Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial

doi:10.1136/bmjopen-2020-046142

. 2021 Mar 2;11(3):e046142.

doi: 10.1136/bmjopen-2020-046142.

Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial

Collaborators, Affiliations

Collaborators

START Trial Group:
Anton Peleg, Terry Haines, Allen Cheng, Trisha Peel, Kathryn Holt, Sarah Hilmer, Yun-Hee Jeon, Andrew Stewardson, Rhonda Stuart, Tim Spelman, Sue Lee, Annette Schmiede, Daniel Wilson, James Trauer, Marilyn Cruickshank, Nicola De Maio, Bupa Aged Care

Affiliations

¹ Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia.
² School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
³ School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
⁴ Departments of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁵ Sydney Nursing School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁶ Monash Infectious Diseases, Monash Health, Monash Medical Centre, Clayton, Victoria, Australia.
⁷ Centre for Population Health, Burnet Institute, Melbourne, Victoria, Australia.
⁸ Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia anton.peleg@monash.edu.
⁹ Monash Biomedicine Discovery Institute, Infection and Immunity Theme, Department of Microbiology, Monash University, Clayton, Victoria, Australia.

PMID: 33653766
PMCID: PMC7929827
DOI: 10.1136/bmjopen-2020-046142

Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial

Natali Jokanovic et al. BMJ Open. 2021.

. 2021 Mar 2;11(3):e046142.

doi: 10.1136/bmjopen-2020-046142.

Authors

Collaborators

START Trial Group:
Anton Peleg, Terry Haines, Allen Cheng, Trisha Peel, Kathryn Holt, Sarah Hilmer, Yun-Hee Jeon, Andrew Stewardson, Rhonda Stuart, Tim Spelman, Sue Lee, Annette Schmiede, Daniel Wilson, James Trauer, Marilyn Cruickshank, Nicola De Maio, Bupa Aged Care

Affiliations

¹ Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia.
² School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
³ School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
⁴ Departments of Clinical Pharmacology and Aged Care, Kolling Institute of Medical Research, Royal North Shore Hospital, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁵ Sydney Nursing School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁶ Monash Infectious Diseases, Monash Health, Monash Medical Centre, Clayton, Victoria, Australia.
⁷ Centre for Population Health, Burnet Institute, Melbourne, Victoria, Australia.
⁸ Department of Infectious Diseases, The Alfred Hospital and Central Clinical School, Monash University, Melbourne, Victoria, Australia anton.peleg@monash.edu.
⁹ Monash Biomedicine Discovery Institute, Infection and Immunity Theme, Department of Microbiology, Monash University, Clayton, Victoria, Australia.

PMID: 33653766
PMCID: PMC7929827
DOI: 10.1136/bmjopen-2020-046142

Abstract

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.

Keywords: geriatric medicine; infectious diseases; public health.

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Conflict of interest statement

Competing interests: None declared.

Figures

**Figure 1**
Stepped-wedge cluster randomised controlled trial design. RACF, residential aged care facility.

See this image and copyright information in PMC

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Pilot study to evaluate the need and implementation of a multifaceted nurse-led antimicrobial stewardship intervention in residential aged care.
Jokanovic N, Lee SJ, Haines T, Hilmer SN, Jeon YH, Travis L, Ayton D, Watson E, Tsindos T, Stewardson AJ, Stuart RL, Cheng AC, Peel TN, Peleg AY; START Trial Group. Jokanovic N, et al. JAC Antimicrob Resist. 2024 Feb 14;6(1):dlae016. doi: 10.1093/jacamr/dlae016. eCollection 2024 Feb. JAC Antimicrob Resist. 2024. PMID: 38371999 Free PMC article.
Using behavioural science to improve antibiotic stewardship in Canadian long-term care homes: Protocol for a multi-center cluster randomized quality improvement study.
Good T, Cila J, Mosher R, Puka K, Reynolds S, Catt B, Mounchili A, Gravel-Tropper D, Quail P, McGeer A, Moser A, Ashcroft M, Daley P, Piggott K, Leis J, Morrissey M. Good T, et al. Can Commun Dis Rep. 2025 Jan 2;51(1):43-53. doi: 10.14745/ccdr.v51i01a06. eCollection 2025 Jan. Can Commun Dis Rep. 2025. PMID: 39781234 Free PMC article.

References

1. Lim CJ, McLellan SC, Cheng AC, et al. . Surveillance of infection burden in residential aged care facilities. Med J Aust 2012;196:327–31. 10.5694/mja12.10085 - DOI - PubMed
1. van Buul LW, van der Steen JT, Veenhuizen RB, et al. . Antibiotic use and resistance in long term care facilities. J Am Med Dir Assoc 2012;13:568.e1–3. 10.1016/j.jamda.2012.04.004 - DOI - PubMed
1. Australian Commission on Safety and Quality in Heatlh Care . AURA 2019: third Australian report on antimicrobial use and resistance in human health. Sydney: ACSQHC, 2019.
1. Lim CJ, Cheng AC, Kennon J, et al. . Prevalence of multidrug-resistant organisms and risk factors for carriage in long-term care facilities: a nested case-control study. J Antimicrob Chemother 2014;69:1972–80. 10.1093/jac/dku077 - DOI - PubMed
1. Department of Health . 2017-18 report on the operation of the aged care act 1997. Australian Government, 2018.

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[1] Lim CJ, McLellan SC, Cheng AC, et al. . Surveillance of infection burden in residential aged care facilities. Med J Aust 2012;196:327–31. 10.5694/mja12.10085 - DOI - PubMed

[2] Lim CJ, McLellan SC, Cheng AC, et al. . Surveillance of infection burden in residential aged care facilities. Med J Aust 2012;196:327–31. 10.5694/mja12.10085 - DOI - PubMed

[3] van Buul LW, van der Steen JT, Veenhuizen RB, et al. . Antibiotic use and resistance in long term care facilities. J Am Med Dir Assoc 2012;13:568.e1–3. 10.1016/j.jamda.2012.04.004 - DOI - PubMed

[4] van Buul LW, van der Steen JT, Veenhuizen RB, et al. . Antibiotic use and resistance in long term care facilities. J Am Med Dir Assoc 2012;13:568.e1–3. 10.1016/j.jamda.2012.04.004 - DOI - PubMed

[5] Australian Commission on Safety and Quality in Heatlh Care . AURA 2019: third Australian report on antimicrobial use and resistance in human health. Sydney: ACSQHC, 2019.

[6] Australian Commission on Safety and Quality in Heatlh Care . AURA 2019: third Australian report on antimicrobial use and resistance in human health. Sydney: ACSQHC, 2019.

[7] Lim CJ, Cheng AC, Kennon J, et al. . Prevalence of multidrug-resistant organisms and risk factors for carriage in long-term care facilities: a nested case-control study. J Antimicrob Chemother 2014;69:1972–80. 10.1093/jac/dku077 - DOI - PubMed

[8] Lim CJ, Cheng AC, Kennon J, et al. . Prevalence of multidrug-resistant organisms and risk factors for carriage in long-term care facilities: a nested case-control study. J Antimicrob Chemother 2014;69:1972–80. 10.1093/jac/dku077 - DOI - PubMed

[9] Department of Health . 2017-18 report on the operation of the aged care act 1997. Australian Government, 2018.

[10] Department of Health . 2017-18 report on the operation of the aged care act 1997. Australian Government, 2018.

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Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial

Collaborators

Affiliations

Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

Figures

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Cited by

References

Publication types

MeSH terms

Substances

Associated data

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical