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OpenTrials
Completed

NCT Number: NCT02046902

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Assessment of Pre-implementation, Post-implementation With Decision Coaching, and Post-implementation Without Decision Coaching

    Time frame: 30 months

    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?"

Secondary outcomes

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

    Time frame: 30 months

    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?"

Sponsors and collaborators

Lead sponsor

University of Missouri, Kansas City

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Acronym: DECIDE-PCI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 28, 2014
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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