SORA

Advancing, promoting and sharing knowledge of health through excellence in teaching, clinical practice and research into the prevention and treatment of illness

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

Walker, AS; Budgell, E; Laskawiec-Szkonter, M; Sivyer, K; Wordsworth, S; Quaddy, J; Santillo, M; Krusche, A; Roope, LSJ; Bright, N; et al. Walker, AS; Budgell, E; Laskawiec-Szkonter, M; Sivyer, K; Wordsworth, S; Quaddy, J; Santillo, M; Krusche, A; Roope, LSJ; Bright, N; Mowbray, F; Jones, N; Hand, K; Rahman, N; Dobson, M; Hedley, E; Crook, D; Sharland, M; Roseveare, C; Hobbs, FDR; Butler, C; Vaughan, L; Hopkins, S; Yardley, L; Peto, TEA; Llewelyn, MJ; ARK trial team (2019) Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial. Trials, 20 (1). p. 421. ISSN 1745-6215 https://doi.org/10.1186/s13063-019-3497-y
SGUL Authors: Sharland, Michael Roy

[img]
Preview
PDF Published Version
Available under License Creative Commons Attribution.

Download (1MB) | Preview

Abstract

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.

Item Type: Article
Additional Information: © The Author(s). 2019 Open Access 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, Antimicrobial stewardship, Hospitals, ARK trial team, Antibiotic prescribing, Hospitals, Antimicrobial stewardship, 1102 Cardiovascular Medicine And Haematology, 1103 Clinical Sciences, Cardiovascular System & Hematology, General & Internal Medicine
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: Trials
ISSN: 1745-6215
Language: eng
Dates:
DateEvent
11 July 2019Published
5 June 2019Accepted
Projects:
Project IDFunderFunder ID
RP-PG-0514-20015National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
PubMed ID: 31296255
Web of Science ID: WOS:000475992700001
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/111083
Publisher's version: https://doi.org/10.1186/s13063-019-3497-y

Actions (login required)

Edit Item Edit Item