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

Liver Diseases Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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 I-VCALD 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 I-VCALD 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 I-VCALD implementation for Veterans with AdvLD; (Aim 2) evaluate the effectiveness of I-VCALD in a randomized controlled study at 4 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 I-VCALD 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 4 VA medical centers assigned (1:1) to Usual Care vs. I-VCALD Intervention. The I-VCALD intervention will consist of a centralized research care counselor who will work with individual patients by telehealth (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 I-VCALD. ;

Related Conditions & MeSH terms

• Liver Diseases

• NCT number: NCT06068491
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Donna L Smith, MEd
• Phone: (713) 791-1414
• Email: Donna.Smithd19d7@va.gov
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Completion date: September 30, 2027