Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection

Study Overview
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Brief Summary
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The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.

Detailed Description
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Study Plan: Qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. Several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups. Study Procedure: We will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making. Subjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential patients. If necessary, patients will also be contacted by a Cardiovascular Research Coordinator and invited to attend a scheduled focus group. After receiving patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. The invitation will be sent via email and followed up with a phone call, if necessary. If a clinician focus group is unable to be scheduled, then individual interviews will be conducted. Setting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital.

Official Title
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Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection

Conditions
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Heart Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old English or Spanish speaking Presence of coronary disease, or a caregiver/relative of one with coronary disease Exclusion Criteria: non-English or non-Spanish speaking dementia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart disease<br>Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention. | |
| Healthy adults<br>Adults without a diagnosis of coronary artery disease. Focus groups will be held. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than doctor alone in response to the question Who chose the type of stent? | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than I don't care or I don't know in response to the question After reviewing the risks and benefits of both types of stents, which type of stent did you want? | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, cardiac stent, PCI procedure, Patient preference