- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04705259
A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study) (ENGAGEMENT)
A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study): Protocol for a Stepped Wedge Cluster Randomised Trial
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alyssa Welch
- Phone Number: +61438629310
- Email: ams.engagementstudy@uq.edu.au
Study Locations
-
-
Queensland
-
Eight Mile Plains, Queensland, Australia, 4113
- Recruiting
- Bethany Christian Care
-
Contact:
- Sue Weller
- Phone Number: +61737375000
- Email: sue.weller@bethanycc.org.au
-
Mitchelton, Queensland, Australia, 4053
- Recruiting
- Carinity Aged Care
-
Contact:
- Tunde Bulman
- Phone Number: +61735503745
-
Rothwell, Queensland, Australia, 4022
- Recruiting
- Beaumont Care
-
Contact:
- Krystell Harward
- Phone Number: +61732033633
- Email: krystellharward@beaumontcare.com.au
-
Upper Mount Gravatt, Queensland, Australia, 4122
- Recruiting
- Vacenti Aged Care
-
Contact:
- Hannah Carroll
- Phone Number: +61734229300
- Email: hannah.carroll@vacenti.com.au
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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:
|
Placebo Comparator: Usual care
Usual facility practices with regards to antibiotic prescribing and review
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urine Samples
Time Frame: 18 months
|
Number of urine samples collected per 1000 resident bed days between the control vs intervention periods
|
18 months
|
Susceptibility of pathogens
Time Frame: 18 months
|
Percent susceptibility of Enterobacteriaceae to ceftriaxone, ciprofloxacin, cephalexin and amoxicillin-clavulanate measured using antibiograms
|
18 months
|
All cause on-year mortality
Time Frame: 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)
|
18 months
|
Hospital admissions
Time Frame: 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)
|
18 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020002193
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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