Development & Testing of a Decision Aid for LVAD Placement
Completed · Not applicable
Conditions studied: End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners), LVAD Caregivers
In brief
The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment. This study seeks to create a decision aid that presents outcomes, risks, projected experiences, and uncertainties about Left Ventricular Assist Device (LVAD) placement to help patients make values-based decisions about placement. The investigators propose a mixed methods design involving a literature search of clinical evidence, semi-structured patient interviews, and quantitative data from a multi-site trial of patients receiving the decision aid compared to patients not receiving the aid.
Key facts
- Study ID
- NCT02248974
- Run by
- Baylor College of Medicine
- People needed
- 98
- Starts
- 2014-02-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2019-05-31
Who can join
Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- LVAD Candidates (NYHA Class III and IV patients with an acceptable surgical risk/benefit ratio for LVAD implantation and with good psychosocial support, coping mechanisms, and financial resources, as determined by "clearance" from the transplant social worker)
- LVAD Patients
- LVAD Decliners
- LVAD Caregivers
You may not qualify if…
- subjects who lack the capacity to give informed consent
Where it is running
- 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
Full record on ClinicalTrials.gov
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