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

Phase

N/A

Condition

Primary Biliary Cholangitis

Treatment

I-VCALD

Vet-CALD

Clinical Study ID

NCT06068491

IIR 21-230

1I01HX003541-01A1

1 I01HX003541-01A1

Ages 18-80
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 moreencounters in primary care or GI/Hepatology in the last 24 months
Patients must have advanced liver disease, defined by ICD-10 codes for cirrhosiscomplications (ever) or MELD 3.0 >12 or MELD-Na >12 or Fibroscan LSM >20kpa

Exclusion

Exclusion Criteria:

Non-Veteran patients
Patients who do not speak English, do not have access to a telephone or computers,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) withprior 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 liverfailure, and hospice patients)
Patients hospitalized, or in long term facilities or nursing homes at the time theymeet inclusion criteria
Patients with chart diagnosis of uncontrolled mental health or schizophrenia

Study Design

I-VCALD

October 01, 2024

September 30, 2027

Study 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 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 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 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 4 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 (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.

Connect with a study center

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas 72205-5484
United States
Site Not Available
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas 77205
United States
Site Not Available
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock 4119403, Arkansas 4099753 72205
United States
Site Not Available
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California 94304-1207
United States
Site Not Available
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California 90073-1003
United States
Site Not Available
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto 5380748, California 5332921 94304-1207
United States
Site Not Available
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles 5408115, California 5332921 90073-1003
United States
Site Not Available
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas 77030-4211
United States
Site Not Available
Michael E. DeBakey VA Medical Center, Houston, TX
Houston 4699066, Texas 4736286 77030-4211
United States
Active - Recruiting

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