Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities

Overview

The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities. The intervention will be assessed in a stepped-wedge cluster randomised controlled trial across 14 residential aged care facilities over an 18-month period.

Full Title of Study: “Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2022

Detailed Description

The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities (RACFs). The antimicrobial stewardship intervention will include the following components: 1. Education – Focused on antimicrobial stewardship and appropriate antimicrobial use – Delivered face-to-face, via workbooks and fact sheets to aged care staff, general practitioners (GPs), pharmacists, and residents and families. Education will be delivered by the research coordinator. 2. Guidelines – Aged care-specific guidelines for the assessment and antimicrobial management of urinary tract infections, respiratory tract infections and skin and soft tissue infections. – Antimicrobial management recommendations including empirical oral therapy, doses and duration of therapy. 3. Communication – Documentation for the assessment and antimicrobial management of infections. – Nurse-led engagement with residents and families. – Newsletters and online updates to highlight evidence-based prescribing practice 4. Audit and feedback – Surveillance and feedback to prescribers on antimicrobial use and facility-level antimicrobial susceptibility data. The intervention bundle will first be implemented and tested for feasibility and acceptability over a 3-month period in two RACFs in Victoria, Australia. This tailored intervention will then be assessed in a stepped-wedge cluster randomised controlled trial across 12 RACFs over an 16-month period. A cluster of two facilities will each transition through three phases over the 16 month trial: – Control phase: baseline data collection. Usual care at each facility. – Transition phase: Delivery of education and integration of the intervention. No data collection. – Intervention phase: implementation of the intervention and outcome data collection. Ongoing education to new and existing staff will be provided as required. Following the 16-month trial, the refined intervention bundle will be implemented nationally across a network of RACFs.

Interventions

  • Behavioral: Antimicrobial stewardship
    • Education, guidelines, communication tools and audit and feedback

Arms, Groups and Cohorts

  • No Intervention: Control
    • All facilities will receive usual care during the control phase of the trial.
  • Experimental: Antimicrobial stewardship
    • Implementation of the nurse-led bundled antimicrobial stewardship intervention

Clinical Trial Outcome Measures

Primary Measures

  • Cumulative proportion of residents prescribed a systemic antimicrobial
    • Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
  • Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
    • Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months

Secondary Measures

  • Number of courses of systemic antimicrobial therapy per 1,000 OBD.
    • Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
  • Proportion of appropriate antimicrobial use.
    • Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
    • Antimicrobials will be considered to be appropriate if minimum criteria for their initiation are met according to guidelines by the Society of Healthcare Epidemiology of America.
  • Frequency of carriage of antimicrobial-resistant organisms
    • Time Frame: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
    • Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
  • Rate of Clostridium Difficile infection
    • Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
  • Change in facility-level antimicrobial susceptibility profile
    • Time Frame: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
    • Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
  • Incidence of resident transfer to hospital for infectious indications
    • Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
  • All-cause mortality
    • Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
  • Perceptions from stakeholders on quality and uptake of the intervention
    • Time Frame: Assessed at the conclusion of the trial at 16 months
    • Semi-structured interviews conducted one-on-one or in moderated focus groups with stakeholders including aged care staff, GPs, residents and families.

Participating in This Clinical Trial

Inclusion Criteria

Residents:

  • All residents from 12 RACFs will have de-identified data collected including antimicrobial use, infection, hospitalisation and mortality. – Residents or their guardians who provide informed consent to monthly biospecimen sampling and participation in one-on-one interviews or focus groups. Health professionals: – Health professionals (including aged care staff and GPs) who provide informed consent to participate in one-on-one interviews or focus groups. Exclusion Criteria:

  • Residents or their guardians who do not consent to biospecimen sampling and/or participation in interviews/focus groups. – Health professionals who do not consent to participate in interviews/focus groups.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayside Health
  • Collaborator
    • Bupa Aged Care Australia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anton Peleg, MBBS, PhD, FRACP, PhD, Principal Investigator, Monash University
  • Overall Contact(s)
    • Natali Jokanovic, BPharm, PhD, +61 3 9903 0087, natali.jokanovic@monash.edu

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