Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001280392
Ethics application status
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Approved
Date submitted
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29/09/2026
Date registered
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26/10/2026
Date last updated
Help: Date last updated
26/10/2026
Date data sharing statement initially provided
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26/10/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Enhanced vs Standard Support for Implementing Evidence-Based Antimicrobial Stewardship Strategies to Reduce Antibiotic Prescribing in Australian General Practice: A Cluster-Randomised, Open-Label, Pragmatic Trial
Scientific title
Evidence-based Antimicrobial Stewardship: Sustainable Implementation in Primary Care (EASSI-PC): A cluster-randomised, open-label, pragmatic, parallel-group trial comparing enhanced support versus standard support implementation packages to reduce antibiotic prescribing in Australian general practice
Additional trial identifiers [1] 317479 0
Nil
Universal Trial Number (UTN)
Trial acronym
EASSI-PC (Evidence-based Antimicrobial Stewardship: Sustainable Implementation in Primary Care)
Related trial records

Health condition
Health condition(s) studied:
Acute Respiratory Infection 342181 0
Urinary Tract Infection 342183 0
Skin and Soft Tissue Infection 342777 0
Condition category
Condition code
Infection 338312 338312 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Brief name: Enhanced support (high-resource-intensive) AMS implementation package.

Why: Aims to support antibiotic prescribing behaviours and the uptake of evidence-based AMS strategies by providing resource-intensive options

What – Materials: All standard support digital materials plus:

Printed document with QR codes to access the different patient information sheets or decision aids, which contain reasons for prescribing prompts. The GP can choose to provide the patient with a delayed antibiotic prescription, advising that the prescription be filled at a pharmacy only after a few days if symptoms are not starting to settle or are becoming more severe.
Printed & Laminated Patient Decision Aids (supporting shared decision making): four aids, one each for acute otitis media, acute sore throat (pharyngitis), rhinosinusitis and acute bronchitis. Each aid is a two-page (double-sided) document that presents options for managing the condition, with and without antibiotics, along with the evidence-based benefits and harms of each.
Printed Patient Information Sheets: five leaflets, one each for acute otitis media, acute sore throat (pharyngitis), acute bronchitis, cystitis and rhinosinusitis. Each leaflet is a one-page document presenting information about the condition, alternative management options to antibiotics, how to prevent its spread, and when to see a doctor.
Printed & Laminated summarised Therapeutic Guidelines antibiotic summary table (consultation room copy and a visual reminder for the consultation room) to support evidence-based prescribing.
Personalised commitment posters [Pledge posters], which may include GP photos and/or signatures. Showing the practice commitment to responsible antibiotic prescribing
Case-based webinars for each strategy with case presentations by GPs/local opinion leaders, followed by Q&A using a problem-based learning structure (average duration: 1 hour per session).

GPs in the enhanced support arm will receive a baseline and two six-month practice-specific audit (at 6 months and 12 months) and feedback reports via email. Opportunities to discuss these reports will be provided through interactive, national case-based webinars scheduled approximately two weeks after the distribution of audit and feedback reports to maximise relevance and engagement.

What - Procedures: The intervention package will be provided to each practice, depending on the delivery methods, after the practice completes the intervention implementation form.

Who provides the intervention: Delivered by the EASSI-PC research team and local GP opinion leaders, facilitating interactive case-based webinars. Audit and feedback produced by central analytics teams at Bond University; in Victoria, additional analyses are performed by the local audit and feedback team at the University of Melbourne.

How: All intervention delivery details will be provided within the intervention package and will depend on the selected mode of delivery, e.g. printed materials delivered physically to practices; digital resources via the EASSI-PC website; interactive webinars online; audit and feedback via email with webinar-based feedback; and physical placement of behavioural cues in consultation or waiting rooms.

Where: General practices in four states (Queensland, Victoria, New South Wales, and South Australia). Depending on the strategy and the supporting resource, materials are intended to be used before, during or after GP consultations.

When and how much: Components delivered sequentially after randomisation; printed materials supplied at initiation; multiple webinar sessions across the intervention period (once every quarter for a 60-minute duration); repeated audit cycles (3 cycles); minimum exposure of 12 months.

Tailoring: No aspect of the intervention will be tailored, other than the choice of which format to use. Practices will choose the order of AMS strategies and delivery formats via an implementation form.

Modifications: Vanguard practices will provide early implementation feedback, which may lead to minor refinements to materials or delivery processes (not affecting core intervention content).

How well – Planned: Website analytics, webinar attendance logs, audit and feedback report access, printed materials usage (stock issued versus used), delayed prescription counts, and software trigger events (if implemented).

How well – Actual: To be reported at analysis: engagement patterns, uptake of AMS strategies, and integration of quantitative fidelity data with qualitative interview findings.
Intervention code [1] 334275 0
Prevention
Intervention code [2] 334933 0
Behaviour
Description of the comparator or control
Brief name: Standard support (low-resource-intensive) AMS implementation package.

Why: Provides basic AMS training and resources through passive, self-directed access. Designed as a scalable, low-cost comparator enabling assessment of the added value of resource-intensive components.

What – Materials: Digital materials only, accessed through the trial website, including patient information leaflets, decision aids, consultation demonstration videos, strategy “how and why” explanations, article summaries, Therapeutic Guidelines antibiotic summary table, generic webinar recordings, generic AMR posters (digital and printed), and a small computer sticker reminding GPs to access the website.

What – Procedures: GPs will be given direct access to the trial website, including all the standard support resources, printed generic posters, and the stickers. At the end of the trial, the GPs will recieve an Audit report showing their prescribing practices.

Who provided: The EASSI-PC research team.

How: All intervention details will be provided within the trial website.

Where: Participating general practices in Queensland, Victoria, New South Wales, and South Australia. Depending on the strategy and the supporting resource, materials are intended to be used before, during, or after GP consultations. The website serves only as a central repository rather than a clinical workflow platform and is not intended to replace advice from Australian national guidelines (e.g., Therapeutic Guidelines) or existing clinical workflows.

When and how much: Access to the website will be provided after randomisation, with a reminder for GPs to access it included in the newsletter dissemination. Each practice will receive a minimum of 12 months of intervention exposure, and all intervention activities will conclude at the common trial closeout.

Tailoring: No aspect of the intervention will be tailored.

Modifications: Vanguard practices will provide early implementation feedback on the website, which may lead to minor refinements.

How well – Planned: The research team will maintain structured logs to document intervention delivery for each practice. GP surveys will assess engagement with and uptake of individual AMS strategies. Attendance at webinars and other learning events will be monitored, and engagement with intervention materials will be tracked via activity on the EASSI-PC website, including access to resources, downloads, and use of online tools.

How well – Actual: To be reported at analysis: engagement patterns, uptake of AMS strategies, and integration of quantitative fidelity data with qualitative interview findings.
Control group
Active

Outcomes
Primary outcome [1] 345659 0
Practice-level prescribing rate: all oral antibiotics prescribed, expressed as the total number of antibiotic prescriptions per 1,000 consultations (derived from electronic medical record data).
Timepoint [1] 345659 0
Baseline (12 months prior to randomisation); end of trial (12–24 months after randomisation, depending on practice recruitment timing).
Primary outcome [2] 345660 0
Dispensing rate: all Pharmaceutical Benefits Scheme-subsidised oral antibiotics dispensed, expressed as the number of consultations in which any oral antibiotics were dispensed per 1,000 consultations derived from Medicare Benefits Schedule data.
Timepoint [2] 345660 0
Baseline (12 months prior to randomisation); end of trial (12–24 months after randomisation, depending on practice recruitment timing).
Secondary outcome [1] 462735 0
Acceptability of Antimicrobial Stewardship resources: Assessed through two ways: surveys will be administered at the beginning and end of the trial, and qualitative interviews. Responses will provide data on GPs’ engagement with the implementation package.
Timepoint [1] 462735 0
Surveys: Baseline & end of trial Interviews: Six months post-randomisation
Secondary outcome [2] 465725 0
Implementation fidelity (receipt and enactment) of the standard and enhanced support intervention packages.
Timepoint [2] 465725 0
Fidelity metrics will be collected throughout the implementation period from randomisation up to end of trial (12–24 months after randomisation, depending on practice recruitment timing). Fidelity interviews will be conducted at approximately 6 and 12 months post-randomisation.
Secondary outcome [3] 465726 0
Composite outcome: Incremental costs and cost-effectiveness of implementing the enhanced support antimicrobial stewardship intervention package compared with the standard support package.
Timepoint [3] 465726 0
End of trial, with modelled longer-term economic evaluation following trial completion.
Secondary outcome [4] 468988 0
Antibiotic prescribing by condition group (ARI): For the ARI condition group, measured using both General Practitioner Electronic Medical Record prescribing data and Pharmaceutical Benefits Scheme dispensing data, the outcome will be expressed as the number of consultations in which one or more target antibiotic was prescribed (Electronic Medical Record) or dispensed (Pharmaceutical Benefits Scheme) per 1,000 consultations in the relevant condition group. The target antibiotics will include the first-line antibiotics recommended for the management of conditions within this group, as indicated by the Australian Therapeutic Guidelines (accounting for any changes during the study period). The target antibiotics will serve as proxies to identify the relevant condition, with limitations (since the same antibiotic may be used across multiple condition groups).
Timepoint [4] 468988 0
Baseline (12 months prior to randomisation); end of trial (12–24 months after randomisation, depending on practice recruitment timing).
Secondary outcome [5] 468989 0
Antibiotic prescribing by condition group (UTI): For the UTI condition group, measured using both General Practitioner Electronic Medical Record prescribing data and Pharmaceutical Benefits Scheme dispensing data, the outcome will be expressed as the number of consultations in which one or more target antibiotic was prescribed (Electronic Medical Record) or dispensed (Pharmaceutical Benefits Scheme) per 1,000 consultations in the relevant condition group. The target antibiotics will include the first-line antibiotics recommended for the management of conditions within this group, as indicated by the Australian Therapeutic Guidelines (accounting for any changes during the study period). The target antibiotics will serve as proxies to identify the relevant condition, with limitations (since the same antibiotic may be used across multiple condition groups).
Timepoint [5] 468989 0
Baseline (12 months prior to randomisation); end of trial (12–24 months after randomisation, depending on practice recruitment timing).
Secondary outcome [6] 468991 0
Antibiotic prescribing by condition group (SSTI): For the SSTI condition group, measured using both General Practitioner Electronic Medical Record prescribing data and Pharmaceutical Benefits Scheme dispensing data, the outcome will be expressed as the number of consultations in which one or more target antibiotic was prescribed (Electronic Medical Record) or dispensed (Pharmaceutical Benefits Scheme) per 1,000 consultations in the relevant condition group. The target antibiotics will include the first-line antibiotics recommended for the management of conditions within this group, as indicated by the Australian Therapeutic Guidelines (accounting for any changes during the study period). The target antibiotics will serve as proxies to identify the relevant condition, with limitations (since the same antibiotic may be used across multiple condition groups).
Timepoint [6] 468991 0
Baseline (12 months prior to randomisation); end of trial (12–24 months after randomisation, depending on practice recruitment timing).
Secondary outcome [7] 468995 0
Perceived usefulness of Antimicrobial Stewardship resources: Assessed through two ways: surveys will be administered at the beginning and end of the trial, and qualitative interviews.
Timepoint [7] 468995 0
Six months post-randomisation; end of trial (12–24 months after randomisation, depending on practice recruitment timing).
Secondary outcome [8] 468998 0
Self-reported use of Antimicrobial Stewardship resources.
Timepoint [8] 468998 0
Every 6 months post-randomisation throughout the implementation period, up to end of trial (12–24 months after randomisation, depending on practice recruitment timing).
Secondary outcome [9] 469000 0
Barriers & enablers influencing implementation of the standard and enhanced support intervention packages.
Timepoint [9] 469000 0
10 to 11 months post-randomisation

Eligibility
Key inclusion criteria
General practices in Queensland, Victoria, New South Wales, and South Australia will be eligible if:

1) One or more general practitioners agree to participate in the study.
2) The practice currently contributes data to the Primary Care Audit, Teaching and Research Open Network repository, or, where not contributing to this repository, is willing and able to provide aggregated practice-level antibiotic prescribing data directly from its electronic medical record system via Structured Query Language queries.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Practices will be excluded if they are currently involved in, or have participated in, studies focused on antibiotic stewardship within the previous two years. Practices will also be excluded if they use practice software other than Best Practice or MedicalDirector.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be prepared and held by an independent statistician, who will maintain allocation concealment until all required consent documentation has been received for a practice. Once both practice-level and general practitioner-level consents are confirmed, the state coordinator will request randomisation directly from the independent statistician. The statistician will then release the practice’s allocation, allowing the coordinator to immediately inform the practice and commence delivery of the assigned intervention package.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur at the practice level using a centrally generated permuted block randomisation strategy. Randomisation will be stratified by state to ensure approximately equal allocation to the enhanced-support and standard-support intervention arms within each participating state. The randomisation sequence will be prepared by an independent statistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The target sample size is 305 GPs from a minimum of 102 general practices. Applying empirical estimates from a previous cluster-randomised trial, the study aims to detect a conservative 8% relative reduction in the mean prescribing and dispensing rates between the enhanced and standard support intervention packages. To allow for potential practice dropout, the study aims to recruit approximately 110 practices. Randomisation will occur at the practice level using a centrally generated permuted-block randomisation strategy stratified by state. Generalised estimating equation (GEE) negative binomial regression will be used to test for differences in mean prescribing and dispensing rates between the two arms, adjusting for clustering, overdispersion, and previous prescribing rates.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2026
Actual
Date of last participant enrolment
Anticipated
1/03/2027
Actual
Date of last data collection
Anticipated
31/08/2029
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 322068 0
Government body
Name [1] 322068 0
Australian Government Department of Health, Disability and Ageing – Medical Research Future Fund (MRFF)
Country [1] 322068 0
Australia
Primary sponsor type
University
Name
Bond University
Address
Country
Australia
Secondary sponsor category [1] 324929 0
University
Name [1] 324929 0
The University of Melbourne
Address [1] 324929 0
Country [1] 324929 0
Australia
Secondary sponsor category [2] 324948 0
University
Name [2] 324948 0
Adelaide University
Address [2] 324948 0
Country [2] 324948 0
Australia
Secondary sponsor category [3] 324949 0
University
Name [3] 324949 0
The University of Newcastle
Address [3] 324949 0
Country [3] 324949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320578 0
Bond University Human Research Ethics Committee
Ethics committee address [1] 320578 0
Ethics committee country [1] 320578 0
Australia
Date submitted for ethics approval [1] 320578 0
13/02/2026
Approval date [1] 320578 0
27/05/2026
Ethics approval number [1] 320578 0
VD00029

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150950 0
Prof Paul Glasziou
Address 150950 0
Institute for Evidence-Based Healthcare (Building 5, Level 4), Bond University, 14 University Drive, Robina QLD 4226
Country 150950 0
Australia
Phone 150950 0
+61 7 5595 1333
Fax 150950 0
Email 150950 0
[email protected]
Contact person for public queries
Name 150951 0
Associate Professor Mina Bakhit
Address 150951 0
Institute for Evidence-Based Healthcare (Building 5, Level 4), Bond University, 14 University Drive, Robina QLD 4226
Country 150951 0
Australia
Phone 150951 0
+61 7 5595 1333
Fax 150951 0
Email 150951 0
[email protected]
Contact person for scientific queries
Name 150952 0
Associate Professor Mina Bakhit
Address 150952 0
Institute for Evidence-Based Healthcare (Building 5, Level 4), Bond University, 14 University Drive, Robina QLD 4226
Country 150952 0
Australia
Phone 150952 0
+61 7 5595 1333
Fax 150952 0
Email 150952 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Access to study data will be restricted to authorised study personnel using secure, institution-managed systems with authentication and multi-factor security. Data transfers between collaborating sites will occur only via approved secure platforms. All reports, audit and feedback materials, and publications will present aggregated or de-identified data only, and no practice or GP will be identifiable in any dissemination outputs.




What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Approval Letter - VD00029_BUHREC.pdf
Informed consent form    Participant Information Sheet and Consent Form (Final).pdf
Study protocol    Study Protocol.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.