Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
280 participants
INTERVENTIONAL
2022-12-31
2024-04-30
Brief Summary
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The trial aims to quantify the benefits and harms of regular asymptomatic testing in care home staff to inform policy. The rationale for regular asymptomatic testing is that it may reduce the risk of severe disease in residents and the frequency/severity of outbreaks.
Participants (care home staff) will perform regular asymptomatic tests for Covid-19. Should they test positive they will be required to refrain from working and be provided with sick pay.
Care providers will be reimbursed for the costs of employing agency staff to cover staff sickness absence that results directly from the trial.
Detailed Description
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The testing intervention will comprise of four modules that will be delivered in combination. Module 1: support payments for staff to enable them to self-isolate when unwell. Module 2: Branding and messaging around testing to promote engagement with testing. Module 3: Accessing training, protocols and planning. Module 4: Regular asymptomatic staff testing for COVID-19 using LFDs.
Asymptomatic testing will be in addition to symptomatic testing for staff and residents, which is standard policy for all care homes in England.
Providers will also receive funding to reimburse costs associated with employing agency staff to cover sickness absence for asymptomatic staff who test positive in the trial.
Non-intervention care home residents and staff will be subject to the testing policy that is in place nationally at the time of the trial. Care home staff in control homes will not receive support payments (Module 1) and testing in control homes will not be supported by branding or messaging (Module 2). The degree to which training and testing protocols are already in place in control homes (Module 3) will be investigated in the stakeholder workshops.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Arm A
LFD testing for Covid-19 with sickness support payment. Care providers will receive funding to reimburse the costs of employing agency staff to cover sickness absence in asymptomatic staff who test positive for COVID.
Lateral Flow Device
Regular asymptomatic staff testing with a Lateral Flow Device including support payments if unwell.
Arm B
Usual Care
No interventions assigned to this group
Interventions
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Lateral Flow Device
Regular asymptomatic staff testing with a Lateral Flow Device including support payments if unwell.
Eligibility Criteria
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Inclusion Criteria
* All care home staff, residents, visitors and relatives are eligible to participate in interviews undertaken as part of the process evaluation.
* All care home residents at participating home are eligible for data collection and analysis of the outcomes specified.
Exclusion Criteria
* Staff who visit the care home to provide care but are not employed by the care home e.g. GPs, health visitors are not eligible to take part in either the interviews or the testing intervention.
ALL
Yes
Sponsors
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University College, London
OTHER
Responsible Party
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Principal Investigators
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Laura Shallcross, Professor
Role: PRINCIPAL_INVESTIGATOR
UCL
Central Contacts
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References
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Stirrup O, Blackstone J, Cullen-Stephenson I, Fenner R, Adams N, Leiser R, Krutikov M, Azmi B, Freemantle N, Gordon A, Regan M, Knapp M, Gosce L, Henderson C, Hopkins S, Verma A, Cassell J, Cadar D, Fowler T, Copas A, Flowers P, Shallcross L. VIVALDI-CT shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff. PLoS One. 2025 Jul 2;20(7):e0324908. doi: 10.1371/journal.pone.0324908. eCollection 2025.
Other Identifiers
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CTU/2022/405
Identifier Type: -
Identifier Source: org_study_id