Continuum of Care in Hospitalized Patients with Opioid Use Disorder and Infectious Complications from Drug Use
Purpose
This is a three-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of two interventions (1) Integrated infectious diseases and Medication for Opioid Use Disorder outpatient clinic (IC) and (2) NavSTAR Intervention (NS) 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.
Conditions
- Opioid Use Disorder
- Injection Related Infections
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years 2. Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine) 3. Injection opioid 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention Treatment As Usual |
Will receive treatment for infection and opioid use disorder per the usual care at each hospital |
|
|
Experimental Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic (IC) |
The Integrated ID/MOUD Clinic will provide facilitated linkage to a clinic providing medical treatment aimed at treating OUD, resolving the sentinel infection, treating existing ID complications of OUD (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and 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 dual goals of the IC intervention are to 1) to facilitate accessibility to ID and OUD care and 2) to ensure care coordination between outpatient ID and MOUD providers. |
|
|
Experimental NavSTAR-CHOICE (NS) |
The NavSTAR (NS) arm will consist of targeted support delivered by a Patient Navigation team (see Navigation Dyad, below) to enhance participants' linkage with outpatient OUD treatment and recommended medical care for infections and other presenting illnesses. The Navigation Dyad will work in concert with existing resources in the hospital system and broader community to ensure continuity of care (initial linkage and subsequent retention) during the 6-month period after hospital discharge when patients are at elevated risk of disengaging from care, inpatient readmission, and other adverse outcomes. |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- Elana Rosenthal
Detailed Description
This is a phase III three arm randomized controlled trial to determine the impact of two interventions (1) Integrated infectious diseases (ID) and Medication for Opioid Use Disorder outpatient clinic (IC) and (2) Navigation Services To Avoid Rehospitalization (NavSTAR )Intervention (NS) compared to treatment as usual on infection related rehospitalization in individuals hospitalized with infections due to injecting opioids, in the 6 month time period after discharge. This study includes both cost effectiveness and implementation outcomes. (1) The Integrated ID/MOUD Clinic (IC) will provide facilitated linkage to a clinic providing medical treatment aimed at treating opioid use disorer (OUD), 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. 2) The NavSTAR Arm (NS) aims to targeted support delivered by a Patient Navigation team to enhance participants' linkage with outpatient OUD treatment and recommended medical care for infections and other presenting illnesses. The Navigation Dyad will work in concert with existing resources in the hospital system and broader community to ensure continuity of care (initial linkage and subsequent retention) during the 6-month period after hospital discharge when patients are at elevated risk of disengaging from care, inpatient readmission, and other adverse outcomes. The study will recruit patients during hospitalization for an infection due to injecting opioids at four hospital systems (five hospitals) and randomly assign approximately 608 inpatients in 1:1:1 ratio to IC vs NS vs TAU. Participants will be followed for 12 months.