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Despite several large clinical trials clearly establishing that coronary revascularization (i.e. percutaneous coronary intervention - PCI) does not prolong survival or prevent myocardial infarction (MI) for stable coronary artery disease (CAD), patients with stable angina continue to believe that PCI is performed to improve these outcomes. Additionally, recent concerns have emerged of overuse of PCI among patients with little or no angina. Thus there is a compelling need to share with patients the risks and benefits of PCI prior to treatment to reach an informed decision.
This study is designed to answer the question of whether a decision aid can improve patient knowledge, decisional conflict and patient satisfaction with decision-making compared to usual care for the treatment of stable angina.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI Choice decision | Active Comparator | Decision Aid intervention is provided to clinician to share with patient |
|
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the PCI Choice Decision aid vs. Usual Care assessed by Patient and Provider Surveys, and encounter Video/Audio Recordings | Efficacy in improving measures of patient knowledge and involvement, decision making quality, treatment choice and clinician satisfaction of the decision aid. | Baseline to Three Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nilay Shah, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27803090 | Derived | Coylewright M, Dick S, Zmolek B, Askelin J, Hawkins E, Branda M, Inselman JW, Zeballos-Palacios C, Shah ND, Hess EP, LeBlanc A, Montori VM, Ting HH. PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial. Circ Cardiovasc Qual Outcomes. 2016 Nov;9(6):767-776. doi: 10.1161/CIRCOUTCOMES.116.002641. Epub 2016 Nov 1. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| D014652 |
| Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |