Clinical trial NCT05639205: Shaping Care Home COVID-19 Testing Policy
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Keywords: Lateral Flow Device
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 280
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this interventional study is to investigate whether continued use of regular asymptomatic testing in staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes.

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: 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.

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.

Primary outcomes:
measure: Primary Outcome
timeFrame: 4 months
Secondary outcomes:
measure: Incidence rate of hospital admissions
timeFrame: 4 months
measure: Incidence rate of COVID-associated mortality in residents
timeFrame: 4 months
measure: Incidence of all-cause mortality in residents
timeFrame: 4 months
measure: Testing uptake in staff
timeFrame: Once per week for 4 months
measure: Prevalence of SARS-CoV-2 among staff who test
timeFrame: Once per week for 4 months
measure: Incidence rate of SARS-CoV-2 infections detected in residents
timeFrame: 4 months
measure: Incidence rate of home-level outbreaks
timeFrame: 4 months
measure: Duration of outbreaks
timeFrame: 4 months
measure: Incidence rate of care home closures due to outbreaks
timeFrame: 4 months
measure: Staff sick
timeFrame: Once per week for 4 months
measure: Agency staff filled shifts
timeFrame: Once per week for 4 months
Other outcomes:
Locations:
Study officials:
affiliation: UCL
name: Laura Shallcross, Professor
role: PRINCIPAL_INVESTIGATOR
References: