Nikhil Seval1, Cynthia A Frank1, Alain H Litwin2, Prerana Roth3, Meredith A Schade4, Martina Pavlicova5, Frances R Levin6, Kathleen T Brady7, Edward V Nunes6, Sandra A Springer8. 1. Yale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA. 2. University of South Carolina School of Medicine Greenville, Prisma Health: Upstate Affiliate, Department of Infectious Disease, Greenville, SC, USA; Department of Medicine, University of South Carolina School of Medicine- Greenville, Greenville, SC, USA. 3. University of South Carolina School of Medicine Greenville, Prisma Health: Upstate Affiliate, Department of Infectious Disease, Greenville, SC, USA. 4. Penn State Milton S. Hershey Medical Center, Department of Medicine, Division of Infectious Diseases, Hershey, PA, USA. 5. Columbia University Mailman School of Public Health, Department of Biostatistics, New York, NY, USA. 6. College of Physicians and Surgeons of Columbia University, New York State Psychiatric Institute/Division on Substance Use Disorders, New York, NY, USA. 7. Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. 8. Yale School of Medicine, Department of Internal Medicine, Section of Infectious Disease, Yale AIDS Program, New Haven, CT, USA. Electronic address: Sandra.springer@yale.edu.
Abstract
BACKGROUND: Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge. METHODS: A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. RESULTS: We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial. CONCLUSIONS: Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population. Published by Elsevier Inc.
BACKGROUND: Hospitalization with co-occurring opioid use disorder (OUD) and infections presents a critical time to intervene to improve outcomes for these intertwined epidemics that are typically managed separately. A surge in life-threatening infectious diseases associated with injection drug use, including bacterial and fungal infections, HIV, and HCV accounts for substantial healthcare utilization, morbidity, and mortality. Infectious Disease (ID) specialists manage severe infections that require hospitalization and are a logical resource to engage patients in medication treatment for OUD (MOUD). An injectable long-acting monthly formulation of buprenorphine (LAB) has a potential advantage for initiating MOUD within hospital settings and bridging to treatment after discharge. METHODS: A randomized multi-site trial tests a new model of care (ID/LAB) in which OUD and infections are managed by ID specialists and hospitalists using LAB coupled with referrals to community resources for long-term MOUD. A sample of 200 adults admitted to three U.S. hospitals for OUD and infections are randomly assigned 1:1 to ID/LAB or treatment as usual (TAU). The primary outcome measure is the proportion of patients enrolled in effective MOUD at 12 weeks after randomization. Secondary outcomes include relapse to opioid use, adherence to infectious disease treatment, infection morbidity and mortality, and drug overdose. RESULTS: We describe the design, procedures, statistical analysis, and early implementation issues of this randomized trial. CONCLUSIONS: Study findings will provide insight into the feasibility and effectiveness of integrated treatment of OUD and serious infections and have the potential to reduce morbidity and mortality in this vulnerable population. Published by Elsevier Inc.
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