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

基本信息

批准号：
10560559
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
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-02-01 至 2025-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10560559
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 Hospitals Injectable Instruction Internet Intervention Liver diseases Measures Medical Monitor Moods Naltrexone Nurses 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 consequences alcohol craving alcohol effect alcohol intervention alcohol measurement alcohol monitoring alcohol relapse alcohol services alcohol use disorder biomarker validation 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 text messaging tau Proteins transplantation therapy treatment adherence treatment as usual treatment services

项目摘要

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) 是第二大常见的肝病适应症移植（LT）。传统上，ALD 患者必须完成为期六个月的强制治疗期 LT 前戒酒。最近，针对严重酒精性肝炎的早期 LT 无需任何移植前酒精治疗，因为与此相关的医疗敏锐度和死亡率很高疾病。重要的是，迄今为止有限的研究表明早期 (ELT) 与标准（SLT）移植受者。重新饮酒是所有患有 ALD 的 LT 接受者的一个主要问题，据估计，酒精复吸率在 16% 到 49% 之间。尽管大多数 LT 诊所都强制执行 LT 前治疗尽管酒精治疗风险高且严重，但对 LT 后服务的关注却少之又少。在此期间复发的后果。有许多基于证据的治疗酒精的方法使用障碍（澳元）。近年来，我们的团队和其他人开发了基于网络和文本的版本这些有经验支持的干预措施旨在扩大其在正规酒精诊所之外的影响范围和可复制性设置。在非传统环境中实施 AUD 干预措施是可行的、患者可以接受的，并且有效减少饮酒。我们建议实施酒精治疗并评估其效果纳入常规 LT 后护理。所有患者都会收到医生的指示，停止饮酒并参与酒精服务（照常治疗：TAU）。 ELT (N=100) 和 SLT (N=100) 患者将被随机分组 2:1 基础上进行综合 AUD 治疗 (IAT) 或 TAU。 IAT 将包括医院中计算机交付的 BI，护士在每次门诊 LT 随访时提供酒精监测咨询，并在家参与在基于网络的 7 次 CBT4CBT 中进行，并辅以定制的短信。也因为有证据 ALD 患者向 LT 提供者显着少报饮酒情况，我们将比较 LT 后的饮酒情况使用经过充分验证的近期饮酒生物标志物（PEth）确定复发率，患者根据经过验证的自我报告酒精仪器，患者向其 LT 提供者报告。最后，我们将确定 LT 后酒精的预测因素 ELT 和 SLT 患者的使用和治疗参与度。主要措施包括：饮酒；参与酒精治疗；移植后后续护理的保留；情绪和焦虑；和质量生活。鉴于 ELT 和 SLT 接受者酒精复发的严重后果，至关重要的是在移植后早期准确识别酒精使用情况并实施酒精干预措施优化短期和长期患者治疗结果，并最终为这一高危人群制定治疗方案。