Development & Testing of a Decision Aid for LVAD Placement (VADDA)

Baylor College of Medicine

Status: Completed

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

Treatments: Other: LVAD Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT02248974

H-34286

CDR-1306-01769 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• subjects who lack the capacity to give informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

LVAD Decision Aid

Active Comparator group

Description:

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.

Treatment:

Other: LVAD Decision Aid

No LVAD Decision Aid

No Intervention group

Description:

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.