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
Ritesh Chimoriya , Sophie James , Leonard Kritharides , Janani Thillainadesan , Samim Behdasht , Shaundeep Sen , Avinash Suryawanshi , Huw Davie , Amy Kitajima , Sarah Joy Aitken
{"title":"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","authors":"Ritesh Chimoriya , Sophie James , Leonard Kritharides , Janani Thillainadesan , Samim Behdasht , Shaundeep Sen , Avinash Suryawanshi , Huw Davie , Amy Kitajima , Sarah Joy Aitken","doi":"10.1016/j.cct.2025.107844","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Methods</h3><div>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.</div></div><div><h3>Conclusion</h3><div>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.</div><div><strong>Trial Registration:</strong> This study has been registered at the Australia New Zealand Clinical Trial Registry (Registration number: ACTRN12623000995673).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107844"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714425000382","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
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).
期刊介绍:
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.