Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04705259




Registration number
NCT04705259
Ethics application status
Date submitted
3/12/2020
Date registered
12/01/2021
Date last updated
14/10/2021

Titles & IDs
Public title
A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study)
Scientific title
A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study): Protocol for a Stepped Wedge Cluster Randomised Trial
Secondary ID [1] 0 0
2020002193
Universal Trial Number (UTN)
Trial acronym
ENGAGEMENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antimicrobial Stewardship 0 0
Antibiotics Causing Adverse Effects in Therapeutic Use 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Antimicrobial Stewardship ENGAGEMENT bundle

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.

Placebo Comparator: Usual care - Usual facility practices with regards to antibiotic prescribing and review


Behaviour: 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
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Defined Daily Doses (DDDs) of Antibiotics
Timepoint [1] 0 0
18 months
Secondary outcome [1] 0 0
Urine Samples
Timepoint [1] 0 0
18 months
Secondary outcome [2] 0 0
Susceptibility of pathogens
Timepoint [2] 0 0
18 months
Secondary outcome [3] 0 0
All cause on-year mortality
Timepoint [3] 0 0
18 months
Secondary outcome [4] 0 0
Hospital admissions
Timepoint [4] 0 0
18 months

Eligibility
Key inclusion 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.



- All residents of RACFs with at least 50 residents

- RACFs located in South East Queensland, Australia
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- RACFs with less than 50 residents;

- RACFs unable to provide reports for baseline data

Study design
Purpose of the study
Health Services Research
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/12/2022
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Bethany Christian Care - Eight Mile Plains
Recruitment hospital [2] 0 0
Carinity Aged Care - Mitchelton
Recruitment hospital [3] 0 0
Beaumont Care - Rothwell
Recruitment hospital [4] 0 0
Vacenti Aged Care - Upper Mount Gravatt
Recruitment postcode(s) [1] 0 0
4113 - Eight Mile Plains
Recruitment postcode(s) [2] 0 0
4053 - Mitchelton
Recruitment postcode(s) [3] 0 0
4022 - Rothwell
Recruitment postcode(s) [4] 0 0
4122 - Upper Mount Gravatt

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04705259
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alyssa Welch
Address 0 0
Country 0 0
Phone 0 0
+61438629310
Fax 0 0
Email 0 0
ams.engagementstudy@uq.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04705259