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Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Mixed Methods Co-design and Evaluation of a DECIsion Support Tool to Enable Shared DEcision Making With People Who Are Considering Revascularisation Options for Coronary Artery Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06567626
Acronym
DECIDE-CAD
Enrollment
126
Registered
2024-08-23
Start date
2024-10-11
Completion date
2027-09-30
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Shared Decision Making, Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)

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.

Interventions

OTHERDecision 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.

Sponsors

University Hospitals, Leicester
CollaboratorOTHER
University of Leicester
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

WP1. DST CO-DESIGN PATIENT PARTICIPANTS Inclusion Criteria Participants may enter the study if ALL of the following applies: 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)

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: 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

Design outcomes

Primary

MeasureTime frameDescription
Rate of eligibility6 monthsEligibility 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 enrolment6 monthsEnrolment will be calculated as patients who provide informed consent and receive the DST as a proportion of all eligible patients.
Rate of attrition6 monthsAttrition will be calculated as patients who do not complete the study as a proportion of all patients enrolled.

Secondary

MeasureTime frameDescription
Preference6 weeksUser preference about revascularisation options, measured using Control Preference Scale and Patients Preferences Questionnaire for Angina treatment before and after revascularisation procedure.
Satisfaction with decision6 weeksUser satisfaction with decision, measured using Satisfaction with Decision Scale after revascularisation procedure.
Decision Regret6 weeksDegree of decision regret about revascularisation treatment received, measured using Decision Regret Scale after revascularisation procedure
Decisional Conflict6 weeksLevel of decisional conflict, measured using Decisional Conflict Scale before and after revascularisation procedure.
Level of shared decision making6 weeksLevel of shared decision making experienced by the user, measured using Shared Decision Making Questionnaire (SDM-Q-9) after revascularisation procedure.
Health status6 weeksHealth status measured using 20-item Short Form Survey before and after revascularisation procedure.
Treatment concordance6 weeksConcordance between user's preferred procedure and the treatment received, assessed after revascularisation procedure.
Acceptability6 weeksUser acceptability of decision support tool, measured using researcher-generated questionnaire after revascularisation procedure.
Knowledge6 weeksUser knowledge about revascularisation options, measured using researcher-regenerated questionnaire before and after revascularisation procedure.

Countries

United Kingdom

Contacts

Primary ContactDr Ann Cheng
decidecad@leicester.ac.uk0116 252 2101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026