RECRUITING

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

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Conditions

Opioid Use DisorderInjection Related InfectionsStimulant Use DisorderDelivery of Health Care, IntegratedSerious Injection Related Infections

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-10-01
Study Completion:2027-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06513156

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years
  2. 2. Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)
  3. 3. Injection opioid or stimulant use in past 90 days - per patient self-report
  4. 4. Active suspected or confirmed qualifying infection (see list) at time of admission.
  5. * Non-vertebral osteomyelitis
  6. * Vertebral osteomyelitis or discitis
  7. * Epidural, subdural, or extradural abscess
  8. * Intracranial or intraspinal abscess
  9. * Native joint septic arthritis
  10. * Prosthetic joint septic arthritis
  11. * Blood stream infection (bacterial or fungal)
  12. * Native valve Endocarditis
  13. * Prosthetic valve endocarditis
  14. * Cardiac Implantable electronic device infection
  15. * Infectious pseudoaneurysm and aneurysm
  16. * Infected vascular graft
  17. * Septic venous thrombosis
  18. * Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis)
  19. * Infected skin ulcer
  20. * Orthopedic hardware infection
  21. * Muscle abscess/myositis
  22. * Central nervous system infection (bacterial or fungal)
  23. * Bacterial or fungal ophthalmologic infection
  24. * Other abscess
  25. * Pulmonary septic emboli
  26. * Other acute bacterial or fungal infection deemed appropriate by site study team
  1. * 1. Infection due to a cause other than injection drug use, per determination of a site PI.
  2. 2. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.
  3. 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

Contacts and Locations

Study Contact

Rachel Silk
CONTACT
301-326-7652
rsilk@ihv.umaryland.edu

Principal Investigator

Elana Rosenthal, MD
PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Elana Rosenthal

  • Elana Rosenthal, MD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2027-10-30

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2027-10-30

Terms related to this study

Keywords Provided by Researchers

  • Delivery of Health Care, Integrated
  • Opioid use disorder
  • Serious Injection Related Infections
  • Stimulant Use Disorder

Additional Relevant MeSH Terms

  • Opioid Use Disorder
  • Injection Related Infections
  • Stimulant Use Disorder