Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)
Vet-CALD
Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)
2 other identifiers
interventional
450
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2027
February 6, 2026
February 1, 2026
2 years
September 28, 2023
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
EHR documentation of consideration for liver transplantation change
Consideration of Liver Transplantation will be measured dichotomously by assigning a value of 1 if the patient's EHR includes at least one clinician note that documents consideration of liver transplantation as a potential treatment option for the patient within 6 months and 12 months of enrollment, and a value of 0 otherwise.
6 and 12 months
EHR documentation of goals of care conversation change
Goals of Care Conversation will be measured dichotomously by assigning a value of 1 if the patient's EHR includes at least one clinician note documenting discussion of goals of care planning within 6 months and 12 months of enrollment, and a value of 0 otherwise.
6 and 12 months
Secondary Outcomes (5)
Receipt of goal concordant care
6 months
Health Related Quality of Life (HRQoL)
6 months
Perceived quality of shared decision-making
6 months
Satisfaction with care
6 months
Quality of symptomatic advanced liver disease (AdvLD) care
12 months
Study Arms (2)
Arm 1: Vet-CALD Intervention
EXPERIMENTALVet-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.
Arm 2: Usual Care
NO INTERVENTIONUsual 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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 with chart diagnosis of uncontrolled mental health or schizophrenia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, 72205, United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207, United States
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003, United States
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770, United States
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211, United States
Related Publications (1)
Kanwal F, Neuschwander-Tetri BA, Loomba R, Rinella ME. Metabolic dysfunction-associated steatotic liver disease: Update and impact of new nomenclature on the American Association for the Study of Liver Diseases practice guidance on nonalcoholic fatty liver disease. Hepatology. 2024 May 1;79(5):1212-1219. doi: 10.1097/HEP.0000000000000670. Epub 2023 Nov 9.
PMID: 38445559RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fasiha Kanwal, MD MSHS
Michael E. DeBakey VA Medical Center, Houston, TX
- PRINCIPAL INVESTIGATOR
Anne M Walling, MD PhD
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
- PRINCIPAL INVESTIGATOR
Steven M. Asch, MD MPH
VA Palo Alto Health Care System, Palo Alto, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Data Collection Coordinator who conducts telephone surveys and chart reviews will be blinded to group assignment.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2023
First Posted
October 5, 2023
Study Start
October 1, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2027
Last Updated
February 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- starting 6 months after publication
- Access Criteria
- Aggregate data will be shared through manuscripts, reports and conference presentations. Corresponding Limited Data Sets (LDS) shared will include all the variables contained within our datasets (except for the 18 HIPAA identifiers). This will allow validation of our results by the recipients. Requests may be submitted to Fasiha Kanwal, MD, the overall PI, starting 6 months after publication and up to 4 years after the study ends.
Data sharing will be accomplished through manuscript publications and presentations at scientific conferences. Requests for Limited Datasets (LDS) will be considered with appropriate data use agreements (DUAs) and IRB approvals. We will remove all HIPAA identifiers before sharing datasets. DUAs will limit use of the dataset and prohibit the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.