Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
Central Arkansas Veterans Healthcare System , Little Rock, AR
NOT_YET_RECRUITING
Little Rock
California
VA Palo Alto Health Care System, Palo Alto, CA
NOT_YET_RECRUITING
Palo Alto
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
NOT_YET_RECRUITING
West Los Angeles
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Contact Information
Primary
Donna L Smith, MEd
Donna.Smithd19d7@va.gov
(713) 440-4423
Backup
Fasiha Kanwal, MD MSHS
Fasiha.Kanwal@va.gov
(713) 440-4495
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 450
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov