Decisional Quality for Patients With Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

677 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-01

Study Completion Date

2018-08-15

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Survey development

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Decision Aid

Patients with stable coronary artery disease will be given a decision aid to review prior to making a treatment decision.

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Decision aid describing treatment choices for patients with coronary artery disease.

CAD Education

Patient with coronary artery disease will be given a general educational handout on coronary artery disease.

Group Type ACTIVE_COMPARATOR

CAD Education

Intervention Type BEHAVIORAL

Education for patients with coronary artery disease

Interventions

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Decision Aid

Decision aid describing treatment choices for patients with coronary artery disease.

Intervention Type BEHAVIORAL

CAD Education

Education for patients with coronary artery disease

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No