RecruitingOBSERVATIONAL

Decision Support Tool for Revascularisation Options in Coronary Artery Disease

This study is working to create a new, easy-to-use tool to help people with coronary artery disease. This condition can lead to heart attacks because of blocked blood vessels in the heart. Treatments include inserting a small tube called a stent or having bypass surgery to create a new path for blood. The best treatment is different for everyone. This new tool, which will be a webpage and also available in print, will explain the pros and cons of each treatment. It encourages people to talk with their doctors and make decisions that fit their own values and what matters most to them. This way, people can play a more active role in their care and get treatment that’s right for them.

At a glance

Status

Recruiting

Sponsor

University of Leicester

Enrolment target

126

Start

11 Oct 2024

Estimated completion

01 Sep 2027

Coronary Artery Disease

What is this study about?

Coronary artery disease is a common heart condition where the blood vessels supplying your heart muscle become narrowed by fatty deposits. This can lead to serious problems like heart attacks. There are two main ways to treat these blockages: one is called a "stent", where a small mesh tube is put into the blood vessel to keep it open. The other is "bypass surgery", where doctors use a healthy blood vessel from another part of your body to go around the blockage.

Choosing between a stent or bypass surgery can be a big decision, and what's best for one person might not be best for another. This study wants to create a special online tool (which will also be available in print for those who prefer it) called a Decision Support Tool. This tool will give you clear information about both treatments, explaining the good points and the not-so-good points of each. It's designed to help you think about what's important to you and your health, so you can have a really good conversation with your doctor and make the choice that feels right for you.

We believe that when people are well-informed and involved in decisions about their health, they get better care. This tool will help you understand your options and your personal situation better, leading to shared decisions with your healthcare team. The tool will also be available in several languages to make sure as many people as possible can use it.

Key takeaways

Help create a new tool to choose heart disease treatments.
Share your experiences with stents or bypass surgery.
Make sure the tool helps people make informed decisions.
Your input will improve future patient care.
Study involves workshops, interviews, and questionnaires.
The tool will be available online and in print, in multiple languages.

Who may be eligible?

This study has different parts, and who can take part depends on which part. In the first part, we are looking for adults aged 18 or over who have already had either a stent or bypass surgery. We also need healthcare professionals who help patients make decisions about these treatments. For this part, you need to be able to speak and understand English.

The second part of the study is for adults aged 18 or over who are currently waiting to have a stent or bypass surgery. You must have had tests to confirm your heart condition. For this part, we need people who can understand and speak English, Polish, Romanian, Urdu, Panjabi, or Gujarati. We can't include you if your doctors are very clear that only one treatment option (stent or surgery) is right for you, or if you can't provide informed consent.

It's important that everyone who takes part is willing and able to agree to be part of the study. If you take part in one specific activity, like a focus group, you might not be able to participate in other activities within the study, like certain interviews or questionnaires.

Quick self-check

Are you 18 years old or older?
Have you had (or are you waiting for) a stent or bypass surgery?
Are you willing to share your thoughts and experiences?
Are you able to provide consent to take part?
Can you understand English, or for some parts, also Polish, Romanian, Urdu, Panjabi, or Gujarati?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This study has two main steps. In the first step, our team will work with patients who’ve already had a stent or bypass surgery, and with healthcare professionals. This involves taking part in workshops, group discussions (focus groups), or one-on-one interviews where you’ll help us design and improve the new information tool. We’ll ask for your thoughts and experiences to make sure the tool is really helpful and easy to understand.

In the second step, we'll ask patients who are waiting for a stent or bypass operation to try out the newly designed tool. This involves using the tool to learn about your treatment choices. We’ll then ask you to fill out questionnaires and take part in interviews to find out if the tool was helpful and easy to use. The exact number of visits or how long you’d be involved can vary depending on which part of the study you join, but full details would be provided if you’re invited to take part.

Potential risks and benefits

Taking part in this study means you’ll be helping to create a new way for people to understand their treatment options for heart disease. This could lead to better care for many people in the future, as you'll be helping doctors and patients make shared decisions together. We don't expect any direct risks to your health from taking part, as it mainly involves sharing your thoughts and experiences. However, talking about health decisions can sometimes be emotional. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

University of Leicester
Leicester, United Kingdom· Not yet recruiting
University Hospitals of Leicester
Leicester, United Kingdom· Recruiting

Common questions

What is coronary artery disease?

It's a condition where the blood vessels that supply your heart become narrowed, which can lead to heart problems like heart attacks.

What are the main treatments this study focuses on?

The study looks at two main treatments: putting in a small tube called a 'stent' to open blocked vessels, or 'bypass surgery' to create a new path for blood around a blockage.

What is a Decision Support Tool?

It's an information tool, like a webpage or printed booklet, that helps you understand treatment options and make choices with your doctor.

Will this tool make decisions for me?

No, the tool will give you information to help you understand your choices better. The final decision will always be yours, made in discussion with your doctor.

Do I have to speak English to take part?

For some parts of the study, you need to understand English. For others, we are also looking for people who speak Polish, Romanian, Urdu, Panjabi, or Gujarati.

How to find out more

Dr Ann Cheng

decidecad@leicester.ac.uk 0116 252 2101 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.