Decision Support Tool for Revascularisation Options in Coronary Artery Disease

NCT06567626 | Recruiting

• 2 other identifiers: 1000IRAS 338504
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Decisional Conflict

  6 weeks

• Acceptability

  6 weeks

• Knowledge

  6 weeks

• Preference

  6 weeks

• Satisfaction with decision

  6 weeks

Study Arms (2)

DST Co-Design (Work Package 1)

* 40 people with lived experience of coronary revascularisation * 38 healthcare professionals

DST Feasibility (Work Package 2)

* 40 people awaiting coronary revascularisation * 8 healthcare professionals

Other: Decision Support Tool (DECIDE-CAD)

Interventions

Decision Support Tool (DECIDE-CAD) OTHER

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.

DST Feasibility (Work Package 2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Participants may enter the study if ALL of the following applies:
• 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)

You may not qualify if:

• 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
• Participants may enter the study if ALL of the following applies:
• 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
• Participants may not enter the study if they are unable to provide informed consent.
• WP2. DST FEASIBILITY PATIENT PARTICIPANTS
• Participants may enter the study if ALL of the following applies:
• Adult (≥ 18 years) awaiting coronary revascularisation
• Has received coronary angiography for definitive diagnosis.
• Willing and able to consent to study participation.
• Able to understand written and spoken English, Polish, Romanian, Urdu, Panjabi, or Gujarati
• Participants may not enter the trial if ANY of the following apply:
• Where clinical consensus strongly recommends one option of revascularisation over another

Sponsors & Collaborators

• University of Leicester: lead
• University Hospitals, Leicester: collaborator

Study Sites (2)

University of Leicester

Leicester, LE1 7RH, United Kingdom

NOT YET RECRUITING

University Hospitals of Leicester

Leicester, LE39QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Dr Ann Cheng

CONTACT

0116 252 2101; decidecad@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: October 11, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Requests must be from studies with appropriate ethics approval in place.

Locations

GB (2)