Continuum of Care in Hospitalized Patients With Opioid Use Disorder and Infectious Complications From Drug Use
NCT Number: NCT06513156
Acronym: CHOICE-STAR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Opioid Use Disorder|Injection Related Infections
Interventions: BEHAVIORAL: Integrated Infectious Diseases and Medication for Opioid Use Disorder Clinic (IC)|BEHAVIORAL: NavSTAR-CHOICE (NS)
Sponsor: Elana Rosenthal
Collaborators: Emory University|George Washington University|West Virginia University|Friends Research Institute, Inc.|Weill Medical College of Cornell University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 608
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-04-30
Locations: George Washington University, Washington, District of Columbia, 20052, United States|Emory University, Atlanta, Georgia, 30322, United States|University of Maryland Baltimore, Baltimore, Maryland, 21201, United States|West Virginia University, Morgantown, West Virginia, 26506, United States

Summary:
This is a three-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of two interventions (1) Integrated infectious diseases and Medication for Opioid Use Disorder outpatient clinic (IC) and (2) NavSTAR Intervention (NS) 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.

Primary Outcome Measures: Infection Rehospitalization, New hospitalization due to infection following discharge for index hospitalization, 6 months after discharge for index hospitalization
Secondary Outcome Measures: 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|Medication for Opioid Use, * On treatment (binary)
* MOUD type (buprenorphine, methadone, naltrexone)
* MOUD Dose
* Dose adequacy
* Source of medication
* Location type
* Co-location with other services
* Reasons for no MOUD (descriptive), 12 months after discharge for index hospitalization|Substance Use, Ongoing opioid use (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, cocaine, amphetamines, other), 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