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

NCT02046902 | Completed Results DMC

• 1 other identifier: CE-1304-6448
• Study Type: observational
• Target: 586
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Diseases

Keywords

coronary artery disease; cardiac stent; PCI procedure; Patient preference

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Concordance Between Stent Preference and Stent Received Was a Secondary Outcome.

  30 months

Study Arms (2)

Heart disease

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

Healthy adults

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults with and without coronary artery disease

You may qualify if:

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

You may not qualify if:

• non-English or non-Spanish speaking
• dementia

Sponsors & Collaborators

• University of Missouri, Kansas City: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Related Publications (2)

• 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.

  PMID: 30764654 DERIVED

• 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.

  PMID: 28168845 DERIVED

MeSH Terms

Conditions

Heart Diseases; Coronary Artery Disease; Patient Preference

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

The lack of randomization, availability of ePrism at hospitals, estimation of TVR risk in the SDM tool without the availability of angiographic data, and physicians were not surveyed for additional variables that impacted their stent selection.

Results Point of Contact

• Title: Carole Decker
• Organization: Saint Luke's Mid America Heart Institute

c1decker@saint-lukes.org

(816) 932-5440

Study Officials

• John A Spertus, MD, MPH

  University of Missouri, Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Daniel Lauer/Missouri Endowed Chair

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 28, 2014
• Study Start: September 1, 2014
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: August 6, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-07

Locations

US (2)