NCT04896021

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,761 (actual)
• Sponsor: Menzies Institute for Medical Research · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Cardiovascular disease risk assessment	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.
DIAGNOSTIC_TEST	Usual care assessment	Usual care in which blood cholesterol results are reported to referring doctors

Timeline

• Start date: 2021-05-26
• Primary completion: 2024-09-23
• Completion: 2024-09-23
• First posted: 2021-05-21
• Last updated: 2025-05-09

Locations

1 site across 1 country: Australia