TY - JOUR
AU - Adams, Natalie
AU - Stirrup, Oliver
AU - Blackstone, James
AU - Krutikov, Maria
AU - Cassell, Jackie A.
AU - Cadar, Dorina
AU - Henderson, Catherine
AU - Knapp, Martin
AU - Goscé, Lara
AU - O’Brien, Lily
AU - Leiser, Ruth
AU - Regan, Martyn
AU - Cullen-Stephenson, Iona
AU - Fenner, Robert
AU - Verma, Arpana
AU - Gordon, Adam L.
AU - Hopkins, Susan
AU - Copas, Andrew J.
AU - Freemantle, Nick
AU - Flowers, Paul
AU - Shallcross, Laura
PY - 2026
DA - February
TI - Asymptomatic testing compared with standard care of the care home staff in shaping care home COVID-19 testing policy: the VIVALDI-CT pragmatic cluster RCT (VIVALDI-CT)
JO - Health and Social Care Delivery Research
DO - https://doi.org/10.3310/GJLS1610
AB - Background Regular severe acute respiratory syndrome coronavirus 2 testing of care home staff was introduced to reduce transmission following significant morbidity, mortality and disruption for residents early in the pandemic. However, evidence was lacking on benefits relative to disadvantages. Objectives The VIVALDI-Clinical Trial aimed to investigate whether regular asymptomatic staff testing for severe acute respiratory syndrome coronavirus 2, alongside funding for sick pay and agency backfill, was feasible and effective in reducing severe coronavirus disease discovered in 2019-related outcomes in residents. Design and methods VIVALDI-Clinical Trial comprised five interlinking work packages. A cluster randomised controlled trial was conducted from January to August 2023. The ‘Test to Care’ intervention was coproduced with the care sector. Settings and participants Eighty-one residential/nursing homes in England providing care to adults aged ≥ 65 years. Forty-one homes were randomised to intervention and 40 to control. Interventions Care homes were randomised 1 : 1 to intervention (twice weekly staff testing, staff sick pay and agency backfill) or control arm (national testing guidance at time of trial). Main outcome measure Primary outcome was incidence of coronavirus disease discovered in 2019-related hospital admissions in residents. Data sources Health data from routine national data sets were used alongside aggregate data from participating homes. Health economic and modelling analyses evaluated costs and cost-effectiveness of staff testing. Interviews with care home managers explored post-pandemic policies on staff testing, sickness pay and absence. A process evaluation was conducted to understand intervention roll-out. A mixed-study design investigated the impact of coronavirus disease discovered in 2019 outbreaks on care home residents’ quality of life. Stakeholder engagement was undertaken to enable the sector to coproduce recommendations for policy-makers. Results The trial stopped early for futility due to site recruitment and primary outcome incidence being lower than expected. There was no significant difference in resident coronavirus disease discovered in 2019-linked hospital admission incidence between intervention and control arms (incidence rate ratio 1.19, 95% confidence interval 0.55 to 2.58; p = 0.66). The process evaluation found that changing epidemiology, policy and social norms around coronavirus disease discovered in 2019 shaped the uptake and maintenance of testing. Interviews with care home managers suggested most homes no longer test staff, even when symptomatic, and do not pay for sickness absence outside of statutory sick pay. Modelling concluded that regular staff testing, when combined with non-pharmaceutical interventions preventing transmission among residents, is an effective strategy to reduce cases and deaths among care home residents that could also lead to significant cost savings. There was lower-than-expected quality of life for 43 residents from 9 care homes without outbreak and 1 home with recent coronavirus disease discovered in 2019 outbreak, with older residents experiencing greater benefits from social care support. Limitations Intervention acceptability was initially high, but waned because of the changing epidemiological, policy and social context. Conclusions Contextual changes undermined our ability to evaluate the intervention’s impact. However, trial set-up was achieved in &lt; 3 months, and we present findings on the feasibility and economic implications of routine testing and impact of disease control measures on residents’ quality of life. Costs associated with severe acute respiratory syndrome coronavirus 2 testing including support payments for care home staff and for care homes to fund agency staff backfill were funded by the United Kingdom Health Security Agency. Future work Our approach provides a model for agile interventional studies in care homes. Research training and capacity building for care home staff are important to ensure that future trials can be delivered efficiently in this setting. Funding This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR154310.
PB - NIHR National Institute for Health Research
UR - https://publichealthscotland.scot/id/225798
KW - Coronavirus (COVID-19)
KW - Older people
KW - Social and community care
ER