Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElana Rosenthal
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
1. Infection due to a cause other than injection drug use, per determination of a site PI.
Trial design
Design model
Parallel
Treatments tested in this trial
Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)
BehavioralIntegrated 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.
Treatment groups
304 Participants
are divided into 2 treatment groupsGroup A: Treatment As UsualNo intervention 0 interventions
Group B: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Infection Rehospitalization
New hospitalization due to infection following discharge for index hospitalization
Time frame
6 months after discharge for index hospitalizationSecondary outcomes
1
Time to first infection related readmission
Time to first infection related readmission
Time frame
12 months after discharge for index hospitalization2
Reason for infection related readmission
Reason for infection related readmission (persistent index infection, new IDU associated infection, other infection)
Time frame
12 months after discharge for index hospitalization3
Hospital services utilization
ED visits (Binary, count, time to first ED visit, cause) and Readmission, all cause (binary, count, time to first readmission, cause)
Time frame
12 months after discharge for index hospitalization4
Mortality
Death (Binary, time to death, cause of death)
Time frame
12 months after discharge for index hospitalizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Elana Rosenthal
Lead sponsor
University of Maryland, Baltimore
Sponsor institution
Emory University
Collaborator
George Washington University
Collaborator
West Virginia University
Collaborator
Weill Medical College of Cornell University
Collaborator
Friends Research Institute, Inc.
Collaborator
Source ClinicalTrials.gov