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

基本信息

批准号：
10461109
负责人：
Laura Fanucchi
金额：
$ 70.01万
依托单位：
UNIVERSITY OF KENTUCKY
依托单位国家：
美国
项目类别：
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/10461109
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 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 Randomized Clinical Trials Reach Effectiveness Adoption Implementation and Maintenance 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 service organization health care settings health economics illicit drug use illicit opioid improved injection drug use innovation opioid epidemic opioid use opioid use disorder primary outcome response safety and feasibility secondary outcome standard of care treatment as usual

项目摘要

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.

抽象的 DAT18-06：因阿片类药物使用障碍 (OUD) 并发症住院，例如传染性心内膜炎 (IE) 和随着阿片类药物的流行，其他严重的注射相关感染 (SIRI) 也急剧增加。因 SIRI 住院的 OUD 患者通常需要住院以完成长时间静脉注射 (IV) 抗生素疗程基于多种假设，例如 1) 如果是门诊患者，患者将向静脉注射非法药物导管并且无法完成规定的抗生素治疗方案，并且 2) 如果住院，患者不会注射药物由于加强监督并将完成抗生素治疗方案。没有证据支持这些不幸的是，住院不仅对医疗保健系统来说成本高昂，而且很少包括综合 OUD 治疗。相比之下，门诊肠外抗生素治疗通过外周插入中心导管 (PICC) 进行的 (OPAT) 是持续静脉注射药物的护理标准适用于病情稳定后无需注射吸毒 (IDU) 的患者，常用于治疗需要长期静脉注射抗生素的感染。 OPAT 具有成本效益，与改善患者状况相关满意度，并降低医院获得性感染的风险。创新门诊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，考虑到长期住院带来的成本和风险。我们进行了一次成功的试点，概念验证、随机研究，旨在确定 OUD 住院患者出院的安全性和可行性和 SIRI 以结合 BUP 治疗的创新、综合、门诊模式完成静脉注射抗生素与OPAT。这项为期 12 周的门诊、随机、平行组研究以我们的初步工作为基础证明综合门诊护理模式（B-OPAT：使用 OPAT 进行 BUP 治疗）的功效。患者使用 OUD 和 SIRI 将被随机 (1:1) 分配至 B-OPAT (n=45) 或照常治疗 (TAU) (n=45)，并且比较了尿液样本中非法阿片类药物呈阴性的比例的主要结果以及关键结果次要结局包括完成推荐的静脉注射抗生素治疗、自我报告的天数门诊治疗中非法阿片类药物戒断和保留的情况。该研究还将纳入对综合门诊护理模式进行全面的经济评估以及定性的评估调查，为未来的实施和传播提供信息。这些结果将证明其功效提供 OUD 和 SIRI 门诊治疗的综合门诊护理模式的成本效益住院后。