Clinical trial NCT06513156: Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Injection Related Infections
Stimulant Use Disorder
Keywords: Delivery of Health Care, Integrated
Opioid use disorder
Serious Injection Related Infections
Stimulant Use Disorder
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Emory University
name: George Washington University
name: West Virginia University
name: Weill Medical College of Cornell University
name: Friends Research Institute, Inc.
First posted: 2024-07-22
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Infection Rehospitalization
timeFrame: 6 months after discharge for index hospitalization
Secondary outcomes:
measure: Time to first infection related readmission
timeFrame: 12 months after discharge for index hospitalization
measure: Reason for infection related readmission
timeFrame: 12 months after discharge for index hospitalization
measure: Hospital services utilization
timeFrame: 12 months after discharge for index hospitalization
measure: Mortality
timeFrame: 12 months after discharge for index hospitalization
measure: Index infection
timeFrame: 3 months after discharge for index hospitalization
measure: Other Infections
timeFrame: 12 months after discharge for index hospitalization
measure: Skin and soft tissue wounds
timeFrame: 12 months after discharge for index hospitalization
measure: New infections not requiring hospitalization
timeFrame: 12 months after discharge for index hospitalization
measure: Outpatient linkage and retention
timeFrame: 12 months after discharge for index hospitalization
measure: Medication for Opioid Use (MOUD)
timeFrame: 12 months after discharge for index hospitalization
measure: Medication for stimulant use (MStUD)
timeFrame: 12 months after discharge for index hospitalization
measure: Substance Use-Opioid
timeFrame: 12 months after discharge for index hospitalization
measure: Substance Use - Stimulant
timeFrame: 12 months after discharge for index hospitalization
measure: Cost Effectiveness
timeFrame: 12 months after discharge for index hospitalization
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: University of Maryland Baltimore
state: Maryland
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: University of Maryland, Baltimore
name: Elana Rosenthal, MD
role: PRINCIPAL_INVESTIGATOR
References: