Oral v Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism

医院口服纳曲酮与注射纳曲酮：治疗酒精中毒的效果比较

基本信息

批准号：
9121362
负责人：
RICHARD SAITZ
金额：
$ 86.54万
依托单位：
BOSTON UNIVERSITY MEDICAL CAMPUS
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-25 至 2019-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9121362
关键词：
Accident and Emergency department Accreditation Acute Address Adherence Admission activity Adopted Alcohol consumption Alcohol dependence Alcoholism Alcohols Behavioral Caring Cause of Death Characteristics Cost Effectiveness Analysis Counseling Disease Dose Effectiveness Emergency Situation Enrollment FDA approved General Hospitals Half-Life Health Heavy Drinking Hospital Departments Hospitalization Hospitals Hour Injectable Injection of therapeutic agent Inpatients Intervention Joints Knowledge Left Link Measures Medical Naltrexone Oral Outcome Patient Preferences Patients Performance Persons Pharmaceutical Preparations Pharmacotherapy Prevalence Professional Organizations Quality of Care Randomized Randomized Controlled Trials Risk Risk Factors Specialist Tablets Testing Time Translating Urban Hospitals Visit Work addiction alcohol abuse therapy alcohol consequences alcohol misuse alcoholism therapy alternative treatment base care seeking clinically relevant comparative effectiveness cost cost effective cost effectiveness design disability drinking effective therapy effectiveness trial follow-up health care service utilization high risk hospital readmission improved innovation inpatient service interest medical specialties medically necessary care primary outcome randomized trial response screening standard care standard of care treatment program

项目摘要

DESCRIPTION (provided by applicant): As many as 40% of general medical hospital admissions are linked to alcohol, and alcohol dependence (AD) is a risk factor for readmission (a marker of poor quality of care for which hospitals are financially penalized). Yet most inpatients with AD receive no effective treatment, leaving them vulnerable to both alcohol-specific consequences, and the deleterious effects of untreated AD on medical conditions and related healthcare utilization. Pharmacotherapy for AD (oral tablet naltrexone, PO-NTX; extended-release injectable naltrexone, XR-NTX) has efficacy but unlike treatments for other medical conditions routinely started at hospital discharge it is rarely prescribed. In addition, litle is known about the effectiveness of pharmacotherapy under real-world conditions compared to other clinically available options, and clinicians have little evidence upon which to base decisions to prescribe a costly (per dose) monthly injection or a daily tablet (that may be less adhered to). Therefore, this proposal (in response to PAS-10-273 Clinically Relevant Comparative Effectiveness of Alcoholism Treatments) aims to test the effectiveness of beginning XR-NTX and PO-NTX for AD in medical inpatients at the time of hospital discharge in a pragmatic comparative effectiveness randomized trial. In the Alcohol Dependence hospital Treatment (ADOPT) study, inpatients will receive counseling in the hospital and at follow-up that is feasible in medical settings, and be randomly assigned to monthly XR-NTX, daily PO- NTX or no medication. The primary outcome is percent heavy drinking days; additional outcomes of interest include alcohol consequences, medical healthcare utilization (hospital and emergency department), AD treatment utilization, and costs. The main hypotheses are that 1) XR-NTX will have greater effectiveness than PO-NTX and 2) than no medication, and that 3) PO-NTX will have greater effectiveness than no medication on drinking, consequences and utilization. Cost-effectiveness analysis will compare the costs and outcomes of the three alternatives. Patient factors that moderate effectiveness will be explored. The study is innovative in its design as a pragmatic comparative effectiveness trial, and because it addresses a question that is unanswered but highly relevant. It is timely in that a national accreditation body recently implemented quality performance measures of AD treatment at hospital discharge despite the absence of evidence for effectiveness in that circumstance. The significance of the study is that results will provide guidance for clinicians and policymakers regarding initiation of pharmacotherapy for alcohol dependence for patients at high risk for costly health consequences who largely receive no effective care at the time of hospital discharge.

描述（由申请人提供）：多达40％的一般医疗医院入院与酒精有关，酒精依赖（AD）是再入院的危险因素（医院在财务上受到惩罚的护理质量差的标志）。然而，大多数AD住院患者都没有得到有效的治疗，使它们容易受到酒精特定后果的影响，并且未经治疗的AD对医疗状况和相关医疗保健利用的有害影响。 AD的药物治疗（口服片剂Naltrexone，PO-NTX；扩展释放的可注射纳曲酮，XR-NTX）具有疗效，但与其他医疗状况的治疗不同，通常在医院出院时开始使用，很少有规定的处方。此外，与其他临床上可用的选择相比，LITLE知道药物疗法在现实情况下的有效性，而临床医生几乎没有证据可以基于确定规定昂贵（每剂）每月注射或每日片剂（可能不太遵守）的决定。因此，该提案（响应于酒精中毒治疗的PAS-10-273临床相关的比较有效性）旨在测试在医院出院时在医疗住院治疗中开始XR-NTX和PO-NTX在一项务实的比较比较有效性随机试验中的有效性。在酒精依赖医院的治疗（采用）研究中，住院病人将在医院和随访中接受咨询，在医疗环境中可行，并随机分配给每月XR-NTX，每日PO-NTX或没有药物。主要结果是大量饮酒的百分比。感兴趣的其他结果包括酒精后果，医疗保健利用（医院和急诊科），AD治疗利用以及成本。主要的假设是1）XR-NTX比PO-NTX和2）比没有药物更有效力，而3）PO-NTX的有效性比没有对饮酒，后果和利用的药物更大。成本效益分析将比较三种选择的成本和结果。将探索中等有效性的患者因素。这项研究是一项务实的比较有效性试验的创新性，并且因为它解决了一个尚未回答但高度相关的问题。及时的是，尽管在这种情况下没有有效性的证据，但国家认证机构最近在出院时在出院时实施了质量绩效指标。该研究的意义在于，结果将为临床医生和决策者提供指导，以启动对酒精依赖的药物疗法，以造成昂贵的健康后果的高风险患者，他们在出院出院时在很大程度上没有获得有效的护理。