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)

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 'Äì 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.