Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use (CHOICE-STAR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Stimulant Use Disorder; Injection Related Infections
• Intervention / Treatment: Behavioral: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)

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.

• Study Type: Interventional
• Enrollment (Estimated): 304
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Silk; Phone Number: 301-326-7652; Email: rsilk@ihv.umaryland.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20052
      • Recruiting
      • George Washington University
      • Sub-Investigator: Irene Kuo, MD
      • Contact: Jill Catalanotti, MD; Email: jcatalanotti@mfa.gwu.edu
      • Principal Investigator: Jill Catalanotti, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Principal Investigator: Joseph Carpenter, MD
      • Contact: Joseph Carpenter, MD; Email: joseph.edward.carpenter@emory.edu
      • Sub-Investigator: Alina Steck, MD
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Baltimore
      • Sub-Investigator: Edward Traver, MD
      • Principal Investigator: Elana Rosenthal, MD
      • Sub-Investigator: Sarah Kattakuzhy, MD
      • Contact: Rachel Silk; Phone Number: 3013267652; Email: rsilk@ihv.umaryland.edu
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University
      • Contact: Rebecca Reece, MD; Email: rreece@hsc.wvu.edu
      • Principal Investigator: Rebecca Reece, MD
      • Sub-Investigator: Clinton Cooper, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual; Will receive treatment for infection and opioid or stimulant use disorder per the usual care at each hospital
Experimental: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection Rehospitalization	New hospitalization due to infection following discharge for index hospitalization	6 months after discharge for index hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first infection related readmission	Time to first infection related readmission	12 months after discharge for index hospitalization
Reason for infection related readmission	Reason for infection related readmission (persistent index infection, new IDU associated infection, other infection)	12 months after discharge for index hospitalization
Hospital services utilization	ED visits (Binary, count, time to first ED visit, cause) and Readmission, all cause (binary, count, time to first readmission, cause)	12 months after discharge for index hospitalization
Mortality	Death (Binary, time to death, cause of death)	12 months after discharge for index hospitalization
Index infection	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)	3 months after discharge for index hospitalization
Other Infections	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)	12 months after discharge for index hospitalization
Skin and soft tissue wounds	Present (binary) Number (count) Per wound Size Location on body Duration (continuous)	12 months after discharge for index hospitalization
New infections not requiring hospitalization	Present (binary); Number (count)	12 months after discharge for index hospitalization
Outpatient linkage and retention	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)	12 months after discharge for index hospitalization
Cost Effectiveness	• ICER for quality adjusted life years (QALYs); opioid-free years (OfYs); and infection-free years (IfYs) gained	12 months after discharge for index hospitalization
Medication for Opioid Use (MOUD)	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)	12 months after discharge for index hospitalization
Medication for stimulant use (MStUD)	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 months after discharge for index hospitalization
Substance Use-Opioid	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, )	12 months after discharge for index hospitalization
Substance Use - Stimulant	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)	12 months after discharge for index hospitalization

Collaborators and Investigators

• Sponsor: Elana Rosenthal
• Collaborators: Emory University; Weill Medical College of Cornell University; George Washington University; West Virginia University; Friends Research Institute, Inc.
• Investigators: Principal Investigator: Elana Rosenthal, MD, University of Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Opioid use disorder; Delivery of Health Care, Integrated; Serious Injection Related Infections; Stimulant Use Disorder
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: HP-00111318

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No