Decision Support Tool for Revascularisation Options in Coronary Artery Disease

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Rate of eligibility [Срок оценки: 6 months]
• Rate of enrolment [Срок оценки: 6 months]
• Rate of attrition [Срок оценки: 6 months]

Вторичные конечные точки (9)

• Decisional Conflict [Срок оценки: 6 weeks]
• Acceptability [Срок оценки: 6 weeks]
• Knowledge [Срок оценки: 6 weeks]
• Preference [Срок оценки: 6 weeks]
• Satisfaction with decision [Срок оценки: 6 weeks]
• Decision Regret [Срок оценки: 6 weeks]
• Treatment concordance [Срок оценки: 6 weeks]
• Level of shared decision making [Срок оценки: 6 weeks]
• Health status [Срок оценки: 6 weeks]

Критерии участия

WP1. DST CO-DESIGN PATIENT PARTICIPANTS

Критерии включения

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)

Критерии исключения

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

Критерии включения

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

Критерии исключения

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

WP2. DST FEASIBILITY PATIENT PARTICIPANTS

Критерии включения

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

Критерии исключения

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

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

WP2. DST FEASIBILITY HCP PARTICIPANTS

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Великобритания · 2 центра

• University of Leicester — Leicester
• University Hospitals of Leicester — Leicester

Идентификаторы

NCT: NCT06567626 · 1000 · IRAS 338504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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