CONtact TrAcing in Care homes using digital Technology (CONTACT) - A pragmatic cluster randomised controlled trial, cost-effectiveness evaluation and theory-informed process evaluation.

Background: 400,000 people live in ~115,000 care homes with and without nursing. With no COVID-19 vaccine, 80% infection and 50% mortality rates in some homes, testing and crucially - contact tracing must become business-as-usual in homes for effective infection control, mortality reduction and minimising community transmission. Traditional contact tracing in care homes is ineffective: ~70% of residents have a cognitive deficit/dementia making reliable recall unfeasible and care staff would need to recall >50 contacts a day. Interview and document-based tracing is labour intensive, expensive and extremely burdensome. Small, wearable, inexpensive, digital devices within secure 'plug and play' wireless networks in homes can provide reliable real-time and historic contact data. Wearables can increase the quantity and quality of contact data, with almost zero burden, using technologies similar to those already present in homes: access fobs, cards and wristbands. The information produced can help homes plan and evaluate infection control procedures such as cohorting of residents/staff, environmental zoning and modification. Systematic reviews of care home infection control suggest 30% improvements in mortality are possible. Research question: Are wearable digital contact tracing devices and tailored feedback of results (the CONTACT intervention) a cost-effective means of contact tracing in care homes, improving infection control and COVID-19 resident infection rates and reducing mortality, compared with contact tracing as usual in homes (the controls)? Research design: pragmatic cluster randomised controlled trial with embedded cost effectiveness analysis, and theory-informed process evaluation. Methods: Over 12 months, residents, staff and visitors in 64 care homes - (80% power to detect a 25-40% improvement in infection rates) in Yorkshire and Midlands will be randomised to the CONTACT intervention or control arms. After brief training for staff and base station installation, CONTACT will provide real time and retrospective data to each home and NHS test and trace services on all individual-individual and individual-home environment contacts (e.g.kitchens,corridors) in homes. Tailored information on contact patterns and trends, including frequency and constituents of contact(s), environment 'pinch points', and deviations from infection control procedures (cohorting/zoning) will be fed back monthly as an emailed PDF and via an electronic dashboard website for each home. Economic data on costs and resource use will be analysed and expressed as £-per-infection-avoided and willingness-to-pay. Determinants for embedding the CONTACT technology will be explored using a mixed method (QUANT|QUAL) process evaluation based on Normalisation Process Theory. Primary analysis of clinical effectiveness will be differences in infection rates (+PCR swab test) and all-cause mortality. Impacts: CONTACT will enable care homes to plan and evaluate infection control procedures efficiently, increasing the likelihood of lower mortality from COVID-19. CONTACT will provide data otherwise unavailable to the NHS Test and Trace system, ensuring contact data does not start and finish at the care home door . It will facilitate more and safer visiting, constructive conversations between homes and the NHS regarding viral transmission risks and offer a minimal-burden approach for care homes to contribute to reducing the impact of COVID-19 on communities.