Integrated Care for Infections from Drug Use
(CTN0121 Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen byLisa R Metsch, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Cognitive impairment, Legal issues, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to test the effectiveness of an integrated infectious disease/substance use disorder (SUD) clinical team intervention approach in patients hospitalized with severe injection-related infections (SIRI) who use drugs. The main question this study aims to answer is whether this intervention approach will be associated with lower mortality and fewer hospital readmissions. Participants will participate in the integrated SUD/ID care team intervention (SIRI Team). Researchers will compare this intervention to treatment as usual (TUA) to see if there are any differences in health outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What data supports the effectiveness of the Integrated SUD/ID Care Team Intervention treatment?
Research shows that integrating care for substance use disorder (SUD) and infectious diseases (ID) can improve health outcomes for people who inject drugs. The SIRI team, which combines medical care, SUD treatment, and patient support, has been shown to positively impact treatment and healthcare use for these patients.
12345Is the Integrated Care for Infections from Drug Use treatment generally safe for humans?
The available research does not provide specific safety information about the Integrated Care for Infections from Drug Use treatment, but it highlights that reporting adverse events in substance use disorder trials can be challenging and burdensome.
678910What makes the SIRI Team treatment unique for infections from drug use?
The SIRI Team treatment is unique because it integrates care for both substance use disorders and infectious diseases, providing a comprehensive approach that includes medical care, substance use treatment, and patient support during and after hospitalization. This integrated model, rooted in harm reduction, aims to improve outcomes by addressing both health issues simultaneously, which is not typically done in standard treatments.
1231112Eligibility Criteria
This trial is for adults over 18 who are hospitalized with severe infections from injecting drugs and have used injection drugs in the past year. They must understand English or Spanish, agree to share health records, and be willing to come back for follow-up visits.Inclusion Criteria
I have given my informed consent.
I am currently suffering from a severe infection due to an injection.
I can provide enough information to be located.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive integrated care from the SIRI Team during their hospital stay and post-discharge for up to four months
4 months
Hospital stay and post-discharge care
Follow-up
Participants are monitored for health outcomes, including mortality and hospital readmissions, at 4, 8, and 12 months post-randomization
12 months
3 visits (4, 8, and 12 months post-randomization)
Participant Groups
The study tests a new care approach combining infectious disease and substance use disorder treatments (SIRI Team) against the usual treatment methods. It aims to see if this integrated care reduces death rates and hospital readmissions.
2Treatment groups
Experimental Treatment
Active Control
Group I: SIRI TeamExperimental Treatment1 Intervention
The study intervention ("SIRI Team") consists of a hospital-based multidisciplinary (ID/SUD consult) team that will provide intensive, integrated care for participants' ID and SUD both during the hospital stay and post-discharge for up to four months post-randomization. The SIRI Team will provide low barrier access to medications and harm reduction services for SUD; streamline ID/SUD treatment; provide longitudinal care with familiar providers; leverage different areas of expertise between physicians, advance practice providers, and patient navigators; and create patient-centered treatment plans, tailored to the individual, and informed by each patient's social circumstances, substance use, and personal goals/desires.
Group II: Treatment as UsualActive Control1 Intervention
Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of New Mexico Health Sciences CenterAlbuquerque, NM
University of PennsylvaniaPhiladelphia, PA
University of Utah HospitalSalt Lake City, UT
University of Alabama at BirminghamBirmingham, AL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
University of MiamiCollaborator
Emory UniversityCollaborator
National Institute on Drug Abuse (NIDA)Collaborator
The Emmes Company, LLCIndustry Sponsor
References
Integrated Infectious Disease and Substance Use Disorder Care for the Treatment of Injection Drug Use-Associated Infections: A Prospective Cohort Study With Historical Control. [2023]To address the infectious disease (ID) and substance use disorder (SUD) syndemic, we developed an integrated ID/SUD clinical team rooted in harm reduction at a county hospital in Miami, Florida. The Severe Injection-Related Infection (SIRI) team treats people who inject drugs (PWID) and provides medical care, SUD treatment, and patient navigation during hospitalization and after hospital discharge. We assessed the impact of the SIRI team on ID and SUD treatment and healthcare utilization outcomes.
Implementing a peer-supported, integrated strategy for substance use disorder care in an outpatient infectious disease clinic is associated with improved patient outcomes. [2023]Substance use disorder (SUD) and infectious disease (ID) care integration may lead to improvements in SUD and ID outcomes. We assessed implementation of integrating peer-supported SUD care in an outpatient ID setting.
Implementation of an integrated infectious disease and substance use disorder team for injection drug use-associated infections: a qualitative study. [2023]Hospitalizations for severe injection drug use-related infections (SIRIs) are characterized by high costs, frequent patient-directed discharge, and high readmission rates. Beyond the health system impacts, these admissions can be traumatizing to people who inject drugs (PWID), who often receive inadequate treatment for their substance use disorders (SUD). The Jackson SIRI team was developed as an integrated infectious disease/SUD treatment intervention for patients hospitalized at a public safety-net hospital in Miami, Florida in 2020. We conducted a qualitative study to identify patient- and clinician-level perceived implementation barriers and facilitators to the SIRI team intervention.
Care cascade for patients with opioid use disorder and serious injection related infections. [2022]To define the care cascade for patients with serious injection drug use related infections (SIRI) in a tertiary hospital system and compare outcomes of those who did and did not participate in an opioid use disorder (OUD) treatment referral program.
Lessons learned from the implementation of a medically enhanced residential treatment (MERT) model integrating intravenous antibiotics and residential addiction treatment. [2020]Hospitalizations for severe infections associated with substance use disorder (SUD) are increasing. People with SUD often remain hospitalized for many weeks instead of completing intravenous antibiotics at home; often, they are denied skilled nursing facility admission. Residential SUD treatment facilities are not equipped to administer intravenous antibiotics. We developed a medically enhanced residential treatment (MERT) model integrating residential SUD treatment and long-term IV antibiotics as part of a broader hospital-based addiction medicine service. MERT had low recruitment and retention, and ended after six months. The goal of this study was to describe the feasibility and acceptability of MERT, to understand implementation factors, and explore lessons learned.
Strategies for safety reporting in substance abuse trials. [2013]Reporting all adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials has yielded limited relevant safety information and has been burdensome to research sites.
Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]The study estimated serious adverse event (SAE) rates among entrants to pharmacotherapies for opioid dependence, during treatment and after leaving treatment.
Emergency department visits for outpatient adverse drug events: demonstration for a national surveillance system. [2022]This project demonstrates the operational feasibility and epidemiologic usefulness of modifying a national injury surveillance system for active surveillance of outpatient adverse drug events treated in hospital emergency departments (EDs).
Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data. [2022]To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data.
Adverse drug events associated with hospital admission. [2017]To increase the knowledge base on the frequency, causality, and avoidability of adverse drug events (ADEs) as a cause for admission in internal medicine or when occurring during hospitalization.
Harm reduction for the treatment of patients with severe injection-related infections: description of the Jackson SIRI Team. [2023]Hospitalizations for severe injection-related infections (SIRI), such as endocarditis, osteomyelitis, and skin and soft tissue infections (SSTI) are increasingly common. People who inject drugs (PWID) experiencing SIRIs often receive inadequate substance use disorder (SUD) treatment and lack of access to harm reduction services. This translates into lengthy hospitalizations with high rates of patient-directed discharge, readmissions, and post-hospitalization mortality. The purpose of this study was to describe the development of an integrated "SIRI Team" and its initial barriers and facilitators to success.
HIV Patients' Preference for Integrated Models of Addiction and HIV Treatment in Vietnam. [2018]Integrated care models for HIV and substance use disorder (SUD) care are proposed as a strategy for closing gaps in the HIV care continuum and decreasing HIV transmission. We examined attitudes regarding integration of HIV and SUD treatment among HIV-infected patients with illicit drug and unhealthy alcohol use.