Contemporary clinical trials · 2025
A randomised controlled trial of a multidisciplinary TEAM-based approach to guide secondary cardiovascular risk reduction for patients with Peripheral Artery Disease (TEAM-PAD) study protocol.
СтатьяПротокол клинического исследованияПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Chimoriya Ritesh, James Sophie, Kritharides Leonard, Thillainadesan Janani, Behdasht Samim, Sen Shaundeep, Suryawanshi Avinash, Davie Huw, Kitajima Amy, Aitken Sarah Joy
Аннотация
BACKGROUND: Peripheral arterial disease (1) is a vascular condition associated with significant cardiovascular morbidity and mortality. Effective secondary prevention strategies are essential to improve cardiovascular outcomes in patients with PAD. The TEAM-PAD study aims to determine if a centralised virtual multidisciplinary team (MDT) model of care is effective in improving guideline-recommended secondary cardiovascular risk reduction for outpatients with PAD.
METHODS: TEAM-PAD is a multicentre, randomised controlled trial involving patients with PAD. Participants will be randomised into two groups: the intervention group, who will receive care supported by cardiovascular risk reduction recommendations from a centralised MDT; and the control group, who will receive usual care by their vascular surgeon. The MDT will consist of the following clinicians: vascular surgeon, cardiologist, endocrinologist, nephrologist, geriatrician, drug health physician and clinical pharmacist. The primary outcome is the change in a composite measure of an individual's 10-year cardiovascular risk between baseline to 9-months follow-up. Secondary outcomes include control of modifiable cardiovascular risk factors and medication optimisation, cardiovascular and limb outcomes, PAD symptom control, quality of life outcomes, and health-service use outcomes.
CONCLUSION: This article details the TEAM-PAD trial protocol, which will provide robust evidence on the benefits of an MDT-based approach to cardiovascular risk reduction in PAD patients. TEAM-PAD has the potential to inform clinical practice by demonstrating whether coordinated, personalised care recommendations can improve cardiovascular risk and potentially reduce cardiovascular events in this high-risk population.
TRIAL REGISTRATION: This study has been registered at the Australia New Zealand Clinical Trial Registry (Registration number: ACTRN12623000995673).
METHODS: TEAM-PAD is a multicentre, randomised controlled trial involving patients with PAD. Participants will be randomised into two groups: the intervention group, who will receive care supported by cardiovascular risk reduction recommendations from a centralised MDT; and the control group, who will receive usual care by their vascular surgeon. The MDT will consist of the following clinicians: vascular surgeon, cardiologist, endocrinologist, nephrologist, geriatrician, drug health physician and clinical pharmacist. The primary outcome is the change in a composite measure of an individual's 10-year cardiovascular risk between baseline to 9-months follow-up. Secondary outcomes include control of modifiable cardiovascular risk factors and medication optimisation, cardiovascular and limb outcomes, PAD symptom control, quality of life outcomes, and health-service use outcomes.
CONCLUSION: This article details the TEAM-PAD trial protocol, which will provide robust evidence on the benefits of an MDT-based approach to cardiovascular risk reduction in PAD patients. TEAM-PAD has the potential to inform clinical practice by demonstrating whether coordinated, personalised care recommendations can improve cardiovascular risk and potentially reduce cardiovascular events in this high-risk population.
TRIAL REGISTRATION: This study has been registered at the Australia New Zealand Clinical Trial Registry (Registration number: ACTRN12623000995673).