Creating a tool to help patients choose treatments for 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
This study is trying to create a helpful tool that guides patients with coronary artery disease in choosing between different treatment options like PCI and CABG based on their personal preferences.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 126 (estimated) |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 2 sites (Leicester and 1 other locations) |
| Trial ID | NCT06567626 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a Decision Support Tool (DST) that assists patients with coronary artery disease in understanding their treatment options, specifically comparing percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). By collaborating with patients and healthcare professionals, the study seeks to ensure that the tool reflects individual preferences and values in treatment decisions. The approach involves co-designing the DST through workshops and focus groups, gathering insights from both patients who have experienced revascularization and healthcare providers involved in decision-making. The goal is to empower patients with information that aids in making informed choices about their care.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have experienced coronary revascularization and can provide informed consent.
Not a fit: Patients who are unable to provide informed consent or do not speak English may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could enhance patient engagement and satisfaction by aligning treatment choices with individual preferences.
How similar studies have performed: Other studies have shown success in using decision support tools to improve patient outcomes in various medical conditions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Leicester and 1 other locations
- University of Leicester — Leicester, United Kingdom (Not_yet_recruiting)
- University Hospitals of Leicester — Leicester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Dr Ann Cheng
- Email: decidecad@leicester.ac.uk
- Phone: 0116 252 2101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.