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

Heart Diseases Clinical Trial

— DECIDE-PCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02046902
• Other study ID #: CE-1304-6448
• Status: Completed
• Start date: September 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: July 2019
• Source: University of Missouri, Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	Truman Medical Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri, Kansas City	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching	The primary outcome was whether or not patients participated in SDM regarding stent choice. Patients were categorized as having participated in SDM if they answered anything other than "doctor alone" in response to the question "Who chose the type of stent?"	30 months
Secondary	Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.	Secondary outcomes included patients' recall of individual aspects of the stent discussion, stent knowledge score, patient preference for stent type, perceived autonomy support from their providers ,and concordance of patient stent preference and type of stent received. Patients were categorized as having voiced a stent preference if they answered anything other than "I don't care" or "I don't know" in response to the question "After reviewing the risks and benefits of both types of stents, which type of stent did you want?"	30 months