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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Clinician perspectives [Срок оценки: First two weeks of study initiation.]

Критерии участия

Критерии включения

(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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Bryan Heart — Lincoln
• Advocate Aurora Health — Milwaukee

Публикации

• Waldenburger N, Steinecke M, Peters L, Junemann F, Bara C, Zimmermann T. Depression, anxiety, fear of progression, and emotional arousal in couples after left ventricular assist device implantation. ESC Heart Fail. 2020 Oct;7(5):3022-3028. doi: 10.1002/ehf2.12927. Epub 2020 Jul 28. PMID 32725771
• 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
• Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104. PMID 23961782
• 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
• Sandau KE, Lee CS, Faulkner KM, Pozehl B, Eckman P, Garberich R, Weaver CE, Joseph SM, Hall S, Carey SA, Chaudhry SP, Schroeder SE, Hoffman RO 3rd, Feldman D, Birati EY, Soni M, Marble JF, Jurgens CY, Hoglund B, Cowger JA. Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire: Initial Psychometrics of a New Instrument. J Cardiovasc Nurs. 2021 Mar-A PMID 33306621
• Birriel B, Alonso W, Kitko LA, Hupcey JE. Family caregiver-reported outcomes regarding decision-making for left ventricular assist device implantation. Heart Lung. 2019 Jul-Aug;48(4):308-312. doi: 10.1016/j.hrtlng.2019.03.002. Epub 2019 Apr 10. PMID 30981423
• Kitko LA, Hupcey JE, Birriel B, Alonso W. Patients' decision making process and expectations of a left ventricular assist device pre and post implantation. Heart Lung. 2016 Mar-Apr;45(2):95-9. doi: 10.1016/j.hrtlng.2015.12.003. Epub 2015 Dec 29. PMID 26742707
• McIlvennan CK, Magid KH, Ambardekar AV, Thompson JS, Matlock DD, Allen LA. Clinical outcomes after continuous-flow left ventricular assist device: a systematic review. Circ Heart Fail. 2014 Nov;7(6):1003-13. doi: 10.1161/CIRCHEARTFAILURE.114.001391. Epub 2014 Oct 7. PMID 25294625

Идентификаторы

NCT: NCT06823583 · MCS-VAD-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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