Development & Testing of a Decision Aid for LVAD Placement

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

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).

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• INTEGRIS Baptist Medical Center

  collaborator OTHER

• Texas Heart Institute

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Jennifer Blumenthal-Barby, PhD · Baylor College of Medicine

• Kristin M Kostick, PhD · Baylor College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2016-12-31

Completion

2017-01-31

Countries

• United States

Study Locations