Decision Support Tool for Revascularisation Options in Coronary Artery Disease
NCT Number: NCT06567626
Acronym: DECIDE-CAD
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Coronary Artery Disease
Interventions: OTHER: Decision Support Tool (DECIDE-CAD)
Sponsor: University of Leicester
Collaborators: University Hospitals, Leicester
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 126
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2027-09

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.

Primary Outcome Measures: Rate of eligibility, 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., 6 months|Rate of enrolment, Enrolment will be calculated as patients who provide informed consent and receive the DST as a proportion of all eligible patients., 6 months|Rate of attrition, Attrition will be calculated as patients who do not complete the study as a proportion of all patients enrolled., 6 months
Secondary Outcome Measures: Decisional Conflict, Level of decisional conflict, measured using Decisional Conflict Scale before and after revascularisation procedure., 6 weeks|Acceptability, User acceptability of decision support tool, measured using researcher-generated questionnaire after revascularisation procedure., 6 weeks|Knowledge, User knowledge about revascularisation options, measured using researcher-regenerated questionnaire before and after revascularisation procedure., 6 weeks|Preference, User preference about revascularisation options, measured using Control Preference Scale and Patients Preferences Questionnaire for Angina treatment before and after revascularisation procedure., 6 weeks|Satisfaction with decision, User satisfaction with decision, measured using Satisfaction with Decision Scale after revascularisation procedure., 6 weeks|Decision Regret, Degree of decision regret about revascularisation treatment received, measured using Decision Regret Scale after revascularisation procedure, 6 weeks|Treatment concordance, Concordance between user's preferred procedure and the treatment received, assessed after revascularisation procedure., 6 weeks|Level of shared decision making, Level of shared decision making experienced by the user, measured using Shared Decision Making Questionnaire (SDM-Q-9) after revascularisation procedure., 6 weeks|Health status, Health status measured using 20-item Short Form Survey before and after revascularisation procedure., 6 weeks