's communication team to disseminate the reminders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Condition | Other | Other: Communication interventionA general communication intervention will occur inviting staff to take up the influenza vaccination, without a specific authority or social norm designated. |
| Authority Condition | Other | Other: Communication interventionA communication intervention will occur inviting staff to take up the influenza vaccination with a specific authority but not a social norm designated. |
| Norms Condition | Other | Other: Communication interventionA communication intervention will occur inviting staff to take up the influenza vaccination with a social norm but not a specific authority designated. |
| Authority + Norms Condition | Other | Other: Communication interventionA communication intervention will occur inviting staff to take up the influenza vaccination with a specific authority and a social norm designated. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All UHB staff eligible for the seasonal influenza vaccination are eligible for this study. (no patients are included)
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 |
|---|---|---|
| Communication interventionThe intervention is a communication inviting staff to take up the influenza vaccination. Different versions of the communication are created, and the investigators will compare uptake rates between staff that received different letters. | Other | Authority + Norms Condition, Authority Condition, Control Condition, Norms Condition |
Primary outcome
Vaccination uptake
Time frame: 3 months
Whether participants vaccinated (Yes, No)
3 secondary outcomes
Vaccination uptake date
Time frame: 3 months
Vaccination uptake reflusal
Time frame: 3 months
Vaccination uptake alternative location
Time frame: 3
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 23 Jan 2019.
- Individual participant dataSharing planned: No. Individual data will not be shared.
Related trials for Influenza Vaccination
Active, not recruiting
Conversational AI for Adult Flu Vaccination Decisions
Influenza, Human, Vaccine Hesitancy
Not yet recruiting
Family Physician Nudges for Influenza Vaccination Among Older Adults
Influenza Vaccination
Active, not recruitingPhase 3
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Influenza (Pandemic), Avian Influenza
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 2/3
Phase 2/3 Clinical Trial to Evaluate the Immunogenicity and Safety of GC3114B in Adults Aged 65 Years or Older
Influenza A, Influenza B, Influenza Vaccination
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.
Richard J Lilford principal investigator
University of Warwick
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication intervention in people with Influenza Vaccination, run by University of Warwick at 1 site in United Kingdom.
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 1 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Vaccination uptake (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.