Coronary Artery Disease
Conditions
Keywords
patient decision aid, multi-vessel coronary artery disease
Brief summary
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
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.
Interventions
BEHAVIORALThe Multi-vessel Coronary Artery Disease Option Grid
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.
BEHAVIORALUsual Care
In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Decisional Conflict | Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion. | The Ottawa Decisional Conflict Scale is a validated measure of a patient's feeling of conflict with the decision making experience |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CollaboRATE Score | Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion. | CollaboRATE is a patient reported measure of shared decision making |
| Treatment Knowledge | Collected immediately following patient's Option Grid or usual care clinical discussion, usually within 15 minutes after finishing the discussion. | 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 |
| Patient Experience | Within five days of the clinical discussion | Patient's qualitative feedback during semi-structured interviews about their decision making experience |
| Clinician Experience | Within five days of the clinical discussion | Clinician's qualitative feedback during semi-structured interviews about their decision making experience |
| Treatment Received | Within 1 month of clinical discussion | Identified through medical records or registry data |
Countries
United States
Outcome results
None listed