Clinical trial NCT04705259: A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study)
Official title: A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study): Protocol for a Stepped Wedge Cluster Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antimicrobial Stewardship
Antibiotics Causing Adverse Effects in Therapeutic Use
Keywords: Antimicrobial stewardship
Antibiotic prescribing
Aged care
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2021-01-12
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge randomised control study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Defined Daily Doses (DDDs) of Antibiotics
timeFrame: 18 months
Secondary outcomes:
measure: Urine Samples
timeFrame: 18 months
measure: Susceptibility of pathogens
timeFrame: 18 months
measure: All cause on-year mortality
timeFrame: 18 months
measure: Hospital admissions
timeFrame: 18 months
Other outcomes:
Locations:
city: Eight Mile Plains
country: Australia
facility: Bethany Christian Care
state: Queensland
city: Mitchelton
country: Australia
facility: Carinity Aged Care
state: Queensland
city: Rothwell
country: Australia
facility: Beaumont Care
state: Queensland
city: Upper Mount Gravatt
country: Australia
facility: Vacenti Aged Care
state: Queensland
Study officials:
References:
citation: Falconer N, Paterson DL, Peel N, Welch A, Freeman C, Burkett E, Hubbard R, Comans T, Hanjani LS, Pascoe E, Hawley C, Gray L. A multimodal intervention to optimise antimicrobial use in residential aged care facilities (ENGAGEMENT): protocol for a stepped-wedge cluster randomised trial. Trials. 2022 May 21;23(1):427. doi: 10.1186/s13063-022-06323-8.