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

The University of Queensland logo

The University of Queensland

Status

Unknown

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use
Antimicrobial Stewardship

Treatments

Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle

Study type

Interventional

Funder types

Other

Identifiers

NCT04705259
2020002193

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Eligibility is at the Residential Aged Care Facility (RACF) level. If the facility is eligible to participate de-identified data from all facility residents will be included for the duration of the the study.

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

18 participants in 2 patient groups, including a placebo group

ENGAGEMENT bundle
Active Comparator group
Description:
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.
Treatment:
Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle
Usual care
Placebo Comparator group
Description:
Usual facility practices with regards to antibiotic prescribing and review
Treatment:
Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle

Trial contacts and locations

4

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Central trial contact

Alyssa Welch

Data sourced from clinicaltrials.gov

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