Decisional Quality for Patients With Coronary Artery Disease

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Behavioral: CAD Education; Behavioral: Decision Aid

• Registration Number: NCT02145481
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2014-05-01
• Study First Submitted: 2014-05-15
• Study First Submitted QC: 2014-05-20
• Study First Posted: 2014-05-23
• Primary Completion: 2018-08-15
• Study Completion: 2018-08-15
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-30
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 677

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAD Education	CAD Education	Patient with coronary artery disease will be given a general educational handout on coronary artery disease.
Decision Aid	Decision Aid	Patients with stable coronary artery disease will be given a decision aid to review prior to making a treatment decision.

Primary Outcome Measures

Name	Time	Method
Decision quality survey	3 months post baseline	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.

Trial Locations

Locations (4)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Truman Medical Center; 🇺🇸 Kansas City, Missouri, United States

St. Luke's Mid-America Heart Institute; 🇺🇸 Kansas City, Missouri, United States