RecruitingNCT06513156ClinicalTrials.gov record

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

Opioid Use Disorder · Injection Related Infections · Stimulant Use Disorder

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THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Not applicable
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 304 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: No masking

Treatment As Usual

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

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.

Behavioral: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) 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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Infection Rehospitalization

Time frame: 6 months after discharge for index hospitalization

New hospitalization due to infection following discharge for index hospitalization