Clinical trial NCT06068491: Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)
Official title: Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases
Keywords: Patient-Centered Care
Randomized Controlled Trial
Delivery of Healthcare, Integrated
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-10-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a hybrid type 1 effectiveness-implementation study utilizing formative implementation assessment prior to an effectiveness trial and assessment of implementation outcomes following the trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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 for 1 year with two or more encounters in primary care
* Patients must have AdvLD, defined based on two ambulatory or one inpatient encounter ICD-10 codes for new onset cirrhosis complications or MELD-Na \>15 in the previous 12 months

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) 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

Primary outcomes:
measure: EHR documentation of consideration for liver transplantation change
timeFrame: 6 and 12 months
measure: EHR documentation of goals of care conversation change
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Receipt of goal concordant care
timeFrame: 6 months
measure: Health Related Quality of Life (HRQoL)
timeFrame: 6 months
measure: Perceived quality of shared decision-making
timeFrame: 6 months
measure: Satisfaction with care
timeFrame: 6 months
measure: Quality of symptomatic advanced liver disease (AdvLD) care
timeFrame: 12 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System , Little Rock, AR
state: Arkansas
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Fasiha Kanwal, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References: