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：
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
项目类别：
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

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）是肝脏的第二常见指示移植（LT）。传统上，ALD患者被要求完成六个月的强制性期限 Lt之前的酒精禁欲。最近，正在不用进行严重酒精性肝炎的早期LT没有由于与此相关的医疗敏锐度和死亡率很高，任何移植前酒精治疗疾病。重要的是，迄今的有限研究表明，早期（ELT）与标准（SLT）移植接受者。返回饮酒是所有具有ALD的LT接收者的主要问题，酒精复发的估计在16％至49％之间。尽管大多数LT诊所都执行了前LT 酒精治疗，尽管风险很高，但对LT后服务的关注程度要少得多在此期间复发的后果。酒精可用于众多循证治疗使用障碍（AUD）。近年来，我们的小组和其他人开发了基于网络和文本的版本这些经验支持的干预措施，以扩大正式酒精诊所之外的覆盖范围和可复制性设置。在非传统设置中提供AUD干预措施是可行的，患者可以接受的，并且有效减少饮酒。我们建议实施和评估酒精治疗的影响集成到常规LT护理中。所有患者都会收到医生的说明，以停止饮酒和参与酒精服务（照常治疗：tau）。 ELT（n = 100）和SLT（n = 100）患者将在A上随机分配 2：1综合AUD处理（IAT）或TAU的基础。 IAT将在医院中包括计算机交付的BI，每次门诊LT随访和在家参与的护士饮酒监测咨询在基于Web的7条CBT4CBT中，并补充了量身定制的短信。另外，由于证据 ALD患者将其饮酒大大低估给LT提供商，我们将比较LT酒精后使用近期饮酒的验证生物标志物（Peth），患者自我报告经过验证的复发率酒精仪器和患者向其LT提供商报告。最后，我们将确定LT酒精后的预测因子 ELT和SLT患者使用和治疗参与。关键措施将包括：饮酒；参与酒精治疗；保留移植后的随访护理；情绪和焦虑；和质量生活。鉴于ELT和SLT接受者之间酒精复发的严重后果，至关重要准确识别饮酒并在移植后期初期实施酒精干预措施优化短期和长期患者的结果，并最终针对这种高危人群量身定制治疗。