Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Not yet recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06567626
• Lead Sponsor: University of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

WP1. DST CO-DESIGN PATIENT PARTICIPANTS<br><br>Inclusion Criteria<br><br>Participants may enter the study if ALL of the following applies:<br><br> 1. Any adult (= 18 years) with lived experience of coronary revascularisation<br><br> 2. Willing and able to consent to study participation.<br><br> 3. Able to understand written and spoken English for decisional needs workshop or focus<br> groups (NB this criterion is not required for cognitive interviews or acceptability<br> questionnaire)<br><br>Exclusion Criteria<br><br>Participants may not enter the study if they are unable to provide informed consent.<br>Individuals who participate in focus groups are ineligible for subsequent participation<br>in cognitive interviews and acceptability questionnaires.<br><br>WP1. DST CO-DESIGN HCP PARTICIPANTS<br><br>Inclusion Criteria<br><br>Participants may enter the study if ALL of the following applies:<br><br> 1. Healthcare professional with a patient-facing clinical role which involves decision<br> making regarding coronary revascularisation<br><br> 2. Willing and able to consent to study participation.<br><br> 3. Able to understand written and spoken English<br><br>Exclusion Criteria<br><br>Participants may not enter the study if they are unable to provide informed consent.<br><br>WP2. DST FEASIBILITY PATIENT PARTICIPANTS<br><br>Inclusion Criteria<br><br>Participants may enter the study if ALL of the following applies:<br><br> 1. Adult (= 18 years) awaiting coronary revascularisation<br><br> 2. Has received coronary angiography for definitive diagnosis.<br><br> 3. Willing and able to consent to study participation.<br><br> 4. Able to understand written and spoken English, Polish, Romanian, Urdu, Panjabi, or<br> Gujarati<br><br>Exclusion Criteria<br><br>Participants may not enter the trial if ANY of the following apply:<br><br> 1. Where clinical consensus strongly recommends one option of revascularisation over<br> another<br><br> 2. Unable to provide informed consent<br><br> 3. Unable to speak one of the aforementioned 6 languages<br><br>WP2. DST FEASIBILITY HCP PARTICIPANTS<br><br>Inclusion Criteria<br><br>Participants may enter the study if ALL of the following applies:<br><br> 1. Healthcare professional with a patient-facing clinical role which involves decision<br> making regarding coronary revascularisation<br><br> 2. Willing and able to consent to study participation.<br><br> 3. Able to understand written and spoken English<br><br>Exclusion Criteria<br><br>Participants may not enter the study if they are unable to provide informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of eligibility;Rate of enrolment;Rate of attrition

Secondary Outcome Measures

Name	Time	Method
Decisional Conflict;Acceptability;Knowledge;Preference;Satisfaction with decision;Decision Regret;Treatment concordance;Level of shared decision making;Health status