Decision Support Tool for Revascularisation Options in Coronary Artery Disease

University of Leicester126 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

126

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 6 months

Rate of attrition

Attrition will be calculated as patients who do not complete the study as a proportion of all patients enrolled.

Time frame: 6 months

Secondary Outcomes

Decisional Conflict

Level of decisional conflict, measured using Decisional Conflict Scale before and after revascularisation procedure.

Time frame: 6 weeks

Acceptability

User acceptability of decision support tool, measured using researcher-generated questionnaire after revascularisation procedure.

Time frame: 6 weeks

Knowledge

User knowledge about revascularisation options, measured using researcher-regenerated questionnaire before and after revascularisation procedure.

Time frame: 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.

Time frame: 6 weeks

Satisfaction with decision

User satisfaction with decision, measured using Satisfaction with Decision Scale after revascularisation procedure.

Time frame: 6 weeks

Decision Regret

Degree of decision regret about revascularisation treatment received, measured using Decision Regret Scale after revascularisation procedure

Time frame: 6 weeks

Treatment concordance

Concordance between user's preferred procedure and the treatment received, assessed after revascularisation procedure.

Time frame: 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.

Time frame: 6 weeks

Health status

Health status measured using 20-item Short Form Survey before and after revascularisation procedure.

Time frame: 6 weeks

Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts