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
Last Update Posted : February 10, 2017
|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 :||695 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.
- Sufficient qualitative findings, and consensus, for decision tool content [ Time Frame: 3 months ]Given that the purpose of this study is to elicit from patients and their caregivers what the most important outcomes of PCI, how they vary by stent choice and the optimal mode of presenting these outcomes, we will use a qualitative research approach where the Research team will review all transcripts seeking theoretical saturation (no new information is gained from subsequent Groups) which signals full illumination of patients' perspectives and the end of the study. The transcripts come from audiotaping each Focus Group where a trained facilitator will lead a discussion of: participant experiences of PCI procedures or other medical/surgical procedure preparation; elicitation of key outcomes (avoiding repeat procedures, costs, bleeding, etc.). In addition, examples of potential visual displays of risk and benefit presentations will be shown; and consensus will be achieved for each Focus Group on the clearest, most optimal mode of presentation.
- Implementing and Testing the SDM Tool for Stent Choice [ Time Frame: 18 months ]Once the desired output of the TVR risk model is defined in Step 1, we will develop a 'template form' into which the PRISM system can insert the output from the models.The next step is to implement the decision aid at 2 PCI centers, Saint Luke's Hospital and Truman Medical Center. While Saint Luke's already uses the PRISM tool in routine clinical care. Once both sites have the ability to generate the PRISM consents, we will be able to test the incremental benefit of the tool.
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|