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Clinical Trials/NCT04705259
NCT04705259
Unknown
Not Applicable

A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study): Protocol for a Stepped Wedge Cluster Randomised Trial

The University of Queensland4 sites in 1 country18 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antimicrobial Stewardship
Sponsor
The University of Queensland
Enrollment
18
Locations
4
Primary Endpoint
Defined Daily Doses (DDDs) of Antibiotics
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 24, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Defined Daily Doses (DDDs) of Antibiotics

Time Frame: 18 months

The primary outcome measure for this trial is antibiotic use as measured by DDDs of antibiotics per 1000 resident bed days.

Secondary Outcomes

  • Urine Samples(18 months)
  • Susceptibility of pathogens(18 months)
  • All cause on-year mortality(18 months)
  • Hospital admissions(18 months)

Study Sites (4)

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