Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001340628
Ethics application status
Approved
Date submitted
23/11/2023
Date registered
19/12/2023
Date last updated
31/05/2024
Date data sharing statement initially provided
19/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A cluster-randomised controlled trial, implementing CONn Syndrome screening and Evaluation in Primary care (CONSEP)
Scientific title
A cluster-randomised controlled trial evaluating the impact of guidance-based requests on screening and diagnosis rates of CONn syndrome in primary care
Secondary ID [1] 310953 0
MRFF2022933
Universal Trial Number (UTN)
Trial acronym
CONSEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 332033 0
Condition category
Condition code
Cardiovascular 328761 328761 0 0
Hypertension
Metabolic and Endocrine 328981 328981 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After randomization, baseline data will be extracted from Best Practice software, and the Provider Survey will be conducted. After completing the above steps, our intervention will take place.

Practices in the intervention arm will receive:

1. A brief 20-30 minutes introduction to CONSEP trial and primary aldosteronism (PA) screening. This introduction will be presented in each practice, participating general practitioners and/or relevant staff can attend face to face, via an online meeting software, or via watching recordings of the education. Presentation slides is made specific for this study based on the latest Harmonisation of Endocrine Dynamic Testing -Adult (HEDTA) states. Printouts will be provided during the presentation, and a webpage link will be provided after the presentation. A research staff from the CONSEP team will administer this intervention. A session attendance checklist will be used to monitor adherence to the intervention.

2. Guided-based requests (GBR) software activation and user education. GBR is a four-step method for ordering consistent pathology tests for common clinical contexts based on existing guidelines. GBR will be activated at the practice. And a brief 10-20 minutes user education presentation will be presented in each practice right after the presentation of introduction to CONSEP trial and PA screening. Similarly, participating general practitioners and/or relevant staff can attend face to face, via an online meeting software, or via watching recordings of the education. Presentation slides made for new GBR users will be used for the presentation, printouts will be provided during the presentation, and online video link will be provided after the presentation. A staff from Sonic Pathology will administer this intervention. A session attendance checklist will be used to monitor adherence to the intervention.

3. An audit of aldosterone to renin ratio (ARR) test ordering and GBR usage after 3 months after the commencement of intervention. The practice manager or a delegated practice staff will assist with this audit.
Intervention code [1] 327392 0
Early detection / Screening
Comparator / control treatment
Practices in the control arm will receive a brief introduction to CONSEP trial and PA screening, and audit of ARR test ordering.
The brief introduction to CONSEP trial and PA screening will be the same as the intervention arm. And the audit of aldosterone to renin ratio (ARR) test ordering will happen at 3 months after the commencement of intervention. The practice manager or a delegated practice staff will administer this audit. A research staff from the CONSEP team may also help to administer this audit.
The only two differences between the practices in the control arm and the intervention arm are that those in the control arm do not receive GBR (part 2 in the intervention arm), and the audit of GBR using (part of part 3 in the intervention arm).
Control group
Active

Outcomes
Primary outcome [1] 336577 0
Proportion of eligible patients screened for primary aldosteronism
Timepoint [1] 336577 0
12 months after the commencement of intervention
Primary outcome [2] 336578 0
Proportion of eligible patients diagnosed with primary aldosteronism
Timepoint [2] 336578 0
24 months after the commencement of intervention
Secondary outcome [1] 428844 0
Rates of blood pressure control in eligible patients.
Timepoint [1] 428844 0
12 and 24 months after the commencement of intervention
Secondary outcome [2] 428845 0
The amount (dose and frequency) of antihypertensive medication use in eligible patients.
Timepoint [2] 428845 0
12 and 24 months after the commencement of intervention
Secondary outcome [3] 428846 0
Evaluate the barriers and enablers to the process of implementing the intervention to increase the screening and diagnosis of primary aldosteronism
Timepoint [3] 428846 0
12 months after the commencement of intervention
Secondary outcome [4] 428847 0
the cost of the intervention
Timepoint [4] 428847 0
during the preparation and delivery of intervention

Eligibility
Key inclusion criteria
To be eligible, practices will:
(1) use Best PracticeTM Clinical Management Software;
(2) be accredited;
(3) provide general primary care services;
(4) plan to be in operation for the next 2 years;
(5) use Sonic Pathology (Melbourne Pathology in VIC, Clinpath Pathology in SA, Hobart Pathology in TAS) as default pathology;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
To be eligible, practices need to be not:
(1) practices recruited for our prior educational intervention;
(2) practices which are previous users, current users or planning to use Guidance-based requests (GBR) to order pathology tests in the next 2 years;
(3) practices which share their database with other practices.

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)
block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/06/2024
Actual
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
840
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
SA,TAS,VIC

Funding & Sponsors
Funding source category [1] 315213 0
Government body
Name [1] 315213 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 315213 0
Australia
Primary sponsor type
Government body
Name
Department of Health and Aged Care
Address
414 La Trobe St, Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 317305 0
None
Name [1] 317305 0
Address [1] 317305 0
Country [1] 317305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314137 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314137 0
Building 3e, Room 111 Research Office Monash University VIC 3800
Ethics committee country [1] 314137 0
Australia
Date submitted for ethics approval [1] 314137 0
10/08/2023
Approval date [1] 314137 0
16/08/2023
Ethics approval number [1] 314137 0

Summary
Brief summary
Missing a diagnosis of primary aldosteronism (PA) leads to adverse patient outcomes above and beyond hypertension. A simple blood test is available to screen for this common and potentially curable condition, but is severely under-utilised. Interventions including education and clinical decision support are likely to increase PA screening in primary care where the vast majority of hypertensive patients are managed. A well-powered trial that incorporates strong implementation strategies and health economic analyses is what we are proposing to address the issue.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130546 0
A/Prof Jun Yang
Address 130546 0
Hudson Institute of Medical Research. 27-31 Wright St, Clayton VIC 3168.
Country 130546 0
Australia
Phone 130546 0
+61 3 8572 2540
Fax 130546 0
Email 130546 0
Jun.Yang@hudson.org.au
Contact person for public queries
Name 130547 0
Dr Linghan Jia
Address 130547 0
Hudson Institute of Medical Research. 27-31 Wright St, Clayton VIC 3168
Country 130547 0
Australia
Phone 130547 0
+61 3 8572 2700
Fax 130547 0
Email 130547 0
consep@monash.edu
Contact person for scientific queries
Name 130548 0
A/Prof Jun Yang
Address 130548 0
Hudson Institute of Medical Research. 27-31 Wright St, Clayton VIC 3168
Country 130548 0
Australia
Phone 130548 0
+61 3 8572 2540
Fax 130548 0
Email 130548 0
consep@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


What supporting documents are/will be available?

No Supporting Document Provided



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.