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

Official 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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• Infection Rehospitalization [Time frame: 6 months after discharge for index hospitalization]

Secondary outcome measures (12)

• Time to first infection related readmission [Time frame: 12 months after discharge for index hospitalization]
• Reason for infection related readmission [Time frame: 12 months after discharge for index hospitalization]
• Hospital services utilization [Time frame: 12 months after discharge for index hospitalization]
• Mortality [Time frame: 12 months after discharge for index hospitalization]
• Index infection [Time frame: 3 months after discharge for index hospitalization]
• Other Infections [Time frame: 12 months after discharge for index hospitalization]
• Skin and soft tissue wounds [Time frame: 12 months after discharge for index hospitalization]
• New infections not requiring hospitalization [Time frame: 12 months after discharge for index hospitalization]
• Outpatient linkage and retention [Time frame: 12 months after discharge for index hospitalization]
• Medication for Opioid Use (MOUD) [Time frame: 12 months after discharge for index hospitalization]
• Medication for stimulant use (MStUD) [Time frame: 12 months after discharge for index hospitalization]
• Substance Use-Opioid [Time frame: 12 months after discharge for index hospitalization]

Eligibility criteria

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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 4 centers

• George Washington University — Washington D.C.
• Emory University — Atlanta
• University of Maryland Baltimore — Baltimore
• West Virginia University — Morgantown

Publications

• 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 treatmen PMID 41776656

Identifiers

NCT: NCT06513156 · HP-00111318

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗