Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT06068491
- Status
- Recruiting
Conditions
- Liver Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Vet-CALD — OTHERVet-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.
Study Details
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.
Key Dates
- Start date
- Oct 1, 2024
- Status verified
- Feb 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 450 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Arm 1: Vet-CALD InterventionVet-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 CareUsual 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.
Primary Outcome Measure
EHR documentation of consideration for liver transplantation change [ Time Frame: 6 and 12 months ]
Central Contacts
- Juana Campos, MA
- Fasiha Kanwal, MD MSHS(713) 440-4495
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System , Little Rock, AR | Little Rock | Arkansas | 72205 | Ragesh B Thandassery, MD (SUB_INVESTIGATOR) |
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California | 90822 | |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | Steven M. Asch, MD MPH (PRINCIPAL_INVESTIGATOR) |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | |
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | |
| Miami VA Healthcare System, Miami, FL | Miami | Florida | 33125 | |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216-7167 | |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | Juana Campos, MA Fasiha Kanwal, MD MSHS (PRINCIPAL_INVESTIGATOR) |
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