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| Name | Class |
|---|---|
| University of Missouri, Kansas City | OTHER |
| Mid America Heart Institute | OTHER |
| Emory University | OTHER |
| Massachusetts General Hospital |
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The objective of the DeQCAD study is to measure the quality of the decision-making process for patients with coronary artery disease (CAD) and Acute Coronary Syndrome (ACS) who are making treatment decisions. In particular, this study is seeking to answer: a) How informed are patients about their treatment choices, b) are patients participating in the decision-making process as much as they would like to, and c) do the treatment decisions made match patients' preferences?
For patients with coronary artery disease (CAD), having a stent (or percutaneous coronary intervention or PCI) involves both risk and inconvenience, and thus it represents a classic "preference-sensitive" situation, in which treatment decisions should be aligned with the patient's preferences.
In this project the investigators will develop the first comprehensive, patient-reported measure of decisional quality for CAD that is feasible to implement in a variety of settings. The investigators will accomplish this by: 1) Identifying the key elements to capture decisional quality and identifying candidate questions to address these elements, using patient and expert feedback; 2) Pilot testing a preliminary instrument in a diverse patient population to assess measurement properties and select a reduced set of candidate questions for further testing; and 3) Establish the reliability and validity of a new comprehensive decisional quality measure for single and repeated examinations. This will result in a multidimensional decisional quality instrument for patients with CAD that will be ready for implementation into routine care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survey development | No Intervention | Patients with coronary artery disease will be given a survey to complete assessing their knowledge, communication with physicians, involvement, and treatment preferences after completing the treatment decision-making process. | |
| Decision Aid | Experimental | Patients with stable coronary artery disease will be given a decision aid to review prior to making a treatment decision. |
|
| CAD Education | Active Comparator | Patient with coronary artery disease will be given a general educational handout on coronary artery disease. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Behavioral | Decision aid describing treatment choices for patients with coronary artery disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decision quality survey | Decision quality for coronary artery disease patients making treatment decisions. Our primary outcome measure is the quality of the decision making process for patients with coronary artery disease including knowledge, communication, involvement, and treatment preferences measured at Baseline and 2 weeks during the pilot test phase, and Baseline, 1 month, and 3 months during the field test phase. | 3 months post baseline |
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Inclusion criteria:
Patients ≥ 18 years old
Able to answer survey questions in English
Diagnosis of coronary artery disease in one of the following categories:
Stable CAD group
Acute coronary syndrome group • Acute coronary syndrome where there is cardiac marker evidence of myocardial necrosis (e.g., elevated troponin or CK-MB) without new ST-segment elevation. Includes non-ST-elevation MI (NSTEMI).
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Adams Dudley, MD, MBA | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States | ||
| Emory University |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| OTHER |
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| CAD Education | Behavioral | Education for patients with coronary artery disease |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| St. Luke's Mid-America Heart Institute | Kansas City | Missouri | 64111 | United States |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |