VIVALDI-CT - regular asymptomatic testing in care home staff v1.0 [CAG Pilot]
Research type
Research Study
Full title
Shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of an intervention to promote regular, asymptomatic testing in care home staff. (VIVALDI-CT)
IRAS ID
320847
Contact name
Laura Shallcross
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN13296529
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
We aim to investigate whether it still makes sense to regularly test staff who do not have symptoms of COVID-19 to protect residents.
Working with 3-4 organisations that provide nursing and/or residential care to residents in England, we will identify 280 of their homes to be randomised into the trial: 140 homes will apply the new ‘regular testing approach’ and the remainder will use the testing policy that is in place nationally when the trial takes place. The extent and impact of COVID-19 in both groups will be compared to understand whether regular testing protects residents from infection.
We will interview care home staff, families and visitors to understand how testing impacts on them and what they thought of the testing approach. We will also interview residents to understand how testing and outbreaks impact on their quality of life.
We will also investigate whether the new ‘testing approach’ is good value for money, and how this might change if COVID becomes more or less serious or more or less common.
We will seek informed consent from individuals who are interviewed. However, we will not seek consent from staff members to participate in the clinical trial because we are randomly choosing care homes rather than individuals to take part. Staff members can ‘opt out’ of regular testing.We will involve relatives, the public, care home staff, residents and provider organisations at all stages, including oversight of the study and will work with people with knowledge of care homes and public advisors to integrate evidence from the different parts of the trial. We will make recommendations for policymakers on the use of regular COVID testing in care home staff, and share our findings with diverse audiences. We will also visit care homes to talk to staff, residents and relatives about our research.
REC name
London - Bromley Research Ethics Committee
REC reference
22/LO/0846
Date of REC Opinion
8 Dec 2022
REC opinion
Further Information Favourable Opinion