Regular asymptomatic COVID-19 testing in care home staff
| ISRCTN | ISRCTN13296529 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13296529 |
| IRAS number | 320847 |
| Secondary identifying numbers | V1.0, IRAS 320847 |
- Submission date
- 24/11/2022
- Registration date
- 05/12/2022
- Last edited
- 09/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
This study will investigate whether the continued use of regular asymptomatic COVID-19 testing in care home staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes. The findings will shape policy across the UK for COVID-19 and inform wider strategies to prevent other respiratory viruses in care homes, such as influenza. This study aims to measure the benefits and harms of regular asymptomatic testing in care home staff to inform policy. Regular asymptomatic testing may reduce the risk of severe disease in residents and the frequency and severity of outbreaks.
Who can participate?
Participants for the testing intervention will be care home staff from a target of 280 care homes. This will also include temporary (agency) staff with no restrictions (i.e. catering staff, administrative staff, and maintenance staff), in addition to those in a resident-facing role.
These care home staff as well as residents, visitors and relatives are all eligible to participate in interviews undertaken as part of the process evaluation.
Participants for the data collection and analysis of the outcomes specified will be care home residents.
What does the study involve?
To finalise the intervention, a series of workshops will be held with care home stakeholders (e.g. home managers, staff, providers) and policymakers (including those with knowledge of testing logistics) to explore the intervention components. These workshops will: 1) consolidate existing insights into routine testing gleaned through past experiences with the COVID-19 pandemic; 2) discuss the intervention prototype; and, 3) operationalise it in ways which are likely to be acceptable and appropriate within the sector.
Any care home staff Interested in participating can either liaise with the care home manager or respond directly to the research team. Upon receipt of staff contact details, interested staff will then be sent participant information sheets about the study, given the option to ask questions about the study, complete online consent forms and provide brief sociodemographic details. The study team will then arrange a time for data collection to take place. Within data collection (focus groups or one-to-one interviews), having checked online consent has already been given and after exploring any remaining unanswered questions raised by the PIS, the participants will be asked to also give recorded oral consent to participate. This consent will be recorded on the audio/video file. Interviewees will be reimbursed for their time (vouchers).
The researchers will also recruit a single workshop with around eight residents (with the capacity to consent), relatives, or visitors to assist with intervention development. Interested parties will then either liaise with the care home manager about their participation or respond directly to the research team. Upon receipt of resident, relative or visitor contact details, interested parties will then be sent participant information sheets about the study, given the option to ask questions about the study, complete online consent forms and provide brief sociodemographic details. The study team will then arrange a time for data collection to take place. Within data collection (focus groups or one-to-one interviews), having checked online consent has already been given, and after exploring any remaining unanswered questions raised by the Participant Information Sheet, the participants will be asked to also give recorded oral consent to participate. This consent will be recorded on the audio/video file. Interviewees will be reimbursed for their time (vouchers).
The testing intervention will be comprised 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: Accessible training, protocols and planning. Module 4: Regular asymptomatic staff testing for COVID-19.
In module 4 care homes participating in the intervention arm of the trial will be provided with lateral flow tests. Asymptomatic testing will be in addition to symptomatic testing for staff and residents and testing as part of the outbreak response.
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.
What are the possible benefits and risks of participating?
Regular asymptomatic testing may reduce the risk of severe disease in residents and the frequency/severity of COVID-19 outbreaks. The trial may identify policies and approaches to testing in care homes which could reduce the risk of reducing residents' risk of severe outcomes following infection in these settings. Participants will indirectly benefit from this research through its influence on the COVID-19 policy on testing in care homes.
The trial could lead to loss of income for providers if asymptomatic testing results in increased detection of low-risk cases leading to potentially unnecessary care home closures. This is mitigated by the trial team who will risk-assess asymptomatic cases that have been detected in staff in the intervention arm to avoid unnecessary escalation of low-risk cases to local public health teams. The trial team includes a number of individuals who have trained in health protection and are thus qualified to undertake this role.
Increased staff sickness absence may reduce staffing ratios and the quality of care that is delivered to residents. There is a risk of introducing infection into the care home when the study team conduct personal data collection (although most data collection is virtual). This risk will be mitigated by complying with infection control protocols in place at the time of the study (including asymptomatic testing where appropriate), not attending if unwell and using virtual meetings where possible.
Where is the study run from?
University College London (UK)
When is the study starting and long is it expected to run for?
November 2022 to April 2024
Who is funding the study?
1. Health and Social Care Delivery Research (HSDR) Programme (UK)
2. UK Health Security Agency (UK)
Who is the main contact?
Prof. Laura Shallcross, l.shallcross@ucl.ac.uk
Contact information
Principal Investigator
Institute of Health Informatics
University College London
222 Euston Road
London
NW1 2DA
United Kingdom
 ORCID ID |
0000-0003-1713-2555 |
|---|---|
| Phone | +44 (0)203 549 5540 |
| l.shallcross@ucl.ac.uk |
Scientific
Institute of Health Informatics
University College London
222 Euston Road
London
NW1 2DA
United Kingdom
| Phone | +44 (0)203 549 5540 |
|---|---|
| l.shallcross@ucl.ac.uk |
Public
Comprehensive Clinical Trials Unit at UCL
90 High Holborn 2nd Floor
London
WC1V 6LJ
United Kingdom
| Phone | +44 (0)20 7907 4669 |
|---|---|
| cctu-enquiries@ucl.ac.uk |
Study information
| Study design | Multi-centre open-label interventional cluster randomized controlled Phase III/IV superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Care home, Workplace |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Shaping care home COVID- testing policy: a pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff |
| Study acronym | VIVALDI-CT |
| Study objectives | Continued use of regular asymptomatic testing in care home staff is a feasible, effective and cost-effective strategy to reduce the impact of COVID-19 in care homes. Findings will shape policy across the UK for COVID-19 and inform wider strategies to prevent other respiratory viruses in care homes, such as influenza. |
| Ethics approval(s) | Approved 19/12/2022, London - Bromley Research Ethics Committee (Temple Quay House, 2 The Square, Temple Quay, Bristol, BS1 6PN, UK; +44 (0)207 104 8118; bromley.rec@hra.nhs.uk), ref: 22/LO/0846 |
| Health condition(s) or problem(s) studied | Prevention of severe COVID-19 (SARS-CoV-2 infection) related outcomes in care home residents |
| Intervention | Intervention: Regular asymptomatic testing of care home staff for COVID-19 using lateral flow devices (LFDs) combined with support payments for sickness absence in those who test positive. Control: COVID-19 testing policy for care home staff that is in place nationally at the time of trial operation. There will be two arms: Arm A and Arm B. Arm A will be comprised of the intervention. This intervention will be delivered via four modules: Module 1: Support payments for staff to enable them to self-isolate when unwell and reimbursement for providers for costs associated with backfill to cover staff absence Module 2: Branding and messaging around testing Module 3: Accessible training, protocols and planning Module 4: Regular asymptomatic staff testing for COVID-19 – twice weekly The intervention will take approximately 3 months. Arm B - Residents and staff in non-intervention care homes 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 and providers in control homes will not receive funding to reimburse the costs of employing agency staff since there is no asymptomatic testing. The degree to which training and testing protocols are already in place in control homes (Module 3) will be investigated in the stakeholder workshops. There is no standard follow-up period. Care homes will be randomised to standard care (the testing policy that is in place at the time of trial) versus intervention (multi-component testing intervention) in a 1:1 ratio. If all providers are ready for trial participation at the same time then all participating homes will be randomised at the same time. Otherwise, the homes from different providers will be randomised in a phased approach, as they become ready. The results of the randomisation process will be communicated to each provider’s project manager. They will be responsible for informing care home managers whether they have been randomised to the control or intervention group. The trial team will draft an email/text that can be used to explain the process of randomisation to care home managers. Randomisation will be performed by the trial statistician after enrolment of care homes and prior to implementation of the intervention, based on pseudo-random number generation. Restricted randomisation (specifically covariate-constrained randomisation) will be used to ensure balance on care home provider, size and region. |
| Intervention type | Other |
| Primary outcome measure | The incidence of COVID-19-related hospital admissions in residents, defined as admissions with 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 24 h following admission or in the 7 days before hospital admission. This has been selected because it is the most important outcome for policymakers. |
| Secondary outcome measures | 1. 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 2. 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* 3. 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. Testing uptake in staff, measured as the proportion of staff at each home participating in testing during each week of the trial 5. Prevalence of SARS-CoV-2 among staff who test, measured as the proportion of staff with positive test results among those with at least one test recorded during each week of the trial 6. 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 7. Incidence rate of home-level outbreaks, measured as events per 1000 days of follow-up over the duration of the trial 8. Duration of outbreaks, measured as days from first to last case within outbreaks occurring within the trial period 9. Incidence rate of care home closures due to outbreaks, measured as events per 1000 days of follow-up over the duration of the trial 10. Proportion of staff per home who are off sick at each home during each week of the trial 11. Proportion of all shifts filled by agency staff at each home during each week 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 the primary or secondary cause of death on the death certificate (using ICD-10 coding) |
| Overall study start date | 01/11/2022 |
| Completion date | 30/04/2024 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 280 care homes (the subjects of the trial are the care homes) |
| Key inclusion criteria | 1. 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. 2. All care home staff, residents, visitors and relatives are eligible to participate in interviews undertaken as part of the process evaluation. 3. All care home residents at participating homes are eligible for data collection and analysis of the outcomes specified. |
| Key exclusion criteria | 1. Visitors, residents and relatives are not eligible to take part in the testing intervention. 2. 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 |
| Date of first enrolment | 05/12/2022 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
-
-
United Kingdom
Sponsor information
University/education
Comprehensive Clinical Trials Unit at UCL
90 High Holborn 2nd Floor
London
WC1V 6LJ
England
United Kingdom
| Phone | +44 (0)20 767 65017 |
|---|---|
| nicholas.freemantle@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Health and Social Care Delivery Research Programme, HSDR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/04/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Laura Shallcross (cctu.vivaldi@ucl.ac.uk). The type of data that will be shared: Fully anonymised data collected from care home records. Dates of availability: From 1st May 2024 Whether consent from participants was required and obtained: Consent was not required under an S251 exemption from CAG Comments on data anonymization: Fully Added 27/04/2023: The datasets generated for analysis of primary and secondary outcomes for this study will be available for research purposes upon request from the Comprehensive Clinical Trials Unit (CCTU) at UCL (cctu.vivaldi@ucl.ac.uk), subject to the provision of a feasible analysis plan and ethical approval. Individual-level consent has not been obtained from participants in this study, and so any data shared would be fully anonymized with minimal individual-level information. Fully anonymised data from the study will be stored by CCTU without a defined time limit. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol article | 14/11/2023 | 16/11/2023 | Yes | No | |
| Protocol (other) | VIVALDI ASCOT and Ethnography Study: protocol for a mixed-methods longitudinal study to evaluate the impact of COVID-19 and other respiratory infection outbreaks on care home residents' quality of life and psychosocial well-being | 07/08/2024 | 09/08/2024 | No | No |
Editorial Notes
09/08/2024: Publication reference added.
16/04/2024: The contact confirmed the record is up to date.
16/11/2023: Publication reference added.
27/04/2023: IPD sharing statement updated.
24/04/2023: IPD sharing statement added.
17/04/2023: Ethics approval details and trial website added. The recruitment end date was changed from 01/04/2023 to 30/04/2023.
24/01/2023: The study setting has been updated from ‘Other’.
01/12/2022: Trial's existence confirmed by the NIHR.
