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

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ClinicalTrials.gov Identifier: NCT03941509
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Bupa Aged Care Australia
Monash University
Information provided by (Responsible Party):
Bayside Health

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 Intervention/treatment Phase
Antimicrobial Stewardship Urinary Tract Infections Respiratory Tract Infections Skin and Soft Tissue Infections Behavioral: Antimicrobial stewardship Not Applicable

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 14 RACFs over an 18-month period.

A cluster of two facilities will each transition through three phases over the 18 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 18-month trial, the refined intervention bundle will be implemented nationally across a network of RACFs.


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Study Type : Interventional  (Clinical Trial)
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 18 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 : August 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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




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 18 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 18 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 18 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 18 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 18 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 18 months ]
  7. All-cause mortality [ Time Frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 18 months ]
  8. Perceptions from stakeholders on quality and uptake of the intervention [ Time Frame: Assessed at the conclusion of the trial at 18 months ]
    Semi-structured interviews conducted one-on-one or in moderated focus groups with stakeholders including aged care staff, GPs, residents and families.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Residents:

  • All residents from 14 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941509


Contacts
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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
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Australia, Victoria
Bupa residential aged care facilities Recruiting
Melbourne, Victoria, Australia
Sponsors and Collaborators
Bayside Health
Bupa Aged Care Australia
Monash University
Investigators
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Principal Investigator: Anton Peleg, MBBS, PhD, FRACP, PhD Monash University

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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: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Respiratory Tract Infections
Soft Tissue Infections
Urologic Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents