Evidence map›Paper›PMID 37963697›Full record

ArticleBMJ open2023

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT).

Natalie Adams, Oliver Stirrup, James Blackstone, Maria Krutikov, Jackie A Cassell, Dorina Cadar, Catherine Henderson, Martin Knapp, Lara Goscé, Ruth Leiser and 10 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Use of the adult social care outcomes toolkit (ASCOT) in research studies: an international scoping review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Natalie AdamsInstitute of Health informatics, University College London, London, UK.ORCID 0000-0002-6131-480X
Oliver StirrupInstitute for Global Health, University College London, London, UK.
James BlackstoneComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.ORCID 0000-0003-4335-5269
Maria KrutikovInstitute of Health informatics, University College London, London, UK.
Jackie A CassellDepartment of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.ORCID 0000-0003-0777-0385
Dorina CadarDepartment of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK.
Catherine HendersonCare Policy and Evaluation Centre, The London School of Economics and Political Science, London, UK.
Martin KnappCare Policy and Evaluation Centre, The London School of Economics and Political Science, London, UK.
Lara GoscéInstitute for Global Health, University College London, London, UK.
Ruth LeiserDepartment of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.
Martyn ReganUK Health Security Agency, London, UK.
Iona Cullen-StephensonComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.
Robert FennerComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.
Arpana VermaManchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
Adam GordonAcademic Unit of Injury, Recovery and Inflammation Sciences (IRIS), School of Medicine, University of Nottingham, Nottingham, UK.ORCID 0000-0003-1676-9853
Susan HopkinsUK Health Security Agency, London, UK.
Andrew CopasInstitute for Global Health, University College London, London, UK.ORCID 0000-0001-8968-5963
Nick FreemantleComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.
Paul FlowersDepartment of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK.ORCID 0000-0001-6239-5616
Laura ShallcrossInstitute of Health informatics, University College London, London, UK l.shallcross@ucl.ac.uk.

Funding

Department of Health 154310
6 · The paper itself

Abstract

introductionCare home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes. METHODS AND ANALYSIS: The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.The trial will be delivered by a multidisciplinary research team through a series of five work packages.The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers. ETHICS AND DISSEMINATION: The study has been approved by the London-Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants. TRIAL REGISTRATION NUMBER: ISRCTN13296529.

Indexed as

COVID-19AdultClinical Trials, Phase III as TopicCOVID-19 TestingEquivalence Trials as TopicHospitalizationHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSARS-CoV-2Tomography, X-Ray ComputedCOVID-19EpidemiologyPublic health

Identifiers

PMID37963697
PMCPMC10649600

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.