Grants and Contracts Details
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.
|Effective start/end date||9/30/20 → 8/31/24|
- National Institute on Drug Abuse: $2,140,233.00
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