Title: Shaping care home COVID- testing policy: A pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff (VIVALDI-CT)
Funder: Department of Health and Social Care

Abstract: Why do this research? During the COVID-19 pandemic care home stakeholders worked closely with scientists/academics to deliver important research that changed national policy. This new way of working together represented a major opportunity to improve care for residents. In this study, our goal is to deliver more research to inform national testing policy in care homes, by investigating whether it still makes sense to regularly COVID test staff who do not have symptoms to protect residents. The problem Regular COVID testing was important at the start of the pandemic to protect residents from infection, but now most people are vaccinated their chance of getting seriously unwell are much lower. Testing also has negative consequences. It is uncomfortable, expensive, it takes time, and care home staff who test positive can’t work so they lose money. The research study (Nov '22 - Apr '24) We will start by building on care homes substantial experience of testing during the pandemic to agree a testing approach for staff that is acceptable to them, and rewards them for testing. We think the approach will include regular use of Lateral Flow Devices and support payments for staff who test positive, so they can afford to self-isolate when unwell. Next we use different types of studies to measure the pros and cons of testing from the perspective of staff, residents, families, the NHS, and care home companies. 1) Clinical trial: We will identify 280 care homes to take part, and randomly choose 140 homes to receive the new ‘testing approach’. The remaining 140 homes will use whatever testing policy is in place nationally when the trial takes place. We will then measure the extent and impact of COVID-19 in homes that did or did not receive the new ‘testing approach’. This will provide evidence on whether the testing approach protects residents from infection. 2) Interviews: We will also interview staff, families and visitors to understand how testing impacts on them and what they thought of the testing approach. We will measure how outbreaks and testing impact on residents quality of life. This will provide evidence on the unintended consequences of regular testing. 3) Analysis of data on cost effectiveness: We also want to see if the testing approach is good value for money. To do this we will use data held by the NHS and care home companies to measure costs and impacts of testing from a NHS, social care and societal perspective. We will consider how these costs might change if COVID becomes more or less common. This will provide evidence on the short and long-term effectiveness of regular testing. We will seek informed consent from individuals who are interviewed. Because we randomly choose care homes to take part, rather than individuals, we will not seek consent from staff members to participate in the clinical trial, but they can ‘opt out’ of testing. Patient and public involvement: We will involve relatives, the public, care home staff and companies at all stages of the research. People with experience of care homes will oversee the study. Research impact and dissemination: We will work with our diverse stakeholders and public advisors to integrate evidence from the different types of studies, make recommendations for policymakers on the use of regular COVID testing in care home staff, and disseminate our findings to different audiences. We will also visit care homes to talk to staff, residents and relatives about our research.

Lay abstract: BACKGROUND: Regular asymptomatic testing of care home staff enables earlier outbreak detection protecting vulnerable residents from COVID-19 infection, but is known to have unintended negative consequences. Currently, there is a lack of evidence concerning: the relative benefits/harms of testing; the best approach to ensure compliance with testing; how to sustain testing over time; the parameters in which ongoing testing is warranted; or the nature of unintended and negative consequences. Interdisciplinary and multi-method research, including a rigorous trial, is urgently required to resolve these questions, inform policy, and direct service delivery. PROJECT AIM: The project examines the relative benefits and harms of regular COVID testing targeting asymptomatic staff in UK care homes. METHODS: The project is delivered by an experienced, inter-disciplinary team between November 2022 and April 2024. It capitalises on existing data infrastructure and partnerships with providers. Work-package 1 – Intervention development: using published literature, stakeholder input, and theory, we will coproduce a sustainable, multi-component testing intervention for staff using Lateral Flow Devices, considering: 1) staff sickness payments; 2) psychological strategies to improve testing compliance; 3) testing frequency. Work-package 2 - Pragmatic cluster randomised trial: we will evaluate the effectiveness of the testing intervention versus testing policy in place nationally at the time of the trial in 140 control and 140 intervention homes. Primary outcome: number of unplanned hospital admissions in residents. Key secondary outcomes: mortality, testing uptake, outbreaks, prevalence of COVID-19 among tested staff. Work-package 3 - Process evaluation of intervention and control: qualitative interviews with staff, families and visitors in 28 homes to establish the acceptability, feasibility and impact of the testing intervention, and refine programme theory detailing how the intervention works, to inform its future roll out if successful. Separately we will assess the impact of testing and COVID-19 outbreaks on social care related quality of life in 3 intervention and 3 control homes using the Adult Social Care Outcomes Tool. Work-package 4 - Economic analysis: using routine NHS datasets and provider administrative records we will itemise the costs and benefits of the testing intervention versus standard care from a NHS, personal social services and societal perspective. We will model COVID-19 transmission in residents and staff to estimate the number of COVID-19 infections and deaths averted by the testing intervention and estimate its cost effectiveness under different epidemiological scenarios. Work-package 5 - Stakeholder engagement: We will hold 4 roundtable discussions for key stakeholders to engage them in the study, and co-develop plans for dissemination and implementation. PUBLIC AND PATIENT ENGAGEMENT: Public advisors will be involved at all stages of the trial. IMPACT AND DISSEMINATION: Findings will inform testing policy and winter planning and longer-term strategies to prevent respiratory infections in care homes. We will disseminate results using traditional and non-traditional media, an in-person conference, virtual knowledge exchange events and by visiting care homes.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: INFECTION