Decision Support Tool for Revascularisation Options in Coronary Artery Disease (DECIDE-CAD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: Decision Support Tool (DECIDE-CAD)

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Dr Ann Cheng; Phone Number: 0116 252 2101; Email: decidecad@leicester.ac.uk

Study Locations

• United Kingdom
  • Leicester, United Kingdom, LE1 7RH
    • Not yet recruiting
    • University of Leicester
    • Contact: Dr Ann Cheng; Phone Number: 01162522101
  • Leicester, United Kingdom, LE39QP
    • Recruiting
    • University Hospitals of Leicester
    • Contact: Dr Ann Cheng; Phone Number: 01162522101; Email: decidecad@leicester.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

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:

1. Adult (≥ 18 years) awaiting coronary revascularisation
2. Has received coronary angiography for definitive diagnosis.
3. Willing and able to consent to study participation.
4. Able to understand written and spoken English, Polish, Romanian, Urdu, Panjabi, or Gujarati

Exclusion Criteria

Participants may not enter the trial if ANY of the following apply:

1. Where clinical consensus strongly recommends one option of revascularisation over another
2. Unable to provide informed consent
3. Unable to speak one of the aforementioned 6 languages

WP2. DST FEASIBILITY 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

Exclusion Criteria

Participants may not enter the study if they are unable to provide informed consent.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Leicester
• Collaborators: University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Shared Decision Making; Percutaneous Coronary Intervention (PCI); Coronary Artery Bypass Grafting (CABG)
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 1000; IRAS 338504 (Other Identifier: Health Research Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Fully anonymised individual participant data can be made available on request for future studies with ethics approval.
• IPD Sharing Access Criteria: Requests must be from studies with appropriate ethics approval in place.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No