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

January 12, 2022 updated by: Bayside Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • Bupa residential aged care facilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Behavioral: Antimicrobial stewardship
Education, guidelines, communication tools and audit and feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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.
Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
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
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.
Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
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
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
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.
Assessed at the conclusion of the trial at 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

Monash University
Bupa Aged Care Australia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 6, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 13, 2022

Last Update Submitted That Met QC Criteria

January 12, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 591/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Respiratory Tract Infections

Clinical Trials on Antimicrobial stewardship

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe