Recruiting

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

Sponsor:

VA Office of Research and Development

Code:

NCT06068491

Conditions

Liver Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Vet-CALD

Study Details

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.

Conditions

Liver Diseases

Study ID

NCT06068491

Start date

Oct 1, 2024

Status verified date

Jun, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 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

Exclusion Criteria:

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

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Arm 1: Vet-CALD Intervention

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) and will work with each patient's usual VA care 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.

no intervention: Arm 2: Usual Care

Usual Care Participants will receive the standard of care from their usual VA healthcare provider. The care counselor will not contact the usual care condition participants.

Interventions

Vet-CALD

Primary outcome measure

EHR documentation of consideration for liver transplantation change [ Time Frame: 6 and 12 months ]
EHR documentation of goals of care conversation change [ Time Frame: 6 and 12 months ]

Central Contacts and Locations

Central contacts

Juana Campos, MA

juana.campos@va.gov

Fasiha Kanwal, MD MSHS

(713) 440-4495 Fasiha.Kanwal@va.gov

Locations

Central Arkansas Veterans Healthcare System , Little Rock, AR

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Donna L Smith, MEd

(713) 440-4423 Donna.Smithd19d7@va.gov

Fasiha Kanwal, MD MSHS

(713) 440-4495 Fasiha.Kanwal@va.gov

VA Palo Alto Health Care System, Palo Alto, CA

Recruiting

Palo Alto, California, United States, 94304-1207

Contacts

Donna L Smith, MEd

(713) 440-4423 Donna.Smithd19d7@va.gov

Fasiha Kanwal, MD MSHS

(713) 440-4495 Fasiha.Kanwal@va.gov

Principal Investigator:

Steven M. Asch, MD MPH

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Recruiting

West Los Angeles, California, United States, 90073-1003

Contacts

Donna L Smith, MEd

713-440-4423 Donna.Smithd19d7@va.gov

Fasiha Kanwal, MD

7134404495 Fasiha.Kanwal@va.gov

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Juana Campos, MA

juana.campos@va.gov

Fasiha Kanwal, MD MSHS

(713) 440-4495 Fasiha.Kanwal@va.gov

Principal Investigator:

Fasiha Kanwal, MD MSHS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

Patient-Centered Care
Randomized Controlled Trial
Delivery of Healthcare, Integrated

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-25.