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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03941509

Recruitment Status Not yet recruiting

First Posted May 8, 2019

Last update posted October 12, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Antimicrobial Stewardship
    Urinary Tract Infections
    Respiratory Tract Infections
    Skin and Soft Tissue Infections
  • Intervention/Treatment: Behavioral: Antimicrobial stewardship
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 700 participants
  • Allocation: Randomized
  • Intervention Model: Crossover Assignment
  • Intervention Model Description: Stepped-wedge design will see a staggered roll out of the intervention over 16 months. Each cluster of two facilities will commence in the control phase (2 months) and transition to the intervention phase until all facilities receive the intervention. A transition phase of 2 months between the control and intervention phase will occur to allow for education and integration of the intervention.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
  • Estimated Study Start Date: January 2021
  • Estimated Primary Completion Date: April 2022
  • Estimated Study Completion Date: June 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Antimicrobial stewardship
Implementation of the nurse-led bundled antimicrobial stewardship intervention
Behavioral: Antimicrobial stewardship
Education, guidelines, communication tools and audit and feedback
Outcome Measures
  • Primary Outcome Measures: 1. 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 ]
  • 2. 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 Outcome Measures: 1. 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 ]
  • 2. 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.
  • 3. 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.
  • 4. 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 ]
  • 5. 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.
  • 6. 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 ]
  • 7. All-cause mortality [ Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months ]
  • 8. 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.
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Natali Jokanovic, BPharm, PhD +61 3 9903 0087 natali.jokanovic@monash.edu

Contact: Trisha Peel, MBBS, FRACP, PhD +61 3 9076 2000 trisha.peel@monash.edu

Locations

Australia, Victoria
Bupa residential aged care facilities
Melbourne

Sponsors and Collaborators

Bayside Health

Bupa Aged Care Australia

Monash University

Investigators

Principal Investigator: Anton Peleg, MBBS, PhD, FRACP, PhD Monash University

More Information
  • Responsible Party: Bayside Health
  • ClinicalTrials.gov Identifier: NCT03941509 History of Changes
  • Other Study ID Numbers: 591/18
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: October 12, 2020
  • Last Verified: October 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Infection
    Communicable Diseases
    Urinary Tract Infections
    Respiratory Tract Infections
    Soft Tissue Infections