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  • 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)

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Infectious diseases
Protocol
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)
  1. Natalie Adams1,
  2. Oliver Stirrup2,
  3. James Blackstone3,
  4. Maria Krutikov1,
  5. Jackie A Cassell4,5,
  6. Dorina Cadar4,6,
  7. Catherine Henderson7,
  8. Martin Knapp7,
  9. Lara Goscé2,8,
  10. Ruth Leiser9,
  11. Martyn Regan5,10,
  12. Iona Cullen-Stephenson3,
  13. Robert Fenner3,
  14. Arpana Verma11,
  15. Adam Gordon12,13,
  16. Susan Hopkins5,
  17. Andrew Copas2,
  18. Nick Freemantle3,
  19. Paul Flowers9,
  20. Laura Shallcross1
  1. 1Institute of Health informatics, University College London, London, UK
  2. 2Institute for Global Health, University College London, London, UK
  3. 3Comprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK
  4. 4Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, UK
  5. 5UK Health Security Agency, London, UK
  6. 6Centre for Dementia Studies, Department of Neuroscience, Brighton and Sussex Medical School, Brighton, UK
  7. 7Care Policy and Evaluation Centre, The London School of Economics and Political Science, London, UK
  8. 8Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK
  9. 9Department of Psychological Sciences and Health, University of Strathclyde, Glasgow, UK
  10. 10Division of Population Health, Health Services Research & Primary Care, School of Health Sciences & Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
  11. 11Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK
  12. 12Academic Unit of Injury, Recovery and Inflammation Sciences (IRIS), School of Medicine, University of Nottingham, Nottingham, UK
  13. 13Applied Research Collaboration-East Midlands (ARC-EM), NIHR, Nottingham, UK
  1. Correspondence to Dr Laura Shallcross; l.shallcross{at}ucl.ac.uk

Abstract

Introduction Care 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.

  • COVID-19
  • Epidemiology
  • Public health
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2023-076210

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    Footnotes

    • Twitter @jackiecassell, @adamgordon1978

    • Contributors NA, JB, MKr, LS and PF developed the study protocol and contributed to the writing of the manuscript. OS and AC were involved in development of the statistical analysis facets of the trial and contributed to the writing of the manuscript. CH and MKn were involved in development of the health economic analysis facets of the study and contributed to the writing of the manuscript. RL was involved in development of the process evaluation of the study and contributed to the writing of the manuscript. DC and JAC were involved in development of the health-related quality of life facets of the study and contributed to the writing of the manuscript. LG was involved in development of the economic modelling of the study and contributed to the writing of the manuscript. IC-S is the trial manager for the study. RF will oversee data collection and management. MR, AV, AG, NF and SH are coapplicants responsible for supporting the operationalisation of the study. LS and PF are the co-chief investigators for the study. All authors critically reviewed and approved the final version.

    • Funding This work is supported by the NIHR Health and Social Care Delivery Research (HSDR) Programme number (154310). Costs associated with SARS-CoV-2 testing including support payments for care home staff and for care homes to fund agency staff backfill will be funded by the UK Health Security Agency (UKHSA). The VIVALDI-CT is sponsored by University College London, represented by the UCL Comprehensive Clinical Trials Unit (UCL CCTU).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.