CONTACT Main Trial [COVID-19]
Research type
Research Study
Full title
CONtact TrAcing in Care homes using digital Technology (CONTACT) – A pragmatic cluster randomised controlled trial with embedded cost effectiveness analysis, and theory-informed process evaluation.
IRAS ID
294390
Contact name
Carl Thompson
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 8 months, 29 days
Research summary
The COVID-19 pandemic has had a tragic impact on the ~411,000 older people that live in 15,517 care homes in England and Wales. With >24750deaths(1) since the start of the pandemic, infection rates within homes as high as 80% and mortality rates of 30-50%[2, 3] it is clear that infection control, informed by regular testing for active virus via reverse-transcriptase polymerase chain reaction (rt-PCR) antibody testing and effective management of contacts between staff, residents and visitors in homes (currently weekly PCR and mid-week Lateral Flow Device for staff and every 28 days for residents) will be key to managing and containing COVID-19.[2] Cohort studies, simulations and epidemiological studies have found staff are a key source of outbreaks and transmission in homes[2]; in particular, staff entry/re-entry, including community and agency nurses.[4, 5]
The national vaccination programme for care homes has begun with most residents>80 years of age offered a vaccine and receiving their first dose of the twin dose vaccines. Numbers of staff vaccinated are unclear, but some reports suggest that as many as 20% of staff may refuse to be vaccinated for religious, health or personal reasons. Vaccination is unlikely to result in zero outbreaks and cases in homes. Numbers of older people in the vaccine trials were comparatively small (so evidence of effects is limited), the immune systems of the very old are not as efficient as the young, and coverage is unlikely to 100% in residents and staff.
Regardless of vaccination for sars-cov-2, there are other diseases that use contact between individuals to transmit within care homes; notably, norovirus, gastroenteritis and influenza. Management of these diseases all rely on monitoring and controlling interpersonal contacts and effective use of ventilation and other environmental adaptations (such as “zoning” areas for care).
Testing of staff and residents, without also contact tracing, will not be enough for effective public health interventions and reduced community transmission and encourages “blanket” (restrictive) policies.[6] Conventional structured interview and documentary contact tracing is likely ineffective in care homes. In the many homes where 70-80% of residents live with dementia and staff have more than 50 contacts per day [26] recalling historic contacts using interviews is unfeasible.
NHS Test and Trace-style contact tracing is labour intensive, inefficient and burdensome for contacts and tracers alike.[6] Smartphone-based solutions to support contact tracing have limited utility even in the general population [27], but have even less in care homes – where few residents use such technology and staff are sometimes discouraged from using them in the workplace.
Wearable digital devices can help overcome the flaws in contact tracing in care homes using human tracers and smartphones. Advances in network technology mean small, discrete, wearables, with battery life of up to a year can capture contacts between individuals and their environments. Key information for contact tracing (when, who, where and how long and frequency of contacts) is easily generated, stored and recalled. Lightweight tags on lanyards, clothing or wristbands, often used already in homes for access control and resembling fitbits™, make real-time and retrospective capture, encryption, storage and recall of contacts realistic.
Feasibility was established using a single-armed non-randomised study in care homes in West Yorkshire. Therefore, we are planning to evaluate, through a large-scale cluster randomised trial in care homes in Yorkshire and the East Midlands, whether wearable digital contact tracing devices and tailored feedback of results (CONTACT intervention) alongside NHS test-and-trace are a cost-effective means of generating contact data in care homes, improving infection control and COVID-19 resident infection rates and mortality, compared with contact tracing as usual. Although contact tracing devices are widely used in manufacturing and other high-risk industries and have been used in academic research contexts [28] they come mostly of smartphone or other “smart” device apps that make use of Bluetooth and similar facilities. Systematic reviews suggest such approaches are limited by (low or partial) take up and empirical evidence of benefits are scarce. [29] Whilst mooted as an industry “solution” to the problems of care home contact tracing [30] we are not aware of any rigorously evaluated non smartphone based digital device contact tracing empirical studies. Whilst devices are beginning to be used in small scale industry context, evaluations have been restricted to simulation-based modelling. [31]
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
21/YH/0095
Date of REC Opinion
27 Apr 2021
REC opinion
Favourable Opinion