NCT02046902

Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 586 (actual)
• Sponsor: University of Missouri, Kansas City · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Heart Diseases

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2014-01-28
• Last updated: 2019-08-06
• Results posted: 2019-07-24

Locations

2 sites across 1 country: United States