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

N/A

Recruiting

Led By Fasiha Kanwal, MD MSHS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have AdvLD, defined based on two ambulatory or one inpatient encounter ICD-10 codes for new onset cirrhosis complications or MELD-Na >15 in the previous 12 months

Patients will be between 18 and 80 years of age

Must not have

Patients with chart diagnosis of uncontrolled mental health or schizophrenia

Patients hospitalized, or in long term facilities or nursing homes at the time they meet inclusion criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help Veterans suffering from advanced liver disease by using a whole person, Veteran-centered approach to identify and match them with curative and supportive care. Outcomes of the study will inform how to better help those suffering.

Who is the study for?

This trial is for Veterans aged 18-80 with advanced liver disease who have been in care at a recruiting site for over a year. They must speak English, have phone or computer access, and be able to consent. Those already on the transplant list or with limited life expectancy are excluded.

What is being tested?

The I-VCALD study tests a telemedicine-based approach where nurses help Veterans understand their illness, identify care preferences, and align treatment options. It aims to increase rates of liver transplant consideration and serious illness discussions.

What are the potential side effects?

Since this intervention involves counseling rather than medication, typical drug side effects aren't expected. However, participants may experience emotional distress when discussing serious health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have advanced liver disease with recent complications or a MELD-Na score over 15.

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with uncontrolled mental health issues or schizophrenia.

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I am currently in a hospital, long-term care facility, or nursing home.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

EHR documentation of consideration for liver transplantation change

EHR documentation of goals of care conversation change

Secondary study objectives

Health Related Quality of Life (HRQoL)

Perceived quality of shared decision-making

Quality of symptomatic advanced liver disease (AdvLD) care

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Vet-CALD InterventionExperimental Treatment1 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.

Group II: Arm 2: Usual CareActive Control1 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.

0 / 4Eligibility criteria met