Title: FluCare: Estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates
Funder: Department of Health and Social Care

Abstract: 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 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. _x000D_ _x000D_ After reviewing the evidence and speaking to care home staff and managers, we 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._x000D_ _x000D_ Our research will test if the following approaches can increase how many staff get vaccinated:_x000D_ - Community pharmacists vaccinating staff in the care home_x000D_ - Providing free vaccinations for everyone_x000D_ - Offering incentives to managers who increase the number of vaccinated staff_x000D_ - Monitoring how many staff get vaccinated and giving feedback to the home_x000D_ - Providing vaccine information leaflets and videos for staff and managers_x000D_ _x000D_ We want to find out which of these approaches is most likely to increase how many staff are vaccinated and provide best value to the NHS._x000D_ _x000D_ Our research has five stages that will take place over 3 years in East Anglia, London and the East Midlands. It has been designed assuming that COVID-19 is still with us._x000D_ _x000D_ We will first spend two months developing each of the above approaches with care home staff and pharmacies. Then, in the middle of next flu season we will test the approaches in 10 care homes. This will show us 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, we will refine the service and decide which mixture of approaches to study on a larger scale. We will do this by carefully listening to those involved and by looking at the quality of information we received._x000D_ _x000D_ Using information from these first three stages, in our main study we will work with 70 homes with low vaccination levels. We will randomise (like flipping a coin) homes to either get our new service or carry on with “service as usual”. At the end of the flu season, we will compare how many staff are vaccinated in the “new service” and “service as usual” groups. We will collect measures of resident health and costs related to the new service. This will show us if the service improves resident health and saves money for the NHS. At the same time, we will find out whether people used the new service as we intended. We will also listen to people involved to find out what did and did not work to learn how to improve the service. Finally, we will use our findings to develop a toolkit. This will tell people about our new service and encourage them to use it._x000D_ _x000D_ While we do this research, we will work closely with residents and relatives. They will help us design and manage the studies, collect information, look at the results and present them to the outside world.

Lay abstract: Background_x000D_ Seasonal influenza (flu) causes thousands of deaths each year in the UK, creating a major risk for care home residents. Whilst the World Health Organisation recommends 75% of social care staff are vaccinated, only 25-40% do so. With a need for tailored interventions, we used the Theoretical Domains Framework (TDF) to create a complex intervention consisting of regular in-care home staff vaccination clinics run by the supplying community pharmacy, free vaccination for all staff, theoretically underpinned information for staff, financial incentives for homes achieving vaccination rates over 70% and regular care home performance monitoring/feedback._x000D_ _x000D_ Aim_x000D_ To estimate the effectiveness and cost-effectiveness of our complex intervention designed to increase staff flu vaccination rates in care homes for older adults._x000D_ _x000D_ Method_x000D_ A public and patient involvement advisory group will contribute throughout the project. The project management team, expert advisory panel, trial steering and data management committees will meet regularly, overseeing project delivery. The TDF and Behaviour Change Wheel will underpin individual phases._x000D_ _x000D_ Phase 1: Intervention finalisation (months 1-2)_x000D_ Intervention components and implementation strategies (e.g. information material production) and trial procedures (e.g. data collection methods, fidelity framework and Mechanisms of Action questionnaire) will be finalised._x000D_ _x000D_ Phase 2: Feasibility study (months 2-11)_x000D_ 10 purposively selected homes will be allocated to receive the full intervention (2), usual care (2) or different parts of the intervention (3x2) to identify which parts, if any, maximise data quality and minimise bias. Within this we will test and refine methods for collecting outcome data, home/staff/resident characteristics and intervention costs. To understand how organisational context shapes intervention delivery, describe intervention fidelity and acceptability and identify sources of contamination between arms, we will use questionnaires, ethnographic visits, up to 40 interviews and documentary review._x000D_ _x000D_ Phase 3: Definitive trial (months 8-28)_x000D_ 70 recruited homes and pharmacies will be randomised to intervention or control. This will provide 90% power at a 5% significance level for detecting an increase in staff vaccination rate from 55% to 75%. A process evaluation will be undertaken to assess intervention fidelity; control arm contamination, any reactivity bias; to enable us to explain trial results and generate recommendations for wide-scale implementation. A cost-consequences analysis comparing costs and outcomes across trial arms for different stakeholders (e.g. care homes, NHS and staff) will be undertaken. The cost per percentage point increase in vaccination rate will be estimated._x000D_ _x000D_ Phase 4: Policy development for dissemination (months 24-32)_x000D_ The TDF and Behaviour Change Wheel will inform our dissemination strategy. We will conduct three stakeholder workshops to identify how to deliver wide-scale intervention implementation in homes. Our policy group will develop and disseminate implementation guidance._x000D_ _x000D_ Impact_x000D_ Higher care home staff flu vaccination rates and improved resident health.

Research activity codes: 3.4 VACCINES
Health categories: INFECTION