Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities
Primary Purpose
Antimicrobial Stewardship, Urinary Tract Infections, Respiratory Tract Infections
Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Antimicrobial stewardship
Sponsored by
About this trial
This is an interventional treatment trial for Antimicrobial Stewardship
Eligibility 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.
Sites / Locations
- Bupa residential aged care facilitiesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Antimicrobial stewardship
Arm Description
All facilities will receive usual care during the control phase of the trial.
Implementation of the nurse-led bundled antimicrobial stewardship intervention
Outcomes
Primary Outcome Measures
Cumulative proportion of residents prescribed a systemic antimicrobial
Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
Secondary Outcome Measures
Number of courses of systemic antimicrobial therapy per 1,000 OBD.
Proportion of appropriate antimicrobial use.
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
Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
Rate of Clostridium Difficile infection
Change in facility-level antimicrobial susceptibility profile
Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
Incidence of resident transfer to hospital for infectious indications
All-cause mortality
Perceptions from stakeholders on quality and uptake of the intervention
Semi-structured interviews conducted one-on-one or in moderated focus groups with stakeholders including aged care staff, GPs, residents and families.
Full Information
NCT ID
NCT03941509
First Posted
May 6, 2019
Last Updated
January 12, 2022
Sponsor
Bayside Health
Collaborators
Bupa Aged Care Australia, Monash University
1. Study Identification
Unique Protocol Identification Number
NCT03941509
Brief Title
Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities
Official Title
Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayside Health
Collaborators
Bupa Aged Care Australia, Monash University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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:
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.
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.
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antimicrobial Stewardship, Urinary Tract Infections, Respiratory Tract Infections, Skin and Soft Tissue Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
All facilities will receive usual care during the control phase of the trial.
Arm Title
Antimicrobial stewardship
Arm Type
Experimental
Arm Description
Implementation of the nurse-led bundled antimicrobial stewardship intervention
Intervention Type
Behavioral
Intervention Name(s)
Antimicrobial stewardship
Intervention Description
Education, guidelines, communication tools and audit and feedback
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
Proportion of appropriate antimicrobial use.
Description
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.
Time Frame
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Title
Frequency of carriage of antimicrobial-resistant organisms
Description
Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
Time Frame
Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Title
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
Title
Change in facility-level antimicrobial susceptibility profile
Description
Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
Time Frame
Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Title
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
Title
All-cause mortality
Time Frame
Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Title
Perceptions from stakeholders on quality and uptake of the intervention
Description
Semi-structured interviews conducted one-on-one or in moderated focus groups with stakeholders including aged care staff, GPs, residents and families.
Time Frame
Assessed at the conclusion of the trial at 16 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natali Jokanovic, BPharm, PhD
Phone
+61 3 9903 0087
Email
natali.jokanovic@monash.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Trisha Peel, MBBS, FRACP, PhD
Phone
+61 3 9076 2000
Email
trisha.peel@monash.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anton Peleg, MBBS, PhD, FRACP, PhD
Organizational Affiliation
Monash University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bupa residential aged care facilities
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
33653766
Citation
Jokanovic N, Haines T, Cheng AC, Holt KE, Hilmer SN, Jeon YH, Stewardson AJ, Stuart RL, Spelman T, Peel TN, Peleg AY; START Trial Group. Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial. BMJ Open. 2021 Mar 2;11(3):e046142. doi: 10.1136/bmjopen-2020-046142.
Results Reference
derived
Learn more about this trial
Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities
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