Veteran-Centered Care for Advanced Liver Disease

(Vet-CALD Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Fasiha Kanwal, MD MSHS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Non-veterans, Advanced cancer, Schizophrenia, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment I-VCALD, Vet-CALD, Veteran-Centered Care for Advanced Liver Disease?

Research suggests that integrated care models, like the one used in the Veteran-Centered Care for Advanced Liver Disease, can improve outcomes by aligning treatments with patient priorities and reducing unplanned hospital visits, as seen in a nurse-led clinic for liver cirrhosis. ^{1 2 3 4 5}

How is the Veteran-Centered Care treatment for advanced liver disease different from other treatments?

This treatment is unique because it focuses on integrating early supportive and palliative care with curative treatments, allowing patients, caregivers, and clinicians to collaboratively identify care that aligns with the patient's priorities, which is not commonly emphasized in standard treatments for advanced liver disease. ^{2 4 6 7 8}

Eligibility Criteria

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.

Inclusion Criteria

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

You must be a Veteran to qualify.

You have been under the care of one of the participating sites for at least 12 consecutive months, including two or more visits to your primary healthcare provider.

Exclusion Criteria

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

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Vet-CALD intervention, which includes 5 monthly 60-minute care counselor sessions over 6 months via telehealth

6 months

5 visits (virtual)

Follow-up

Participants are monitored for changes in consideration for liver transplantation and goals of care conversations

12 months

Treatment Details

Interventions

• I-VCALD (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Arm 1: Vet-CALD Intervention Experimental Treatment 1 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 Care Active Control 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Central Arkansas Veterans Healthcare System , Little Rock, AR Little Rock, AR

VA Palo Alto Health Care System, Palo Alto, CA Palo Alto, CA

VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles, CA

Michael E. DeBakey VA Medical Center, Houston, TX Houston, TX

More Trial Locations

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

A novel, nurse-led 'one stop' clinic for patients with liver cirrhosis results in fewer liver-related unplanned readmissions and improved survival. [2023] Delivering effective secondary preventive and integrated care has the potential to break the revolving-door phenomenon of frequent readmissions in patients with advanced chronic liver disease. To address this, we launched the Care Coordination of Liver Disease (CCoLD) pilot, a novel nurse-led cirrhosis clinic in Western Sydney.

2. United States pubmed.ncbi.nlm.nih.gov

Improving Advance Care Planning in Outpatients With Decompensated Cirrhosis: A Pilot Study. [2021] Despite significant morbidity and mortality among patients with decompensated cirrhosis, reported rates of advance directive (AD) completion and goals of care discussions (GCDs) between patients and providers are very low. We aimed to improve these rates by implementing a hepatologist-led advance care planning (ACP) intervention.

3. United States pubmed.ncbi.nlm.nih.gov

Resource utilization and survival among Medicare patients with advanced liver disease. [2021] The prevalence of advanced liver disease and its complications may be on the rise within the Medicare population. The study aim was trend assessment for prevalence, mortality and resource utilization of patients with advanced liver disease.

4. United States pubmed.ncbi.nlm.nih.gov

Integrated Model for Patient-Centered Advanced Liver Disease Care. [2022] Advanced liver disease (AdvLD) is a high-risk common condition with a progressive, highly morbid, and often fatal course. Despite effective treatments, there are substantial shortfalls in access to and use of evidence-based supportive and palliative care for AdvLD. Although patient-centered, chronic illness models that integrate early supportive and palliative care with curative treatments hold promise, there are several knowledge gaps that hinder development of an integrated model for AdvLD. We review these evidence gaps. We also describe a conceptual framework for a patient-centered approach that explicates key elements needed to improve integrated care. An integrated model of AdvLD would allow clinicians, patients, and caregivers to work collaboratively to identify treatments and other healthcare that best align with patients' priorities.

5. United States pubmed.ncbi.nlm.nih.gov

Core implementation strategies for improving cirrhosis care in the Veterans Health Administration. [2023] The Veterans Health Administration (VHA) provides care for more than 80,000 veterans with cirrhosis. This longitudinal, multimethod evaluation of a cirrhosis care quality improvement program aimed to (1) identify implementation strategies associated with evidence-based, guideline-concordant cirrhosis care over time, and (2) use qualitative interviews to operationalize strategies for a manualized intervention.

6. United States pubmed.ncbi.nlm.nih.gov

Access to Comprehensive Services for Advanced Liver Disease in the Veterans Health Administration. [2022] The Veterans Health Administration (VHA) provides care to the one of the largest cohorts of patients with advanced liver disease (ALD) in the USA.

7. United States pubmed.ncbi.nlm.nih.gov

Comprehensive Care of Patients with Chronic Liver Disease. [2015] Chronic liver disease results from a wide range of conditions, for which individual management is beyond the scope of this article. General education, counseling, and harm reduction practices are important to the primary care of these patients, as are monitoring for cirrhosis and management of its complications. For patients with advanced liver disease, comprehensive care includes considering referral for liver transplantation, educating and empowering patients to prioritize goals of care, and optimizing symptom relief.

8. United States pubmed.ncbi.nlm.nih.gov

Advance care planning (ACP) for specialists managing cirrhosis: A focus on patient-centered care. [2018] Advance care planning (ACP) and goals of care designation (GCD) are being integrated into modern health care. In cirrhosis, uptake and adoption of these practices have been limited with physicians citing many perceived barriers and limitations. Recognizing the many tangible benefits of ACP and GCD processes in patients with life-limiting chronic diseases, the onus is on health practitioners to initiate and direct these conversations with their patients and surrogates. Drawing upon the literature and our experiences in palliative care and cirrhosis, we provide an actionable framework that can be readily implemented into a busy clinical setting by a practitioner. Conversation starters, visual aids, educational resources (for patients and practitioners), and videos of mock physician-patient scenarios are presented and discussed. Importantly, we have customized each of these tools to meet the unique health care needs of patients with cirrhosis. The inherent flexibility of our approach to ACP discussions and GCD can be further modified to accommodate practitioner preferences.