DAT- Integrated Outpatient Treatment of Opioid Use Disorder and Injection-Related Infections

DAT-阿片类药物使用障碍和注射相关感染的综合门诊治疗

• 批准号: 10673063
• 负责人: Laura Fanucchi
• 金额: $ 66.47万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10673063
• 关键词: Abstinence; Address; Adoption; Alcohol consumption; Ambulatory Care; Antibiotic Therapy; Antibiotics; Buprenorphine; Catheters; Client satisfaction; Clinical; Counseling; Criminal Justice; Development; Dissemination and Implementation; Dose; Drug usage; Educational process of instructing; Effectiveness of Interventions; Endocarditis; Enrollment; Evidence based treatment; Health Care Costs; Health Care Sector; Health Services; Healthcare Systems; Home; Hospitalization; Hospitals; Illicit Drugs; Infection; Injections; Inpatients; Intervention; Interview; Intravenous; Investigation; Length of Stay; Medical; Medical Care Team; Methadone; Modeling; National Institute of Drug Abuse; Nosocomial Infections; Observational Study; Outcome; Outpatients; Participant; Patient Self-Report; Patient-Focused Outcomes; Patients; Peripheral; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Productivity; Provider; Quality-Adjusted Life Years; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Regimen; Research; Resources; Risk; Running; Sampling; Schedule; Self Administration; Supervision; Testing; Time; Tobacco Use Disorder; Urine; Work; addiction; buprenorphine treatment; clinical practice; cost; cost effective; cost effectiveness; economic evaluation; effectiveness outcome; future implementation; health care model; health care settings; health economics; illicit drug use; illicit opioid; improved; injection drug use; innovation; intravenous administration; opioid epidemic; opioid use; opioid use disorder; primary outcome; randomized, clinical trials; response; safety and feasibility; secondary outcome; standard of care; treatment as usual

ABSTRACT DAT18-06: Hospitalizations for complications of opioid use disorder (OUD), like infectious endocarditis (IE) and other severe, injection-related infections (SIRI), have increased dramatically along with the opioid epidemic. Persons with OUD hospitalized with SIRI, often remain inpatient to complete prolonged intravenous (IV) antibiotic courses due to several assumptions such as 1) if outpatient, patients will inject illicit drugs into the IV catheter and will fail to complete prescribed antibiotic regimens, and 2) if inpatient, patients will not inject drugs because of the increased supervision and will complete the antibiotic regimen. No evidence supports these assumptions, and unfortunately, the inpatient stay is not only very costly to the healthcare system, but infrequently includes comprehensive OUD treatment. In contrast, outpatient parenteral antibiotic therapy (OPAT) via a peripherally-inserted central catheter (PICC) is the standard of care for continuing IV medications for patients without injection drug use (IDU) once medically stable, and is commonly used in treatment infections requiring prolonged IV antibiotics. OPAT is cost-effective, associated with improved patient satisfaction, and with decreased risks of hospital-acquired infections. Development of innovative outpatient clinical models is urgently needed to improve the management and transition plan of persons with OUD and SIRI, given the costs and risks associated with prolonged hospitalizations. We conducted a successful pilot, proof-of-concept, randomized, study to establish the safety and feasibility of discharging inpatients with OUD and SIRI to complete IV antibiotics in an innovative, integrated, outpatient model combining BUP treatment with OPAT. This 12-week outpatient, randomized, parallel-group study builds on our preliminary work to demonstrate efficacy of the integrated outpatient care model (B-OPAT: BUP treatment with OPAT). Patients with OUD and SIRI will be randomized (1:1) to either B-OPAT (n=45) or treatment-as-usual (TAU) (n=45) and compared on the primary outcome of the proportion of urine samples negative for illicit opioids, and on critical secondary outcomes including completion of recommended IV antibiotic therapy, self-reported number of days of illicit opioid abstinence and retention in outpatient treatment. The study will also incorporate a comprehensive economic evaluation of the integrated outpatient care model as well as a qualitative investigation to inform future implementation and dissemination. These results will demonstrate the efficacy and cost effectiveness of an integrated outpatient care model to provide outpatient treatment of OUD and SIRI after hospitalization.

摘要 DAT 18 -06：因阿片类药物使用障碍（OUD）并发症住院，如感染性心内膜炎（IE）和 其他严重的注射相关感染（SIRI）随着阿片类药物的流行而沿着急剧增加。 因SIRI住院的OUD患者通常仍需住院以完成长期静脉（IV） 抗生素疗程由于几个假设，如1）如果门诊，患者将注射非法药物到IV 导管并将无法完成规定的抗生素治疗方案，以及2）如果住院，患者将不会注射药物 因为加强了监督，并将完成抗生素治疗方案。没有证据支持这些 假设，不幸的是，住院不仅对医疗保健系统来说非常昂贵， 很少包括全面的OUD治疗。相比之下，门诊肠外抗生素治疗 经外周静脉置入中心静脉导管（PICC）的OPAT是持续IV药物治疗的标准治疗方法 用于未经注射药物使用（IDU）的患者，一旦病情稳定，通常用于治疗 需要长时间静脉注射抗生素的感染。OPAT具有成本效益，与患者改善相关 满意度，并降低医院获得性感染的风险。创新门诊的发展 迫切需要临床模型来改善OUD患者的管理和过渡计划， SIRI，考虑到与长期住院相关的成本和风险。我们进行了一次成功的试点， 一项旨在确定OUD住院患者出院的安全性和可行性的概念验证、随机化研究 和SIRI在一个创新的，综合的，结合BUP治疗的门诊模式中完成静脉注射抗生素 关于OPAT这项为期12周的门诊、随机、平行组研究建立在我们的初步工作基础上， 证明综合门诊护理模式（B-OPAT：OPAT治疗BUP）的有效性。患者 OUD和SIRI患者将随机（1：1）接受B-OPAT（n=45）或常规治疗（TAU）（n=45）， 比较了非法阿片类药物阴性尿样比例的主要结局， 次要结局包括完成推荐的IV抗生素治疗，自我报告的天数 门诊治疗中的非法阿片类药物戒断和保留。该研究还将纳入一项 综合门诊护理模式的综合经济评价以及定性 为今后的实施和传播提供信息。这些结果将证明 提供OUD和SIRI门诊治疗的综合门诊护理模式的成本效益 住院后。

项目成果

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.

• DOI: 10.1177/20499361221108005
• 发表时间: 2022-01
• 期刊: THERAPEUTIC ADVANCES IN INFECTIOUS DISEASE
• 影响因子: 5.7
• 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.
• 通讯作者: Lofwall, Michelle R.