Integrated Care for Infections from Drug Use

(CTN0121 Trial)

Recruiting at 5 trial locations

Overseen By Terri Liguori, M.Ed., Ed.S.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cognitive impairment, Legal issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 4 months

480 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{6 7 8 9 10}

What 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. ^{1 2 3 11 12}

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.

Research Team

Lisa R Metsch, PhD

Principal Investigator

Columbia University

Daniel J Feaster, PhD

Principal Investigator

University of Miami

Carlos del Rio, MD

Principal Investigator

Emory University

David P Serota, MD, MSc

Principal Investigator

University of Miami

Eligibility 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.

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)

Treatment Details

Interventions

• SIRI Team
• Treatment as Usual

Trial Overview 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.

Participant Groups

Group I: SIRI Team Experimental Treatment 1 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 Usual Active Control 1 Intervention

Treatment as Usual (TAU) will consist of the current healthcare landscape at each participating hospital site.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

The Emmes Company, LLC

Industry Sponsor

Trials

149

Recruited

1,052,000+

Peter Ronco

The Emmes Company, LLC

Chief Executive Officer since 2023

BSc from Nottingham University

Dr. Joe Sliman

The Emmes Company, LLC

Chief Medical Officer since 2020

MD from Uniformed Services University of the Health Sciences, MPH from Johns Hopkins University, BSc in Molecular and Cell Biology from Pennsylvania State University

Findings from Research

The Severe Injection-Related Infection (SIRI) team significantly reduced the risk of death or readmission within 90 days post-hospital discharge by 45% for patients who inject drugs (PWID), compared to a historical control group.

Patients treated by the SIRI team were much more likely to initiate medications for opioid use disorder (93% vs 33%) and complete their antibiotic treatment (90% vs 60%), indicating improved healthcare outcomes for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Infectious Disease and Substance Use Disorder Care for the Treatment of Injection Drug Use-Associated Infections: A Prospective Cohort Study With Historical Control. Serota, DP., Rosenbloom, L., Hervera, B., et al.[2023]

The RESTORE program successfully integrated peer-supported substance use disorder (SUD) care into an outpatient infectious disease (ID) clinic, leading to an eightfold increase in clinicians prescribing buprenorphine from 5% to 39%.

Patients engaged in the program showed significant improvements over six months, including a reduction in illicit opioid use from 52% to 32%, decreased cocaine use, and fewer emergency department visits and hospitalizations, indicating effective outcomes from the integration of SUD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a peer-supported, integrated strategy for substance use disorder care in an outpatient infectious disease clinic is associated with improved patient outcomes. Falade-Nwulia, O., Agee, T., Kelly, SM., et al.[2023]

The Jackson SIRI team intervention, which integrates infectious disease and substance use disorder treatment, shows promise in managing severe injection drug use-related infections, but faces barriers such as clinician stigma and resource limitations for patients experiencing homelessness.

Facilitators for successful implementation include a non-judgmental, harm reduction approach, strong patient advocacy, and comprehensive follow-up care that addresses the broader needs of patients, indicating that holistic support is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an integrated infectious disease and substance use disorder team for injection drug use-associated infections: a qualitative study. Hervera, B., Seo, G., Bartholomew, TS., et al.[2023]

In a study of 334 patients admitted for serious injection drug use related infections (SIRI), those referred to the Engaging Patients in Care Coordination (EPICC) program had a significantly lower 90-day readmission rate (23.7%) compared to those not referred (41.0%).

This suggests that participation in an opioid use disorder (OUD) treatment referral program can improve patient outcomes and reduce the likelihood of readmission after treatment for SIRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care cascade for patients with opioid use disorder and serious injection related infections. Upadhyaya, A., Marks, LR., Schwarz, ES., et al.[2022]

The Medically Enhanced Residential Treatment (MERT) model aimed to combine residential treatment for substance use disorder with long-term intravenous antibiotics, but faced significant challenges in recruitment and retention, with only 7 out of 45 eligible patients enrolling and only 3 completing their antibiotic course.

Barriers to MERT's success included patient ambivalence towards residential treatment, concerns about physical health needs, and the stigma associated with being a MERT patient, highlighting the need for better integration strategies for managing both substance use and medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from the implementation of a medically enhanced residential treatment (MERT) model integrating intravenous antibiotics and residential addiction treatment. Englander, H., Wilson, T., Collins, D., et al.[2020]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

A study of 1244 opioid-dependent individuals found that those who stopped naltrexone treatment experienced significantly higher overdose rates (39 overdoses per 100 person-years) compared to those who left agonist treatments, indicating a critical risk period immediately after stopping naltrexone.

Overall, individuals who left any pharmacotherapy for opioid dependence had much higher rates of serious adverse events and deaths (six per 100 person-years) compared to when they were in treatment, highlighting the need for ongoing support and risk education after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). Digiusto, E., Shakeshaft, A., Ritter, A., et al.[2022]

The study successfully implemented an active surveillance system for outpatient adverse drug events in 9 emergency departments, identifying 598 cases (7 per 1,000 visits) within a short reporting timeframe, with over 98% of key data elements completed.

Unintentional overdoses were the most common cause of adverse drug events (39%), and patients experiencing these overdoses had a significantly higher likelihood of hospitalization compared to those with other types of adverse reactions, highlighting the need for targeted prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department visits for outpatient adverse drug events: demonstration for a national surveillance system. Budnitz, DS., Pollock, DA., Mendelsohn, AB., et al.[2022]

Over a ten-year period, there were 603,663 hospitalizations in Brazil due to adverse drug events, with a mortality rate of 2.5%, indicating a significant public health concern.

The study found that while hospitalization rates remained stable overall, there was a notable increase in hospitalizations among women, and the most common adverse drug events were related to mental and behavioral disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data. Silva, LT., Modesto, ACF., Oliveira, RA., et al.[2022]

In a study of 156 hospitalized patients, 38 adverse drug events (ADEs) were identified, with 15 being the reason for admission and 22 (57.9%) deemed avoidable, primarily due to therapeutic errors.

The most common ADEs affected the neurologic, renal, and hematologic systems, highlighting the need for improved patient history assessment to reduce the risk of these events and enhance drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events associated with hospital admission. Peyriere, H., Cassan, S., Floutard, E., et al.[2017]

The Jackson SIRI Team, which integrates infectious disease and substance use disorder (SUD) treatment, successfully treated 21 patients with severe injection-related infections (SIRIs) over 8 months, with a high discharge survival rate of 95%.

This model emphasizes harm reduction and patient-centered care, resulting in 70% of patients continuing medication for opioid use disorder (MOUD) at 90 days post-discharge, suggesting it may improve both infection management and addiction outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harm reduction for the treatment of patients with severe injection-related infections: description of the Jackson SIRI Team. Serota, DP., Tookes, HE., Hervera, B., et al.[2023]

A survey of 312 HIV-infected patients in Hanoi revealed that 81.4% preferred integrated treatment for HIV and substance use disorder (SUD), indicating strong support for this care model.

Factors influencing the preference for integrated care included having a college education, experiencing depression, receiving medication-assisted treatment for opioid use, and comfort discussing substance use with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV Patients' Preference for Integrated Models of Addiction and HIV Treatment in Vietnam. Nguyen Bich, D., Korthuis, PT., Nguyen Thu, T., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Implementing a peer-supported, integrated strategy for substance use disorder care in an outpatient infectious disease clinic is associated with improved patient outcomes. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Implementation of an integrated infectious disease and substance use disorder team for injection drug use-associated infections: a qualitative study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Care cascade for patients with opioid use disorder and serious injection related infections. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lessons learned from the implementation of a medically enhanced residential treatment (MERT) model integrating intravenous antibiotics and residential addiction treatment. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Serious adverse events in the Australian National Evaluation of Pharmacotherapies for Opioid Dependence (NEPOD). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Emergency department visits for outpatient adverse drug events: demonstration for a national surveillance system. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events associated with hospital admission. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Harm reduction for the treatment of patients with severe injection-related infections: description of the Jackson SIRI Team. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

HIV Patients' Preference for Integrated Models of Addiction and HIV Treatment in Vietnam. [2018]