Walker, Ann Sarah, Budgell, Eric, Laskawiec-Szkonter1, Magda, Sivyer, Katy, Wordsworth, Sarah, Quaddy, Jack, Santillo, Marta, Krusche, Adele, Roope, Laurence, Bright, Nicole, Mowbray, Fiona, Jones, Nicola, Hand, Kieran, Rahman, Najib, Dobson, Melissa, Hedley, Emma, Crook, Derrick, Sharland, Mike, Roseveare, Chris, Hobbs, FD Richard, Butler, Chris, Vaughan, Louella, Hopkins, Susan, Yardley, Lucy, Peto, Timothy and Llewelyn, Martin (2019) Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial. Trials, 20 (1), 1-16, [421]. (doi:10.1186/s13063-019-3497-y).
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’.
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