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

NCT ID: NCT02046902

Last Updated: 2019-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 586 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Heart disease

Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention.

No interventions assigned to this group

Healthy adults

Adults without a diagnosis of coronary artery disease. Focus groups will be held.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• >18 years old
• English or Spanish speaking
• Presence of coronary disease, or a caregiver/relative of one with coronary disease

Exclusion Criteria

• non-English or non-Spanish speaking
• dementia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Missouri, Kansas City

OTHER

Sponsor Role: lead

Responsible Party

John A. Spertus

Daniel Lauer/Missouri Endowed Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John A Spertus, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Missouri, Kansas City

Locations

Truman Medical Center

Kansas City, Missouri, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30764654 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28168845 (View on PubMed)

Other Identifiers

CE-1304-6448

Identifier Type: -

Identifier Source: org_study_id