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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03941509
Registration number
NCT03941509
Ethics application status
Date submitted
6/05/2019
Date registered
8/05/2019
Date last updated
13/01/2022
Titles & IDs
Public title
Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities
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Scientific title
Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
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Secondary ID [1]
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591/18
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Antimicrobial Stewardship
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Urinary Tract Infections
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Respiratory Tract Infections
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Skin and Soft Tissue Infections
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Behaviour - Antimicrobial stewardship
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
Behaviour: Antimicrobial stewardship
Education, guidelines, communication tools and audit and feedback
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Intervention code [1]
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Behaviour
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cumulative proportion of residents prescribed a systemic antimicrobial
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Assessment method [1]
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Timepoint [1]
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Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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Primary outcome [2]
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Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
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Assessment method [2]
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Timepoint [2]
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Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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Secondary outcome [1]
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Number of courses of systemic antimicrobial therapy per 1,000 OBD.
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Assessment method [1]
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Timepoint [1]
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Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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Secondary outcome [2]
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Proportion of appropriate antimicrobial use.
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Assessment method [2]
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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.
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Timepoint [2]
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Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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Secondary outcome [3]
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Frequency of carriage of antimicrobial-resistant organisms
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Assessment method [3]
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Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
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Timepoint [3]
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Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
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Secondary outcome [4]
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Rate of Clostridium Difficile infection
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Assessment method [4]
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Timepoint [4]
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Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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Secondary outcome [5]
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Change in facility-level antimicrobial susceptibility profile
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Assessment method [5]
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Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
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Timepoint [5]
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Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
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Secondary outcome [6]
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Incidence of resident transfer to hospital for infectious indications
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Assessment method [6]
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Timepoint [6]
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Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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Secondary outcome [7]
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All-cause mortality
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Assessment method [7]
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Timepoint [7]
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Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
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Secondary outcome [8]
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Perceptions from stakeholders on quality and uptake of the intervention
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Assessment method [8]
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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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Timepoint [8]
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Assessed at the conclusion of the trial at 16 months
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Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2022
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Bupa residential aged care facilities - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Bayside Health
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Bupa Aged Care Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash University
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03941509
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Anton Peleg, MBBS, PhD, FRACP, PhD
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Natali Jokanovic, BPharm, PhD
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Address
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Country
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Phone
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+61 3 9903 0087
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03941509
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