Clinical trial NCT02046902: Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Official title: Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Keywords: coronary artery disease
cardiac stent
PCI procedure
Patient preference
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-01-28
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with and without coronary artery disease

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.

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

Primary outcomes:
measure: Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching
timeFrame: 30 months
Secondary outcomes:
measure: Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.
timeFrame: 30 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
affiliation: University of Missouri, Kansas City
name: John A Spertus, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.