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

Walker, A; Budgell, E; Laskawiec-Szkonter, M; Sivyer, K; Wordsworth, S; Quaddy, J; Santillo, M; ... Llewelyn, MJ; + view all (2019) Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped wedge cluster randomized controlled trial. Trials , 20 , Article 421. 10.1186/s13063-019-3497-y. Green open access

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Abstract

Background: To ensure patients continue to get early access to antibiotics at admission, safely reducing antibiotic use in hospitals 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 & revision’ 24-72 hours 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: ARK-hospital is a complex ‘review & 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 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%) as an acute/general medical inpatient, and superior in terms of defined-daily-doses (DDD) of antibiotics per acute/general medical admission (co-primary outcomes). The unit of observation is a hospital organisation, a single or group of hospital(s) organised with one executive board and governance framework (NHS 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 total of a minimum of 36 organisations. Randomisation will occur over 18 months from November 2017 with a further 12 month 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 generalizable mechanism for increasing antibiotic stopping in patients who no longer need to receive them at ‘review & revise’.

Type: Article
Title: Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped wedge cluster randomized controlled trial
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/s13063-019-3497-y
Publisher version: https://doi.org/10.1186/s13063-019-3497-y
Language: English
Additional information: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: Antibiotic prescribing, hospitals, antimicrobial stewardship
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Infection and Immunity
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10075584
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