Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool

Conditions

• Advanced Heart Failure
• Anticipatory Guidance
• Ventricular Assist Device

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Study Details

There are a variety of educational documents available to help in a participant's decision for VAD implant, however there is little information available to potential participants to help understand areas of satisfaction and concern following a VAD implant as various time points. The investigators want to provide better patient care through increased education and awareness beyond surgical outcomes and contribute to patient understanding of "what to expect" following a VAD implant. The investigators have created an anticipatory guidance (AG) tool based upon previous responses recorded in a local program's database, from the Quality of Life with a Left Ventricular Assist Device (QoLVAD) questionnaire. This questionnaire has five different domains (physical, social, emotional, cognitive thinking and spiritual/well-being). Investigators have previously analyzed responses to determine common areas of satisfaction and concern at 3-, 6-, 12- and 24-months post-VAD implant to better understand quality of life when living with a VAD. Investigators have had both VAD clinicians and VAD patients initially evaluate the tool to determine accuracy and effectiveness of the anticipatory guidance (AG) tool.

Key Dates

Start date

Aug 17, 2025

Status verified

Sep 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

10 participants (estimated)

Arms

• Arm: VAD Clinician Cohort
  Up to four VAD Clinicians at each of the three participating sites (a maximum total of 12) will provide feedback and evaluation of the VAD AG Tool v5.0 following consenting.
• Arm: VAD Patient Cohort
  Each of the three sites will enroll a minimum of 3 patients and no more than 5 potential VAD patients (total of 21 for the three sites) to provide evaluation and feedback of accuracy and feasibility of the VAD AG Tool v5.0, occurring at 3-, 6- and 12-months following VAD implant. All patient participants following consenting, will receive the tool pre-surgery and provide evaluation and guidance post surgery, along with de-identifiable demographic and clinic data.

Primary Outcome Measure

Clinician perspectives [ Time Frame: First two weeks of study initiation. ]

Central Contacts

• Sarah E Schroeder, PhD, MSN, BSN, RN-Diploma
  402-481-8450
  [email protected]
• Kristin Sandau, PhD, RN
  612-625-0186
  [email protected]

Locations (2)

Find similar trials in Lincoln, NE

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