Liver DiseasesVet-CALDNCT06068491
Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)
A study testing Vet-CALD in people with Liver Diseases, run by VA Office of Research and Development at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Vet-CALD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Oct 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-Veteran patients
- Patients who do not speak English, do not have access to a telephone or computers, have cognitive impairments, 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Juana Campos, MA contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
Donna L Smith, MEd, 713-440-4423, Donna.Smithd19d7@va.gov
Fasiha Kanwal, MD, 7134404495, Fasiha.Kanwal@va.gov
- Recruiting
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Juana Campos, MA, juana.campos@va.gov
Fasiha Kanwal, MD MSHS, (713) 440-4495, Fasiha.Kanwal@va.gov
- Recruiting
Central Arkansas Veterans Healthcare System , Little Rock, AR
Little Rock, Arkansas, 72205
Donna L Smith, MEd, (713) 440-4423, Donna.Smithd19d7@va.gov
Fasiha Kanwal, MD MSHS, (713) 440-4495, Fasiha.Kanwal@va.gov
- Not yet recruiting
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
Donna L Smith, MEd, 713-440-4423, Donna.Smithd19d7@va.gov
Fasiha Kanwal, MD, 7134404495, Fasiha.Kanwal@va.gov
- Not yet recruiting
Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
Donna L Smith, MEd, 713-440-4423, Donna.Smithd19d7@va.gov
Fasiha Kanwal, MD, 7134404495, Fasiha.Kanwal@va.gov
- Recruiting
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1207
Donna L Smith, MEd, (713) 440-4423, Donna.Smithd19d7@va.gov
Fasiha Kanwal, MD MSHS, (713) 440-4495, Fasiha.Kanwal@va.gov
- Not yet recruiting
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Donna L Smith, MEd, 713-440-4423, Donna.Smithd19d7@va.gov
Fasiha Kanwal, MD, 7134404495, Fasiha.Kanwal@va.gov
- Recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Donna L Smith, MEd, 713-440-4423, Donna.Smithd19d7@va.gov
Fasiha Kanwal, MD, 7134404495, Fasiha.Kanwal@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Diseases
- Being tested
- Vet-CALD
- Keywords
- Patient-Centered Care, Randomized Controlled Trial, Delivery of Healthcare, Integrated
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vet-CALDOther
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 group | Role | What they receive |
|---|---|---|
| Arm 1: Vet-CALD Intervention | Experimental | 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. Receives: Other: Vet-CALD |
| Arm 2: Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 and 12 months
Secondary outcomes (5)
Receipt of goal concordant care
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.
Measured: 6 months
Health Related Quality of Life (HRQoL)
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.).
Measured: 6 months
Perceived quality of shared decision-making
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)
Measured: 6 months
Satisfaction with care
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).
Measured: 6 months
Quality of symptomatic advanced liver disease (AdvLD) care
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Oct 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a hybrid type 1 effectiveness-implementation study utilizing formative implementation assessment prior to an effectiveness trial and assessment of implementation outcomes following the trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Fasiha Kanwal, MD MSHS, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TXAnne M Walling, MD PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CASteven M. Asch, MD MPH, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068491
- Sponsor's protocol ID
- IIR 21-230
- Other IDs
- 1I01HX003541-01A1
- Acronym
- Vet-CALD
- Status last verified
- Jun 2026
- First submitted
- 28 Sep 2023
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38445559
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Veteran-Centered Care for Advanced Liver Disease (I-VCALD)
- ClinicalTrials.gov ID
- NCT06068491
- Acronym / sponsor ID
- Vet-CALD / IIR 21-230
- Conditions
- Liver Diseases
- Keywords
- Patient-Centered Care, Randomized Controlled Trial, Delivery of Healthcare, Integrated
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a hybrid type 1 effectiveness-implementation study utilizing formative implementation assessment prior to an effectiveness trial and assessment of implementation outcomes following the trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Vet-CALD Intervention | Experimental | Other: Vet-CALDVet-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 intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Non-Veteran patients
- Patients who do not speak English, do not have access to a telephone or computers, have cognitive impairments, 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vet-CALDVet-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 | Arm 1: Vet-CALD Intervention |
Primary outcome
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.
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.
5 secondary outcomes
Receipt of goal concordant care
Time frame: 6 months
Health Related Quality of Life (HRQoL)
Time frame: 6 months
Perceived quality of shared decision-making
Time frame: 6 months
Satisfaction with care
Time frame: 6 months
Quality of symptomatic advanced liver disease (AdvLD) care
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Results publication: PubMed 38445559Kanwal 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juana Campos, MA contact
Fasiha Kanwal, MD MSHS principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
Anne M Walling, MD PhD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Steven M. Asch, MD MPH principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vet-CALD in people with Liver Diseases, run by VA Office of Research and Development at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juana Campos, MA (juana.campos@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EHR documentation of consideration for liver transplantation change (time frame: 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06068491, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.