Shaping Care Home COVID-19 Testing Policy: A Pragmatic Cluster Randomised Controlled Trial of Asymptomatic Testing Compared to Standard Care in Care Home Staff.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 280
- 主要终点
- Primary Outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Outcome
时间窗: 4 months
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.
次要结局
- Incidence rate of care home closures due to outbreaks(4 months)
- Incidence rate of hospital admissions(4 months)
- Incidence rate of COVID-associated mortality in residents(4 months)
- Incidence of all-cause mortality in residents(4 months)
- Testing uptake in staff(Once per week for 4 months)
- Prevalence of SARS-CoV-2 among staff who test(Once per week for 4 months)
- Duration of outbreaks(4 months)
- Staff sick(Once per week for 4 months)
- Incidence rate of SARS-CoV-2 infections detected in residents(4 months)
- Incidence rate of home-level outbreaks(4 months)
- Agency staff filled shifts(Once per week for 4 months)