Shaping Care Home COVID-19 Testing Policy

COVID-19 Clinical Trial

— VIVALDI-CT  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05639205
• Other study ID #: CTU/2022/405
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2022
• Est. completion date: April 2024

Study information

• Verified date: December 2022
• Source: University College, London
• Contact: Laura Shallcross, Professor
• Phone: 0203 549 5540
• Email: l.shallcross[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 280
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Lateral Flow Device
Regular asymptomatic staff testing with a Lateral Flow Device including support payments if unwell.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	The primary outcome is the incidence of COVID-19 related hospital admissions in residents, defined as admissions with a relevant ICD-10 codes (COVID hospitalisations to be defined as any hospital admission record with a primary or secondary ICD10 code of 'U071') and/or admissions in residents who test positive for COVID-19 within 24h following admission or in the 7 days before hospital admission. This has been selected because it is the most important outcome for policymakers.	4 months
Secondary	Incidence rate of hospital admissions	Incidence rate of hospital admissions (all-cause) in residents for non-elective care, measured as events per 100,000 person-days of follow-up over the duration of the trial	4 months
Secondary	Incidence rate of COVID-associated mortality in residents	Incidence rate of COVID-associated mortality in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial.; COVID-associated mortality will be defined as death within 28 days of a positive SARS-CoV-2 test and/or COVID-19 recorded as primary or secondary cause of death on the death certificate (using ICD-10 coding).	4 months
Secondary	Incidence of all-cause mortality in residents	Incidence of all-cause mortality in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial	4 months
Secondary	Testing uptake in staff	Testing uptake in staff, measured as proportion of staff at each home participating in testing during each week of the trial	Once per week for 4 months
Secondary	Prevalence of SARS-CoV-2 among staff who test	Prevalence of SARS-CoV-2 among staff who test, measured as proportion of staff with positive test result among those with at least one test recorded during each week of the trial	Once per week for 4 months
Secondary	Incidence rate of SARS-CoV-2 infections detected in residents	Incidence rate of SARS-CoV-2 infections detected in residents, measured as events per 100,000 person-days of follow-up over the duration of the trial	4 months
Secondary	Incidence rate of home-level outbreaks	Incidence rate of home-level outbreaks, measured as events per 1000 days of follow-up over the duration of the trial	4 months
Secondary	Duration of outbreaks	Duration of outbreaks, measured as days from first to last case within outbreaks occurring within the trial period	4 months
Secondary	Incidence rate of care home closures due to outbreaks	Incidence rate of care home closures due to outbreaks, measured as events per 1000 days of follow-up over the duration of the trial	4 months
Secondary	Staff sick	Proportion of staff per home who are off sick at each home during each week of the trial	Once per week for 4 months
Secondary	Agency staff filled shifts	Proportion of all shifts filled by agency staff at each home during each week of the trial	Once per week for 4 months