Improved Cardiovascular Disease hEALth Service Delivery in Australia: Cluster Randomised Controlled Trial (IDEAL Study)

NCT04896021 | Completed

• 2 other identifiers: HREC23015GNT1170815
• Study Type: interventional
• Target: 2,761
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular disease risk management

Outcome Measures

Primary Outcomes (1)

• Antihypertensive and/or statin medications dispensed

  Antihypertensive and/or statin medications dispensed, confirmed by data linkage to Pharmaceutical Benefits Scheme

  1 year after randomization

Secondary Outcomes (2)

• Cost effectiveness

  1 year after randomization

• Barriers and enablers

  1 year after randomization

Other Outcomes (1)

• Cardiovascular outcomes

  This tertiary-level exploratory analysis will be conducted to determine power for future trials. Analysis will be performed after accrual of events that are anticipated to occur after at least 2 years follow-up

Study Arms (2)

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.

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.

Diagnostic Test: Usual care assessment

Interventions

Cardiovascular disease risk assessment DIAGNOSTIC_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.

Intervention

Usual care assessment DIAGNOSTIC_TEST

Usual care in which blood cholesterol results are reported to referring doctors

Control

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menzies Institute for Medical Research: lead
• National Health and Medical Research Council, Australia: collaborator
• Diagnostic Services Pty Ltd: collaborator
• Department of Health, Tasmania: collaborator
• Primary Health Tasmania: collaborator
• National Heart Foundation, Australia: collaborator
• Healthcare Software Pty Ltd: collaborator
• Uscom Limited: collaborator

Study Sites (1)

Menzies Institute for Medical Research

Hobart, Tasmania, 7000, Australia

Location

Related Publications (1)

• 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.

  PMID: 38828679 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• James E Sharman, PhD

  Menzies Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation is concealed from all people involved in eligibility screening and recruitment. Pathology services reception and blood collection staff members may be employed across different collection centers that could include both intervention and control sites. Thus, concealment at the cluster level (as per this study design) is critical and all procedures undertaken by staff members interacting with participants (reception and blood collection staff) will be identical. At the participant level, there will be no indication provided regarding allocation (all participants will have the same information and undergo the same protocol at baseline assessment). Investigators will be blinded to participant allocation. Outcomes assessment is via linkage to health outcomes data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 21, 2021
• Study Start: May 26, 2021
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 12 months after publication of the principal findings
• Access Criteria: Access subject to approvals by the Principal Investigator consistent with the Australian Code for the Responsible Conduct of Research.

Locations

AU (1)