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 — OTHER
    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.

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 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.

Primary Outcome Measure

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

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Central Arkansas Veterans Healthcare System , Little Rock, ARLittle RockArkansas72205
Donna L Smith, MEd
713-440-4423
Fasiha Kanwal, MD MSHS
(713) 440-4495
Ragesh B Thandassery, MD (SUB_INVESTIGATOR)
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Donna L Smith, MEd
713-440-4423
Fasiha Kanwal, MD
7134404495
VA Palo Alto Health Care System, Palo Alto, CAPalo AltoCalifornia94304-1207
Donna L Smith, MEd
713-440-4423
Fasiha Kanwal, MD MSHS
(713) 440-4495
Steven M. Asch, MD MPH (PRINCIPAL_INVESTIGATOR)
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Donna L Smith, MEd
713-440-4423
Fasiha Kanwal, MD
7134404495
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Donna L Smith, MEd
713-440-4423
Fasiha Kanwal, MD
7134404495
Miami VA Healthcare System, Miami, FLMiamiFlorida33125
Donna L Smith, MEd
713-440-4423
Fasiha Kanwal, MD
7134404495
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Donna L Smith, MEd
713-440-4423
Fasiha Kanwal, MD
7134404495
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Juana Campos, MA
Fasiha Kanwal, MD MSHS
(713) 440-4495
Fasiha Kanwal, MD MSHS (PRINCIPAL_INVESTIGATOR)

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