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

Antimicrobial Stewardship Clinical Trial

— ENGAGEMENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04705259
• Other study ID #: 2020002193
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 24, 2022

Study information

• Verified date: November 2020
• Source: The University of Queensland
• Contact: Alyssa Welch
• Phone: +61438629310
• Email: ams.engagementstudy[@]uq.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 24, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotics Causing Adverse Effects in Therapeutic Use
• Antimicrobial Stewardship

Intervention

Behavioral:
• Antimicrobial Stewardship ENGAGEMENT bundle
Given that a single intervention is unlikely to be effective in stewardship programs, nor in care improvement processes at RACFs [7], this trial will deliver a set of multimodal, multidisciplinary interventions to optimise antibiotic use in RACFs. This RACF AMS ENGAGEMENT bundle will comprise the following key interventions: Education and engagement of prescribers, nurses, pharmacists and residents and family members Nursing initiatives to improve UTI diagnosis and reduce inappropriate urine testing Guideline development specific to antibiotic use in RACF residents Antimicrobial stewardship team creation in RACF with GP involvement EMergency department liaison and use of clinical pathways to ensure consistency of practice across the care continuum ElectroNic decision support to guide RACF urine testing and GP antibiotic prescribing Telehealth support for key intervention components

Locations

Country	Name	City	State
Australia	Bethany Christian Care	Eight Mile Plains	Queensland
Australia	Carinity Aged Care	Mitchelton	Queensland
Australia	Beaumont Care	Rothwell	Queensland
Australia	Vacenti Aged Care	Upper Mount Gravatt	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Defined Daily Doses (DDDs) of Antibiotics	The primary outcome measure for this trial is antibiotic use as measured by DDDs of antibiotics per 1000 resident bed days.	18 months
Secondary	Urine Samples	Number of urine samples collected per 1000 resident bed days between the control vs intervention periods	18 months
Secondary	Susceptibility of pathogens	Percent susceptibility of Enterobacteriaceae to ceftriaxone, ciprofloxacin, cephalexin and amoxicillin-clavulanate measured using antibiograms	18 months
Secondary	All cause on-year mortality	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)	18 months
Secondary	Hospital admissions	Number of RACF residents admitted to hospital during the control vs intervention periods (per 1000 resident bed days and median rate across facilities)	18 months