An observational study in Coronary Artery Disease, sponsored by University of Leicester. Recruiting at 2 sites in United Kingdom. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by University of Leicester · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 126 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University of Leicester is the lead sponsor of 166 studies on the registry; 51 are open to participants now.
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Work Package 1:
Work Package 2:
WP1. DST CO-DESIGN PATIENT PARTICIPANTS
Inclusion Criteria
Participants may enter the study if ALL of the following applies:
Exclusion Criteria
Participants may not enter the study if they are unable to provide informed consent. Individuals who participate in focus groups are ineligible for subsequent participation in cognitive interviews and acceptability questionnaires.
WP1. DST CO-DESIGN HCP PARTICIPANTS
Inclusion Criteria
Participants may enter the study if ALL of the following applies:
Exclusion Criteria
Participants may not enter the study if they are unable to provide informed consent.
WP2. DST FEASIBILITY PATIENT PARTICIPANTS
Inclusion Criteria
Participants may enter the study if ALL of the following applies:
Exclusion Criteria
Participants may not enter the trial if ANY of the following apply:
WP2. DST FEASIBILITY HCP PARTICIPANTS
Inclusion Criteria
Participants may enter the study if ALL of the following applies:
Exclusion Criteria
Participants may not enter the study if they are unable to provide informed consent.
* 40 people with lived experience of coronary revascularisation * 38 healthcare professionals
* 40 people awaiting coronary revascularisation * 8 healthcare professionals
Other: 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.
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.
Time frame: 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.
Time frame: 6 months
Rate of attrition
Attrition will be calculated as patients who do not complete the study as a proportion of all patients enrolled.
Time frame: 6 months
Decisional Conflict
Level of decisional conflict, measured using Decisional Conflict Scale before and after revascularisation procedure.
Time frame: 6 weeks
Acceptability
User acceptability of decision support tool, measured using researcher-generated questionnaire after revascularisation procedure.
Time frame: 6 weeks
Knowledge
User knowledge about revascularisation options, measured using researcher-regenerated questionnaire before and after revascularisation procedure.
Time frame: 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.
Time frame: 6 weeks
Satisfaction with decision
User satisfaction with decision, measured using Satisfaction with Decision Scale after revascularisation procedure.
Time frame: 6 weeks
Decision Regret
Degree of decision regret about revascularisation treatment received, measured using Decision Regret Scale after revascularisation procedure
Time frame: 6 weeks
Treatment concordance
Concordance between user's preferred procedure and the treatment received, assessed after revascularisation procedure.
Time frame: 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.
Time frame: 6 weeks
Health status
Health status measured using 20-item Short Form Survey before and after revascularisation procedure.
Time frame: 6 weeks
Plan to share: Yes — Fully anonymised individual participant data can be made available on request for future studies with ethics approval.
Supporting information: Study protocol
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University of Leicester