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Decisional Quality for Patients With Coronary Artery Disease (DeQCAD)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
CAD Education
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring coronary artery disease, decision quality, decision making, survey, measure development, patient-centered care, cardiology, heart disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco
  • Emory University
  • Truman Medical Center
  • St. Luke's Mid-America Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Survey development

Decision Aid

CAD Education

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 15, 2014
Last Updated
November 30, 2018
Sponsor
University of California, San Francisco
Collaborators
University of Missouri, Kansas City, Mid America Heart Institute, Emory University, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02145481
Brief Title
Decisional Quality for Patients With Coronary Artery Disease
Acronym
DeQCAD
Official Title
Decisional Quality for Patients With Stable Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Missouri, Kansas City, Mid America Heart Institute, Emory University, Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, decision quality, decision making, survey, measure development, patient-centered care, cardiology, heart disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
677 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Survey development
Arm Type
No Intervention
Arm Description
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.
Arm Title
Decision Aid
Arm Type
Experimental
Arm Description
Patients with stable coronary artery disease will be given a decision aid to review prior to making a treatment decision.
Arm Title
CAD Education
Arm Type
Active Comparator
Arm Description
Patient with coronary artery disease will be given a general educational handout on coronary artery disease.
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Intervention Description
Decision aid describing treatment choices for patients with coronary artery disease.
Intervention Type
Behavioral
Intervention Name(s)
CAD Education
Intervention Description
Education for patients with coronary artery disease
Primary Outcome Measure Information:
Title
Decision quality survey
Description
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.
Time Frame
3 months post baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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). 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: 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. 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). Acute coronary syndrome with hemodynamic instability (e.g., cardiogenic shock, hypotension, cardiac arrest, ongoing or recurrent chest pain, dynamic ST change). 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. Cognitive impairment such that the patient cannot give informed consent for himself or herself. Unable to answer survey questions in English. Unavailable for follow-up surveys
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
R. Adams Dudley, MD, MBA
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
St. Luke's Mid-America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Decisional Quality for Patients With Coronary Artery Disease

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