Plain English Summary
Background and study aims
Every year flu caught from staff and visitors causes serious illness and death in care home residents. The best defence against flu is vaccination, which prepares the body to be able to fight it. While vaccines work in most people, there are always some for whom they do not work. That means that if we give vaccines to care home residents, some will still not be protected. The best way to protect residents is, therefore, to vaccinate care home staff as well. This further reduces residents’ chances of catching the flu. To best protect care home residents, the World Health Organisation therefore recommends that over three-quarters of care home staff should be vaccinated. In the UK less than half of care home staff are vaccinated which means that residents are put at higher risk.
After reviewing the evidence and speaking to care home staff and managers, the researchers found three main reasons for why staff do or do not get vaccinated. These are: how easily they can access vaccines; how important their manager sees staff vaccination; and attitudes and beliefs around vaccination.
This study will test if the following approaches can increase how many staff get vaccinated:
1. Community pharmacists vaccinating staff in the care home
2. Providing free vaccinations for everyone
3. Offering incentives to managers who increase the number of vaccinated staff
4. Monitoring how many staff get vaccinated and giving feedback to the home
5. Providing vaccine information leaflets and videos for staff and managers
The aim is to find out which of these approaches is most likely to increase the number of staff who are vaccinated and provides the best value to the NHS.
Who can participate?
All staff employed at the long-stay care homes for older residents or dementia registration recruited to the study
What does the study involve?
This study will take place over 3 years. It has been designed assuming that COVID-19 is still with us. The researchers will spend two months developing each of the above approaches with care home staff and pharmacies. During the 2021-2022 flu season, they will test the approaches in 10 care homes. This will show how the ideas work in practice, how to best collect data, and what happens in groups who carry on with “service as usual”. Learning from this, the researchers will refine the service and decide which mixture of approaches to study on a larger scale. They will do this by carefully listening to those involved and by looking at the quality of information they collect. During the 2022-2023 flu season, using the information from the first two stages, the main study will recruit care homes in England with low vaccination levels. Homes will be allocated at random (like flipping a coin) to either get our new service or to carry on with “service as usual”. Care homes in the 'new service' group will be allocated to implement the FluCare intervention and pharmacy and/or GP practices will provide vaccination services. At the end of the flu season, the researchers will compare how many staff are vaccinated in the 'new service' and 'service as usual' groups. They will collect measures of resident health and costs related to the new service. This will show if the service improves resident health and saves money for the NHS. At the same time, the researchers will find out whether people used the new service as intended. They will also listen to people involved to find out what did and did not work to learn how to improve the service. Finally, they will use their findings to develop a toolkit. This will tell people about the new service and encourage them to use it. The researchers will work closely with PPI groups (residents and relatives) who will help design and manage the studies, collect information, look at the results and present them to the outside world.
What are the possible benefits and risks of participating?
There are several direct benefits for those taking part in the study. First, helping to provide evidence to obtain more investment in the social care sector (e.g. making flu vaccination free for all staff). Second, improved resident health. Third, reduced costs on the NHS and social care sector.
There are no obvious risks for those taking part in the study. Any adverse events will be managed by the research team working closely with care homes and pharmacies affected. There will be close oversight from the Trial Steering Committee and Norwich Clinical Trials Unit in handling any difficulties.
Where is the study run from?
University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
September 2021 to August 2025
Who is funding the study?
National Institute for Health and Care Research (UK)
Who is the main contact?
1. Dr Amrish Patel, Amrish.Patel@uea.ac.uk
2. Prof David Wright, d.j.wright@leicester.ac.uk
Study website
Contact information
Type
Principal Investigator
Contact name
Dr Amrish Patel
ORCID ID
http://orcid.org/0000-0002-2374-6409
Contact details
School of Economics
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 597644
amrish.patel@uea.ac.uk
Type
Public
Contact name
Dr Erika Sims
ORCID ID
Contact details
Norwich Clinical Trials Unit
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603597178
e.sims@uea.ac.uk
Type
Scientific
Contact name
Prof David Wright
ORCID ID
http://orcid.org/0000-0003-3690-9593
Contact details
School of Healthcare
The University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
+44 (0)116 252 5992
d.j.wright@leicester.ac.uk
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
316820
ClinicalTrials.gov number
Nil known
Protocol/serial number
R209939, IRAS 316820, CPMS 53812
Study information
Scientific title
FluCare Phase 3: Estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates – a definitive study
Acronym
FluCare
Study hypothesis
By providing short videos, posters, leaflets, together with onsite within hours and out of hours vaccination service provided by GP practice and/or pharmacies, it is possible to change the behaviour of care home staff in England to increase uptake of the influenza vaccination compared to usual care.
Ethics approval(s)
1. Approved 02/08/2022, The University of East Anglia Faculty of Health and Medical Sciences Ethics Board (Faculty of Medicine and Health Sciences Research Ethics Subcommittee, The School of Medicine, University of East Anglia Norwich Research Park Norwich NR4 7TJ, UK; Tel: not available; fmh.ethics@uea.ac.uk), ref: ETH 2122-2419
2. Submitted 12/06/2024, The University of East Anglia Faculty of Health and Medical Sciences Ethics Board (Faculty of Medicine and Health Sciences Research Ethics Subcommittee (The School of Medicine, University of East Anglia Norwich Research Park, Norwich, NR4 7TJ, UK; Tel: not available; fmh.ethics@uea.ac.uk), ref: ETH 2122-2419
Study design
Two-arm open-label randomized controlled trial with an embedded process evaluation
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Care home, Workplace
Study type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Influenza vaccination in care home staff
Intervention
In this study the researchers will recruit 78 care homes in England.
Stratified randomisation will be used. The sequence will be generated using REDCAP based on stratified randomisation with a binary variable of the percentage of staff identifying as non-white. Blocked randomisation will be undertaken, however, given the small number of homes randomised in order to ensure that the risk of imbalance is small a small block size will be used and specified in the allocation system specification. The classification of the percentage of staff identifying as non-white into two groups will be decided on the basis of the collection of the site profile questionnaires which are expected to be collected for a number of care homes prior to the start of any care home being randomised.
39 care homes will be allocated to implement the FluCare intervention and pharmacy and/or GP practices will provide vaccination services. 39 care homes will be allocated to the control arm.
Usual Care
Arm A (39 care homes): Usual care with regular monitoring
Intervention:
Arm B (39 care homes): A multi-component intervention targeting barriers to care home staff flu vaccine uptake: free, in-care home vaccination clinics; information/videos for staff; regular monitoring and feedback; financial incentives for managers.
The intervention duration is October 2022 to March 2023, and follow-up data collection (for both arms) will last 1 month after the intervention ends.
Added 09/07/2024:
The study duration has been extended by the NIHR. Steps were needed to further reduce recruitment challenges and data collection burden. For the former, the researchers will use community pharmacists as the primary mechanism for recruiting CHs, utilising their existing local relationships. For the latter, they will utilise routinely collected data as our outcome data. These steps will reduce administrative burden during the trial, as contracting with CHs will no longer be required. Additional refinements have been made to the FluCare intervention to reflect its new focus as a community pharmacy-led intervention. Due to the shift to a community pharmacy led intervention, additional materials guiding engagement with care homes using findings from the earlier trials will be implemented in addition to the original flu care intervention materials and incentives.
The embedded process evaluation will identify and explore initiatives within Integrated Care Systems for increasing care home staff flu vaccination initiatives, characteristics of community pharmacies (and their staff) delivering the intervention and their relationships with care homes to which the intervention is being delivered, and barriers and enablers to delivery of the intervention. As the intervention will be delivered as a service to care homes and all data used in this study will be from routine data collection sources, care homes will not be aware that the opportunity to receive the intervention (or not) is part of a research study. Care homes will not therefore be consented. However, after the end of the flu season, community pharmacy staff involved with delivering the vaccination clinics, care home managers and staff in care homes who received the intervention will be invited to participate in a focus group or semi-structured interview.
Intervention type
Behavioural
Primary outcome measure
Staff flu vaccination rate: the total number of staff vaccinated in a flu season over the total number of staff employed at any point throughout that flu season (all directly contracted staff (care staff, cleaners, cooks, administrative staff) + agency staff), measured using anonymised staff data logs on a monthly basis, starting at baseline for 6 months or until the end of March 2023, whichever is the earliest
Secondary outcome measures
Measured using anonymised staff data logs and aggregated resident data logs on a monthly basis, for 6 months or until the end of March 2023, whichever is the earliest:
1. Staff flu vaccination rate disaggregated by caregiving and non-caregiving roles at the end of November
2. Number of staff sick days
3. GP and nurse visits to care home
4. Care home resident hospitalisations
5. Care home resident mortality
Health economic outcomes:
1. Intervention delivery costs
We will conduct a within-trial (i.e., up to the 6 months of the trial) cost-consequences analysis (CCA) comparing costs and outcomes between trial arms across different perspectives/stakeholders (e.g., care homes, NHS and staff). CCA is a standard evaluation approach recognized as being particularly useful for evaluating interventions that have impacts on multiple domains of outcome and perspectives.
We will determine the resources involved in, and associated costs of, delivering the FluCare intervention. Resources required for intervention delivery are expected to consist primarily of clinician time to deliver the FluCare clinics and the vaccinations. Information on these and other resources will be collected from clinic logs, process evaluation and augmented with expert opinion as needed. Resources will be costed in the most recent cost year for which published NHS and PSS unit costs are available.
Process evaluation outcomes:
1. The amount (or dose) of the intervention delivered to each home
In Intervention care homes the dose of intervention material will be described -
1.1. No. of times videos played (embedded in videos)
1.2. Where posters displayed and engagement with them (interviews at the end of study)
1.3. No. of pharmacy visits to homes (pharmacist logs completed and returned after each clinic)
1.4. Length and time of pharmacist/healthcare practitioner visits to home (Vaccination log completed and returned after each clinic)
1.5. No. of incentive payments made to homes (study records at the end of study)
2. The mechanisms of action, adaptions and variations across care homes
The MAQ will be distributed to a purposively selected number of intervention and control care homes at the beginning of the study, inviting the care home staff to take part in the survey. Care Home staff who complete the first survey will be invited to take part in the second survey approximately 4 months later. Care Home staff who complete the survey may be invited to take part in process evaluation interviews to further understand their views and thoughts about the study.
Added 09/07/2024:
Aggregate, care home level resident hospitalisations and mortality as reported to the CQC over that flu season counted as 01/09/2024 to 31/03/2025
Health Economic Outcomes:
1. Resource use and costs of delivering staff vaccination and the FluCare intervention, measured using vaccination logs, CQC data, the DHSC capacity tracker, and earlier study components (e.g. previous trial) collected throughout the trial period and analysed using a within-trial approach.
2. The wider impact on the NHS in terms of resident hospitalisations, measured using aggregated CQC data collected over the trial period.
Process Evaluation Outcomes:
The amount (or dose) of the intervention delivered, measured using:
1. Clinics: clinic logs for numbers of clinics delivered and staff vaccinated per care home
2. FluCare video: video analytics (number of clicks and duration of video viewed per care home)
This is collected for each care home at the end of the intervention period.
Overall study start date
01/09/2021
Overall study end date
31/08/2025
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Care homes (CHs):
1. Registered to provide care for older residents, which may include people with dementia
2. Self-reported staff vaccination rate <40%
3. Must be signed up or willing to sign up to the DHSC Capacity Tracker and willing to submit weekly updates on flu vaccine status of staff and residents
Added 09/07/2024:
Community pharmacies:
1. Has an ongoing relationship with a care home that meets the CH inclusion/exclusion criteria
2. Willing to provide flu vaccinations within the care home to all directly employed care home staff
3. Have adequate staff available to deliver a flu vaccination clinic within the care home
Participant type(s)
Health professional
Age group
Adult
Sex
Both
Target number of participants
280 care homes: 140 intervention and 140 usual care
Participant exclusion criteria
1. Fewer than 10 staff members (as insufficient qualitative and quantitative data likely to be produced)
2. Participated in the FluCare feasibility trial
Added 09/07/2024:
3. Planning a flu vaccination initiative similar to the FluCare intervention
4. Participated in FluCare feasibility or randomised controlled study
Recruitment start date
10/10/2022
Recruitment end date
31/12/2024
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Norwich Clinical Trials Unit
University of East Anglia
Norwich Business Park
Norwich
NR4 7TJ
United Kingdom
Sponsor information
Organisation
University of East Anglia
Sponsor details
Research and Innovation Services (RIN)
Registry
Norwich
NR4 7TJ
England
United Kingdom
+44 (0)1603 591482
t.moulton@uea.ac.uk
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health and Care Research
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
The intervention itself is an important output. The researchers also anticipate eight peer-review publications:
1. Feasibility study protocol
2. Feasibility study results (including HE)
3. Process evaluation protocol
4. Process evaluation analysis
5. Process evaluation mechanisms analysis
6. Trial protocol
7. Evaluation of the effectiveness of the FluCare complex intervention via a cluster-RCT (including HE)
8. Development of a FluCare implementation toolkit
The researchers will also publish two education articles in both community pharmacy and care home journals introducing the FluCare implementation toolkit.
Updated 09/07/2024:
Two planned publications:
1. A methodology paper
2. End of trial results paper
Intention to publish date
31/05/2025
Individual participant data (IPD) sharing plan
The datasets generated by the FluCare Programme of research, including this current study, will be available upon request from Dr Amrish Patel, (amrish.patel@uea.ac.uk). Consent has been sought for data sharing for secondary analysis. The requested data will be provided anonymously. During the trial and up to the publication of results, Dr Patel and the Programme Management Group will consider and approve requests, where appropriate. Following the publication of the results, Dr Amrish Patel should be contacted in the first instance. Dr Patel, representatives from the FluCare collaboration as well as Sponsor, will be responsible for reviewing and approving requests.
Data, including pseudonymised care home staff and resident data logs, vaccination logs, site profile data and anonymised interview transcripts will be retained for 10 years. All data will be anonymised prior to sharing for secondary analysis, as requested by HRA.
IPD sharing plan summary
Stored in non-publicly available repository, Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.1 | 05/08/2022 | 28/10/2022 | No | No |
| Protocol article | 09/12/2022 | 12/12/2022 | Yes | No | |
| Protocol file | version 1.2 | 15/11/2022 | 10/01/2023 | No | No |
| Protocol file | version 1.3 | 10/01/2023 | 10/02/2023 | No | No |
| Protocol article | Protocol of the process evaluation | 15/09/2023 | 18/09/2023 | Yes | No |