Clinical trial NCT06823583: Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool
Official title: Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Assist Device
Advanced Heart Failure
Anticipatory Guidance
Keywords: expectations
VAD
Advanced Heart Failure
Anticipatory Guidance
quality of life
Lead sponsor: Bryan Heart
Sponsor class: OTHER
Collaborators: name: International Consortium of Circulatory Assist Clinicians
name: International Society for Heart and Lung Transplantation
First posted: 2025-02-12
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced heart failure patients will be approached by their internal VAD teams who have been scheduled for a VAD implantation. Only age requirement is \>/= 19 as the age of majority in most states for consenting is 19. The goal is to consent consecutively so as to limit selection bias as much as able to. This is a feasibility study so consecutive approaching is key.

Brief summary: 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.

Detailed description: Advanced heart failure (HF) accounts for up to 10% of the overall HF population, and is demonstrated through increased hospitalizations, worsening shortness of breath and decrease in energy. A left ventricular assist device (VAD) and/or cardiac transplantation are promising surgical options to treat advanced HF beyond traditional guideline driven medical therapy, however not always designed for everyone. There are extensive educational materials available preoperatively designed to provide additional information to ease the decision-making process when receiving a VAD, yet most of this material is used to help decide on whether to get a VAD and has less to do with what to expect following a VAD. No information exists to date on describing expectations and outcomes at various time points following VAD. Anticipatory guidance (AG) models primarily exist in the pediatric populations to help parents and caregivers understand the "typical" milestones of what to expect. There are scarce AG models available for adults with chronic comorbid conditions, such as HF. An AG tool specific to VAD patients would be beneficial as preoperative education for potential VAD patients to help better understand the more commonly defined expectations of outcomes beyond adverse event risks, and in turn, hopefully decreases anxiety and depression post-VAD implant, improve domains of health-related quality of life (HRQoL), and decrease hospitalizations.

The Phase 1 study evaluated the development of a prototype AG tool from both longitudinal data analyzed from internal "Quality of Life with a Left Ventricular Assist Device" (QoLVAD) questionnaires that were previously completed as part of a local program's database, and from additional supporting literature. The prototype AG tool has undergone a two-part Delphi method evaluation by 10 international VAD clinicians, and necessary modifications were made based upon results from the two-part Delphi method. An additional round of Delphi method evaluation with local VAD patients was completed with final modifications to reflect the responses from the VAD patients to develop the "VAD AG Tool v5.0". The Phase 2 tool will be referred to as the "VAD AG tool v5.0".

For this phase 2 study, the purpose is to evaluate the VAD AG tool v5.0 across three VAD implanting centers in the United States, with the perspectives of both VAD patients and clinicians. This will be accomplished through four aims: 1. Evaluate clinician perspectives of the VAD AG Tool v5.0; 2. Preoperative distribution of the VAD AG tool v5.0 for consented participants across three VAD implanting centers, to read preoperatively, and evaluate at postoperative time points (3, 6 and 12-months); 3. Describe postoperative VAD patient perceptions of VAD AG tool v5.0 at three time points (3, 6, and 12-months); and 4. Evaluate relationships between HRQoL and the following: anxiety, depression, cognition, and hospital readmissions.

Eligibility criteria: Inclusion Criteria:

(For patient inclusion):

* scheduled for a VAD implantation
* English-speaking as the VAD AG Tool v5.0 has not yet been translated beyond English age ≥19 years at the time of implant as most states in North America have an age of majority for consent signing.

(-VAD clinician for the clinician evaluation process)

Exclusion Criteria:

* Not scheduled for VAD surgery
* Non English speaking
* \<19 yrs of age (Not a VAD Clinician for the clinician evaluation process)

Primary outcomes:
measure: Clinician perspectives
timeFrame: First two weeks of study initiation.
Secondary outcomes:
Other outcomes:
measure: Distribution of the Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
timeFrame: 12 months
measure: Postoperative patient perceptions of Ventricular Assist Device Anticipatory Guidance Tool (VAD AG Tool) v5.0
timeFrame: 12 months
measure: Complete post-operative Quality of Life with a Left Ventricular Assist Device (QoLVAD)
timeFrame: 12 months
measure: Complete post-operative Generalized Anxiety Disorder 7-item scale at three different time points
timeFrame: 12 months
measure: Complete post-operative Patient Health Questionnaire-9 tool at three different time points
timeFrame: 12 months
measure: Complete post-operative Trailmaking B assessment at three different time points
timeFrame: 12 months
Locations:
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
Study officials:
affiliation: Bryan Heart
name: Mathue Baker, MD
role: STUDY_CHAIR
References:
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citation: Longitudinal Quality of Life Assessment Following Ventricular Assist Device Therapy: A Pilot Study Using the QOLVAD Questionnaire Schroeder, S.E. et al. The Journal of Heart and Lung Transplantation, Volume 39, Issue 4, S91
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