Antimicrobial StewardshipENGAGEMENTNCT04705259
A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study)
A study testing Antimicrobial Stewardship ENGAGEMENT bundle in people with Antimicrobial Stewardship and Antibiotics Causing Adverse Effects in Therapeutic Use, run by The University of Queensland at 4 sites in Australia.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Stewardship, Antibiotics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Antimicrobial Stewardship ENGAGEMENT bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 4 sitesAustralia
- Study dates
- 1 Oct 2021to 24 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All residents of RACFs with at least 50 residents
- RACFs located in South East Queensland, Australia
Who cannot join
- RACFs with less than 50 residents;
- RACFs unable to provide reports for baseline data
Trial locations and contacts
4 sites in 1 country.
Australia4 sites, 4 recruiting
- Recruiting
Bethany Christian Care
Eight Mile Plains, Queensland, 4113
Sue Weller, +61737375000, sue.weller@bethanycc.org.au
- Recruiting
Carinity Aged Care
Mitchelton, Queensland, 4053
Tunde Bulman, +61735503745
- Recruiting
Beaumont Care
Rothwell, Queensland, 4022
Krystell Harward, +61732033633, krystellharward@beaumontcare.com.au
- Recruiting
Vacenti Aged Care
Upper Mount Gravatt, Queensland, 4122
Hannah Carroll, +61734229300, hannah.carroll@vacenti.com.au
About this 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
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.
Read the 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.
- Being tested
- Antimicrobial Stewardship ENGAGEMENT bundle
- Keywords
- Antimicrobial stewardship, Antibiotic prescribing, Aged care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Stewardship ENGAGEMENT bundleBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| ENGAGEMENT bundle | Active comparator | 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. Receives: Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle |
| Usual care | Placebo comparator | Usual facility practices with regards to antibiotic prescribing and review Receives: Behavioral: Antimicrobial Stewardship ENGAGEMENT bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (4)
Urine Samples
Number of urine samples collected per 1000 resident bed days between the control vs intervention periods
Measured: 18 months
Susceptibility of pathogens
Percent susceptibility of Enterobacteriaceae to ceftriaxone, ciprofloxacin, cephalexin and amoxicillin-clavulanate measured using antibiograms
Measured: 18 months
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)
Measured: 18 months
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)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Oct 2021
- Primary completion30 May 2022 (estimated)
- Study completion24 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antimicrobial StewardshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge randomised control study
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705259
- Sponsor's protocol ID
- 2020002193
- Acronym
- ENGAGEMENT
- Status last verified
- Nov 2020
- First submitted
- 3 Dec 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35597993
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Intervention to Optimise Antimicrobial Use in Residential Aged Care Facilities (ENGAGEMENT Study): Protocol for a Stepped Wedge Cluster Randomised Trial
- ClinicalTrials.gov ID
- NCT04705259
- Acronym / sponsor ID
- ENGAGEMENT / 2020002193
- Keywords
- Antimicrobial stewardship, Antibiotic prescribing, Aged care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 24 Dec 2022 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge randomised control study
| Arm | Type | Receives |
|---|---|---|
| ENGAGEMENT bundle | Active comparator | Behavioral: Antimicrobial Stewardship ENGAGEMENT bundleA 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. |
| Usual care | Placebo comparator | Behavioral: Antimicrobial Stewardship ENGAGEMENT bundleUsual facility practices with regards to antibiotic prescribing and review |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All residents of RACFs with at least 50 residents
- RACFs located in South East Queensland, Australia
Key exclusion criteria (2 listed)
- RACFs with less than 50 residents;
- RACFs unable to provide reports for baseline data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antimicrobial Stewardship ENGAGEMENT bundleGiven 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 | Behavioural | ENGAGEMENT bundle, Usual care |
Primary outcome
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.
4 secondary outcomes
Urine Samples
Time frame: 18 months
Susceptibility of pathogens
Time frame: 18 months
All cause on-year mortality
Time frame: 18 months
Hospital admissions
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Derived from this study: PubMed 35597993Falconer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial Stewardship ENGAGEMENT bundle in people with Antimicrobial Stewardship and Antibiotics Causing Adverse Effects in Therapeutic Use, run by The University of Queensland at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alyssa Welch (+61438629310, ams.engagementstudy@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defined Daily Doses (DDDs) of Antibiotics (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.