Coronary Artery DiseaseDECIDE-CADNCT06567626
Decision Support Tool for Revascularisation Options in Coronary Artery Disease
An observational study of Coronary Artery Disease, run by University of Leicester at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Decision Support Tool (DECIDE-CAD)
- How many people
- 126 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 11 Oct 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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)
- 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
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- Willing and able to consent to study participation.
- Able to understand written and spoken English
- 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 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
Who cannot join
- 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 not enter the study if they are unable to provide informed consent.
- WP2. DST FEASIBILITY PATIENT PARTICIPANTS
- Participants may not enter the trial if ANY of the following apply:
- Where clinical consensus strongly recommends one option of revascularisation over another
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- Unable to provide informed consent
- Unable to speak one of the aforementioned 6 languages
- WP2. DST FEASIBILITY HCP PARTICIPANTS
- Participants may not enter the study if they are unable to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
University of Leicester
Leicester, LE1 7RH
Dr Ann Cheng, 01162522101
- Recruiting
University Hospitals of Leicester
Leicester, LE39QP
Dr Ann Cheng, 01162522101, decidecad@leicester.ac.uk
About this study
Official title: 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.
Read more
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
- Being tested
- Decision Support Tool (DECIDE-CAD)
- Keywords
- Shared Decision Making, Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Decision Support Tool (DECIDE-CAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Rate of attrition
Attrition will be calculated as patients who do not complete the study as a proportion of all patients enrolled.
Measured: 6 months
Secondary outcomes (9)
Decisional Conflict
Level of decisional conflict, measured using Decisional Conflict Scale before and after revascularisation procedure.
Measured: 6 weeks
Acceptability
User acceptability of decision support tool, measured using researcher-generated questionnaire after revascularisation procedure.
Measured: 6 weeks
Knowledge
User knowledge about revascularisation options, measured using researcher-regenerated questionnaire before and after revascularisation procedure.
Measured: 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.
Measured: 6 weeks
Satisfaction with decision
User satisfaction with decision, measured using Satisfaction with Decision Scale after revascularisation procedure.
Measured: 6 weeks
Decision Regret
Degree of decision regret about revascularisation treatment received, measured using Decision Regret Scale after revascularisation procedure
Measured: 6 weeks
Treatment concordance
Concordance between user's preferred procedure and the treatment received, assessed after revascularisation procedure.
Measured: 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.
Measured: 6 weeks
Health status
Health status measured using 20-item Short Form Survey before and after revascularisation procedure.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start11 Oct 2024
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567626
- Sponsor's protocol ID
- 1000
- Other IDs
- IRAS 338504
- Acronym
- DECIDE-CAD
- Status last verified
- Mar 2025
- First submitted
- 20 Aug 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymised individual participant data can be made available on request for future studies with ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06567626
- Acronym / sponsor ID
- DECIDE-CAD / 1000
- Conditions
- Coronary Artery Disease
- Keywords
- Shared Decision Making, Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DST Co-Design (Work Package 1) | – | –* 40 people with lived experience of coronary revascularisation * 38 healthcare professionals |
| DST Feasibility (Work Package 2) | – | Other: Decision Support Tool (DECIDE-CAD)* 40 people awaiting coronary revascularisation * 8 healthcare professionals |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (17 listed)
- 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)
- Healthcare professional with a patient-facing clinical role which involves decision making regarding coronary revascularisation
- Willing and able to consent to study participation.
Key exclusion criteria (10 listed)
- 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 not enter the study if they are unable to provide informed consent.
- WP2. DST FEASIBILITY PATIENT PARTICIPANTS
- Where clinical consensus strongly recommends one option of revascularisation over another
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | DST Feasibility (Work Package 2) |
Primary outcome
Rate of eligibility
Time frame: 6 months
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.
Rate of enrolment
Time frame: 6 months
Enrolment will be calculated as patients who provide informed consent and receive the DST as a proportion of all eligible patients.
Rate of attrition
Time frame: 6 months
Attrition will be calculated as patients who do not complete the study as a proportion of all patients enrolled.
9 secondary outcomes
Decisional Conflict
Time frame: 6 weeks
Acceptability
Time frame: 6 weeks
Knowledge
Time frame: 6 weeks
Preference
Time frame: 6 weeks
Satisfaction with decision
Time frame: 6 weeks
Decision Regret
Time frame: 6 weeks
Treatment concordance
Time frame: 6 weeks
Level of shared decision making
Time frame: 6 weeks
Health status
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Yes. Fully anonymised individual participant data can be made available on request for future studies with ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Leicester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ann Cheng (0116 252 2101, decidecad@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of eligibility (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.