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Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection (DECIDE-PCI)

U

University of Missouri, Kansas City

Status

Completed

Conditions

Heart Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT02046902
CE-1304-6448

Details and patient eligibility

About

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.

Full 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.

Enrollment

586 patients

Sex

All

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

586 participants in 2 patient groups

Heart disease
Description:
Adults with a diagnosis of coronary artery disease and may have had a percutaneous coronary intervention.
Healthy adults
Description:
Adults without a diagnosis of coronary artery disease. Focus groups will be held.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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