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

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ClinicalTrials.gov Identifier: NCT02046902
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : February 10, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
John A. Spertus, University of Missouri, Kansas City

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.

Condition or disease
Heart Diseases

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.


Study Type : Observational
Actual Enrollment : 695 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Developing and Testing a Personalized Evidence-based Shared Decision-making Tool for Stent Selection
Study Start Date : September 2014
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort
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.



Primary Outcome Measures :
  1. Sufficient qualitative findings, and consensus, for decision tool content [ Time Frame: 3 months ]
    Given that the purpose of this study is to elicit from patients and their caregivers what the most important outcomes of PCI, how they vary by stent choice and the optimal mode of presenting these outcomes, we will use a qualitative research approach where the Research team will review all transcripts seeking theoretical saturation (no new information is gained from subsequent Groups) which signals full illumination of patients' perspectives and the end of the study. The transcripts come from audiotaping each Focus Group where a trained facilitator will lead a discussion of: participant experiences of PCI procedures or other medical/surgical procedure preparation; elicitation of key outcomes (avoiding repeat procedures, costs, bleeding, etc.). In addition, examples of potential visual displays of risk and benefit presentations will be shown; and consensus will be achieved for each Focus Group on the clearest, most optimal mode of presentation.

  2. Implementing and Testing the SDM Tool for Stent Choice [ Time Frame: 18 months ]
    Once the desired output of the TVR risk model is defined in Step 1, we will develop a 'template form' into which the PRISM system can insert the output from the models.The next step is to implement the decision aid at 2 PCI centers, Saint Luke's Hospital and Truman Medical Center. While Saint Luke's already uses the PRISM tool in routine clinical care. Once both sites have the ability to generate the PRISM consents, we will be able to test the incremental benefit of the tool.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adults with and without coronary artery disease
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046902


Locations
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
University of Missouri, Kansas City
Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: John A Spertus, MD, MPH University of Missouri, Kansas City

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John A. Spertus, Daniel Lauer/Missouri Endowed Chair, University of Missouri, Kansas City
ClinicalTrials.gov Identifier: NCT02046902     History of Changes
Other Study ID Numbers: CE-1304-6448
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We would be happy to collaborate with others to run analyses, but do not plan on freely distributing our data. You can see my editorial in CCQO to understand my concerns.

Keywords provided by John A. Spertus, University of Missouri, Kansas City:
coronary artery disease
cardiac stent
PCI procedure
Patient preference

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases