Integrated care for hospitalized patients with opioid and stimulant use disorders and infections
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
This study tests if a new combined care approach for patients with infections from using opioids or stimulants can help them stay healthier and avoid going back to the hospital compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 304 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 4 sites (Washington D.C., District of Columbia and 3 other locations) |
| Trial ID | NCT06513156 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a two-group randomized controlled trial conducted at five hospitals across the U.S. It aims to evaluate the effectiveness of an Integrated Infectious Diseases and Substance Use Disorder outpatient clinic compared to standard treatment in reducing infection-related readmissions and improving health outcomes for patients hospitalized with infections due to injecting opioids or stimulants. Participants will be randomly assigned to either the integrated care model or treatment as usual and will be followed for 12 months post-discharge. The study also assesses cost-effectiveness and implementation outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been hospitalized with an infection related to injecting opioids or stimulants within the past 90 days.
Not a fit: Patients who do not have a qualifying infection or who have not used opioids or stimulants in the past 90 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce hospital readmissions and improve overall health outcomes for patients with substance use disorders and related infections.
How similar studies have performed: Other studies have shown promise in integrated care approaches for substance use disorders, suggesting potential success for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine) 3. Injection opioid or stimulant use in past 90 days - per patient self-report 4. Active suspected or confirmed qualifying infection (see list) at time of admission. Qualifying infections: * Non-vertebral osteomyelitis * Vertebral osteomyelitis or discitis * Epidural, subdural, or extradural abscess * Intracranial or intraspinal abscess * Native joint septic arthritis * Prosthetic joint septic arthritis * Blood stream infection (bacterial or fungal) * Native valve Endocarditis * Prosthetic valve endocarditis * Cardiac Implantable electronic device infection * Infectious pseudoaneurysm and aneurysm * Infected vascular graft * Septic venous thrombosis * Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis) * Infected skin ulcer * Orthopedic hardware infection * Muscle abscess/myositis * Central nervous system infection (bacterial or fungal) * Bacterial or fungal ophthalmologic infection * Other abscess * Pulmonary septic emboli * Other acute bacterial or fungal infection deemed appropriate by site study team Exclusion Criteria: * 1\. Infection due to a cause other than injection drug use, per determination of a site PI. 2\. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment. 3\. Unwilling to provide informed consent 4. Unable to receive potential interventions due to geography 5. On comfort measures or planned for discharge to hospice care 6. Incarcerated at the time of hospitalization 7. Other criteria at the discretion of the site investigator
Where this trial is running
Washington D.C., District of Columbia and 3 other locations
- George Washington University — Washington D.C., District of Columbia, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- University of Maryland Baltimore — Baltimore, Maryland, United States (Recruiting)
- West Virginia University — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Elana Rosenthal, MD — University of Maryland, Baltimore
- Study coordinator: Rachel Silk
- Email: rsilk@ihv.umaryland.edu
- Phone: 301-326-7652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.