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

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.

Keywords: Antibiotic prescribing; Antimicrobial stewardship; Hospitals.

Fig. 1

Defining the patient population from routinely collected electronic health records

Fig. 2

Analysis model

Fig. 3

ARK schedule of enrolment, interventions, and assessments (SPIRIT figure). * Healthcare organisations are recruited to the study before enrolment but at varying calendar times, based on the fact that they can provide historical patient electronic healthcare record data pre-implementation. They are allocated an implementation date based on the stepped-wedge design. ** Follow-up finishes 12 months after the last randomised organisation implements the intervention, estimated June 2020. † There are no formal assessments. Outcomes are assessed using routinely collected electronic health records from patients admitted to acute/general medicine over the entire study period, pooled periodically during the trial

Fig. 4

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents