Alcohol Related Liver Disease, Alcohol Use Disorder, Liver Transplant Recipient
Conditions
Keywords
Alcohol use disorder, Alcohol Related Liver Disease, Liver transplant recipient, Peer support specialist
Brief summary
Liver transplant (LT) recipients with a history of alcohol-related liver disease (ALD) may encounter various psychosocial and medical challenges during post-LT recovery, even beyond the initial post-transplant period. Effective and sustainable interventions will be crucial for improving patient outcomes. This clinical trial will examine the impact of peer support specialists (PSS) on the recovery experience of individuals who received LT for ALD. The trial seeks to answer two main questions: * Are LT recipients who work with PSS less likely to resume alcohol use or tend to drink less overall? * Do LT recipients who work with PSS engage more with recommended medical care and have better overall survival?
Detailed description
In the United States, ALD is the most common indication for LT. Resuming alcohol use is a major concern for all LT recipients with a history of ALD, with estimates ranging from 16% to 49% and increasing with more time since LT. Although most LT programs have required pre-LT alcohol treatment, post-LT services have been far more heterogeneous, despite the potentially severe consequences of alcohol relapse during this period. The present study proposes implementing and evaluating a care model for LT recipients with a history of ALD after the first post-LT year. The investigators will conduct a single-arm clinical trial to integrate PSS into routine medical care starting in years 2 through 4 following LT. The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will first receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality. The PSS will then meet with study participants at regular intervals between standard clinic visits. The investigators will follow participants working with PSS for 1 year and compare the participants with a historical control group of transplant recipients without PSS to determine whether the intervention improves outcomes. Key endpoints will include alcohol use (by self-report and biomarker), retention in post-transplant medical care, and overall survival.
Interventions
BEHAVIORALPeer Support
The study will recruit PSS based on lived experiences with ALD/LT and interpersonal skills. The PSS will receive tailored skills training from the study team in areas such as delivering brief counseling, active listening, and maintaining confidentiality. Participants will meet regularly with a PSS between standard clinic visits throughout a one-year study period. The PSS will deliver brief counseling interventions at each session. Study investigators will meet with the PSS at scheduled intervals to review progress. Study investigators will also review up to 20% of the audio recordings of sessions between PSS and study participants to assess fidelity to the intervention protocol.
Sponsors
Johns Hopkins University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speakers * Received a liver transplant for alcohol-associated liver disease * Has 1 to 3 years of continuous alcohol abstinence at the time of trial entry
Exclusion criteria
* Liver transplant recipients without a history of alcohol-associated liver disease * Inability to provide informed consent * Active participation in a separate intervention trial for alcohol use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption | Up to 1 year | Any use or excessive use (i.e., \>7/\>14 drinks per week for women/men) by biomarker or self-report |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Transplant Medical Treatment Engagement | Up to 1 year | Proportion of kept/scheduled LT follow-up medical appointments |
| Overall Post-Liver Transplant Survival | Up to 1 year | All-cause mortality |
Countries
United States
Contacts
CONTACTPo-Hung Chen, MD, PhD
CONTACTMary E. McCaul, PhD
PRINCIPAL_INVESTIGATORPo-Hung Chen, MD, PhD
Johns Hopkins University
Outcome results
None listed