Decisional Quality for Patients With Coronary Artery Disease



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:May 1, 2014
End Date:August 15, 2018

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Decisional Quality for Patients With Stable Coronary Artery Disease

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.

Inclusion criteria:

1. Patients ≥ 18 years old

2. Able to answer survey questions in English

3. Diagnosis of coronary artery disease in one of the following categories:

1. Stable CAD group

- Meets any 1 of the following 3 criteria for stable CAD: 1) The patient has a
clinical diagnosis or prior history of CAD; 2) Angina without change in
frequency or pattern for the 6 weeks prior to enrollment; 3) Angina is
controlled by rest and/or sublingual/oral/transcutaneous medications.

- Accelerating pattern of stable angina with: 1) no ECG changes at rest; 2) no
cardiac marker evidence of myocardial necrosis (e.g., elevated troponin or
CK-MB); 3) scheduled for elective or urgent cardiac catheterization after
being evaluated in the outpatient setting (i.e., not from the emergency
department or inpatient hospitalization).

2. 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:

1. Diagnosis of ST-elevation MI (STEMI), defined as an acute coronary syndrome in which
there is cardiac marker evidence of myocardial necrosis (eg, positive troponin or
CK-MB) and new (or presumably new if no prior ECG is available) ST-segment elevation
or left bundle branch block on the admission ECG.

2. Unstable angina, defined as 1) Angina occurring at rest and prolonged, usually ≥ 10
minutes; 2) New onset angina of at least CCS classification III severity (i.e., marked
limitation of ordinary physical activity - angina occurs on walking 1 to 2 blocks on
the level and climbing 1 flight of stairs in normal conditions and at a normal pace);
3) no cardiac marker evidence of myocardial necrosis (e.g., negative troponin or
CK-MB).

3. Acute coronary syndrome with hemodynamic instability (e.g., cardiogenic shock,
hypotension, cardiac arrest, ongoing or recurrent chest pain, dynamic ST change).

4. Noncardiac chest pain: Pain in the chest, neck, arms, or abdomen (or other clinical
manifestation) not clearly exertional or not otherwise consistent with pain or
discomfort of myocardial ischemic origin.

5. Cognitive impairment such that the patient cannot give informed consent for himself or
herself.

6. Unable to answer survey questions in English.

7. Unavailable for follow-up surveys
We found this trial at
4
sites
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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2301 Holmes
Kansas City, Missouri 64108
816-404-1000
Truman Medical Center Located in the heart of downtown Kansas City, TMC Hospital Hill is...
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Kansas City, Missouri 64111
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San Francisco, California 94143
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San Francisco, CA
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