Patient-Reported Preferences Affecting Revascularization Decisions

NCT ID: NCT02272062

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-06-30

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.

Conditions

Coronary Artery Disease; Angina Pectoris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Preferences Not Provided

Subjects will complete a shared decision-making tool and express preferences regarding treatment for coronary artery disease, but these preferences will NOT be shared with the treating clinicians.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Preferences Provided

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.

Group Type: EXPERIMENTAL

Decision-making tool for coronary artery disease treatment

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manesh Patel

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Hospital

Durham, North Carolina, United States

Countries

United States

References

Doll JA, Jones WS, Lokhnygina Y, Culpepper S, Parks RL, Calhoun C, Au DH, Patel MR. PREPARED Study: A Study of Shared Decision-Making for Coronary Artery Disease. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005244. doi: 10.1161/CIRCOUTCOMES.118.005244.

Reference Type: DERIVED

PMID: 30764651 (View on PubMed)

Other Identifiers

Pro00055866

Identifier Type: -

Identifier Source: org_study_id