Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial
,
Andrew Stewardson,
Allen C Cheng,
Tim Spelman,
Sarah N Hilmer,
Allen Cheng,
Sarah Hilmer,
Terry Haines,
Trisha Peel,
Anton Peleg,
Natali Jokanovic,
Rhonda L Stuart,
Daniel Wilson,
Kathryn E Holt,
Yun-Hee Jeon,
Andrew J Stewardson,
Trisha N Peel,
Anton Y Peleg,
Kathryn Holt,
Rhonda Stuart,
Sue Lee,
Annette Schmiede,
James Trauer,
Marilyn Cruickshank,
Nicola De Maio,
Bupa Aged Care
Affiliations
4Association of British Neurologists
Andrew Stewardson
Department of Infectious Diseases, Alfred Health, Melbourne, Victoria, Australia
Allen C Cheng
School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia
Tim Spelman
10Department of Clinical Neuroscience, Swedish MS Registry, Solna, Sweden
Sarah N Hilmer
Clinical Pharmacology and Aged Care, Royal North Shore Hospital, St Leonards, New South Wales, Australia
Allen Cheng
Sarah Hilmer
3 Department of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital School, Saint Leonards, New South Wales, Australia
Terry Haines
School of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia
Trisha Peel
Department of Infectious Diseases, Monash University and Alfred Health, Melbourne, Victoria, Australia
Anton Peleg
Natali Jokanovic
Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia
Rhonda L Stuart
5 School of Clinical Sciences, Monash University, Clayton, Victoria, Australia
Daniel Wilson
Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia
Kathryn E Holt
Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia
Yun-Hee Jeon
3 Sydney Nursing School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
Andrew J Stewardson
Department of Infectious Diseases, Alfred Hospital, Melbourne, Victoria, Australia
Trisha N Peel
Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia
Anton Y Peleg
1 Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia
Kathryn Holt
Rhonda Stuart
Sue Lee
Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand
Annette Schmiede
James Trauer
School of Public Health and Preventative Medicine, Monash University, Clayton, Victoria, Australia
Introduction Antimicrobial resistance is a growing global health threat, driven by increasing inappropriate use of antimicrobials. High prevalence of unnecessary use of antimicrobials in residential aged care facilities (RACFs) has driven demand for the development and implementation of antimicrobial stewardship (AMS) programmes. The Stepped-wedge Trial to increase antibiotic Appropriateness in Residential aged care facilities and model Transmission of antimicrobial resistance (START) will implement and evaluate the impact of a nurse-led AMS programme on antimicrobial use in 12 RACFs.Methods and analysis The START trial will implement and evaluate a nurse-led AMS programme via a stepped-wedge cluster randomised controlled trial design in 12 RACFs over 16 months. The AMS programme will incorporate education, aged care-specific treatment guidelines, documentation forms, and audit and feedback strategies that will target aged care staff, general practitioners, pharmacists, and residents and their families. The intervention will primarily focus on urinary tract infections, lower respiratory tract infections, and skin and soft tissue infections. RACFs will transition from control to intervention phases in random order, two at a time, every 2 months, with a 2-month transition, wash-in period. The primary outcome is the cumulative proportion of residents within each facility prescribed an antibiotic during each month and total days of antibiotic use per 1000 occupied bed days. Secondary outcomes include the number of courses of systemic antimicrobial therapy, antimicrobial appropriateness, antimicrobial resistant organisms, Clostridioides difficile infection, change in antimicrobial susceptibility profiles, hospitalisations and all-cause mortality. Analyses will be conducted according to the intention-to-treat principle.Ethics and dissemination Ethics approval has been granted by the Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/591). Research findings will be disseminated through peer-reviewed publications, conferences and summarised reports provided to participating RACFs.Trial registration number NCT03941509.
