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

NCT ID: NCT06823583

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-17
• Study Completion Date: 2026-12-31

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.

Conditions

Ventricular Assist Device; Advanced Heart Failure; Anticipatory Guidance

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Consortium of Circulatory Assist Clinicians

OTHER

Sponsor Role: collaborator

International Society for Heart and Lung Transplantation

OTHER

Sponsor Role: collaborator

Bryan Heart

OTHER

Sponsor Role: lead

Responsible Party

Sarah E Schroeder

Left Ventricular Assist Device Nurse Practitioner and Program Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mathue Baker, MD

Role: STUDY_CHAIR

Bryan Heart

Locations

Bryan Heart

Lincoln, Nebraska, United States

Site Status: RECRUITING

Advocate Aurora Health

Milwaukee, Wisconsin, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Sarah E Schroeder, PhD, MSN, BSN, RN-Diploma

Role: CONTACT

sarah.schroeder@bryanheart.com

402-481-8450

Kristin Sandau, PhD, RN

Role: CONTACT

KSandau@umn.edu

612-625-0186

Facility Contacts

Sarah E Schroeder, PhD, MSN, BSN, RN

Role: primary

sarah.schroeder@bryanheart.com

4024833333

Riley Rossbach, BSBME

Role: primary

riley.rossbach@aah.org

4142227434

References

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Reference Type: BACKGROUND

PMID: 32725771 (View on PubMed)

Highs and Lows of Life with a Left Ventricular Assist Device: Multi-Dimensional Perspectives Schroeder, S.E. et al. The Journal of Heart and Lung Transplantation, Volume 43, Issue 4, S606

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 36074476 (View on PubMed)

Bytyci I, Bajraktari G. Mortality in heart failure patients. Anatol J Cardiol. 2015 Jan;15(1):63-8. doi: 10.5152/akd.2014.5731. Epub 2014 Aug 19.

Reference Type: BACKGROUND

PMID: 25550250 (View on PubMed)

Other Identifiers

MCS-VAD-003

Identifier Type: -

Identifier Source: org_study_id