Oral v Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism

描述（由申请人提供）：多达40%的普通医院入院与酒精有关，酒精依赖（AD）是再入院的一个风险因素（这是医疗质量差的标志，医院会受到经济惩罚）。然而，大多数AD住院患者没有得到有效的治疗，使他们容易受到酒精特异性后果的影响，以及未经治疗的AD对医疗条件和相关医疗保健利用的有害影响。药物治疗阿尔茨海默病（口服片剂纳曲酮，PO-NTX；缓释注射纳曲酮，XR-NTX）有疗效，但不像其他医疗条件的治疗通常在出院时开始，很少开处方。此外，与其他临床可用的选择相比，药物治疗在现实条件下的有效性知之甚少，临床医生几乎没有证据来决定是每月（每剂量）昂贵的注射还是每日片剂（可能不太坚持）。因此，本提案（响应PAS-10-273酒精中毒治疗的临床相关比较有效性）旨在通过一项实用的比较有效性随机试验，测试在出院时开始使用XR-NTX和PO-NTX治疗住院患者AD的有效性。在酒精依赖医院治疗（ADOPT）研究中，住院患者将在医院接受咨询，并在医疗机构可行的随访中接受咨询，并随机分配每月XR-NTX，每日PO- NTX或不用药。主要指标是重度饮酒天数的百分比；其他值得关注的结果包括酒精后果、医疗保健利用（医院和急诊科）、AD治疗利用和费用。主要假设是：1)XR-NTX比PO-NTX更有效，2)比不用药更有效，3)PO-NTX在饮酒、后果和利用方面比不用药更有效。成本效益分析将比较三种替代方案的成本和结果。探讨影响疗效适中的患者因素。这项研究的创新之处在于它的设计是一个实用的比较有效性的试验，因为它解决了一个没有答案但高度相关的问题。这是及时的，因为一个国家认证机构最近实施了出院时AD治疗的质量绩效指标，尽管在这种情况下缺乏有效性的证据。这项研究的意义在于，研究结果将为临床医生和政策制定者提供指导，指导他们对酒精依赖患者进行药物治疗，这些患者在出院时大多没有得到有效的治疗。

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.