Antimicrobial StewardshipNCT03941509
Nurse-led Antimicrobial Stewardship Intervention to Increase Antibiotic Appropriateness in Residential Aged Care Facilities
A study testing Antimicrobial stewardship in people with Antimicrobial Stewardship and Urinary Tract Infections, run by Bayside Health at 1 site in Australia.
Trial summary
The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities. The intervention will be assessed in a stepped-wedge cluster randomised controlled trial across 14 residential aged care facilities over an… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antimicrobial Stewardship, Urinary Tract Infections, Respiratory Tract Infections
- What is being tested?
- Antimicrobial stewardship
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2021to Jun 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents:
- All residents from 12 RACFs will have de-identified data collected including antimicrobial use, infection, hospitalisation and mortality.
- Residents or their guardians who provide informed consent to monthly biospecimen sampling and participation in one-on-one interviews or focus groups.
- Health professionals:
- Health professionals (including aged care staff and GPs) who provide informed consent to participate in one-on-one interviews or focus groups.
Who cannot join
- Residents or their guardians who do not consent to biospecimen sampling and/or participation in interviews/focus groups.
- Health professionals who do not consent to participate in interviews/focus groups.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Bupa residential aged care facilities
Melbourne, Victoria
About this study
Official title: Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities. The intervention will be assessed in a stepped-wedge cluster randomised controlled trial across 14 residential aged care facilities over an 18-month period.
Read the detailed description
The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities (RACFs).
The antimicrobial stewardship intervention will include the following components:
- Education
- Focused on antimicrobial stewardship and appropriate antimicrobial use
- Delivered face-to-face, via workbooks and fact sheets to aged care staff, general practitioners (GPs), pharmacists, and residents and families. Education will be delivered by the research coordinator.
- Guidelines
- Aged care-specific guidelines for the assessment and antimicrobial management of urinary tract infections, respiratory tract infections and skin and soft tissue infections.
- Antimicrobial management recommendations including empirical oral therapy, doses and duration of therapy.
- Communication
- Documentation for the assessment and antimicrobial management of infections.
- Nurse-led engagement with residents and families.
- Newsletters and online updates to highlight evidence-based prescribing practice
- Audit and feedback - Surveillance and feedback to prescribers on antimicrobial use and facility-level antimicrobial susceptibility data.
The intervention bundle will first be implemented and tested for feasibility and acceptability over a 3-month period in two RACFs in Victoria, Australia. This tailored intervention will then be assessed in a stepped-wedge cluster randomised controlled trial across 12 RACFs over an 16-month period.
A cluster of two facilities will each transition through three phases over the 16 month trial:
- Control phase: baseline data collection. Usual care at each facility.
- Transition phase: Delivery of education and integration of the intervention. No data collection.
- Intervention phase: implementation of the intervention and outcome data collection. Ongoing education to new and existing staff will be provided as required.
Following the 16-month trial, the refined intervention bundle will be implemented nationally across a network of RACFs.
- Conditions
- Antimicrobial Stewardship, Urinary Tract Infections, Respiratory Tract Infections, Skin and Soft Tissue Infections
- Being tested
- Antimicrobial stewardship
- Medical subject headings
- Urinary Tract Infections, Respiratory Tract Infections, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial stewardshipBehavioural
Education, guidelines, communication tools and audit and feedback
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | All facilities will receive usual care during the control phase of the trial. |
| Antimicrobial stewardship | Experimental | Implementation of the nurse-led bundled antimicrobial stewardship intervention Receives: Behavioral: Antimicrobial stewardship |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative proportion of residents prescribed a systemic antimicrobial
Measured: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
Measured: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Secondary outcomes (8)
Number of courses of systemic antimicrobial therapy per 1,000 OBD.
Measured: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Proportion of appropriate antimicrobial use.
Antimicrobials will be considered to be appropriate if minimum criteria for their initiation are met according to guidelines by the Society of Healthcare Epidemiology of America.
Measured: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Frequency of carriage of antimicrobial-resistant organisms
Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
Measured: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Rate of Clostridium Difficile infection
Measured: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Change in facility-level antimicrobial susceptibility profile
Monthly biospecimen sampling will be collected from residents including nasal, faecal/rectal and wound specimens.
Measured: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Incidence of resident transfer to hospital for infectious indications
Measured: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
All-cause mortality
Measured: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Perceptions from stakeholders on quality and uptake of the intervention
Semi-structured interviews conducted one-on-one or in moderated focus groups with stakeholders including aged care staff, GPs, residents and families.
Measured: Assessed at the conclusion of the trial at 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Jan 2021
- Primary completionApr 2022 (estimated)
- Study completionJun 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped-wedge design will see a staggered roll out of the intervention over 16 months. Each cluster of two facilities will commence in the control phase (2 months) and transition to the intervention phase until all facilities receive the intervention. A transition phase of 2 months between the control and intervention phase will occur to allow for education and integration of the intervention.
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayside Health
- Sponsor type
- Other government
- Collaborators
- Bupa Aged Care Australia, Monash University
- Responsible party
- Sponsor
- Investigators
- Anton Peleg, MBBS, PhD, FRACP, PhD, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941509
- Sponsor's protocol ID
- 591/18
- Status last verified
- Jan 2022
- First submitted
- 6 May 2019
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jokanovic N, Haines T, Cheng AC, Holt KE, Hilmer SN, Jeon YH, Stewardson AJ, Stuart RL, Spelman T, Peel TN, Peleg AY; START Trial Group. Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial. BMJ Open. 2021 Mar 2;11(3):e046142. doi: 10.1136/bmjopen-2020-046142.
PubMed 33653766
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
- ClinicalTrials.gov ID
- NCT03941509
- Acronym / sponsor ID
- 591/18
- Conditions
- Antimicrobial Stewardship, Urinary Tract Infections, Respiratory Tract Infections, Skin and Soft Tissue Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Bayside HealthOther government
- Collaborators
- Bupa Aged Care Australia, Monash University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 8 May 2019 (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 study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities. The intervention will be assessed in a stepped-wedge cluster randomised controlled trial across 14 residential aged care facilities over an 18-month period.
Detailed description
The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities (RACFs).
The antimicrobial stewardship intervention will include the following components:
- Education
- Focused on antimicrobial stewardship and appropriate antimicrobial use
- Delivered face-to-face, via workbooks and fact sheets to aged care staff, general practitioners (GPs), pharmacists, and residents and families. Education will be delivered by the research coordinator.
- Guidelines
- Aged care-specific guidelines for the assessment and antimicrobial management of urinary tract infections, respiratory tract infections and skin and soft tissue infections.
- Antimicrobial management recommendations including empirical oral therapy, doses and duration of therapy.
- Communication
- Documentation for the assessment and antimicrobial management of infections.
- Nurse-led engagement with residents and families.
- Newsletters and online updates to highlight evidence-based prescribing practice
- Audit and feedback - Surveillance and feedback to prescribers on antimicrobial use and facility-level antimicrobial susceptibility data.
The intervention bundle will first be implemented and tested for feasibility and acceptability over a 3-month period in two RACFs in Victoria, Australia. This tailored intervention will then be assessed in a stepped-wedge cluster randomised controlled trial across 12 RACFs over an 16-month period.
A cluster of two facilities will each transition through three phases over the 16 month trial:
- Control phase: baseline data collection. Usual care at each facility.
- Transition phase: Delivery of education and integration of the intervention. No data collection.
- Intervention phase: implementation of the intervention and outcome data collection. Ongoing education to new and existing staff will be provided as required.
Following the 16-month trial, the refined intervention bundle will be implemented nationally across a network of RACFs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge design will see a staggered roll out of the intervention over 16 months. Each cluster of two facilities will commence in the control phase (2 months) and transition to the intervention phase until all facilities receive the intervention. A transition phase of 2 months between the control and intervention phase will occur to allow for education and integration of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –All facilities will receive usual care during the control phase of the trial. |
| Antimicrobial stewardship | Experimental | Behavioral: Antimicrobial stewardshipImplementation of the nurse-led bundled antimicrobial stewardship intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All residents from 12 RACFs will have de-identified data collected including antimicrobial use, infection, hospitalisation and mortality.
- Residents or their guardians who provide informed consent to monthly biospecimen sampling and participation in one-on-one interviews or focus groups.
- Health professionals (including aged care staff and GPs) who provide informed consent to participate in one-on-one interviews or focus groups.
Key exclusion criteria (2 listed)
- Residents or their guardians who do not consent to biospecimen sampling and/or participation in interviews/focus groups.
- Health professionals who do not consent to participate in interviews/focus groups.
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 stewardshipEducation, guidelines, communication tools and audit and feedback | Behavioural | Antimicrobial stewardship |
Primary outcome
Cumulative proportion of residents prescribed a systemic antimicrobial
Time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
Time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
8 secondary outcomes
Number of courses of systemic antimicrobial therapy per 1,000 OBD.
Time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Proportion of appropriate antimicrobial use.
Time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Frequency of carriage of antimicrobial-resistant organisms
Time frame: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Rate of Clostridium Difficile infection
Time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Change in facility-level antimicrobial susceptibility profile
Time frame: Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).
Incidence of resident transfer to hospital for infectious indications
Time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
All-cause mortality
Time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Perceptions from stakeholders on quality and uptake of the intervention
Time frame: Assessed at the conclusion of the trial at 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 33653766Jokanovic N, Haines T, Cheng AC, Holt KE, Hilmer SN, Jeon YH, Stewardson AJ, Stuart RL, Spelman T, Peel TN, Peleg AY; START Trial Group. Multicentre stepped-wedge cluster randomised controlled trial of an antimicrobial stewardship programme in residential aged care: protocol for the START trial. BMJ Open. 2021 Mar 2;11(3):e046142. doi: 10.1136/bmjopen-2020-046142.
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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.
Anton Peleg, MBBS, PhD, FRACP, PhD principal investigator
Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial stewardship in people with Antimicrobial Stewardship and Urinary Tract Infections, run by Bayside Health at 1 site 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 5 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 Natali Jokanovic, BPharm, PhD (+61 3 9903 0087, natali.jokanovic@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative proportion of residents prescribed a systemic antimicrobial (time frame: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months). The study lists 2 primary outcomes in all. 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 NCT03941509, 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 13 Jan 2022.