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| ID | Type | Description | Link |
|---|---|---|---|
| P50AA027054 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Support Specialist (PSS) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Consumption | Any use or excessive use (i.e., >7/>14 drinks per week for women/men) by biomarker or self-report | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Transplant Medical Treatment Engagement | Proportion of kept/scheduled LT follow-up medical appointments | Up to 1 year |
| Overall Post-Liver Transplant Survival | All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Po-Hung Chen, MD, PhD | Contact | 410-550-1793 | pchen37@jhmi.edu | |
| Mary E. McCaul, PhD | Contact | 410-955-9526 | mmccaul1@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Po-Hung Chen, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
Patient reported outcomes and phosphatidylethanol biomarker results
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Data will be shared with the general research community at the time of an associated publication, or the end of the award/grant period, whichever comes first. Data will be shared indefinitely.
Summaries of NIAAA Data Archive (NIAAADA) data are publicly available to anyone through the NDA Query Tool without an account. Access to individual participant data and supporting documentation is limited to qualified researchers who create an NDA account and submit a Data Access Request (DAR), including completion of the NDA Data Use Certification (DUC). Requests are reviewed by a NIAAA committee to ensure responsible data use. Individual-level data are accessed through the NDA Query Tool once approval is granted.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Up to 1 year |