Abstract
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
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.