Veteran-Centered Care for Advanced Liver Disease (Vet-CALD) (Vet-CALD)

February 3, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 increasing symptoms and hospitalizations. Although many patients hope for curative liver transplantation, few receive it while experiencing an increasingly severe illness. In previous studies, many patients with AdvLD reported unmet curative and supportive care needs. They also reported preferences to align care with their outcome goals earlier in the AdvLD course than is now common. The Vet-CALD program is a Whole Health program in AdvLD that focuses on what matters most to patients, shared goals, and goal-aligned treatments, and could improve both curative and supportive care.

Project Objectives: The overall goal of the Vet-CALD project is to develop and test a novel sustainable Whole Health program in caring for patients with AdvLD. Using a hybrid type 1 effectiveness-implementation study design, the project will: (Aim 1) conduct a formative assessment of Vet-CALD implementation for Veterans with AdvLD; (Aim 2) evaluate the effectiveness of Vet-CALD in a randomized controlled study at 8 VA centers; and (Aim 3) conduct a summative assessment of implementation outcomes.

Project Methods: In Aim 1, the study team will conduct in-depth qualitative interviews with clinical stakeholders and patients to identify steps necessary to refine the Vet-CALD intervention, develop engagement processes for patients, and establish integrated workflows at the four targeted VA sites.

In Aim 2 the study team will conduct a randomized clinical trial (N=450) with patients from 8 VA medical centers assigned (1:1) to Usual Care vs. Vet-CALD Intervention. The Vet-CALD intervention will consist of a centralized research care counselor who will work with individual patients by telehealth (3 to 5 visits over 6 months) to assess and cultivate their understanding of their illness and identify personal healthcare goals. The counselor will be part of a centralized care team (hepatologist and supportive care physician) and will work with each patient's usual 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.

In Aim 3, Summative assessment will provide context for the effectiveness results and inform necessary adaptations to and dissemination of Vet-CALD.

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Central Arkansas Veterans Healthcare System , Little Rock, AR
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ragesh B Thandassery, MD
    • California
      • Long Beach, California, United States, 90822
        • Not yet recruiting
        • VA Long Beach Healthcare System, Long Beach, CA
        • Contact:
        • Contact:
      • Palo Alto, California, United States, 94304-1207
        • Recruiting
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steven M. Asch, MD MPH
      • West Los Angeles, California, United States, 90073-1003
        • Recruiting
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • Contact:
        • Contact:
    • Connecticut
      • West Haven, Connecticut, United States, 06516-2770
        • Not yet recruiting
        • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
        • Contact:
        • Contact:
    • Florida
      • Miami, Florida, United States, 33125
        • Not yet recruiting
        • Miami VA Healthcare System, Miami, FL
        • Contact:
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216-7167
        • Not yet recruiting
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
        • Contact:
        • Contact:
      • Houston, Texas, United States, 77030-4211
        • Recruiting
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Principal Investigator:
          • Fasiha Kanwal, MD MSHS
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other: Vet-CALD
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EHR documentation of consideration for liver transplantation change
Time Frame: 6 and 12 months
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
Time Frame: 6 and 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Receipt of goal concordant care
Time Frame: 6 months
Receipt of Goal Concordant Care will be measured using a 2-item survey. The first question defines patient preferences for either extending life or ensuring comfort. The second question assesses patients' perceptions of their current treatment with the same choices. The outcome is a dichotomous variable measuring whether preferences matched the patient's report of current care.
6 months
Health Related Quality of Life (HRQoL)
Time Frame: 6 months
HRQoL will be measured at baseline and 6-months using the 10-item Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 instrument, which measures general domains of health including physical function, emotional distress, social health, as well as perceptions of general health that cut across domains, plus fatigue and pain. PROMIS-10 items are scored from 1 to 5 (Poor to Excellent; Not at All to Completely; Always to Never; Very Severe to None) and averaged to provide a mean HRQoL score ranging from 1 to 5. (T-score, higher score indicates better HRQoL.).
6 months
Perceived quality of shared decision-making
Time Frame: 6 months
Perceived shared decision making will be measured using the 3-item CollaboRATE scale (scored 0 to 9; possible range 0-100; = 0.89 higher score indicates greater perceived shared decision-making and goal ascertainment)
6 months
Satisfaction with care
Time Frame: 6 months
Satisfaction with Care will be measured using the 4-item Satisfaction with Care - Feeling Heard and Understood survey. (scored 0-4; Not at All True to Completely True; possible range 0-16; higher score indicates greater satisfaction with care and goal ascertainment).
6 months
Quality of symptomatic advanced liver disease (AdvLD) care
Time Frame: 12 months
Quality of symptomatic care will be measured using a broad measure of quality based on selected AASLD's process-based quality indicators (QIs). Adherence to a given QI will be scored as 1 with evidence for satisfying the indicator. Quality of care at the patient level will be calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the 12-month follow up time.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Anne M Walling, MD PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Principal Investigator: Fasiha Kanwal, MD MSHS, Michael E. DeBakey VA Medical Center, Houston, TX
  • Principal Investigator: Steven M. Asch, MD MPH, VA Palo Alto Health Care System, Palo Alto, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 21-230
  • 1I01HX003541-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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