Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Other: Decision Support Tool (DECIDE-CAD)

• Registration Number: NCT06567626
• Lead Sponsor: University of Leicester

Brief Summary

Together with patients and healthcare professionals, we want to design a Decision Support Tool (DST) that will help people with coronary artery disease to understand and choose treatments that best reflect their preferences and values.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-23
• Study Start: 2024-10-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-03
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DST Feasibility (Work Package 2)	Decision Support Tool (DECIDE-CAD)	* 40 people awaiting coronary revascularisation * 8 healthcare professionals

Primary Outcome Measures

Name	Time	Method
Rate of eligibility	6 months	Eligibility will be calculated as all patients eligible for study participation as a proportion of all patients who receive ACS treatment during the study period.
Rate of enrolment	6 months	Enrolment will be calculated as patients who provide informed consent and receive the DST as a proportion of all eligible patients.
Rate of attrition	6 months	Attrition will be calculated as patients who do not complete the study as a proportion of all patients enrolled.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with decision	6 weeks	User satisfaction with decision, measured using Satisfaction with Decision Scale after revascularisation procedure.
Knowledge	6 weeks	User knowledge about revascularisation options, measured using researcher-regenerated questionnaire before and after revascularisation procedure.
Treatment concordance	6 weeks	Concordance between user's preferred procedure and the treatment received, assessed after revascularisation procedure.
Acceptability	6 weeks	User acceptability of decision support tool, measured using researcher-generated questionnaire after revascularisation procedure.
Decisional Conflict	6 weeks	Level of decisional conflict, measured using Decisional Conflict Scale before and after revascularisation procedure.
Preference	6 weeks	User preference about revascularisation options, measured using Control Preference Scale and Patients Preferences Questionnaire for Angina treatment before and after revascularisation procedure.
Decision Regret	6 weeks	Degree of decision regret about revascularisation treatment received, measured using Decision Regret Scale after revascularisation procedure
Level of shared decision making	6 weeks	Level of shared decision making experienced by the user, measured using Shared Decision Making Questionnaire (SDM-Q-9) after revascularisation procedure.
Health status	6 weeks	Health status measured using 20-item Short Form Survey before and after revascularisation procedure.

Trial Locations

Locations (2)

University of Leicester; 🇬🇧 Leicester, United Kingdom

University Hospitals of Leicester; 🇬🇧 Leicester, United Kingdom