Clinical trial NCT02272062: Patient-Reported Preferences Affecting Revascularization Decisions
Official title: Patient-Reported Preferences Affecting Revascularization Decisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Keywords: Coronary artery disease
Angina
Shared decision-making
Patient preferences
Percutaneous coronary intervention
Coronary artery bypass graft
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2014-10-22
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Concordance of patient preference with delivered treatment
timeFrame: 3 months
Secondary outcomes:
measure: Knowledge
timeFrame: Within 2 hours of angiography
measure: Knowledge
timeFrame: 3 months
measure: Decisional conflict
timeFrame: Within 2 hours of angiography
measure: Patient satisfaction
timeFrame: Within 2 hours of angiography
measure: Patient satisfaction
timeFrame: 3 months
measure: Informed values congruence
timeFrame: Within 2 hours of angiography
measure: Angina
timeFrame: 3 months
measure: Ad hoc percutaneous coronary intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Manesh Patel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.