VIVALDI Clinical Trial

National study launched to investigate COVID-19 infections in care homes, led by UCL IHI's Professor Laura Shallcross MBE.

Background

Regular COVID-19 testing was important at the start of the pandemic, but now most people are vaccinated their chance of getting seriously unwell is much lower, although protection against infection can reduce over time.

COVID-19 testing also has negative consequences. It is uncomfortable, expensive, it takes time, and care home staff who test positive cannot work so they lose money. Staff sickness can also affect how care is delivered to care home residents. These negative consequences of testing are not usually measured and so they are not very visible to policymakers.  There is also no evidence on whether regular testing is beneficial to residents and whether it is cost-effective.

In this trial, our aim is to investigate whether it still makes sense to regularly test staff who do not have symptoms of COVID-19 in order to protect residents.

Once we have collected data on the pros and cons of testing, we will work with care home residents, families, staff, and care providers to think about what our results mean for care homes, and to work together to produce recommendations on how testing should be used in future.

During the COVID-19 pandemic care home staff and care provider organisations worked closely with scientists to deliver important research that changed national policy in successful collaborations, such as the VIVALDI study. This new way of working represents a major opportunity to improve care for residents of care homes.

The Research

The VIVALDI clinical trial is a national research project, led by University College London (UCL) and funded by the United Kingdom Health Security Agency (UKHSA) and National Institute for Health and Care Research (NIHR).

Our aim is for around 280 care homes to take part in the trial.  Half of the homes will be randomly assigned to carry out regular (twice-weekly) COVID-19 testing in staff using Lateral Flow Devices.  Staff in these homes also get support payments if they test positive so they are not disadvantaged by taking part in the trial and these homes are reimbursed for agency staff that they employ to cover staff sickness absence. The remaining homes that are not assigned to regular testing will follow the testing policy that is in place nationally at the time that we operate the trial. 

As part of the trial, we are using different approaches to measure the pros and cons of testing from the perspective of staff, residents, families, the NHS, and care home companies. These will include measuring whether regularly testing staff reduces the number of hospital admissions among residents, the economic impact of regular testing on homes, and we will find out about the experiences of testing by talking to staff.

Based on these discussions, we will also develop methods to make testing easier for staff that we can recommend for future use.

As with the original VIVALDI study, our results will be used to help inform national policy on COVID-19 testing.

Timeline

The study is funded from November 2022 and will run until April 2024.

Publications

We will publish our protocol and our results in pre-print and peer-reviewed journals. 

Funder

• National Institute for Heath and Care Research
• UK Health Security Agency

UCL Staff

• Professor Laura Shallcross, Institute of Health Informatics
• Dr Andrew Copas, Institute for Global Health
• Dr Oliver Stirrup, Institute for Global Health
• James Blackstone, Comprehensive Clinical Trials Unit
• Iona Cullen-Stephenson, Comprehensive Clinical Trials Unit
• Professor Nick Freemantle, Comprehensive Clinical Trials Unit
• Dominic Hague, Comprehensive Clinical Trials Unit
• Robert Fenner, Comprehensive Clinical Trials Unit
• Dr Lara Goscé, Institute for Global Health
• Dr Maria Krutikov, Institute of Health Informatics
• Dr Natalie Adams, Institute of Health Informatics
• Borscha Azmi, Institute of Health Informatics 

Wider Network

• Professor Paul Flowers, University of Strathclyde
• Dr Ruth Leiser, University of Strathclyde
• Dr Catherine Henderson, London School of Economics
• Professor Jackie Cassell, Brighton and Sussex Medical School & UK Health Security Agency
• Dr Dorina Cadar, Brighton and Sussex Medical School
• Natasha Southall, Four Seasons Healthcare
• Professor Martyn Regan, University of Manchester & UK Health Security Agency
• Professor Adam Gordon, University of Nottingham
• Professor Aparna Verma, University of Manchester
• Professor Susan Hopkins, UK Health Security Agency
• Dr Tom Fowler, UK Health Security Agency
• Dr Sarah Tunkel, UK Health Security Agency

Other Information and Contact

Contact us cctu.vivaldi@ucl.ac.uk