Status:
RECRUITING
Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Liver Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
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 s...
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 inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06068491
Start Date
October 1 2024
End Date
September 30 2027
Last Update
September 22 2025
Active Locations (4)
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1
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, United States, 72205
2
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
3
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
4
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211