Development & Testing of a Decision Aid for LVAD Placement
NCT ID: NCT02248974
Last Updated: 2019-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
NA
98 participants
INTERVENTIONAL
2014-02-28
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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LVAD Decision Aid
Decision aid presented to subjects was developed from patient and clinician feedback to increase patient knowledge on the risks, benefits, misconceptions or mispredictions regarding LVADs to help patients make an informed decision on accepting or declining LVAD placement.
LVAD Decision Aid
Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
No LVAD Decision Aid
The standard education processis institution-specific and unstandardized. The education consists of viewing education pamphlets that are created by device manufacturers. The traditional informed consent process may also include viewing and manipulating the actual device and meeting a patient with a device already implanted. Additionally, the LVAD coordinator describes the device and answers any questions LVAD candidates have.
No interventions assigned to this group
Interventions
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LVAD Decision Aid
Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE).
Eligibility Criteria
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Inclusion Criteria
* LVAD Patients
* LVAD Decliners
* LVAD Caregivers
Exclusion Criteria
30 Years
85 Years
ALL
No
Sponsors
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The Methodist Hospital Research Institute
OTHER
The University of Texas Health Science Center, Houston
OTHER
M.D. Anderson Cancer Center
OTHER
INTEGRIS Baptist Medical Center
OTHER
Texas Heart Institute
OTHER
Wake Forest University Health Sciences
OTHER
The Cleveland Clinic
OTHER
Patient-Centered Outcomes Research Institute
OTHER
Ochsner Health System
OTHER
Baylor College of Medicine
OTHER
Responsible Party
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Jennifer Blumenthal-Barby
Assistant Professor of Philosophy/Bioethics
Principal Investigators
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Jennifer Blumenthal-Barby, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Kristin M Kostick, PhD
Role: STUDY_DIRECTOR
Baylor College of Medicine
Locations
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Ochsner Health System
New Orleans, Louisiana, United States
Cleveland Clinic
Cleveland, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
CHI ST. Luke's - Baylor St. Lukes Medical Center / Texas Heart Institute
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Aurora Health Care
Milwaukee, Wisconsin, United States
Countries
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References
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Bruce CR, Delgado E, Kostick K, Grogan S, Ashrith G, Trachtenberg B, Estep JD, Bhimaraj A, Pham L, Blumenthal-Barby JS. Ventricular assist devices: a review of psychosocial risk factors and their impact on outcomes. J Card Fail. 2014 Dec;20(12):996-1003. doi: 10.1016/j.cardfail.2014.09.006. Epub 2014 Sep 17.
Blumenthal-Barby, J. S., Kristin M. Kostick, Estevan D. Delgado, Robert J. Volk, Holland M. Kaplan, L. A. Wilhelms, Sheryl A. McCurdy, Jerry D. Estep, Matthias Loebe, and Courtenay R. Bruce.
Kostick KM, Bruce CR, Minard CG, Volk RJ, Civitello A, Krim SR, Horstmanshof D, Thohan V, Loebe M, Hanna M, Bruckner BA, Blumenthal Barby JS, Estep JD. A Multisite Randomized Controlled Trial of a Patient-Centered Ventricular Assist Device Decision Aid (VADDA Trial). J Card Fail. 2018 Oct;24(10):661-671. doi: 10.1016/j.cardfail.2018.08.008. Epub 2018 Sep 7.
Bruce CR, Minard CG, Wilhelms LA, Abraham M, Amione-Guerra J, Pham L, Grogan SD, Trachtenberg B, Smith ML, Bruckner BA, Estep JD, Kostick KM. Caregivers of Patients With Left Ventricular Assist Devices: Possible Impacts on Patients' Mortality and Interagency Registry for Mechanically Assisted Circulatory Support-Defined Morbidity Events. Circ Cardiovasc Qual Outcomes. 2017 Jan;10(1):e002879. doi: 10.1161/CIRCOUTCOMES.116.002879.
Kostick KM, Minard CG, Wilhelms LA, Delgado E, Abraham M, Bruce CR, Estep JD, Loebe M, Volk RJ, Blumenthal-Barby JS. Development and validation of a patient-centered knowledge scale for left ventricular assist device placement. J Heart Lung Transplant. 2016 Jun;35(6):768-76. doi: 10.1016/j.healun.2016.01.015. Epub 2016 Jan 21.
Bruce CR, Blumenthal-Barby JS, Meyers D. Benefits and Challenges of Early Introduction of Left Ventricular Assist Device Placement: A Patient-Centered Perspective. J Am Coll Cardiol. 2015 Oct 20;66(16):1762-1765. doi: 10.1016/j.jacc.2015.08.852. No abstract available.
Blumenthal-Barby JS, Kostick KM, Delgado ED, Volk RJ, Kaplan HM, Wilhelms LA, McCurdy SA, Estep JD, Loebe M, Bruce CR. Assessment of patients' and caregivers' informational and decisional needs for left ventricular assist device placement: Implications for informed consent and shared decision-making. J Heart Lung Transplant. 2015 Sep;34(9):1182-9. doi: 10.1016/j.healun.2015.03.026. Epub 2015 Mar 31.
Related Links
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Project Website
Other Identifiers
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CDR-1306-01769
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-34286
Identifier Type: -
Identifier Source: org_study_id
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