Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000989549
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
13/08/2024
Date last updated
10/11/2024
Date data sharing statement initially provided
13/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of educational interventions to improve the quality use of medicines in Australian general practice for people with gout and older adults prescribed antidepressants
Scientific title
Can co-designed, tailored and facilitated educational interventions improve general practice management of people with gout and older adults prescribed antidepressants? A pragmatic cluster randomised controlled trial
Secondary ID [1] 311735 0
None
Universal Trial Number (UTN)
U1111-1309-1192
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 334072 0
Anxiety 334073 0
Depression 334674 0
Condition category
Condition code
Mental Health 330743 330743 0 0
Depression
Mental Health 330744 330744 0 0
Anxiety
Musculoskeletal 330745 330745 0 0
Other muscular and skeletal disorders
Public Health 331244 331244 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participating general practices will be randomised to receive a co-designed, tailored and facilitated intervention (virtual educational visits and peer group learning seminars) designed to improve the provision of evidence-based care for either people with gout (Group 1) or older adults prescribed antidepressant medication (Group 2). Each group will act as the other’s control.

Key messages of the program for gout will include:
- Start urate-lowering therapy at a low dose
- Commence flare prophylaxis concomitantly with urate-lowering therapy
- Slowly titrate urate-lowering therapy to achieve target serum urate levels and monitor regularly

Key messages of the program for older adults prescribed antidepressants will include:
- Tailor antidepressant choice to the individual and use informed consent to agree on treatment goals and patient expectations
- Review antidepressant treatment early and regularly, assessing the need for additional support to optimise outcomes
- GPs and patients to develop a plan for the safe reduction or cessation of antidepressants that incorporates appropriate supports

The virtual educational visits and peer group learning seminars will be delivered online by an experienced education facilitator.

Virtual educational visits involve a trained facilitator meeting with health professionals (general practitioners (GPs), practice nurses and pharmacists) in their practice setting to deliver information with the aim of improving care. The experienced education facilitator will discuss the key messages of the program for gout and antidepressants topics, explore barriers to best practice and provide strategies (e.g., clinical care scenarios) to support best practice care. The education is tailored to the needs of the health professionals and the practice. A case study may be used to highlight salient points. Although health professionals other than GPs may be involved in the educational visits, this trial focusses on GP outcomes.

Peer group learning seminars involve a trained facilitator meeting with health professionals from multiple settings to deliver education with the aim of improving care. The experienced education facilitator will discuss the key messages of the program for gout and antidepressants topics and may use a case study to highlight salient points. Large groups will be separated into smaller groups (up to 10 participants) for break-outs and facilitated discussions. Seminars will generally include a subject matter expert (eg specialist or specialised GP) sharing expert commentary of the topic. Sessions encourage discussion and exchange of ideas between participants.

GPs within each practice will be offered a virtual educational visit and/or a peer group learning seminar for the topic to which they are randomised (i.e. gout management or antidepressant prescription in older adults) at a time which has been mutually negotiated. The duration of engagement with each intervention will be approximately 45-60 minutes. Facilitated and tailored educational interventions for adults with gout will be offered from 1 August 2024 until 31 January 2025 while these educational interventions for antidepressant prescription in older adults will be offered from 1 November 2024 until 30 April 2025. These end-dates will be flexible to optimise participation.

The facilitator with record participant attendance and complete a checklist to monitor intervention fidelity of each intervention.

Both groups will have access to webinars, mini-audits, case-based blogs/online modules, podcasts and clinical decision support tools for both topics via the Medcast online education platform, and access to these will be recorded.
Intervention code [1] 328791 0
Behaviour
Comparator / control treatment
Both groups will have access to educational resources available on demand for both topics via the Medcast online education platform. These include webinars, mini-audits, case-based blogs, podcasts and clinical decision support tools (e.g., management algorithms, decision aids and management plans).

Webinars (45-60 minutes) will aim to deliver best practice advice to GPs in an online format. They will be presented by a subject matter expert and questions will be answered either through a live chat or by the presenters. Webinars will be delivered live to large groups (up to 500 participants) on a few occasions and recordings will be available on demand.

A mini-audit will be self-directed and request GPs to identify a subset of relevant patients for each topic and review their management in comparison to educational materials outlining evidence-based care.

Case-based blogs will be short, online articles that outline evidence-based care using a real-world exemplar and commentary from key opinion leaders for each topic.

Podcasts will be a pre-recorded conversation with a clinical expert and/or an expert consumer and aim to outline evidence-based care for each topic.

A management algorithm will be a flowchart that provides step by step guidance outlining evidence-based care for each topic.
A patient decision aid aims to provide the potential benefits and harms for each treatment option so as to encourage consumers to consider the best option for their personal situation and preferences.

A care plan will provide information about each health topic and its management.

These educational resources will not be individually tailored or modified and will be available on demand.

The duration of engagement with each resource is estimated to between 10 to 30 minutes. Non-tailored educational resources for adults with gout will be available from 1 July 2024 and will be ongoing. Non-tailored educational resources for antidepressant prescription in older adults will be available from 1 September 2024 and will be ongoing.

Engagement with these educational resources will be collected via the number of downloads and GP self-report.
Control group
Active

Outcomes
Primary outcome [1] 338504 0
Change in proportion of eligible people with gout who:
- have been prescribed any type of urate-lowering therapy and have achieved their target serum urate levels (<0.36mmol/L for non-tophaceous gout or <0.30mmol/L for those with tophi, chronic gouty arthritis or recurrent flares)
AND/OR
- have had any type of urate-lowering therapy prescribed continuously since commencement (based on the dose, number of repeats and pack sizes prescribed) and have had their serum urate levels tested at least once within 12 months.
Timepoint [1] 338504 0
Baseline (12 months predating the intervention delivery period) and 12 months following the end of the intervention delivery period for gout.
Primary outcome [2] 338505 0
Change in proportion of eligible older people who are prescribed any antidepressant medication (code N06A in the Anatomical Therapeutic Classification System) for greater than 6 months within the past 4 years and have their dose reduced or ceased.
Timepoint [2] 338505 0
Baseline (12 months predating the intervention delivery period) and 12 months following the end of the intervention delivery period for antidepressant prescription.
Secondary outcome [1] 436192 0
Change in proportion of eligible people with gout who have had a serum urate test within the last 12 months
Timepoint [1] 436192 0
Baseline (12 months predating the intervention delivery period) and 12 months following the end of the intervention delivery period for gout
Secondary outcome [2] 436193 0
Change in proportion of eligible people with gout who have been prescribed any class of urate-lowering therapy
Timepoint [2] 436193 0
Baseline (12 months predating the intervention delivery period) and 12 months following the end of the intervention delivery period for gout
Secondary outcome [3] 436194 0
Change in proportion of eligible people with gout with a concomitant colchicine, NSAID or glucocorticoid prescription (i.e., for prophylaxis against gout flares) at initiation of urate-lowering therapy (i.e. first prescription of urate-lowering therapy)
Timepoint [3] 436194 0
Baseline (12 months predating the intervention delivery period) and 12 months following the end of the intervention delivery period for gout
Secondary outcome [4] 436196 0
Change in proportion of eligible people with gout with presumed urate-lowering therapy persistence at 12 months after intervention delivery (continuous prescription of any urate-lowering therapy based on the dose, number of repeats and pack sizes prescribed)
Timepoint [4] 436196 0
Baseline (12 months predating the intervention period) and 12 months following the end of the intervention delivery period for gout
Secondary outcome [5] 436313 0
Change in knowledge about evidence-based care for people with gout
Timepoint [5] 436313 0
Baseline (12 months predating the intervention delivery period) and at the end of the intervention delivery period for gout
Secondary outcome [6] 436314 0
Confidence to provide evidence-based care to people with gout
Timepoint [6] 436314 0
End of the intervention delivery period for gout
Secondary outcome [7] 436315 0
Intention to change practice of adults with gout
Timepoint [7] 436315 0
End of the intervention delivery period for gout
Secondary outcome [8] 436316 0
Change in proportion of eligible older adults prescribed any antidepressant medication who have had their dosage reduced after 2 years of initial prescription or are prescribed antidepressants for less than 3 years in total
Timepoint [8] 436316 0
Baseline (12 months predating the intervention delivery period) and 12 months following the end of the intervention delivery period for antidepressant prescription
Secondary outcome [9] 436317 0
Change in rate of any antidepressant prescription in eligible older adults per GP
Timepoint [9] 436317 0
Baseline (12 months predating the intervention delivery period) and 12 months following the end of the intervention delivery period for antidepressant prescription
Secondary outcome [10] 436318 0
Change in knowledge about evidence-based care for older adults prescribed antidepressants
Timepoint [10] 436318 0
Baseline (12 months predating the intervention delivery period) and at the end of the intervention delivery period for antidepressants
Secondary outcome [11] 436319 0
Confidence to provide evidence-based care to older adults prescribed antidepressants
Timepoint [11] 436319 0
End of the intervention delivery period for antidepressants
Secondary outcome [12] 436320 0
Intention to change practice of older adults prescribed antidepressants
Timepoint [12] 436320 0
End of the intervention delivery period for antidepressants

Eligibility
Key inclusion criteria
GPs registered and practising in Australia and working in a general practice within consenting Primary Health Networks in NSW and Victoria who contribute data to the POpulation Level and Analysis Reporting (POLAR) database.

Eligible people with gout will be active patients (defined as attending a general practice three or more times in the past two years), aged 18 years or over with a diagnosis of gout, operationalised as:
- a diagnostic code of gout, tophaceous gout, or tophi in patient record (SNOMED Text chronic gouty nephropathy, date gout treatment started, gouty tophus, gout, articular gout, and/or tophus) and/or
- prescription of allopurinol, and/or febuxostat and/or
- confirmed identification of monosodium urate crystals under polarised microscopy in synovial or bursal fluid or tophi or
- detection of urate crystal deposition by ultrasound or dual-energy CT (DECT)

People prescribed colchicine without any other confirmatory evidence of gout will be excluded.

Eligible older adults will be active patients (defined as attending a general practice three or more times in the past two years), aged 65 years or over or aged 50 years and over in those who identify as being of Aboriginal and/or Torres Strait Islander origin with a diagnostic code of anxiety or depression.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trainee GPs will be excluded

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 study biostatistician will generate the random sequence using stratified block randomisation. Once notice of practice consent is received by an administrator (not otherwise involved in the trial), the request for group allocation will be sent to the study biostatistician based on the stratification factors (practice size and geographic location).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated using the ‘ralloc’ command in Stata17. This will generate a set of permuted blocks, with block sizes of 2, 4 and 6. Stratification factors will include practice size (small (less than or equal to 75 weekday activities), medium (76-149 weekday activities) or large (greater than or equal to 150 weekday activities)) and geographic location (metropolitan vs regional using the Modified Monash Model).
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
Statistical methods / analysis
A detailed statistical analysis plan will be developed prior to the data lock and subsequent analysis. We will 1) compare the difference in the change in proportion of eligible patients who receive evidence-based care for gout from GPs randomised to receive the gout intervention versus the GPs randomised to receive the antidepressant intervention and 2) compare the difference in the change in proportion of eligible patients who receive evidence-based antidepressant care from GPs randomised to receive the antidepressant intervention versus the GPs randomised to receive the gout intervention. For both analyses this will be over 12 months following intervention delivery.

The primary analysis will be conducted based on the intention-to-treat (ITT) principle with level of significance for each primary outcome set at p<0.025 to account for multiplicity. The primary outcome will be assessed using multilevel mixed effect regression analysis (with practice used as a random factor), adjusted for GPs’ years in practice, gender, volume of patients treated, baseline level of concordance and stratification factors. The results will be reported as adjusted mean differences with 97.5% confidence intervals.

Sample size calculation will be guided by the number of eligible active gout patients per practice as we expect there to be higher numbers of eligible older patients prescribed antidepressants attending each general practice. Based on conservative estimates of approximately 290 patients with gout per practice, interclass correlation of 0.1 and variable cluster size (CV= 0.2), 26 practices (13 practices per arm) will need to be recruited to achieve 80% power to detect a 6% difference in evidence-based care between the group receiving co-designed, tailored and facilitated intervention versus the control group who didn’t receive the intervention for that topic (assuming two-sided alpha of 0.025 and 20% drop out rate). Based on an average of 5 GPs per practice, we will recruit approximately 130 GPs.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/08/2024
Actual
30/10/2024
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
150
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 316065 0
Government body
Name [1] 316065 0
Australian Government, Department of Health and Aged Care
Country [1] 316065 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318950 0
None
Name [1] 318950 0
Address [1] 318950 0
Country [1] 318950 0
Other collaborator category [1] 283112 0
Commercial sector/Industry
Name [1] 283112 0
Medcast
Address [1] 283112 0
Country [1] 283112 0
Australia
Other collaborator category [2] 283113 0
Commercial sector/Industry
Name [2] 283113 0
QUM Alliance
Address [2] 283113 0
Country [2] 283113 0
Australia
Other collaborator category [3] 283114 0
Commercial sector/Industry
Name [3] 283114 0
Outcome Health
Address [3] 283114 0
Country [3] 283114 0
Australia
Other collaborator category [4] 283115 0
Other
Name [4] 283115 0
South West Sydney Primary Health Network
Address [4] 283115 0
Country [4] 283115 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314884 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314884 0
Ethics committee country [1] 314884 0
Australia
Date submitted for ethics approval [1] 314884 0
23/05/2024
Approval date [1] 314884 0
17/06/2024
Ethics approval number [1] 314884 0
42926

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

Contacts
Principal investigator
Name 133054 0
Prof Rachelle Buchbinder
Address 133054 0
Monash University, Level 4, 553 St Kilda Road, Melbourne, Victoria 3004
Country 133054 0
Australia
Phone 133054 0
+61418105043
Fax 133054 0
Email 133054 0
rachelle.buchbinder@monash.edu
Contact person for public queries
Name 133055 0
Romi Haas
Address 133055 0
Monash University, School of Public Health and Preventive Medicine, Level 4, 553 St Kilda Road, Melbourne, Victoria, 3004
Country 133055 0
Australia
Phone 133055 0
+61409010626
Fax 133055 0
Email 133055 0
romi.haas@monash.edu
Contact person for scientific queries
Name 133056 0
Romi Haas
Address 133056 0
Monash University, School of Public Health and Preventive Medicine, Level 4, 553 St Kilda Road, Melbourne, 3004
Country 133056 0
Australia
Phone 133056 0
+61409010626
Fax 133056 0
Email 133056 0
romi.haas@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data will not be available for sharing as the data access and use agreement with Outcome Health, the custodians of the database, is only for aggregated analysis of results and does not permit the copy or transfer of unit record data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24054Study protocol    We plan to publish the protocol and statistical an... [More Details]
24055Statistical analysis plan    We plan to publish the protocol and statistical an... [More Details]



Results publications and other study-related documents

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