Patient-Reported Preferences Affecting Revascularization Decisions (PREPARED)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02272062|
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Angina Pectoris||Other: Decision-making tool for coronary artery disease treatment||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Patient-Reported Preferences Affecting Revascularization Decisions|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
No Intervention: 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.
Experimental: 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.
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.
- Concordance of patient preference with delivered treatment [ Time Frame: 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.
- Knowledge [ Time Frame: Within 2 hours of angiography ]Performance on a 6-item knowledge questionnaire
- Knowledge [ Time Frame: 3 months ]Performance on a 6-item knowledge questionnaire
- Decisional conflict [ Time Frame: Within 2 hours of angiography ]Performance on a 16-item scale assessing decisional self-efficacy
- Patient satisfaction [ Time Frame: Within 2 hours of angiography ]Performance on the decisional regret scale
- Patient satisfaction [ Time Frame: 3 months ]Performance on the decisional regret scale
- Informed values congruence [ Time Frame: 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
- Angina [ Time Frame: 3 months ]7-item Seattle Angina Questionnaire
- Ad hoc percutaneous coronary intervention [ Time Frame: 3 months ]Percentage of percutaneous coronary intervention performed at time of diagnostic angiography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272062
|United States, North Carolina|
|Duke University Hospital|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Manesh Patel||Duke University|