Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000815369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
17/05/2026
Date registered
Help: Date registered
7/07/2026
Date last updated
Help: Date last updated
7/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
7/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of educational interventions on the quality use of medicines in Australian general practice for secondary prevention of stroke
Scientific title
Effectiveness of educational interventions on the quality use of medicines in Australian general practice management for secondary stroke prevention: A pragmatic cluster randomised controlled trial
Additional trial identifiers [1] 317316 0
Nil
Universal Trial Number (UTN)
U1111-1340-8991
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Stroke 341959 0
Depression 341960 0
Anxiety 342276 0
Condition category
Condition code
Stroke 338034 338034 0 0
Ischaemic
Stroke 338035 338035 0 0
Haemorrhagic
Mental Health 338036 338036 0 0
Depression
Mental Health 338387 338387 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participating Primary Healthcare Networks (PHNs) in the state of Victoria, including the general practices and general practitioners (GPs) within their catchment areas, who are
randomised to a tailored multicomponent educational intervention to improve the provision of evidence-based secondary stroke prevention care for people who have had a stroke and/or transient ischaemic attack (TIA) will have access to the following interventions provided by Medcast on their QHub platform:

• A single 60-minute Educational Visit delivered virtually or face-to-face, depending on practice preferences and facilitator availability: A trained facilitator will meet with GP(s) +/- practice nurse(s) and pharmacists to deliver education to promote evidence-based care using a case-based academic detailing approach. Facilitators are pharmacists with experience in educational outreach and small-group facilitation, who have received program-specific training regarding educational content, facilitation approaches, behaviour change principles and delivery of key educational messages.
The facilitator will discuss key guideline recommendations (Australian Stroke Living Guidelines and Therapeutic Guidelines) including antithrombotic therapy, blood pressure management, lipid management and medicine optimisation, explore barriers to best practice and provide strategies to support best practice care.
The education will be tailored to the needs of clinicians and the practice, with facilitators adapting the case discussion, therapeutic emphasis and practical examples according to participant experience, patient population, local referral pathways and practice workflows while maintaining core educational objectives and key messages. Fidelity will be supported through use of a standardised facilitator guide, structured presentation materials, predefined key messages, facilitator training and consistent case-based activities. Facilitators will be encouraged to adhere to core learning outcomes and behaviour change objectives while allowing contextual tailoring.

• Self-directed mini-audit (3 hours): GPs will be invited to identify a subset of 3 relevant patients for the secondary stroke prevention clinical topic and review their management in comparison to educational materials outlining evidence-based care (estimated time 60 minutes per patient).
This mini audit reflective activity comprises four core components and one optional component:
1. Select patient encounter
2. Review best practice guidance
3. Reflect on practice
4. Upload your reflections
5. Discuss your reflections with peers (optional)

• A single pre-recorded webinar (60 minutes) will deliver best practice advice to GPs in an online format. This will be case based and presented by a subject matter expert. The webinar will be available with live question time on one occasion in August 2026, with the webinar recording then available on demand throughout the trial period.

• A Clinical Guide (2 page A4 PDF downloadable and printable), based upon the Australian and New Zealand Living Clinical Guidelines for Stroke Management and Therapeutic Guidelines, will provide summarised, step by step guidance outlining evidence-based care for secondary stroke prevention. The Clinical Guide will be developed to translate complex evidence into a clear, accessible format that supports rapid, consistent and evidence-based decision-making, improving efficiency, clinician confidence and patient care outcomes.

• A patient Decision Aid (2 page A4 PDF downloadable and printable) will present the potential benefits and harms for each treatment option, encouraging patients to consider the best option for their personal situation and preferences. The aid will be designed as an interactive, fillable worksheet to be used by health professionals during or alongside a consultation to guide structured discussion in a step-based approach:
Step 1: Introduce secondary stroke prevention concepts
Step 2: Discuss treatment options
Step 3: Elicit patient preferences
Step 4: Co-develop an action plan
Step 5: Plan follow-up and support
Step 6: Encourage ongoing reflection (patients can use the decision aid between visits and add notes/questions over time

• MedLuma, a curated clinical AI search tool for health professionals to ask questions and receive answers drawing from validated evidence-based Australian sources (e.g. Australian Living Stroke Guidelines and Therapeutic Guidelines and Medcast content). This is only available to GPs who have a Medcast account and have provided their AHPRA number.

GPs may choose to engage with all, some or none of the allocated educational components, which are part of an educational program delivered by Medcast on their QHub platform.

Participants in this arm will also have access to education on other topics available on the Medcast QHub platform, which include depression and/or anxiety in teenagers and young people, eczema, gout, antidepressants for older people, anticoagulants for people with atrial fibrillation, and menopause. Educational visits will be available on demand for depression and/or anxiety in teenagers and young people during the trial 4-month intervention delivery period.

Fidelity will be monitored where feasible. Medcast will collect data for participation in Educational Visits. Participation data will also be available for Mini-audits, Webinar views and MedLuma use, as these components of the education require enrolment. Medcast will collate these data to record participation by Medcast ID for linkage with POLAR data.
Intervention code [1] 334094 0
Behaviour
Description of the comparator or control
Participating Primary Healthcare Networks (PHNs) in the state of Victoria, including the general practices and general practitioners (GPs) within their catchment areas, who are randomised to the control group will not be offered education for secondary prevention of stroke.

Participants in this arm will have access to education on other topics available on the Medcast QHub platform which include depression and/or anxiety in teenagers and young people, eczema, gout, antidepressants for older people, anticoagulants for people with atrial fibrillation, menopause. Educational visits will be available on demand for depression and/or anxiety in teenagers and young people during the trial 4-month intervention delivery period.

After completion of the trial, participants in this arm will have access to the secondary stroke prevention education.

Control group
Active

Outcomes
Primary outcome [1] 345441 0
The proportion of adult patients with a documented diagnosis of stroke and/or TIA prescribed (and/or documented as receiving) all of the following evidence-based, guideline-concordant therapies for secondary stroke prevention for which they are eligible: Ischaemic stroke and/or TIA: - antithrombotic medication for patients with ischaemic stroke and/or TIA: anticoagulants for those with atrial fibrillation (AF) and antiplatelet agents for those without AF, AND - antihypertensive medication, AND - statins Haemorrhagic stroke: - antihypertensive medication This will be assessed for a combined patient cohort and as a composite outcome.
Timepoint [1] 345441 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [1] 461682 0
Proportion of adult patients with a documented diagnosis of ischaemic stroke and/or TIA prescribed (and/or documented as having received) antithrombotic medications (i.e., antiplatelet for those without atrial fibrillation (AF) or anticoagulant for those with AF). This will be assessed for a combined patient cohort.
Timepoint [1] 461682 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [2] 461683 0
Proportion of adult patients with a documented diagnosis of ischaemic stroke and/or TIA prescribed (and/or documented as having received) antihypertensive medications. This will be assessed for a combined patient cohort.
Timepoint [2] 461683 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [3] 461684 0
Proportion of adult patients with a documented diagnosis of ischaemic stroke and/or TIA prescribed (and/or documented as having received) any statin. This will be assessed for a combined patient cohort.
Timepoint [3] 461684 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [4] 461685 0
Proportion of adult patients with a documented diagnosis of ischaemic stroke and/or TIA prescribed (and/or documented as having received) high-potency statin (atorvastatin, rosuvastatin, 20/40/80 mg). This will be assessed for a combined patient cohort.
Timepoint [4] 461685 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [5] 461686 0
Proportion of adult patients with a documented diagnosis of haemorrhagic stroke prescribed (and/or documented as receiving) antihypertensive medication.
Timepoint [5] 461686 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [6] 461687 0
Proportion of teenagers and young adult patients (aged 13 to 24 years) with a documented diagnosis of depression and/or anxiety who were referred to a mental health specialist (defined as referral to a psychiatrist, psychologist, or provision of a Mental Health Care Plan).
Timepoint [6] 461687 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [7] 461689 0
Proportion of teenagers (age 13 – 17 years) and young people (18 – 24 years) with a documented diagnosis of depression and/or anxiety prescribed (and/or documented as receiving) evidence-based, guideline-concordant therapies for which they are eligible: For depression Age 13 to 17 years: - Fluoxetine - Other SSRIs (citalopram, escitalopram, fluvoxamine, sertraline) if fluoxetine contraindicated Age 18 to 24 years: - SSRIs (fluoxetine, citalopram, escitalopram, fluvoxamine, sertraline) or mirtazapine For anxiety Age 13 to 24 years: - SSRIs (fluoxetine, citalopram, escitalopram, fluvoxamine, sertraline) This will be assessed as a composite outcome.
Timepoint [7] 461689 0
Over the 6 months following the end of the (4-month) intervention delivery period.
Secondary outcome [8] 463086 0
Proportion of adult patients with a documented diagnosis of stroke (ischaemic or hemorrhagic) and/or TIA with blood pressure (BP) assessed/recorded. This will be assessed for a combined patient cohort and as a composite outcome.
Timepoint [8] 463086 0
Over the 6 months following the end of the (4-month) intervention delivery period.

Eligibility
Key inclusion criteria
PHNs are eligible to participate if they are located in the state of Victoria, Australia, the Chief Executive Officer (CEO) of relevant PHNs or their delegate agrees to study participation, and 50% or more of general practices within their catchment area contribute de-identified patient data to the POpulation Level Analysis and Reporting (POLAR) database.

Practices and GPs will be included if they work within the catchment area of participating PHNs and have agreed to the use of their de-identified POLAR data for research purposes as part of their agreement with Outcome Health for POLAR usage.

De-identified POLAR data will be the source of the trial outcomes. Secure use of these data is covered by existing data governance agreements for PHN-approved research and quality improvement evaluation purposes.

Patients are not being recruited.


Minimum age
24 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. GPs who do not work in one of the participating PHNs.
2. GPs who do not work in a general practice that contributes de-identified patient and other clinical data to the POLAR database.
3. GPs or the general practice in which they work, have opted out of sharing de-identified POLAR data for research purposes.

Patients are not being recruited.

There are no other specific exclusions.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be created in Excel, using the rand() function,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Power calculation:
We anticipate recruiting at least four PHNs (with equal representation of predominantly regional and predominantly metropolitan PHNs in each group), with the number of practices per PHN ranging between ~100 and over 560. Assuming an average of five GPs per practice, intra-class correlation (ICC) of 0.01 to account for clustering of GPs within practices and a coefficient of variation of 0.25 for practice size, and moderate correlation between baseline and follow-up outcomes at the PHN level (rho= 0.5–0.6), this sample is expected to provide over 90% power to detect a 6 percentage-point absolute improvement in performance between intervention and control groups, while appropriately accounting for the clustered design and the small number of participating PHNs.

Data analysis:
All primary and secondary trial outcomes will be measured at the individual GP level (using ITT protocol) at baseline and follow-up and analysed using multilevel mixed-effect regression models, with GPs nested within practices, and practices nested within PHNs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/07/2026
Actual
Date of last participant enrolment
Anticipated
31/10/2026
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 321883 0
Government body
Name [1] 321883 0
Australian Government Department of Health, Disability and Ageing
Country [1] 321883 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 324744 0
None
Name [1] 324744 0
Address [1] 324744 0
Country [1] 324744 0
Other collaborator category [1] 283947 0
Other
Name [1] 283947 0
Medcast
Address [1] 283947 0
Country [1] 283947 0
Australia
Other collaborator category [2] 283984 0
Other Collaborative groups
Name [2] 283984 0
QUM Alliance
Address [2] 283984 0
Country [2] 283984 0
Australia
Other collaborator category [3] 283987 0
Other Collaborative groups
Name [3] 283987 0
Outcome Health
Address [3] 283987 0
Country [3] 283987 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320422 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 320422 0
Ethics committee country [1] 320422 0
Australia
Date submitted for ethics approval [1] 320422 0
Approval date [1] 320422 0
24/02/2026
Ethics approval number [1] 320422 0
50769

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

Contacts
Principal investigator
Name 150434 0
Prof Rachelle Buchbinder
Address 150434 0
School of Public Health and Preventive Medicine, Monash University Level 4, 553 St Kilda Rd, Melbourne, VIC 3004
Country 150434 0
Australia
Phone 150434 0
+613 9903 8687
Fax 150434 0
Email 150434 0
[email protected]
Contact person for public queries
Name 150435 0
Dr Matthew Quigley
Address 150435 0
School of Public Health and Preventive Medicine, Monash University Level 4, 553 St Kilda Rd, Melbourne, VIC 3004
Country 150435 0
Australia
Phone 150435 0
+613 9903 8687
Fax 150435 0
Email 150435 0
[email protected]
Contact person for scientific queries
Name 150436 0
Professor Denise O'Connor
Address 150436 0
School of Public Health and Preventive Medicine, Monash University Level 4, 553 St Kilda Rd, Melbourne, VIC 3004
Country 150436 0
Australia
Phone 150436 0
+613 9903 8687
Fax 150436 0
Email 150436 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be available for sharing as the data access and use agreement with Outcome Health is only for aggregated analysis of data and does not permit the copy or transfer or unit record data.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    We plan to publish the protocol before data analys... [More Details]
Statistical analysis plan    We plan to publish the statistical analysis plan b... [More Details]


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.