Life In The Slower Lane

Here is the structured PICO analysis for the twentieth article you uploaded:

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Full Title (verbatim and exact):

“A multimodal intervention to optimise antimicrobial use in residential aged care facilities (ENGAGEMENT): protocol for a stepped-wedge cluster randomised trial”

Falconer N, Paterson DL, Peel N, Welch A, Freeman C, et al.

Trials (2022); 23:427

DOI: https://doi.org/10.1186/s13063-022-06323-8

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Type of Article:

Study protocol for a stepped-wedge cluster-randomised controlled trial

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PICO Analysis:

Population:

• Residents of 18 residential aged care facilities (RACFs) in Queensland, Australia
• RACFs with ≥50 residents; study involves de-identified data on antimicrobial use, demographics, and outcomes 

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Intervention:

AMS ENGAGEMENT Bundle – a multimodal antimicrobial stewardship (AMS) program comprising:

1. Education for general practitioners (GPs), nurses, pharmacists, residents, and families
2. Nursing initiatives to reduce inappropriate urine testing and improve UTI diagnosis
3. Telehealth support and decision tools
4. Facility-level AMS teams
5. Antibiotic prescribing guidelines tailored for RACFs
6. Emergency department liaison and consistent clinical pathways
7. Electronic decision support tools and webinars 

Intervention tailored to RACF needs via a Needs Assessment Toolkit (NAT). Delivered using remote-compatible formats (e.g., print, webinars, digital).

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Comparator:

• Usual care delivered during the facility’s control period prior to receiving the intervention
• Each site acts as its own control in a stepped-wedge design, transitioning from control to intervention over 20 months 

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Outcome:

1. Person-centred outcomes:

• Mortality rate and hospital admissions per 1000 resident bed days
• C. difficile-associated diarrhoea cases per 1000 bed days
• No individual patient surveys or quality of life metrics are used 

2. Process outcomes:

• Primary outcome:
  • Antibiotic consumption measured as Defined Daily Doses (DDDs) per 1000 occupied bed days
• Secondary outcomes:
  • Number of urine samples collected
  • Antibiotic susceptibility profiles (Enterobacteriaceae)
  • Days of therapy, incidence of use, and antimicrobial therapy rates
  • Assessment of antimicrobial resistance (AMR) trends over time 

3. Health system outcomes:

• Economic evaluation including:
  • Medication, pathology, hospitalisation, and educational costs
  • Cost-effectiveness modelling from health system payer perspective
  • Long-term modelling of reduced AMR impact
• Process evaluation using RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) 

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Summary Conclusion:

This protocol outlines a large, rigorously designed Australian stepped-wedge RCT to evaluate a tailored, multimodal antimicrobial stewardship intervention across 18 RACFs. The trial addresses inappropriate antibiotic use—particularly for UTIs, respiratory infections, and skin conditions—by embedding clinical governance, staff education, digital tools, and localised AMS teams. Outcomes include antibiotic use reduction, safety (mortality, C. difficile), and cost-effectiveness. Process evaluation will support translation to broader practice. Results aim to guide sustainable improvements in AMS in aged care settings nationally.

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