Patient-Reported Preferences Affecting Revascularization Decisions

Coronary Artery Disease Clinical Trial

— PREPARED  

Official title:

Patient-Reported Preferences Affecting Revascularization Decisions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272062
• Other study ID #: Pro00055866
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: August 2, 2016
• Start date: November 2014
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Decision-making tool for coronary artery disease treatment
A brief internet-based tool will provide education about coronary artery disease and assess patient preferences regarding treatment options (medical management, percutaneous coronary intervention, or coronary artery bypass graft). This information will be provided to the treating interventional cardiologist at the time of coronary angiography in the treatment group.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance of patient preference with delivered treatment	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.	3 months	No
Secondary	Knowledge	Performance on a 6-item knowledge questionnaire	Within 2 hours of angiography	No
Secondary	Knowledge	Performance on a 6-item knowledge questionnaire	3 months	No
Secondary	Decisional conflict	Performance on a 16-item scale assessing decisional self-efficacy	Within 2 hours of angiography	No
Secondary	Patient satisfaction	Performance on the decisional regret scale	Within 2 hours of angiography	No
Secondary	Patient satisfaction	Performance on the decisional regret scale	3 months	No
Secondary	Informed values congruence	Concordance of the subject's stated preference for treatment with treatment-specific results from the Patient Preferences Questionnaire for Angina Treatment	Within 2 hours of angiography	No
Secondary	Angina	7-item Seattle Angina Questionnaire	3 months	No
Secondary	Ad hoc percutaneous coronary intervention	Percentage of percutaneous coronary intervention performed at time of diagnostic angiography	3 months	No