Cardiovascular DiseasesIDEALNCT04896021
Improved Cardiovascular Disease hEALth Service Delivery in Australia: Cluster Randomised Controlled Trial (IDEAL Study)
A study testing Cardiovascular disease risk assessment in people with Cardiovascular Diseases, run by Menzies Institute for Medical Research at 1 site in Australia.
Trial summary
The IDEAL study is a randomized controlled trial among people referred to pathology services to have blood cholesterol measured. Study participants will have cardiovascular risk factors (e.g. age, sex, blood pressure, diabetes, smoking status) measured within an assessment station at pathology services. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiovascular disease risk assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,761 participants
- Where
- 1 siteAustralia
- Study dates
- 26 May 2021to 23 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred to pathology services for blood cholesterol (lipids; total cholesterol and HDL cholesterol) who are eligible for absolute CVD risk assessment according to the National Vascular Disease Prevention Alliance guidelines (this includes all adults aged 45 years and over without a known history of CVD, or Aboriginal and Torres Strait Islander people aged 35 years or over) and willing to provide permission to access to PBS-linked data on medications prescribed and dispensed.
- Adults already deemed to be at increased risk that do not require absolute CVD risk assessment according to guidelines will also be included because there is evidence that these people are undertreated (Heeley EL, et al Med J Aust 2010;192:254-9; Peiris DP, et al Med J Aust 2009;191:304-9) and therefore may benefit from improved assessment. This includes adults with any of the following: Diabetes and age >60 years; Diabetes with microalbuminuria (>20 mcg/min or urinary albumin:creatinine ratio >2.5 mg/mmol for males, >3.5 mg/mmol for females); Moderate or severe CKD (persistent proteinuria or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2); A previous diagnosis of familial hypercholesterolaemia; Serum total cholesterol >7.5 mmol/L; Aboriginal and Torres Strait Islander adults aged over 74
Who cannot join
- Adults already taking antihypertensive or lipid lowering medications (determined by self-report at baseline)
- if the referring doctor is not from a general practice included in the study cluster list,
- if participants cannot provide an email address to be used to provide a copy of their signed consent form.
- If at least one measurement of blood pressure is unable to be obtained at baseline assessment.
- For safety reasons, people will be excluded if they are found at the time of assessment at the pathology services with an average systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Menzies Institute for Medical Research
Hobart, Tasmania, 7000
About this study
The IDEAL study is a randomized controlled trial among people referred to pathology services to have blood cholesterol measured. Study participants will have cardiovascular risk factors (e.g. age, sex, blood pressure, diabetes, smoking status) measured within an assessment station at pathology services. A report on cardiovascular risk, in addition to blood cholesterol results, will be sent to the referring doctor along with recommended treatment strategies among those participants randomized to intervention. For control participants, the usual care process will be provided in which only blood cholesterol results will be sent to the referring doctor. The new intervention is expected to lead to better identification and treatment of people at high risk for cardiovascular disease events.
Read the detailed description
The IDEAL study aims to improve the way doctors identify and manage patients at risk of cardiovascular disease, including conditions such as heart attack or stroke. This research focuses on an improved service to work out a patient's risk of heart attack or stroke and deliver this information to doctors to help them make well-informed treatment decisions to prevent cardiovascular disease and improve outcomes for their patients.
This IDEAL study is a randomized clinical trial of the IDEAL service to be conducted among 9,714 participants attending pathology services in Tasmania, Australia.
Patients attending pathology service clinics around Tasmania for a cholesterol test may be invited to participate. Participants will have their risk of cardiovascular disease assessed in a purpose-built assessment station where information about their cardiovascular disease risk factors, such as smoking, will be collected and blood pressure measured. An estimate of the chances of that patient having a heart attack or stroke in the next 5 years will be calculated and sent to their referring doctor along with their pathology results on the requested blood test report.
Based on the patient's risk of cardiovascular disease, appropriate advice according to recommended treatment guidelines will be provided on the pathology report as an aid for doctors to make better-informed decisions to manage patients at risk of cardiovascular disease.
Participants will also be asked to complete a questionnaire to explore issues of cardiovascular disease risk in more depth, with follow-up questionnaires at 6 and 12 months. After 12 months researchers will examine if there is an improvement in cardiovascular disease risk management and health outcomes for participants whose doctors received the cardiovascular disease risk information on the pathology report. This will be done through data linkage with national and state level data, as well as through asking participants to re-complete the questionnaire.
In addition, a qualitative research program will be conducted to understand the barriers and enablers to uptake of the IDEAL service from the perspective of pathology staff, doctors and patients.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiovascular disease risk assessment, Usual care assessment
- Keywords
- Cardiovascular disease risk management
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular disease risk assessmentDiagnostic test
Intervention in which the addition of guideline-recommended absolute cardiovascular disease risk assessment is embedded into point-of-care blood collection services for cholesterol measurement and results (including risk score) are reported to referring doctors.
Usual care assessmentDiagnostic test
Usual care in which blood cholesterol results are reported to referring doctors
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | On referral to Tasmanian pathology services for blood cholesterol, intervention participants will have their blood pressure measured and collated with other cardiovascular disease risk factors. An absolute cardiovascular disease risk score is calculated, interpreted according to guideline recommendations and reported to referring doctors via the established pathology system. High risk is highlighted in red as per usual practice for pathology tests outside of normal range, and advice provided regarding appropriate action according to National Vascular Disease Prevention Alliance guidelines. Receives: Diagnostic Test: Cardiovascular disease risk assessment |
| Control | Active comparator | On referral to Tasmanian pathology services for blood cholesterol, control participants will have their blood pressure measured and collated with other cardiovascular disease risk factors as per the intervention arm. However, only the results relating to blood cholesterol are reported to the referring doctor, as per usual practice. Receives: Diagnostic Test: Usual care assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antihypertensive and/or statin medications dispensed
Antihypertensive and/or statin medications dispensed, confirmed by data linkage to Pharmaceutical Benefits Scheme
Measured: 1 year after randomization
Secondary outcomes (2)
Cost effectiveness
Cost effectiveness of intervention compared with usual care
Measured: 1 year after randomization
Barriers and enablers
Barriers and enablers to implementation and uptake of intervention as ascertained from pathology services staff, referring doctors and patients
Measured: 1 year after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start26 May 2021
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants attending pathology services for blood cholesterol assessment will be randomized to intervention or control arms. Randomization is clustered at the level of general practice clinics (n=60 target) referring patients to pathology services for blood cholesterol assessment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2,761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies Institute for Medical Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Diagnostic Services Pty Ltd, Department of Health, Tasmania, Primary Health Tasmania, National Heart Foundation, Australia, Healthcare Software Pty Ltd, Uscom Limited
- Responsible party
- Principal investigator, james E sharman, Menzies Institute for Medical Research
- Investigators
- James E Sharman, PhD, Principal investigator, Menzies Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896021
- Sponsor's protocol ID
- HREC23015
- Other IDs
- GNT1170815
- Acronym
- IDEAL
- Status last verified
- May 2025
- First submitted
- 11 May 2021
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The deidentified study data, including data dictionaries, will be made publicly available on reasonable request via the University of Tasmania's Research Data Portal (consistent with the Australian Code for the Responsible Conduct of Research).
Publications
Pagano L, Sharman JE, Nash R, Sutton L, Donovan S, Owens D, Murfett L, Heathcote S, Wells G, Zurynski Y, Sarkies M, Chapman N. Implementing absolute cardiovascular disease risk assessment into pathology collection services. J Eval Clin Pract. 2024 Oct;30(7):1239-1250. doi: 10.1111/jep.14034. Epub 2024 Jun 3.
PubMed 38828679
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Cardiovascular Disease hEALth Service Delivery in Australia: Cluster Randomised Controlled Trial (IDEAL Study)
- ClinicalTrials.gov ID
- NCT04896021
- Acronym / sponsor ID
- IDEAL / HREC23015
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiovascular disease risk management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,761 participants (actual)
- Lead sponsor
- Menzies Institute for Medical ResearchUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Diagnostic Services Pty Ltd, Department of Health, Tasmania, Primary Health Tasmania, National Heart Foundation, Australia, Healthcare Software Pty Ltd, Uscom Limited
- Study start
- 26 May 2021 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 21 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The IDEAL study is a randomized controlled trial among people referred to pathology services to have blood cholesterol measured. Study participants will have cardiovascular risk factors (e.g. age, sex, blood pressure, diabetes, smoking status) measured within an assessment station at pathology services. A report on cardiovascular risk, in addition to blood cholesterol results, will be sent to the referring doctor along with recommended treatment strategies among those participants randomized to intervention. For control participants, the usual care process will be provided in which only blood cholesterol results will be sent to the referring doctor. The new intervention is expected to lead to better identification and treatment of people at high risk for cardiovascular disease events.
Detailed description
The IDEAL study aims to improve the way doctors identify and manage patients at risk of cardiovascular disease, including conditions such as heart attack or stroke. This research focuses on an improved service to work out a patient's risk of heart attack or stroke and deliver this information to doctors to help them make well-informed treatment decisions to prevent cardiovascular disease and improve outcomes for their patients.
This IDEAL study is a randomized clinical trial of the IDEAL service to be conducted among 9,714 participants attending pathology services in Tasmania, Australia.
Patients attending pathology service clinics around Tasmania for a cholesterol test may be invited to participate. Participants will have their risk of cardiovascular disease assessed in a purpose-built assessment station where information about their cardiovascular disease risk factors, such as smoking, will be collected and blood pressure measured. An estimate of the chances of that patient having a heart attack or stroke in the next 5 years will be calculated and sent to their referring doctor along with their pathology results on the requested blood test report.
Based on the patient's risk of cardiovascular disease, appropriate advice according to recommended treatment guidelines will be provided on the pathology report as an aid for doctors to make better-informed decisions to manage patients at risk of cardiovascular disease.
Participants will also be asked to complete a questionnaire to explore issues of cardiovascular disease risk in more depth, with follow-up questionnaires at 6 and 12 months. After 12 months researchers will examine if there is an improvement in cardiovascular disease risk management and health outcomes for participants whose doctors received the cardiovascular disease risk information on the pathology report. This will be done through data linkage with national and state level data, as well as through asking participants to re-complete the questionnaire.
In addition, a qualitative research program will be conducted to understand the barriers and enablers to uptake of the IDEAL service from the perspective of pathology staff, doctors and patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants attending pathology services for blood cholesterol assessment will be randomized to intervention or control arms. Randomization is clustered at the level of general practice clinics (n=60 target) referring patients to pathology services for blood cholesterol assessment.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Cardiovascular disease risk assessmentOn referral to Tasmanian pathology services for blood cholesterol, intervention participants will have their blood pressure measured and collated with other cardiovascular disease risk factors. An absolute cardiovascular disease risk score is calculated, interpreted according to guideline recommendations and reported to referring doctors via the established pathology system. High risk is highlighted in red as per usual practice for pathology tests outside of normal range, and advice provided regarding appropriate action according to National Vascular Disease Prevention Alliance guidelines. |
| Control | Active comparator | Diagnostic Test: Usual care assessmentOn referral to Tasmanian pathology services for blood cholesterol, control participants will have their blood pressure measured and collated with other cardiovascular disease risk factors as per the intervention arm. However, only the results relating to blood cholesterol are reported to the referring doctor, as per usual practice. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred to pathology services for blood cholesterol (lipids; total cholesterol and HDL cholesterol) who are eligible for absolute CVD risk assessment according to the National Vascular Disease Prevention Alliance guidelines (this includes all adults aged 45 years and over without a known history of CVD, or Aboriginal and Torres Strait Islander people aged 35 years or over) and willing to provide permission to access to PBS-linked data on medications prescribed and dispensed.
- Adults already deemed to be at increased risk that do not require absolute CVD risk assessment according to guidelines will also be included because there is evidence that these people are undertreated (Heeley EL, et al Med J Aust 2010;192:254-9; Peiris DP, et al Med J Aust 2009;191:304-9) and therefore may benefit from improved assessment. This includes adults with any of the following: Diabetes and age >60 years; Diabetes with microalbuminuria (>20 mcg/min or urinary albumin:creatinine ratio >2.5 mg/mmol for males, >3.5 mg/mmol for females); Moderate or severe CKD (persistent proteinuria or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2); A previous diagnosis of familial hypercholesterolaemia; Serum total cholesterol >7.5 mmol/L; Aboriginal and Torres Strait Islander adults aged over 74
Key exclusion criteria (5 listed)
- Adults already taking antihypertensive or lipid lowering medications (determined by self-report at baseline)
- if the referring doctor is not from a general practice included in the study cluster list,
- if participants cannot provide an email address to be used to provide a copy of their signed consent form.
- If at least one measurement of blood pressure is unable to be obtained at baseline assessment.
- For safety reasons, people will be excluded if they are found at the time of assessment at the pathology services with an average systolic blood pressure =180 mmHg or diastolic blood pressure =110 mmHg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular disease risk assessmentIntervention in which the addition of guideline-recommended absolute cardiovascular disease risk assessment is embedded into point-of-care blood collection services for cholesterol measurement and results (including risk score) are reported to referring doctors. | Diagnostic test | Intervention |
| Usual care assessmentUsual care in which blood cholesterol results are reported to referring doctors | Diagnostic test | Control |
Primary outcome
Antihypertensive and/or statin medications dispensed
Time frame: 1 year after randomization
Antihypertensive and/or statin medications dispensed, confirmed by data linkage to Pharmaceutical Benefits Scheme
2 secondary outcomes
Cost effectiveness
Time frame: 1 year after randomization
Barriers and enablers
Time frame: 1 year after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Derived from this study: PubMed 38828679Pagano L, Sharman JE, Nash R, Sutton L, Donovan S, Owens D, Murfett L, Heathcote S, Wells G, Zurynski Y, Sarkies M, Chapman N. Implementing absolute cardiovascular disease risk assessment into pathology collection services. J Eval Clin Pract. 2024 Oct;30(7):1239-1250. doi: 10.1111/jep.14034. Epub 2024 Jun 3.
- Individual participant dataSharing planned: Yes. The deidentified study data, including data dictionaries, will be made publicly available on reasonable request via the University of Tasmania's Research Data Portal (consistent with the Australian Code for the Responsible Conduct of Research).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Sharman, PhD principal investigator
Menzies Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular disease risk assessment in people with Cardiovascular Diseases, run by Menzies Institute for Medical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antihypertensive and/or statin medications dispensed (time frame: 1 year after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04896021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.