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

NCT ID: NCT06513156

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-07-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment As Usual

Will receive treatment for infection and opioid or stimulant use disorder per the usual care at each hospital

Group Type: NO_INTERVENTION

No interventions assigned to this group

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

The Integrated ID/SUD Clinic will provide facilitated linkage to a clinic providing medical treatment aimed at treating SUD, resolving the sentinel infection, treating existing ID complications of OUD/stimulants (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 SUD 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 SUD providers.

Group Type: EXPERIMENTAL

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role: collaborator

Elana Rosenthal

OTHER

Sponsor Role: lead

Responsible Party

Elana Rosenthal

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Elana Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

George Washington University

Washington D.C., District of Columbia, United States

Site Status: RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

University of Maryland Baltimore

Baltimore, Maryland, United States

Site Status: RECRUITING

West Virginia University

Morgantown, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Silk

Role: CONTACT

rsilk@ihv.umaryland.edu

301-326-7652

Facility Contacts

Jill Catalanotti, MD

Role: primary

jcatalanotti@mfa.gwu.edu

Joseph Carpenter, MD

Role: primary

joseph.edward.carpenter@emory.edu

Rachel Silk

Role: primary

rsilk@ihv.umaryland.edu

3013267652

Rebecca Reece, MD

Role: primary

rreece@hsc.wvu.edu

Other Identifiers

HP-00111318

Identifier Type: -

Identifier Source: org_study_id