Project 2-Optimization of Post-Transplant care via Biomarkers and Behavioral Interventions

项目 2 - 通过生物标志物和行为干预优化移植后护理

• 批准号: 10093987
• 负责人: MARY E MCCAUL
• 金额: $ 40.68万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10093987
• 关键词: Alcohol consumption; Alcoholic Hepatitis; Alcoholic Liver Diseases; Alcohols; Allografting; Anxiety; Attention; Behavior Therapy; Biological Markers; Caring; Cessation of life; Clinic; Clinical; Cognitive Therapy; Computers; Consumption; Counseling; Data; Disease; Disease Progression; Drug usage; Early Intervention; Ethanol; Evidence based treatment; Failure; Family; Heavy Drinking; Home; Hospital Nursing; Injectable; Instruction; Internet; Intervention; Liver diseases; Measures; Medical; Monitor; Moods; Naltrexone; Online Systems; Oral; Outcome; Outcome Measure; Outpatients; Patient Preferences; Patient Self-Report; Patient-Focused Outcomes; Patients; Persons; Pharmacotherapy; Physicians; Provider; Psychiatric therapeutic procedure; Quality of life; Randomized; Recording of previous events; Relapse; Reporting; Resources; Schedule; Services; Social support; Speed; Testing; Text; Text Messaging; Transplant Recipients; Transplantation; United States; Visit; alcohol abstinence; alcohol abuse therapy; alcohol availability; alcohol consequences; alcohol craving; alcohol effect; alcohol intervention; alcohol measurement; alcohol monitoring; alcohol relapse; alcohol services; alcohol use disorder; base; brief alcohol intervention; drinking; experience; follow-up; high risk; high risk population; implementation study; improved; individualized medicine; instrument; interdisciplinary approach; liver transplantation; mortality; post-transplant; prospective; psychiatric symptom; reduced alcohol use; relapse patients; specific biomarkers; transplantation therapy; treatment adherence; treatment as usual; treatment services

In the United States, alcoholic liver disease (ALD) is the second most common indication for liver transplant (LT). Traditionally, ALD patients have been required to complete a six-month mandatory period of alcohol abstinence before LT. More recently early LT for severe alcoholic hepatitis is being performed without any pre-transplant alcohol treatment because of the high medical acuity and mortality associated with this disease. Importantly, the limited studies to-date demonstrate comparable survival among early (ELT) versus standard (SLT) transplant recipients. Return to alcohol use is a major concern for all LT recipients with ALD, with estimates of alcohol relapse ranging between 16 and 49%. Although most LT clinics have enforced pre-LT alcohol treatment, far less attention has been paid to post-LT services, despite the high risk and severe consequences of relapse during this period. Numerous evidence-based treatments are available for alcohol use disorder (AUD). In recent years, our group and others have developed web- and text-based versions of these empirically-supported interventions to expand their reach and replicability outside of formal alcohol clinic settings. Delivery of AUD interventions in non-traditional settings is feasible, acceptable to patients, and effective in reducing alcohol use. We propose to implement and evaluate the effects of alcohol treatment integrated into routine post-LT care. All patients receive physician instructions to stop drinking and engage in alcohol services (treatment as usual: TAU). ELT (N=100) and SLT (N=100) patients will be randomized on a 2:1 basis to integrated AUD treatment (IAT) or TAU. IAT will include computer-delivered BI in the hospital, nurse-delivered alcohol monitoring counseling at each outpatient LT follow-up visit, and at-home participation in web-based, 7-session CBT4CBT, supplemented by tailored text messages. Also, because of the evidence that ALD patients significantly underreport their drinking to LT providers, we will compare post-LT alcohol relapse rates using a well-validated biomarker of recent drinking (PEth), patient self-report on a validated alcohol instrument, and patient report to their LT provider. Finally, we will identify predictors of post-LT alcohol use and treatment engagement for ELT and SLT patients. Key measures will include: alcohol use; engagement in alcohol treatment; retention in post-transplant follow-up care; mood and anxiety; and quality of life. Given the severe consequences of alcohol relapse among both ELT and SLT recipients, it is critical to accurately identify alcohol use and implement alcohol interventions early in the post-transplant period to optimize short- and long-term patient outcomes and ultimately tailor treatments for this high-risk population.

在美国，酒精性肝病（ALD）是第二个最常见的肝脏适应症