Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)
ConditionLiver Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorVA Office of Research and Development
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Vet-CALD
Other interventionVet-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.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Vet-CALD InterventionExperimental treatment 1 intervention
Group B: Arm 2: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 and 12 months2
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.
Time frame
6 and 12 monthsSecondary outcomes
1
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.
Time frame
6 months2
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.).
Time frame
6 months3
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)
Time frame
6 months4
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).
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov