Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Leicester

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any adult (≥ 18 years) with lived experience of coronary revascularisation

Willing and able to consent to study participation.

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)

Disqualifiers

Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation

Willing and able to consent to study participation.

Able to understand written and spoken English

Adult (≥ 18 years) awaiting coronary revascularisation

Trial population

Work Package 1: * 40 people with lived experience of coronary revascularisation * 38 healthcare professionals Work Package 2: * 40 people awaiting coronary revascularisation * 8 healthcare professionals

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Decision Support Tool (DECIDE-CAD)

    Other intervention

    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.

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: DST Co-Design (Work Package 1)0 interventions
Group B: DST Feasibility (Work Package 2)1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

Decisional Conflict

Level of decisional conflict, measured using Decisional Conflict Scale before and after revascularisation procedure.

Time frame
6 weeks
2

Acceptability

User acceptability of decision support tool, measured using researcher-generated questionnaire after revascularisation procedure.

Time frame
6 weeks
3

Knowledge

User knowledge about revascularisation options, measured using researcher-regenerated questionnaire before and after revascularisation procedure.

Time frame
6 weeks
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Leicester

Lead sponsor

University Hospitals, Leicester

Collaborator