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NCT Number: NCT06513156

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

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Injection Related Infections Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Stimulant Use Disorder Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)
  • Injection opioid or stimulant use in past 90 days - per patient self-report
  • 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.
  • Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Infection Rehospitalization

    Time frame: 6 months after discharge for index hospitalization

    New hospitalization due to infection following discharge for index hospitalization

Secondary outcomes

  1. Time to first infection related readmission

    Time frame: 12 months after discharge for index hospitalization

    Time to first infection related readmission

  2. Reason for infection related readmission

    Time frame: 12 months after discharge for index hospitalization

    Reason for infection related readmission (persistent index infection, new IDU associated infection, other infection)

  3. Hospital services utilization

    Time frame: 12 months after discharge for index hospitalization

    ED visits (Binary, count, time to first ED visit, cause) and Readmission, all cause (binary, count, time to first readmission, cause)

  4. Mortality

    Time frame: 12 months after discharge for index hospitalization

    Death (Binary, time to death, cause of death)

  5. Index infection

    Time frame: 3 months after discharge for index hospitalization

    Completion of antibiotics (binary, reason for incomplete antibiotics); Resolution of index infection (binary) Skilled Nursing Facility (SNF) Admitted to SNF (binary) Discharge type from SNF (planned, PDD, dead, transfer)

  6. Other Infections

    Time frame: 12 months after discharge for index hospitalization

    HCV Active HCV (binary) Clinical evaluation (binary) DAA prescribed (binary) DAA initiated (binary) SVR achieved (binary) HIV Diagnosis status (binary) HIV VL undetectable (binary) ART Taking (binary) Type (pills vs injections) Adherence (# missed doses in last 30 days) PrEP Eligible (CDC Criteria, binary, indication) Offered by healthcare provider (binary) Taking (binary) Type (pills vs injections) Adherence (# missed doses in last 30 days)

  7. Skin and soft tissue wounds

    Time frame: 12 months after discharge for index hospitalization

    Present (binary) Number (count) Per wound Size Location on body Duration (continuous)

  8. New infections not requiring hospitalization

    Time frame: 12 months after discharge for index hospitalization

    • Present (binary)
    • Number (count)

  9. Outpatient linkage and retention

    Time frame: 12 months after discharge for index hospitalization

    • Infectious Diseases Clinic (binary, time to linkage, count)
    • Medication for OUD Treatment (binary, time to linkage, count)
    • Non-medication based OUD Treatment (binary, time to linkage, count)

  10. Medication for Opioid Use (MOUD)

    Time frame: 12 months after discharge for index hospitalization

    • On treatment (binary)
    • MOUD type
    • MOUD Dose
    • MOUD Dose adequacy
    • MOUD Source of medication
    • MOUD Location type
    • MOUD Co-location with other services
    • Reasons for no MOUD (descriptive)

  11. Medication for stimulant use (MStUD)

    Time frame: 12 months after discharge for index hospitalization

    • On treatment (binary) MStUD type
    • MStUD Dose
    • MStUD Dose adequacy
    • MStUD Source of medication
    • MStUD Location type
    • MStUD Co-location with other services
    • Reasons for no MStUD (descriptive)

  12. Substance Use-Opioid

    Time frame: 12 months after discharge for index hospitalization

    Ongoing opioid (binary, mode)

    • Opioid use frequency
    • Mode of opioid use
    • Opioid craving
    • Other drug use (binary, mode)
    • Other drug use frequency
    • IDU (binary, frequency, mode (IM, IV, skin, other), location, syringe reuse, ssp engagement).
    • Severity (DAST)
    • Overdose (binary, count)
    • Tobacco use
    • UDS (binary - presence of opioids, )

  13. Substance Use - Stimulant

    Time frame: 12 months after discharge for index hospitalization

    Ongoing stimulant use (binary, mode)

    • Stimulant use frequency
    • Mode of stimulant use
    • Cocaine craving
    • Methamphetamine craving
    • Other drug use (binary, mode)
    • Other drug use frequency
    • IDU (binary, frequency, mode (IM, IV, skin, other), location, syringe reuse, ssp engagement).
    • Severity (DAST)
    • Overdose (binary, count)
    • Tobacco use
    • UDS (binary - presence of cocaine, amphetamines, other)

  14. Cost Effectiveness

    Time frame: 12 months after discharge for index hospitalization

    • ICER for quality adjusted life years (QALYs); opioid-free years (OfYs); and infection-free years (IfYs) gained

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Silk

CONTACT

[email protected]

301-326-7652

Sponsors and collaborators

Lead sponsor

Elana Rosenthal

Other

Collaborators

  • Emory University
  • Friends Research Institute, Inc.
  • George Washington University
  • Weill Medical College of Cornell University
  • West Virginia University

Registry information

Official study 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

Acronym: CHOICE-STAR

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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