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| Name | Class |
|---|---|
| Emory University | OTHER |
| George Washington University | OTHER |
| West Virginia University | OTHER |
| Weill Medical College of Cornell University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment As Usual | No Intervention | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infection Rehospitalization | New hospitalization due to infection following discharge for index hospitalization | 6 months after discharge for index hospitalization |
| 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) |
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Inclusion Criteria:
Qualifying infections:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Silk | Contact | 301-326-7652 | rsilk@ihv.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elana Rosenthal, MD | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Recruiting | Washington D.C. | District of Columbia | 20052 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41776656 | Derived | Rosenthal ES, Lavoie MC, Traver E, Gryczynski J, Nordeck C, Carpenter JE, Reece R, Kuo I, Catalanotti JS, Steck AR, Cooper G, Fujita AW, Murphy SM, Mansfield ME, Ramadhani HO, Silk R, Masur H, Kattakuzhy S. Continuum of care in hospitalized patients with opioid or stimulant use disorder and infectious complications of drug use-substance use/infectious disease integrated clinic compared to treatment as usual to prevent infection-related readmission (CHOICE-STAR): a study protocol for an effectiveness-implementation randomized controlled trial. Trials. 2026 Mar 4;27(1):291. doi: 10.1186/s13063-026-09550-5. |
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| OTHER |
| Friends Research Institute, Inc. | OTHER |
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|
| 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 |
| 12 months after discharge for index hospitalization |
| Outpatient linkage and retention |
| 12 months after discharge for index hospitalization |
| Medication for Opioid Use (MOUD) |
| 12 months after discharge for index hospitalization |
| Medication for stimulant use (MStUD) |
| 12 months after discharge for index hospitalization |
| Substance Use-Opioid | Ongoing opioid (binary, mode)
| 12 months after discharge for index hospitalization |
| Substance Use - Stimulant | Ongoing stimulant use (binary, mode)
| 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 |
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
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| University of Maryland Baltimore | Recruiting | Baltimore | Maryland | 21201 | United States |
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| West Virginia University | Recruiting | Morgantown | West Virginia | 26506 | United States |
|
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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