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Clinical Trials/NCT06567626
NCT06567626
Recruiting
Not Applicable

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

University of Leicester2 sites in 1 country126 target enrollmentOctober 11, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University of Leicester
Enrollment
126
Locations
2
Primary Endpoint
Rate of eligibility
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 11, 2024
End Date
September 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Rate of eligibility

Time Frame: 6 months

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.

Rate of enrolment

Time Frame: 6 months

Enrolment will be calculated as patients who provide informed consent and receive the DST as a proportion of all eligible patients.

Rate of attrition

Time Frame: 6 months

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

Secondary Outcomes

  • Satisfaction with decision(6 weeks)
  • Knowledge(6 weeks)
  • Treatment concordance(6 weeks)
  • Acceptability(6 weeks)
  • Decisional Conflict(6 weeks)
  • Preference(6 weeks)
  • Decision Regret(6 weeks)
  • Level of shared decision making(6 weeks)
  • Health status(6 weeks)

Study Sites (2)

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