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
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Le résumé fourni par la source
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.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- 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
- Date Crossref
- 02/07/2025
- Éditeur
- Public Library of Science (PLoS)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University College London Institute for Global Health pays non établi dans la noticeUniversité ou école supérieure
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UK Health Security Agency pays non établi dans la noticeOrganisme public
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University of Strathclyde pays non établi dans la noticeUniversité ou école supérieure
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University of Nottingham pays non établi dans la noticeUniversité ou école supérieure
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Manchester Academic Health Science Centre pays non établi dans la noticeÉtablissement de santé
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London School of Economics and Political Science Department of Health Policy pays non établi dans la noticeUniversité ou école supérieure
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London School of Hygiene & Tropical Medicine Department of Infectious Disease Epidemiology pays non établi dans la noticeUniversité ou école supérieure
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Brighton and Sussex Medical School pays non établi dans la noticeUniversité ou école supérieure
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University of Brighton Brighton & Sussex Medical School pays non établi dans la noticeUniversité ou école supérieure
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UCL Biomedical Research Centre pays non établi dans la noticeÉtablissement de santé
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School of Psychological Sciences and Health pays non établi dans la noticeUniversité ou école supérieure
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Institute of Health Informatics pays non établi dans la noticeStructure de recherche
Institute for Global Health — University College London, UK Health Security Agency et University of Strathclyde, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.