Clinical trial NCT06567626: Decision Support Tool for Revascularisation Options in Coronary Artery Disease
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Shared Decision Making
Percutaneous Coronary Intervention (PCI)
Coronary Artery Bypass Grafting (CABG)
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University Hospitals, Leicester
First posted: 2024-08-23
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility 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.

Primary outcomes:
measure: Rate of eligibility
timeFrame: 6 months
measure: Rate of enrolment
timeFrame: 6 months
measure: Rate of attrition
timeFrame: 6 months
Secondary outcomes:
measure: Decisional Conflict
timeFrame: 6 weeks
measure: Acceptability
timeFrame: 6 weeks
measure: Knowledge
timeFrame: 6 weeks
measure: Preference
timeFrame: 6 weeks
measure: Satisfaction with decision
timeFrame: 6 weeks
measure: Decision Regret
timeFrame: 6 weeks
measure: Treatment concordance
timeFrame: 6 weeks
measure: Level of shared decision making
timeFrame: 6 weeks
measure: Health status
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University of Leicester
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
Study officials:
References: