NCT06513156

Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use

Continuum of Care in Hospitalized Patients With Opioid or Stimulant Use Disorder and Infectious Complications of Drug Use - Substance Use/ID Integrated Clinic vs. TAU to Prevent Infection Related Readmission

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Elana Rosenthal · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases/Substance Use Disorder outpatient clinic (IC) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids or stimulants.

Detailed description

This is a phase III two arm randomized controlled trial to determine the impact and Integrated infectious diseases (ID) and Substance Use Disorder outpatient clinic (IC) compared to treatment as usual on infection related rehospitalization in individuals hospitalized with infections due to injecting opioids or Stimulants, in the 6 month time period after discharge. This study includes both cost effectiveness and implementation outcomes. (1) IC will provide facilitated linkage to a clinic providing medical treatment aimed at treating substance use disorder (SUD), resolving the index infection, treating existing ID complications of OUD (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and medication for OUD (MOUD) treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and MOUD providers. The study will recruit patients during hospitalization for an infection due to injecting opioids or stimulants at four hospital systems (five hospitals) and randomly assign approximately 304 inpatients in 1:1 ratio to IC vs TAU. Participants will be followed for 12 months.

Conditions

• Opioid Use Disorder
• Injection Related Infections
• Stimulant Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)	Integrated medication for opioid/stimulant use disorder and infectious disease care provided into single appointment either in person or via telemedicine with a minimum of monthly appointments for 6 months.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-07-30
• Completion: 2027-07-30
• First posted: 2024-07-22
• Last updated: 2025-10-31

Locations

4 sites across 1 country: United States