Title: CONtact TrAcing in Care homes using digital Technology (CONTACT) - A pragmatic cluster randomised controlled trial, cost-effectiveness evaluation and theory-informed process evaluation.
Funder: Department of Health and Social Care

Abstract: At the start of the COVID-19 pandemic around four hundred thousand people lived in some form of care home. In some homes up to 8 out of every 10 residents have been infected with COVID-19 and up to half of these people have died. Family visiting has largely stopped, to try and make the risks of infection smaller. Many residents - especially with dementia - have suffered as a result. As restrictions begin to be relaxed, homes and families are keen to find ways to start safe visits again. There is no vaccine for COVID-19; even if a vaccine is developed, older people may react differently and may not be as well protected as the rest of the population. It is important that care homes know who has the virus but also who they have come into contact with so they can use infection control methods to slow its spread and reduce the chances of residents, staff and wider community members dying too soon. _x000D_ _x000D_ The NHS uses a system called “Test and Trace” and people call "contact tracers" to interview people that have tested positive for or come into contact with COVID-19. For people living and working in care homes this way of contact tracing may not work very well. Many people that live in care homes have memory and communication difficulties. Care home staff sometimes have more than fifty contacts with residents and other staff each day. Remembering the details of contacts, even from the same day, can be difficult and so the information provided to NHS Test and Trace cannot be relied upon and the system will not work properly._x000D_ _x000D_ We want to use small wearable devices, like a fitbit/digital watch or small broach, to record contacts between staff, residents and visitors in homes more reliably and without people having to do anything other than wear the device. Over one year, we will ask 32 care homes in Yorkshire and the Midlands to encourage staff, residents and visitors to wear the devices and 32 others to wait a while and work with NHS Test and Trace. In the study – called CONTACT – we will record and analyse the data on contacts in homes and summarise it for them so homes (and NHS Test and Trace) can see how patterns and trends of contacts are changing. We will measure how many residents test positive for COVID-19, how many die and how much money and time is involved in homes using the CONTACT devices. We want to understand how best to encourage homes to use the CONTACT technology and to understand why and if it works as it should, so we will look at the things about the care homes, the staff and the technology that make using the devices and equipment easier or more difficult._x000D_ _x000D_ CONTACT will mean that care homes will be able to play their part in reducing the risk of COVID-19 infection to/from the communities in which they are located, including how they work with hospitals to reduce risks to residents and staff, deal with residents, staff or visitors testing positive for COVID-19 more effectively and how they can safely manage visiting to increase the quality of life for residents families and staff through more and safer social contact.

Lay abstract: 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. _x000D_ 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. _x000D_ 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)?_x000D_ Research design: pragmatic cluster randomised controlled trial with embedded cost effectiveness analysis, and theory-informed process evaluation._x000D_ 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. _x000D_ 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.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES;7.3 MANAGEMENT AND DECISION MAKING
Health categories: INFECTION