Decisional Quality for Patients With Coronary Artery Disease

NCT02145481 | Completed

• 1 other identifier: HL114918-01A1
• Study Type: interventional
• Target: 677
• Locations: 1 country
• Sites: 4

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?

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; decision quality; decision making; survey; measure development; patient-centered care; cardiology; heart disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Behavioral: Decision Aid

CAD Education

ACTIVE COMPARATOR

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

Behavioral: CAD Education

Interventions

Decision Aid BEHAVIORAL

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

Decision Aid

CAD Education BEHAVIORAL

Education for patients with coronary artery disease

CAD Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Missouri, Kansas City: collaborator
• Mid America Heart Institute: collaborator
• Emory University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (4)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

St. Luke's Mid-America Heart Institute

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• R. Adams Dudley, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: May 23, 2014
• Study Start: May 1, 2014
• Primary Completion: August 15, 2018
• Study Completion: August 15, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)