Patient-Reported Preferences Affecting Revascularization Decisions

Not Applicable

Completed

• Conditions: Angina Pectoris; Coronary Artery Disease
• Interventions: Other: Decision-making tool for coronary artery disease treatment

• Registration Number: NCT02272062
• Lead Sponsor: Duke University

Brief Summary

Selection of a treatment strategy for patients with symptoms due to coronary artery disease requires consideration of patient preferences. In current clinical practice, patient preferences for treatment may not be known prior to diagnostic coronary angiography. The investigators will test an internet-based shared decision-making tool which will provide education and solicit preference information prior to angiography. The investigators seek to determine if this tool can accurately assess patient preferences, and if these preferences will lead to a change in clinical management.

Detailed Description

Selecting a treatment strategy for patients with symptomatic coronary artery disease (CAD) requires integrated consideration of symptom burden, patient preferences, and practice guidelines. In many clinical scenarios, there is equipoise regarding the need to revascularize (percutaneous coronary intervention (PCI) vs. medical management) and/or the type of revascularization (PCI vs. bypass surgery). Patients may have minimal direct input in the decision to proceed to a revascularization procedure, especially in the case of ad hoc PCI.

There is little guidance in the literature regarding strategies to improve patient participation in revascularization decisions. There is no shared decision-making tool to provide accessible information to the interventional cardiologist prior to PCI. An educational program that provides basic information regarding CAD and revascularization procedures could lead to improved patient knowledge and informed participation in these critical decisions. A clinical survey that assesses patient symptom burden and preferences could provide valuable information to physicians at the time of angiography. The investigators aim to test a clinical tool that addresses both of these needs and can be administered in the pre-procedure area immediately prior to angiography. If successful, this tool could lead to greater informed patient participation in revascularization procedures and improved patient satisfaction.

First, the investigators will conduct a pre-post analysis. The first 100 enrolled patients will undergo usual care without the use of the decision-making tool. Surveys prior to angiography and at 3 months will test knowledge and decisional self-efficacy. Subsequently, 200 patients will utilize the decision-making tool and will complete the same surveys. Comparison of these groups will test the ability of the decision-making tool to improve knowledge about CAD and accurately assess preferences.

Among the 200 patients utilizing the decision-making tool, patients will be randomly assigned to have, or not have, their preferences shared with the interventional cardiologist at the time of catheterization. This randomized portion of the study will test the impact of patient preferences on treatment decisions.

Study Timeline

• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Study Start: 2014-11
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• Patients referred to the catheterization laboratory for diagnostic coronary angiography with a reasonable expectation of coronary artery disease, defined as chronic stable angina, chest pain with a positive functional study, unstable angina, or non-ST segment elevation myocardial infarction.

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Exclusion Criteria

• Unable to provide informed consent
• Unable to speak or read English
• Critical illness
• When a delay in angiography to administer the decision aid could lead to adverse clinical outcome

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preferences Provided	Decision-making tool for coronary artery disease treatment	Subjects will complete a shared decision-making tool and express preferences regarding treatment for coronary artery disease, and these preferences WILL be shared with the treating clinicians.

Primary Outcome Measures

Name	Time	Method
Concordance of patient preference with delivered treatment	3 months	Among patients with significant coronary artery disease on diagnostic angiography, the percentage of subjects with delivered therapy (medical management, percutaneous coronary intervention, coronary artery bypass graft) identical to preferences expressed prior to angiography.

Secondary Outcome Measures

Name	Time	Method
Angina	3 months	7-item Seattle Angina Questionnaire
Knowledge	3 months	Performance on a 6-item knowledge questionnaire
Decisional conflict	Within 2 hours of angiography	Performance on a 16-item scale assessing decisional self-efficacy
Patient satisfaction	3 months	Performance on the decisional regret scale
Informed values congruence	Within 2 hours of angiography	Concordance of the subject's stated preference for treatment with treatment-specific results from the Patient Preferences Questionnaire for Angina Treatment
Ad hoc percutaneous coronary intervention	3 months	Percentage of percutaneous coronary intervention performed at time of diagnostic angiography

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States