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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
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Angina Pectoris Other: Decision-making tool for coronary artery disease treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Knowledge [ Time Frame: Within 2 hours of angiography ]
    Performance on a 6-item knowledge questionnaire

  2. Knowledge [ Time Frame: 3 months ]
    Performance on a 6-item knowledge questionnaire

  3. Decisional conflict [ Time Frame: Within 2 hours of angiography ]
    Performance on a 16-item scale assessing decisional self-efficacy

  4. Patient satisfaction [ Time Frame: Within 2 hours of angiography ]
    Performance on the decisional regret scale

  5. Patient satisfaction [ Time Frame: 3 months ]
    Performance on the decisional regret scale

  6. 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

  7. Angina [ Time Frame: 3 months ]
    7-item Seattle Angina Questionnaire

  8. Ad hoc percutaneous coronary intervention [ Time Frame: 3 months ]
    Percentage of percutaneous coronary intervention performed at time of diagnostic angiography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Gilead Sciences
Investigators
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Principal Investigator: Manesh Patel Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02272062    
Other Study ID Numbers: Pro00055866
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016
Keywords provided by Duke University:
Coronary artery disease
Angina
Shared decision-making
Patient preferences
Percutaneous coronary intervention
Coronary artery bypass graft
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms