维瓦尔第CT塑造养老院新冠肺炎检测政策：一项针对养老院工作人员无症状检测与标准护理对比的实用整群随机对照试验。

VIVALDI-CT shaping care home COVID-19 testing policy: A pragmatic cluster randomised controlled trial of asymptomatic testing compared to standard care in care home staff.

作者信息

Stirrup Oliver, Blackstone James, Cullen-Stephenson Iona, Fenner Robert, Adams Natalie, Leiser Ruth, Krutikov Maria, Azmi Borscha, Freemantle Nick, Gordon Adam, Regan Martyn, Knapp Martin, Goscé Lara, Henderson Catherine, Hopkins Susan, Verma Arpana, Cassell Jackie, Cadar Dorina, Fowler Tom, Copas Andrew, Flowers Paul, Shallcross Laura

机构信息

Institute for Global Health, University College London, London, United Kingdom.

Comprehensive Clinical Trials Unit, University College London, London, United Kingdom.

出版信息

PLoS One. 2025 Jul 2;20(7):e0324908. doi: 10.1371/journal.pone.0324908. eCollection 2025.

DOI:10.1371/journal.pone.0324908

PMID:40601586

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12221029/

Abstract

BACKGROUND

Non-pharmaceutical interventions were used widely in care homes for older people during the COVID-19 pandemic, but there have been few randomised trials to support policy decisions. We aimed to evaluate the effect of biweekly asymptomatic staff testing with support funding for sick pay and agency staffing on the clinical outcomes of residents.

METHODS

We conducted a cluster randomised unblinded superiority trial, aiming to recruit up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. Homes were randomised 1:1 to the control arm, which followed national testing policy (comprising symptomatic plus outbreak testing at trial initiation) or intervention (additional twice weekly asymptomatic staff testing for SARS-CoV-2, staff sick pay and agency backfill). Outcomes were evaluated using health data from routine national datasets in combination with aggregate data from participating homes. The primary outcome was the incidence of COVID-19-related hospital admissions in residents.

RESULTS

The trial was conducted from January to August 2023, with 41 care homes randomised to intervention and 40 randomised to control included in the analysis. The trial was stopped early as it was not adequately powered for the primary outcome due to site recruitment and primary outcome events being substantially lower than expected. There was no significant difference in the primary outcome of resident COVID-linked hospital admission incidence between intervention and control arms (22.7/1000 person-years vs 15.0/1000 person-years, incidence rate ratio 1.19, 95%CI 0.55-2.58, P = 0.66; incidence rate difference 4.0, 95%CI -14.3 to 22.2). Trial set up took less than three months. Most trial outcomes were derived from routinely collected data. Recorded uptake of staff testing in the intervention arm was low (mean per home each week 14.4%).

CONCLUSION

This trial was not well-powered to evaluate the impact of the intervention on the primary outcome, and recorded uptake of staff testing was low. However, our pre-existing care home network underpinned by linked routinely collected data provides a model for more agile interventional studies in the care home setting.

CLINICALTRIALS.GOV REGISTRATION: NCT05639205.

摘要

背景

在新冠疫情期间，非药物干预措施在养老院中被广泛使用，但支持政策决策的随机试验却很少。我们旨在评估每两周对无症状工作人员进行一次检测，并提供病假工资和机构人员配备支持资金，对居民临床结局的影响。

方法

我们进行了一项整群随机非盲优效性试验，目标是招募英格兰多达280家为65岁以上成年人提供护理服务的养老院。养老院按1:1随机分为对照组，对照组遵循国家检测政策（包括试验开始时的有症状检测加疫情检测）或干预组（额外每周两次对工作人员进行无症状SARS-CoV-2检测、工作人员病假工资和机构人员补充）。使用来自国家常规数据集的健康数据结合参与养老院的汇总数据来评估结局。主要结局是居民中与新冠相关的住院率。

结果

该试验于2023年1月至8月进行，分析中包括41家随机分配到干预组的养老院和40家随机分配到对照组的养老院。由于招募地点和主要结局事件远低于预期，该试验因对主要结局的检验效能不足而提前终止。干预组和对照组居民新冠相关住院率这一主要结局无显著差异（22.7/1000人年 vs 15.0/1000人年，发病率比1.19，95%CI 0.55 - 2.58，P = 0.66；发病率差异4.0，95%CI -14.3至22.2）。试验设置用时不到三个月。大多数试验结局来自常规收集的数据。干预组记录的工作人员检测参与率较低（每家养老院每周平均14.4%）。