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.
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: 1. 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. 2. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
14
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.
In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.
Maine Medical Center
Portland, Maine, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical Center
Albany, New York, United States
Albany Stratton VA Medical Center
Albany, New York, United States
Patient Decisional Conflict
The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience
Time frame: Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion.
CollaboRATE Score
CollaboRATE is a patient reported measure of shared decision making
Time frame: 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
Time frame: 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
Time frame: Within five days of the clinical discussion
Clinician Experience
Clinician's qualitative feedback during semi-structured interviews about their decision making experience
Time frame: Within five days of the clinical discussion
Treatment Received
Identified through medical records or registry data
Time frame: Within 1 month of clinical discussion
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