NCT02248974

Development & Testing of a Decision Aid for LVAD Placement

Development and User Testing of a Decision Aid for Left Ventricular Assist Device (LVAD) Placement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• End-Stage Heart Failure
• Bridge-to-Transplant LVAD Placement (BTT)
• Destination Therapy LVAD Placement (DT)
• Refusal of LVAD Placement (Decliners)
• LVAD Caregivers

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2014-09-25
• Last updated: 2019-05-31
• Results posted: 2019-05-31

Locations

7 sites across 1 country: United States