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A cluster-randomised controlled trial, implementing CONn Syndrome screening and Evaluation in Primary care (CONSEP)

A cluster-randomised controlled trial evaluating the impact of guidance-based requests on screening and diagnosis rates of CONn syndrome in primary care

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001340628
Acronym
CONSEP
Enrollment
0
Registered
2023-12-19
Start date
2024-06-14
Completion date
2024-08-30
Last updated
2024-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 so

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.

Sponsors

Department of Health and Aged Care
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

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;

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026