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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941509
• Other study ID #: 591/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: June 2022

Study information

• Verified date: January 2022
• Source: Bayside Health
• Contact: Natali Jokanovic, BPharm, PhD
• Phone: +61 3 9903 0087
• Email: natali.jokanovic[@]monash.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: June 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Antimicrobial Stewardship
• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Skin and Soft Tissue Infections
• Soft Tissue Infections
• Urinary Tract Infections

Intervention

Behavioral:
• Antimicrobial stewardship
Education, guidelines, communication tools and audit and feedback

Locations

Country	Name	City	State
Australia	Bupa residential aged care facilities	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
Bayside Health	Bupa Aged Care Australia, Monash University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative proportion of residents prescribed a systemic antimicrobial		Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Primary	Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)		Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary	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
Secondary	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.	Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary	Frequency of carriage of antimicrobial-resistant organisms	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).
Secondary	Rate of Clostridium Difficile infection		Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary	Change in facility-level antimicrobial susceptibility profile	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).
Secondary	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
Secondary	All-cause mortality		Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary	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.	Assessed at the conclusion of the trial at 16 months