Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Antimicrobial Stewardship
- Sponsor
- Bayside Health
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
- Last Updated
- 4 years ago
Overview
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: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Proportion of appropriate antimicrobial use.(Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months)
- Number of courses of systemic antimicrobial therapy per 1,000 OBD.(Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months)
- Rate of Clostridium Difficile infection(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(Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).)
- All-cause mortality(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(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(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(Assessed at the conclusion of the trial at 16 months)