Patient-Reported Preferences Affecting Revascularization Decisions (PREPARED)
Primary Purpose
Coronary Artery Disease, Angina Pectoris
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision-making tool for coronary artery disease treatment
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, Angina, Shared decision-making, Patient preferences, Percutaneous coronary intervention, Coronary artery bypass graft
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
Sites / Locations
- Duke University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Preferences Not Provided
Preferences Provided
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Concordance of patient preference with delivered treatment
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
Knowledge
Performance on a 6-item knowledge questionnaire
Knowledge
Performance on a 6-item knowledge questionnaire
Decisional conflict
Performance on a 16-item scale assessing decisional self-efficacy
Patient satisfaction
Performance on the decisional regret scale
Patient satisfaction
Performance on the decisional regret scale
Informed values congruence
Concordance of the subject's stated preference for treatment with treatment-specific results from the Patient Preferences Questionnaire for Angina Treatment
Angina
7-item Seattle Angina Questionnaire
Ad hoc percutaneous coronary intervention
Percentage of percutaneous coronary intervention performed at time of diagnostic angiography
Full Information
NCT ID
NCT02272062
First Posted
October 20, 2014
Last Updated
August 2, 2016
Sponsor
Duke University
Collaborators
Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02272062
Brief Title
Patient-Reported Preferences Affecting Revascularization Decisions
Acronym
PREPARED
Official Title
Patient-Reported Preferences Affecting Revascularization Decisions
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina Pectoris
Keywords
Coronary artery disease, Angina, Shared decision-making, Patient preferences, Percutaneous coronary intervention, Coronary artery bypass graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preferences Not Provided
Arm Type
No Intervention
Arm Description
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.
Arm Title
Preferences Provided
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Decision-making tool for coronary artery disease treatment
Intervention Description
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 Measure Information:
Title
Concordance of patient preference with delivered treatment
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Knowledge
Description
Performance on a 6-item knowledge questionnaire
Time Frame
Within 2 hours of angiography
Title
Knowledge
Description
Performance on a 6-item knowledge questionnaire
Time Frame
3 months
Title
Decisional conflict
Description
Performance on a 16-item scale assessing decisional self-efficacy
Time Frame
Within 2 hours of angiography
Title
Patient satisfaction
Description
Performance on the decisional regret scale
Time Frame
Within 2 hours of angiography
Title
Patient satisfaction
Description
Performance on the decisional regret scale
Time Frame
3 months
Title
Informed values congruence
Description
Concordance of the subject's stated preference for treatment with treatment-specific results from the Patient Preferences Questionnaire for Angina Treatment
Time Frame
Within 2 hours of angiography
Title
Angina
Description
7-item Seattle Angina Questionnaire
Time Frame
3 months
Title
Ad hoc percutaneous coronary intervention
Description
Percentage of percutaneous coronary intervention performed at time of diagnostic angiography
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manesh Patel
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30764651
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.
Results Reference
derived
Learn more about this trial
Patient-Reported Preferences Affecting Revascularization Decisions
We'll reach out to this number within 24 hrs