COVID-19 Clinical Trial
— VIVALDI-CTOfficial 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.
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.
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University College, London |
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 |
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