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

Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial
Antibiotic Review Kit for Hospitals (ARK-Hospital): study protocol for a stepped-wedge cluster-randomised controlled trial
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’.
1745-6215
Walker, Ann Sarah
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Budgell, Eric
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Laskawiec-Szkonter1, Magda
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Sivyer, Katy
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Wordsworth, Sarah
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Quaddy, Jack
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Santillo, Marta
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Krusche, Adele
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Roope, Laurence
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Bright, Nicole
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Mowbray, Fiona
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Jones, Nicola
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Hand, Kieran
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Rahman, Najib
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Dobson, Melissa
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Hedley, Emma
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Crook, Derrick
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Sharland, Mike
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Roseveare, Chris
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Hobbs, FD Richard
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Butler, Chris
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Vaughan, Louella
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Hopkins, Susan
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Yardley, Lucy
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Peto, Timothy
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Llewelyn, Martin
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Walker, Ann Sarah
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Budgell, Eric
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Laskawiec-Szkonter1, Magda
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Sivyer, Katy
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Wordsworth, Sarah
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Quaddy, Jack
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Santillo, Marta
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Krusche, Adele
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Roope, Laurence
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Bright, Nicole
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Mowbray, Fiona
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Jones, Nicola
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Hand, Kieran
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Rahman, Najib
c20ab4ea-18f3-4981-bd5c-b32a04dc0ea3
Dobson, Melissa
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Hedley, Emma
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Crook, Derrick
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Sharland, Mike
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Roseveare, Chris
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Hobbs, FD Richard
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Butler, Chris
95583b3d-b015-42de-ba2d-10de4ba67707
Vaughan, Louella
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Hopkins, Susan
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Yardley, Lucy
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Peto, Timothy
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Llewelyn, Martin
63b583ab-69de-4bd0-b0a7-051f16e69542

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. (doi:10.1186/s13063-019-3497-y).

Record type: Article

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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ARK protocol paper revision 2019-05-27 CLEAN - Accepted Manuscript
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Accepted/In Press date: 5 June 2019
Published date: 11 July 2019

Identifiers

Local EPrints ID: 432949
URI: https://eprints.soton.ac.uk/id/eprint/432949
ISSN: 1745-6215
PURE UUID: 5d80ea3f-1011-471a-a792-338a1fecbe17
ORCID for Katy Sivyer: ORCID iD orcid.org/0000-0003-4349-0102
ORCID for Fiona Mowbray: ORCID iD orcid.org/0000-0002-3297-4163
ORCID for Kieran Hand: ORCID iD orcid.org/0000-0002-3834-2415
ORCID for Lucy Yardley: ORCID iD orcid.org/0000-0002-3853-883X

Catalogue record

Date deposited: 01 Aug 2019 16:30
Last modified: 17 Aug 2019 00:38

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Contributors

Author: Ann Sarah Walker
Author: Eric Budgell
Author: Magda Laskawiec-Szkonter1
Author: Katy Sivyer ORCID iD
Author: Sarah Wordsworth
Author: Jack Quaddy
Author: Marta Santillo
Author: Adele Krusche
Author: Laurence Roope
Author: Nicole Bright
Author: Fiona Mowbray ORCID iD
Author: Nicola Jones
Author: Kieran Hand ORCID iD
Author: Najib Rahman
Author: Melissa Dobson
Author: Emma Hedley
Author: Derrick Crook
Author: Mike Sharland
Author: Chris Roseveare
Author: FD Richard Hobbs
Author: Chris Butler
Author: Louella Vaughan
Author: Susan Hopkins
Author: Lucy Yardley ORCID iD
Author: Timothy Peto
Author: Martin Llewelyn

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