Patient-Reported Preferences Affecting Revascularization Decisions
| Status: | Completed |
|---|---|
| Conditions: | Angina, Angina, Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2016 |
| Start Date: | November 2014 |
| End Date: | June 2016 |
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.
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.
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.
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.
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
We found this trial at
1
site
Durham, North Carolina 27705
Principal Investigator: Manesh R Patel, MD
Phone: 919-668-7969
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