Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection (DECIDE-PCI)
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|ClinicalTrials.gov Identifier: NCT02046902|
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : July 24, 2019
Last Update Posted : August 6, 2019
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||586 participants|
|Official Title:||Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention.
Adults without a diagnosis of coronary artery disease. Focus groups will be held.
- Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching [ Time Frame: 30 months ]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?"
- Concordance Between Stent Preference and Stent Received Was a Secondary Outcome. [ Time Frame: 30 months ]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?"
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): NCT02046902
|United States, Missouri|
|Truman Medical Center|
|Kansas City, Missouri, United States, 64108|
|Saint Luke's Hospital of Kansas City|
|Kansas City, Missouri, United States, 64111|
|Principal Investigator:||John A Spertus, MD, MPH||University of Missouri, Kansas City|