- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03637036
An Improvement Project Around Staffs' Influenza Vaccine Uptake
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Birmingham, United Kingdom, B15 2GW
- University Hospitals Birmingham NHS Foundation Trust (UHB)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All UHB staff eligible for the seasonal influenza vaccination are eligible for this study. (no patients are included)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control Condition
A general communication intervention will occur inviting staff to take up the influenza vaccination, without a specific authority or social norm designated.
|
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.
|
|
Other: Authority Condition
A communication intervention will occur inviting staff to take up the influenza vaccination with a specific authority but not a social norm designated.
|
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.
|
|
Other: Norms Condition
A communication intervention will occur inviting staff to take up the influenza vaccination with a social norm but not a specific authority designated.
|
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.
|
|
Other: Authority + Norms Condition
A communication intervention will occur inviting staff to take up the influenza vaccination with a specific authority and a social norm designated.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccination uptake
Time Frame: 3 months
|
Whether participants vaccinated (Yes, No)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaccination uptake date
Time Frame: 3 months
|
The date participants received vaccination (DD-MM-YYYY or blank if not vaccinated)
|
3 months
|
|
Vaccination uptake reflusal
Time Frame: 3 months
|
Whether participants formally indicated refusal to vaccinate (Yes, No)
|
3 months
|
|
Vaccination uptake alternative location
Time Frame: 3
|
Whether participants formally indicated being vaccinated at another location (Yes, No)
|
3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Group number
Time Frame: 3 months
|
This data describes what communication participants received
|
3 months
|
|
Worksite
Time Frame: 3 months
|
This data describes what location within the organization participants work
|
3 months
|
|
Job Role
Time Frame: 3 months
|
This data describes participants' job roles
|
3 months
|
|
Gender
Time Frame: 3 months
|
This data describes participants' gender
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard J Lilford, University of Warwick
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRK6479
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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