Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial.
geriatric medicine
infectious diseases
public health
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
02 03 2021
02 03 2021
Historique:
entrez:
3
3
2021
pubmed:
4
3
2021
medline:
20
5
2021
Statut:
epublish
Résumé
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. 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, 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. NCT03941509.
Identifiants
pubmed: 33653766
pii: bmjopen-2020-046142
doi: 10.1136/bmjopen-2020-046142
pmc: PMC7929827
doi:
Substances chimiques
Anti-Infective Agents
0
Banques de données
ClinicalTrials.gov
['NCT03941509']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e046142Investigateurs
Anton Peleg
(A)
Terry Haines
(T)
Allen Cheng
(A)
Trisha Peel
(T)
Kathryn Holt
(K)
Sarah Hilmer
(S)
Yun-Hee Jeon
(YH)
Andrew Stewardson
(A)
Rhonda Stuart
(R)
Tim Spelman
(T)
Sue Lee
(S)
Annette Schmiede
(A)
Daniel Wilson
(D)
James Trauer
(J)
Marilyn Cruickshank
(M)
Nicola De Maio
(N)
None Bupa Aged Care
Informations de copyright
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: None declared.
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