Decision Support Tool for Revascularisation Options in Coronary Artery Disease
NCT ID: NCT06567626
Last Updated: 2025-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
126 participants
OBSERVATIONAL
2024-10-11
2027-09-30
Brief Summary
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Coronary artery disease (CAD) is a leading cause of death. Blood vessels supplying oxygen to the heart muscle become narrowed by a gradual build-up of fatty material. This can result in heart attacks, heart failure, and sudden death. One way to treat the blockage is by inserting an inner sleeve called a "stent" into the blood vessel and clearing the blockage by forcing it into the artery wall. Another method involves diverting the blood supply around the blockage using a vessel harvested from another body site; this is called "bypass surgery". The best treatment, either stents or surgery, is different for everyone.
A Decision Support Tool (DST) will provide key information on the pros and cons of stents or surgery and how these match an individual's preferences and values. People are then empowered to make shared decisions about treatment with their doctors. Personalising treatment decisions in this way can reduce inequalities in care and improve shared decision making. Our proposed research will develop a DST in the form of a webpage with alternative print material for those at risk of digital poverty. The DST will be developed in multiple languages to improve accessibility.
There are two parts to the study: the first part will use the experience of patients, who have already had stent or surgery, and healthcare professionals to design and refine a DST prototype; this will be done through workshops, focus groups, and cognitive interviews. The second part will test whether it is possible to use the DST by people with CAD waiting for a procedure; this will be done through questionnaires and interviews. The result of this study can then subsequently inform an assessment of the refined DST on a national level, with the hopes of enabling more effective shared decision making.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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DST Co-Design (Work Package 1)
* 40 people with lived experience of coronary revascularisation
* 38 healthcare professionals
No interventions assigned to this group
DST Feasibility (Work Package 2)
* 40 people awaiting coronary revascularisation
* 8 healthcare professionals
Decision Support Tool (DECIDE-CAD)
DECIDE-CAD is a decision support tool - designed using mixed methods through this study - which aims to enable shared decision making with people who are considering revascularisation options for coronary artery disease.
Interventions
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Decision Support Tool (DECIDE-CAD)
DECIDE-CAD is a decision support tool - designed using mixed methods through this study - which aims to enable shared decision making with people who are considering revascularisation options for coronary artery disease.
Eligibility Criteria
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Inclusion Criteria
1. Any adult (≥ 18 years) with lived experience of coronary revascularisation
2. Willing and able to consent to study participation.
3. Able to understand written and spoken English for decisional needs workshop or focus groups (NB this criterion is not required for cognitive interviews or acceptability questionnaire)
Participants may enter the study if ALL of the following applies:
1. Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation
2. Willing and able to consent to study participation.
3. Able to understand written and spoken English
Participants may enter the study if ALL of the following applies:
1. Adult (≥ 18 years) awaiting coronary revascularisation
2. Has received coronary angiography for definitive diagnosis.
3. Willing and able to consent to study participation.
4. Able to understand written and spoken English, Polish, Romanian, Urdu, Panjabi, or Gujarati
Participants may enter the study if ALL of the following applies:
1. Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation
2. Willing and able to consent to study participation.
3. Able to understand written and spoken English
Exclusion Criteria
WP1. DST CO-DESIGN HCP PARTICIPANTS
Participants may not enter the study if they are unable to provide informed consent.
WP2. DST FEASIBILITY PATIENT PARTICIPANTS
Participants may not enter the trial if ANY of the following apply:
1. Where clinical consensus strongly recommends one option of revascularisation over another
2. Unable to provide informed consent
3. Unable to speak one of the aforementioned 6 languages
WP2. DST FEASIBILITY HCP PARTICIPANTS
Participants may not enter the study if they are unable to provide informed consent.
ALL
Yes
Sponsors
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University Hospitals, Leicester
OTHER
University of Leicester
OTHER
Responsible Party
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Locations
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University of Leicester
Leicester, , United Kingdom
University Hospitals of Leicester
Leicester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dr Ann Cheng
Role: primary
Other Identifiers
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IRAS 338504
Identifier Type: OTHER
Identifier Source: secondary_id
1000
Identifier Type: -
Identifier Source: org_study_id
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