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: 10356014
• 负责人: MARY E MCCAUL
• 金额: $ 42.19万
• 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/10356014
• 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; 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; tailored messaging; 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）是肝脏疾病的第二大常见适应症。 移植（LT）。传统上，ALD患者被要求完成为期六个月的强制性治疗期， LT前戒酒。最近，重型酒精性肝炎的早期LT正在进行， 任何移植前的酒精治疗，因为高医疗敏锐度和死亡率与此相关 疾病重要的是，迄今为止有限的研究表明，早期（ELT）与 标准（非标准）移植受者。恢复饮酒是所有ALD LT接受者的主要问题， 估计酒精复发率在16%到49%之间。虽然大多数LT诊所都强制执行LT前 酒精治疗，远不重视LT后服务，尽管高风险和严重 在此期间复发的后果。许多基于证据的治疗方法可用于酒精 使用障碍（AUD）。近年来，我们的团队和其他人开发了基于Web和文本的版本， 这些医疗支持的干预措施，以扩大其覆盖面和复制以外的正规酒精诊所， 设置.在非传统环境中进行AUD干预是可行的，患者可以接受， 有效减少酒精使用。我们建议实施和评估酒精治疗的效果 纳入常规LT后护理。所有患者都接受医生的指导，停止饮酒， 酒精服务（治疗照常：TAU）。ELT（N=100）和ELT（N=100）患者将随机分配至 2：1的基础上，综合AUD治疗（IAT）或TAU。IAT将包括医院中的计算机交付BI， 在每次门诊LT随访时由护士提供酒精监测咨询，并在家中参与 以网络为基础，举行7次“能力建设对能力建设”会议，并辅以专门的文字信息。同时，由于证据 ALD患者严重低估了他们对LT提供者的饮酒情况，我们将比较LT后的酒精含量， 复发率使用最近饮酒（PEth）的有效生物标志物，患者自我报告， 酒精仪器和患者报告给他们的LT提供者。最后，我们将确定LT后酒精的预测因素 使用和治疗参与ELT和慢性阻塞性肺病患者。主要措施包括：饮酒; 参与酒精治疗;保留在移植后的后续护理;情绪和焦虑;和质量 生活考虑到ELT和ESTA接受者中酒精复发的严重后果， 准确识别酒精使用，并在移植后早期实施酒精干预， 优化患者的短期和长期结果，并最终为这一高风险人群量身定制治疗。