Official Title
Shaping Care Home COVID-19 Testing Policy: A Pragmatic Cluster Randomised Controlled Trial of Asymptomatic Testing Compared to Standard Care in Care Home Staff.
Brief Summary

The goal of this interventional study is to investigate whether continued use of regularasymptomatic testing in staff is a feasible, effective and cost-effective strategy toreduce the impact of COVID-19 in care homes.The trial aims to quantify the benefits and harms of regular asymptomatic testing in carehome staff to inform policy. The rationale for regular asymptomatic testing is that itmay reduce the risk of severe disease in residents and the frequency/severity ofoutbreaks.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 providedwith sick pay.Care providers will be reimbursed for the costs of employing agency staff to cover staffsickness absence that results directly from the trial.

Detailed Description

To date the evidence based underpinning elements of the intervention has been developed
through engagement work with the National Care Forum, senior managers of care homes and
three stakeholder events with front-line care home staff. It will be finalised through a
series of further workshops. These workshops will 1) consolidate existing insights into
routine testing gleaned through past experiences in the COVID-19 pandemic; 2) discuss the
intervention prototype; 3) operationalise it in ways which are likely to be acceptable
and appropriate within the sector.

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.

Unknown status
COVID-19

Diagnostic Test: Lateral Flow Device

Regular asymptomatic staff testing with a Lateral Flow Device including support payments
if unwell.

Eligibility Criteria

Inclusion Criteria:

- Only care home staff are eligible to participate in the testing intervention. This
includes temporary (agency) staff with no restrictions i.e. catering staff,
administrative staff, maintenance staff, in addition to those in a resident-facing
role.

- 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:

- Visitors, residents and relatives are not eligible to take part in the testing
intervention.

- 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.

Eligibility Gender
All
Eligibility Age
Minimum: N/A ~ Maximum: N/A
Locations

Not Provided

Contacts

Laura Shallcross, Professor
0203 549 5540
l.shallcross@ucl.ac.uk

CCTU Enquiries
020 7907 4669
cctu-enquiries@ucl.ac.uk

Laura Shallcross, Professor, Principal Investigator
UCL

University College, London
NCT Number
Keywords
Lateral Flow Device
MeSH Terms
COVID-19