Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)

Официальное название

Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)

Обзор

Advanced liver disease is a serious illness that disproportionately affects Veterans, many of whom hope for curative liver transplantation. However, too few receive a transplant and most continue to suffer from increasing symptoms and hospitalizations. The proposed project uses a whole person, Veteran-centered approach that identifies Veterans with advanced liver disease using a population-based health management system and integrates curative and early supportive care using a telemedicine-based nurse care counselor to (1) discuss patient's understanding of illness severity and prognosis, (2) identify priorities and care preferences and (3) align curative and supportive care options to achieve patient priorities. Study outcomes include changes in (1) rates of consideration for liver transplantation, and (2) completion of serious illness discussions. Findings will inform adaptations to the intervention and facilitators for its dissemination.

Подробное описание

Project Background and Rationale: Advanced liver disease (AdvLD) is a serious illness. As many as half of AdvLD patients die within 2 years of developing liver complications, and nearly all suffer increasing symptoms and hospitalizations. Although many patients hope for curative liver transplantation, few receive it while experiencing an increasingly severe illness. In previous studies, many patients with AdvLD reported unmet curative and supportive care needs. They also reported preferences to align care with their outcome goals earlier in the AdvLD course than is now common. The Vet-CALD program is a Whole Health program in AdvLD that focuses on what matters most to patients, shared goals, and goal-aligned treatments, and could improve both curative and supportive care.

Project Objectives: The overall goal of the Vet-CALD project is to develop and test a novel sustainable Whole Health program in caring for patients with AdvLD. Using a hybrid type 1 effectiveness-implementation study design, the project will: (Aim 1) conduct a formative assessment of Vet-CALD implementation for Veterans with AdvLD; (Aim 2) evaluate the effectiveness of Vet-CALD in a randomized controlled study at 8 VA centers; and (Aim 3) conduct a summative assessment of implementation outcomes.

Project Methods: In Aim 1, the study team will conduct in-depth qualitative interviews with clinical stakeholders and patients to identify steps necessary to refine the Vet-CALD intervention, develop engagement processes for patients, and establish integrated workflows at the four targeted VA sites.

In Aim 2 the study team will conduct a randomized clinical trial (N=450) with patients from 8 VA medical centers assigned (1:1) to Usual Care vs. Vet-CALD Intervention. The Vet-CALD intervention will consist of a centralized research care counselor who will work with individual patients by telehealth (3 to 5 visits over 6 months) to assess and cultivate their understanding of their illness and identify personal healthcare goals. The counselor will be part of a centralized care team (hepatologist and supportive care physician) and will work with each patient's usual providers to help tailor treatment plans and education to better align with each patient's understanding of their disease prognosis and their healthcare goals and priorities.

In Aim 3, Summative assessment will provide context for the effectiveness results and inform necessary adaptations to and dissemination of Vet-CALD.

Вмешательства

• Другое Vet-CALD
  Vet-CALD Participants will receive the standard of care from their usual VA healthcare provider, plus they will participate in 5 monthly 60-minute care counselor sessions over a period of 6 months via VA Video Connect (VVC) or by telephone. The purpose of care counselor visits is to assess and cultivate the patient's understanding of their illness and identify personal healthcare goals. The counselor will be part of a centralized research care team (hepatologist and supportive care physician) an

Первичные конечные точки

• EHR documentation of consideration for liver transplantation change [Срок оценки: 6 and 12 months]
• EHR documentation of goals of care conversation change [Срок оценки: 6 and 12 months]

Вторичные конечные точки (5)

• Receipt of goal concordant care [Срок оценки: 6 months]
• Health Related Quality of Life (HRQoL) [Срок оценки: 6 months]
• Perceived quality of shared decision-making [Срок оценки: 6 months]
• Satisfaction with care [Срок оценки: 6 months]
• Quality of symptomatic advanced liver disease (AdvLD) care [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Patients will be between 18 and 80 years of age
• Patients must be Veterans
• Patients must have been in care at one of the recruiting sites with 1 or more encounters in primary care or GI/Hepatology in the last 24 months
• Patients must have advanced liver disease, defined by ICD-10 codes for cirrhosis complications (ever) or MELD 3.0 >12 or MELD-Na >12 or Fibroscan LSM >20kpa

Критерии исключения

• Non-Veteran patients
• Patients who do not speak English, do not have access to a telephone or computers, have cognitive impairments, or who are unable to complete a valid informed consent form after three attempts
• Patients who have already made significant progress toward our endpoints: a) with prior history of liver transplantation, or b) on the liver transplant waiting list, or c) had formal evaluation for liver transplantation in the past 3 years
• Patients with very limited life expectancy (advanced cancer, acute-on-chronic liver failure, and hospice patients)
• Patients hospitalized, or in long term facilities or nursing homes at the time they meet inclusion criteria
• Patients with chart diagnosis of uncontrolled mental health or schizophrenia

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 8 центров

• Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock
• VA Long Beach Healthcare System, Long Beach, CA — Long Beach
• VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
• VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles
• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
• Miami VA Healthcare System, Miami, FL — Miami
• VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX — Dallas
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston

Публикации

• Kanwal F, Neuschwander-Tetri BA, Loomba R, Rinella ME. Metabolic dysfunction-associated steatotic liver disease: Update and impact of new nomenclature on the American Association for the Study of Liver Diseases practice guidance on nonalcoholic fatty liver disease. Hepatology. 2024 May 1;79(5):1212-1219. doi: 10.1097/HEP.0000000000000670. Epub 2023 Nov 9. PMID 38445559

Идентификаторы

NCT: NCT06068491 · IIR 21-230 · 1I01HX003541-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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