Antibiotic Review Kit for Hospitals (ARK-Hospital): Study protocol for a stepped-wedge cluster-randomised controlled trial

Ann Sarah Walker*, Eric Budgell, Magda Laskawiec-Szkonter, Katy Sivyer, Sarah Wordsworth, Jack Quaddy, Marta Santillo, Adele Krusche, Laurence S.J. Roope, Nicole Bright, Fiona Mowbray, Nicola Jones, Kieran Hand, Najib Rahman, Melissa Dobson, Emma Hedley, Derrick Crook, Mike Sharland, Chris Roseveare, F. D.Richard HobbsChris Butler, Louella Vaughan, Susan Hopkins, Lucy Yardley, Timothy E.A. Peto, Martin J. Llewelyn

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

2 Citations (Scopus)


Background: To ensure patients continue to get early access to antibiotics at admission, while also safely reducing antibiotic use in hospitals, one needs to target the continued need for antibiotics as more diagnostic information becomes available. UK Department of Health guidance promotes an initiative called 'Start Smart then Focus': early effective antibiotics followed by active 'review and revision' 24-72 h later. However in 2017, < 10% of antibiotic prescriptions were discontinued at review, despite studies suggesting that 20-30% of prescriptions could be stopped safely. Methods/design: Antibiotic Review Kit for Hospitals (ARK-Hospital) is a complex 'review and revise' behavioural intervention targeting healthcare professionals involved in antibiotic prescribing or administration in inpatients admitted to acute/general medicine (the largest consumers of non-prophylactic antibiotics in hospitals). The primary study objective is to evaluate whether ARK-Hospital can safely reduce the total antibiotic burden in acute/general medical inpatients by at least 15%. The primary hypotheses are therefore that the introduction of the behavioural intervention will be non-inferior in terms of 30-day mortality post-admission (relative margin 5%) for an acute/general medical inpatient, and superior in terms of defined daily doses of antibiotics per acute/general medical admission (co-primary outcomes). The unit of observation is a hospital organisation, a single hospital or group of hospitals organised with one executive board and governance framework (National Health Service trusts in England; health boards in Northern Ireland, Wales and Scotland). The study comprises a feasibility study in one organisation (phase I), an internal pilot trial in three organisations (phase II) and a cluster (organisation)-randomised stepped-wedge trial (phase III) targeting a minimum of 36 organisations in total. Randomisation will occur over 18 months from November 2017 with a further 12 months follow-up to assess sustainability. The behavioural intervention will be delivered to healthcare professionals involved in antibiotic prescribing or administration in adult inpatients admitted to acute/general medicine. Outcomes will be assessed in adult inpatients admitted to acute/general medicine, collected through routine electronic health records in all patients. Discussion: ARK-Hospital aims to provide a feasible, sustainable and generalisable mechanism for increasing antibiotic stopping in patients who no longer need to receive them at 'review and revise'. Trial registration: ISRCTN Current Controlled Trials, ISRCTN12674243. Registered on 10 April 2017.

Original languageEnglish
Article number421
Issue number1
Publication statusPublished - 11 Jul 2019

Bibliographical note

Funding Information:
The ARK-Hospital study is funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research (Grant Reference Number RP-PG-0514-20015). ASW, DWC, TEAP and ML are supported by the NIHR Biomedical Research Centre, Oxford. ASW, DWC, TEAP and CCB are NIHR Senior Investigators. FDRH acknowledges partial support from the NIHR School for Primary Care Research (SPCR), the NIHR Collaboration for Leadership in Applied Research in Health and Care (CLARHC) Oxford and the NIHR Biomedical Research Centre (BRC), Oxford. The ARK online tool was developed using the LifeGuide software, which was partly funded by the NIHR BRC, Southampton. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The study sponsor and funders have had no role in study design or in collection or management of data, and will not have any role in the analysis and interpretation of data, writing of the report or the decision to submit the report for publication, nor will they will have ultimate authority over any of these activities. Sponsor University of Oxford

Publisher Copyright:
© 2019 The Author(s).


  • Antibiotic prescribing
  • Antimicrobial stewardship
  • Hospitals


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