Treatment Decisions for Multi-vessel CAD

Study Overview
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Brief Summary
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This study is a multi-center randomized trial to evaluate the Multi-vessel Coronary Artery Disease Option Grid patient decision aid compared to usual care in patient reported decisional conflict, knowledge, and shared decision making.

Detailed Description
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Multi-vessel coronary artery disease can be treated through percutaneous coronary intervention, coronary artery bypass grafting, or medical therapy. Treatments have risk benefit tradeoffs, making patient preference integral to the treatment decision. The Multi-vessel Coronary Artery Disease Option Grid patient decision aid was developed to improve the decision making process for patients and clinicians. Objectives: Evaluate The Multi-vessel Coronary Artery Disease Option Grid impact on patient treatment decisional conflict, knowledge, and shared decision making. The randomized controlled trial will compare validated and standardized measures of patient decisional conflict, shared decision making, and condition specific treatment knowledge between Option Grid and usual care patients. The investigators hypothesize Option Grid patients will have improvements in patient decisional conflict, shared decision making, and knowledge compared to usual care patients. Baseline feasibility enrollment at each site prior to randomization will be used to identify current treatment patterns, and prepare intervention delivery and fidelity. Registry data will be used to identify patient treatment received and compared between Option Grid and usual care arms. Examine the physician and patient process of and factors influencing Multi-vessel Coronary Artery Disease Option Grid use. Semi-structured interviews and process evaluations will be used to describe Option Grid use and experience and identify factors that are associated with beneficial Option Grid use.

Official Title
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Treatment Decisions for Multi-vessel Coronary Artery Disease Patients

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Behavioral: The Multi-vessel Coronary Artery Disease Option Grid
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable multi-vessel coronary artery disease diagnosed by coronary angiography defined as left main disease (>50% stenosis) or multi-vessel coronary artery disease (>70% stenosis in two or more coronary arteries) At relative equipoise for at least two potential treatment options, in which the treating cardiologist or surgeon has determined the treatments are anatomically feasible and safe. Exclusion Criteria: Prior coronary artery bypass grafting Unable to read or write English Not cognitively able to participate in the Option Grid as determined by clinician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Option Grid<br>Patients randomized to the Option Grid arm will receive the Multi-vessel Coronary Artery Disease Option Grid at the time of enrollment. The treating physician will then discuss the patient diagnosis and treatment choice reviewing the Option Grid within the conversation to facilitate patient understanding and shared decision making | Behavioral: The Multi-vessel Coronary Artery Disease Option Grid<br>* The Multi-vessel Coronary Artery Disease Option Grid is a patient decision aid used during the clinical visit. It is one page and contains a table a patient's frequently asked questions and the respective information for each treatment strategy. The Multi-vessel Coronary Artery Disease Option Grid was developed using patient and provider feedback and has been field-tested in clinic by cardiologists and surgeons.<br>|
| Other: Usual Care<br>Patients randomized to usual care will discuss the patient diagnosis and treatment options typical to the physician's routine care. | Behavioral: Usual Care<br>* In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Decisional Conflict | The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience | Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CollaboRATE Score | CollaboRATE is a patient reported measure of shared decision making | Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion. | 
| Treatment Knowledge | Questions about multi-vessel coronary artery disease treatment knowledge. Response options are 'true/false/unsure.' Scores will be based off of the percentage of correct responses from 0 to 100 | Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion. | 
| Patient Experience | Patient's qualitative feedback during semi-structured interviews about their decision making experience | Within five days of the clinical discussion | 
| Clinician Experience | Clinician's qualitative feedback during semi-structured interviews about their decision making experience | Within five days of the clinical discussion | 
| Treatment Received | Identified through medical records or registry data | Within 1 month of clinical discussion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient decision aid, multi-vessel coronary artery disease