Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to gather input from patients who have undergone PCI, their family and/or caregivers, and clinicians to develop a patient decision aid. The purpose of the decision aid is to deliver information, including individualized estimates of patients' restenosis risk, in an understandable format that would be informative and assist in decision-making for patients undergoing PCI.
Study Plan: Qualitative research methods (focus groups) will be used to gather the information that would be helpful in decision making as well as review several possible output formats. Several sets of focus groups will be convened, with particular attention to recruitment of a diverse population, including women and underserved minority groups.
Study Procedure: We will gather input to create a clinically useful format for presenting the risk estimates for desired outcomes and support clinical decision-making.
Subjects: We anticipate 2 or 3 patient focus groups of 6-8 individuals and 2 clinician focus groups of 3-5 individuals will be scheduled. Fliers will be posted to enlist potential patients. If necessary, patients will also be contacted by a Cardiovascular Research Coordinator and invited to attend a scheduled focus group. After receiving patient/family/caregiver input, selected clinicians from the Saint Lukes Hospital Staff, including cardiologists, cardiac nurses and other cardiology staff, will be invited to attend a scheduled focus group. The invitation will be sent via email and followed up with a phone call, if necessary. If a clinician focus group is unable to be scheduled, then individual interviews will be conducted.
Setting: Patient and Clinician focus group sessions will be held at Saint Luke's Hospital.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart disease | Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention. | ||
| Healthy adults | Adults without a diagnosis of coronary artery disease. Focus groups will be held. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?" | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than "I don't care" or "I don't know" in response to the question "After reviewing the risks and benefits of both types of stents, which type of stent did you want?" |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Adults with and without coronary artery disease
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John A Spertus, MD, MPH | University of Missouri, Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Truman Medical Center | Kansas City | Missouri | 64108 | United States | ||
| Saint Luke's Hospital of Kansas City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30764654 | Derived | Chhatriwalla AK, Decker C, Gialde E, Catley D, Goggin K, Jaschke K, Jones P, deBronkart D, Sun T, Spertus JA. Developing and Testing a Personalized, Evidence-Based, Shared Decision-Making Tool for Stent Selection in Percutaneous Coronary Intervention Using a Pre-Post Study Design. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e005139. doi: 10.1161/CIRCOUTCOMES.118.005139. | |
| 28168845 |
Not provided
Not provided
We would be happy to collaborate with others to run analyses, but do not plan on freely distributing our data. You can see my editorial in CCQO to understand my concerns.
Not provided
Not provided
Not provided
Not provided
Not provided
Between May 2014 and December 2016, patients were recruited from 2 percutaneous coronary intervention (PCI) centers, Saint Luke's Mid America Heart Institute (MAHI) and Truman Medical Center (TMC), following institutional review board (IRB) approval at each site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pre-Implementation | Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching. |
| FG001 | Post-implementation With Decision Coaching | Patients received the consent form, the SDM tool for stent selection, and decision coaching |
| FG002 | Post-implementation Without Decision Coaching | Patients received the consent form and the SDM tool, but no decision coaching |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pre-Implementation | Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching | The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?" | Posted | Count of Participants | Participants | 30 months |
|
Not provided
There was not a Data Safety Monitoring Board as this was deemed low risk and no Serious, and Other [Not Including Serious] Adverse Events were monitored/recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-Implementation | Patients who undergo coronary angiography and possible percutaneous coronary intervention (PCI) received an Patient Risk Information Systems Manager (ePRISM) consent form with personalized risk estimates for mortality, bleeding, and target vessel revascularization (TVR) with bare-metal stents (BMS) and drug-eluting stents (DES), but neither the shared decision-making (SDM) tool nor decision coaching. |
Not provided
Not provided
The lack of randomization, availability of ePrism at hospitals, estimation of TVR risk in the SDM tool without the availability of angiographic data, and physicians were not surveyed for additional variables that impacted their stent selection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carole Decker | Saint Luke's Mid America Heart Institute | (816) 932-5440 | c1decker@saint-lukes.org |
Not provided
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D003324 | Coronary Artery Disease |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 months |
| Kansas City |
| Missouri |
| 64111 |
| United States |
| Derived |
| Qintar M, Chhatriwalla AK, Arnold SV, Tang F, Buchanan DM, Shafiq A, Pokharel Y, deBronkart D, Ashraf JM, Spertus JA. Beyond restenosis: Patients' preference for drug eluting or bare metal stents. Catheter Cardiovasc Interv. 2017 Sep 1;90(3):357-363. doi: 10.1002/ccd.26946. Epub 2017 Feb 7. |
| BG001 | Post-implementation With Decision Coaching | Patients received the consent form, the SDM tool for stent selection, and decision coaching |
| BG002 | Post-implementation Without Decision Coaching | patients received the consent form and the SDM tool, but no decision coaching |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| Site | Count of Participants | Participants |
|
| Diabetes | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Peripheral arterial disease | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| Prior Coronary Artery Bypass Graft | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| Prior Percutaneous Coronary Intervention | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| Admission Status | Number analyzed for this baseline measure reflects data captured and does account for missing or unknown data. | Count of Participants | Participants |
|
| OG001 | Post-implementation With Decision Coaching | Patients received the consent form, the SDM tool for stent selection, and decision coaching |
| OG002 | Post-implementation Without Decision Coaching | Patients received the consent form and the SDM tool, but no decision coaching |
|
|
| Secondary | Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. | Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than "I don't care" or "I don't know" in response to the question "After reviewing the risks and benefits of both types of stents, which type of stent did you want?" | Posted | Count of Participants | Participants | 30 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Post-implementation With Decision Coaching | Patients received the consent form, the SDM tool for stent selection, and decision coaching | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Post-implementation Without Decision Coaching | Patients received the consent form and the SDM tool, but no decision coaching | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D017060 | Patient Satisfaction |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Truman Medical Center/Univ. of Missouri KC |
|
| Outpatient |
|
| Emergent |
|
| I don't care |
|
| I don't know |
|