Design and protocol of the Buprenorphine plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) study: a randomized clinical trial of integrated outpatient treatment of opioid use disorder and severe, injection-related infections.
Design and protocol of the Buprenorphine plus Outpatient Parenteral Antimicrobial Therapy (B-OPAT) study: a randomized clinical trial of integrated outpatient treatment of opioid use disorder and severe, injection-related infections.
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DOI：
10.1177/20499361221108005
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发表时间：
2022-01
影响因子：
5.7
通讯作者：
Lofwall, Michelle R.
中科院分区：
文献类型：
--
作者：
Fanucchi, Laura C.;Murphy, Sean M.;Surratt, Hilary;Kapadia, Shashi N.;Walsh, Sharon L.;Grubbs, James A.;Thornton, Alice C.;Nuzzo, Paul;Lofwall, Michelle R.
严重注射相关感染（SIRI）住院治疗的显著增加与阿片类药物流行有关。门诊肠外抗生素治疗（OPAT）通常不提供给阿片类药物使用障碍（OUD）和SIRI患者，尽管越来越多的证据表明它可能是可行和安全的。本研究评估了丁丙诺啡治疗OUD与OPAT治疗SIRI（B-OPAT）相结合的综合护理模式与常规治疗OUD，传染病和卫生经济结果的疗效和成本效益。B-OPAT扩展并整合了已建立的临床模型的关键要素，包括OUD的丁丙诺啡住院治疗、SIRI的住院传染病咨询、OUD的办公室治疗和OPAT，并包括比标准OPAT更频繁的临床门诊访视。包括定性评价，以了解有效性结果的背景，并确定干预措施的采用和实施的障碍和促进因素。B-OPAT是一项单中心、随机、平行组、优效性试验，招募了90例因OUD和SIRI住院的成人住院患者，这些患者需要至少2周的静脉（IV）抗生素治疗。筛选后，合格的受试者以1：1的比例随机分配，一旦病情稳定，即可出院，接受丁丙诺啡和OPAT（B-OPAT）联合的综合门诊治疗护理模式，或接受药物治疗（TAU）。主要结果指标是出院后12周内非法阿片类药物阴性尿样的比例。关键的次要OUD结局包括自我报告的非法阿片类药物戒断天数和丁丙诺啡治疗的12周保留时间。感染结局包括完成推荐的IV抗生素治疗、外周插入中心静脉导管（PICC）并发症和与原发性SIRI相关的再入院。B-OPAT研究将有助于解决一个重要问题，即将OUD和SIRI患者出院到一个综合门诊护理模式中是否具有临床有效性和成本效益，该模式将OUD治疗与OPAT相结合，相对于TAU（Clinicaltrials.gov标识符：NCT 04677114）。
A marked increase in hospitalizations for severe, injection-related infections (SIRI) has been associated with the opioid epidemic. Outpatient parenteral antibiotic therapy (OPAT) is typically not offered to persons with opioid use disorder (OUD) and SIRI, though increasing evidence suggests it may be feasible and safe. This study evaluates the efficacy and cost-effectiveness of an integrated care model combining Buprenorphine treatment of OUD with OPAT for SIRI (B-OPAT) compared with treatment as usual on key OUD, infectious disease, and health economic outcomes. B-OPAT expands and incorporates key elements of established clinical models, including inpatient initiation of buprenorphine for OUD, inpatient infectious disease consultation for SIRI, office-based treatment of OUD, and OPAT, and includes more frequent clinical outpatient visits than standard OPAT. A qualitative evaluation is included to contextualize effectiveness outcomes and identify barriers and facilitators to intervention adoption and implementation. B-OPAT is a single-site, randomized, parallel-group, superiority trial recruiting 90 adult inpatients hospitalized with OUD and SIRI who require at least 2 weeks of intravenous (IV) antibiotic therapy. After screening, eligible participants are randomized 1:1 to either discharge once medically stable to an integrated outpatient treatment care model combining Buprenorphine and OPAT (B-OPAT) or to Treatment As Usual (TAU). The primary outcome measure is the proportion of urine samples negative for illicit opioids in the 12 weeks after discharge from the hospital. Key secondary OUD outcomes include self-reported number of days of illicit opioid abstinence and 12-week retention in buprenorphine treatment. The infection outcomes are completion of recommended IV antibiotic therapy, peripherally inserted central catheter (PICC) complications, and readmission related to primary SIRI. The B-OPAT study will help address the important question of whether it is clinically effective and cost-effective to discharge persons with OUD and SIRI to an integrated outpatient care model combining OUD treatment with OPAT relative to TAU (Clinicaltrials.gov Identifier: NCT04677114).
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影响因子：
3
作者：
Braithwaite, R. Scott;Meltzer, David O.;Roberts, Mark S.
通讯作者：
Roberts, Mark S.
影响因子：
39
作者：
Fiellin DA;Schottenfeld RS;Cutter CJ;Moore BA;Barry DT;O'Connor PG
通讯作者：
O'Connor PG
影响因子：
5.1
作者：
Fanucchi, Laura C.;Walsh, Sharon L.;Lofwall, Michelle R.
通讯作者：
Lofwall, Michelle R.
影响因子：
2.5
作者：
Bhandari, A;Wagner, T
通讯作者：
Wagner, T
影响因子：
4.2
作者：
D'Couto, Helen T.;Robbins, Gregory K.;Nelson, Sandra B.
通讯作者：
Nelson, Sandra B.