A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study)

Not Applicable

• Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use; Antimicrobial Stewardship
• Interventions: Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle

• Registration Number: NCT04705259
• Lead Sponsor: The University of Queensland

Brief Summary

The antimicrobial stewardship ENGAGEMENT study aims to deliver a bundle of interventions, including education of GPs and nursing staff, guideline implementation and telehealth support for 18 residential aged care facilities (RACFs) in Queensland Australia to help optimise antibiotic prescribing and reduce inappropriate use. The trial will involve 18 licenced RACFs with 50 or more residents and is set to commence in June 2021.

Detailed Description

INTRODUCTION Inappropriate antibiotic use can cause harm and promote antimicrobial resistance, which has been declared a major health challenge by the World Health Organisation. In Australian Residential Aged Care Facilities (RACFs), the most common indications for antibiotic prescribing are for suspected infections of the urinary tract, respiratory tract, and skin and soft tissue. Studies indicate that a high proportion of these prescriptions are noncompliant with best prescribing guidelines. To date a variety of interventions have been reported to address inappropriate prescribing and overuse of antibiotics but with mixed outcomes. The present study aims to identify the impact of a set of sustainable, multi-modal interventions in residential aged care targeting three common infection types, using a robust methodology.

METHODS AND ANALYSIS This study will be conducted using a stepped-wedge cluster randomised trial that will recruit 18 RACFs (each RACF will be considered as one cluster), over a 20 month observation period. Initially an antimicrobial stewardship needs assessment toolkit will be piloted in seven RACFs from different service providers. This will enable the refinement and targeted implementation of the intervention bundle, based on existing requirement of facilities. A multimodal multi-disciplinary set of interventions, the 'ENGAGEMENT bundle', will be tailored to the needs of facilities. This bundle will be implemented as part of the stepped wedge randomised control trial. The key elements of the intervention bundle include education for nurses and general practitioners, telehealth support and formation of an antimicrobial stewardship team. Prior to the sequential introduction of the intervention, each site will act as its own control, in relation to usual care processes for antibiotic use and stewardship.

The primary outcome for this study will be antibiotic consumption measured using defined daily doses (DDDs). Cluster-level rates will be calculated using total occupied bed numbers within each RACF during the post-randomisation observation period as the denominator. Results will be expressed as rates per 1000 occupied bed days. An economic analysis will be conducted to compare the costs associated with the intervention to that of usual care.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-12-03
• Study First Submitted QC: 2021-01-11
• Study First Posted: 2021-01-12
• Study Start: 2021-10-01
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-14
• Primary Completion: 2022-05-30
• Study Completion: 2022-12-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• All residents of RACFs with at least 50 residents
• RACFs located in South East Queensland, Australia

Exclusion Criteria

• RACFs with less than 50 residents;
• RACFs unable to provide reports for baseline data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ENGAGEMENT bundle	Antimicrobial Stewardship ENGAGEMENT bundle	A multimodal bundle of interventions to optimise antibiotic prescribing in residential aged care facilities. The bundle includes education for nurses and general practitioners caring for residents, telehealth support and implementation of state-wide guidelines.
Usual care	Antimicrobial Stewardship ENGAGEMENT bundle	Usual facility practices with regards to antibiotic prescribing and review

Primary Outcome Measures

Name	Time	Method
Defined Daily Doses (DDDs) of Antibiotics	18 months	The primary outcome measure for this trial is antibiotic use as measured by DDDs of antibiotics per 1000 resident bed days.

Secondary Outcome Measures

Name	Time	Method
Urine Samples	18 months	Number of urine samples collected per 1000 resident bed days between the control vs intervention periods
Susceptibility of pathogens	18 months	Percent susceptibility of Enterobacteriaceae to ceftriaxone, ciprofloxacin, cephalexin and amoxicillin-clavulanate measured using antibiograms
All cause on-year mortality	18 months	All-cause on-year mortality rates of residential aged care facility (RACF) residents between the control vs intervention periods (per 1000 resident bed days and median rate across facilities)
Hospital admissions	18 months	Number of RACF residents admitted to hospital during the control vs intervention periods (per 1000 resident bed days and median rate across facilities)

Trial Locations

Locations (4)

Carinity Aged Care; 🇦🇺 Mitchelton, Queensland, Australia

Bethany Christian Care; 🇦🇺 Eight Mile Plains, Queensland, Australia

Beaumont Care; 🇦🇺 Rothwell, Queensland, Australia

Vacenti Aged Care; 🇦🇺 Upper Mount Gravatt, Queensland, Australia