Integrated care for patients with severe infections and substance use disorders
Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
This study tests if a special care team can help hospitalized patients with severe infections and substance use issues recover better than those who get regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 6 sites (Birmingham, Alabama and 5 other locations) |
| Trial ID | NCT05688423 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a multidisciplinary team approach for hospitalized patients suffering from severe injection-related infections and substance use disorders. The intervention, known as the SIRI Team, provides integrated care during hospitalization and extends support for up to four months post-discharge. Participants will receive tailored treatment plans that incorporate harm reduction strategies and continuous care from familiar healthcare providers. The study will compare outcomes between those receiving the SIRI Team intervention and those receiving standard treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are hospitalized with severe injection-related infections and have a history of injecting drug use.
Not a fit: Patients who are unable to provide informed consent due to cognitive impairments or those currently incarcerated may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to lower mortality rates and fewer hospital readmissions for patients with severe infections and substance use disorders.
How similar studies have performed: Other studies have shown promise in integrated care approaches for similar patient populations, indicating potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Be admitted to a participating hospital at the time of randomization * Be 18 years of age or older * Currently be experiencing a severe injection-related infection/SIRI or suspected SIRI * Have an indication of injecting drugs in the prior year * Provide informed consent * Ability to communicate in English * Provide sufficient locator information * Sign a HIPAA form and/or EHR release to facilitate record abstraction * Report being willing to return for follow-up visits Exclusion Criteria: All individuals meeting any of the exclusion criteria will be excluded from study participation. Specifically, individuals will be excluded from participation if they: * have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent * (or their legal guardian/representative) are unable or unwilling to give written informed consent * are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities * are terminated via site principal investigator decision with agreement from one of the study lead investigators.
Where this trial is running
Birmingham, Alabama and 5 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of Miami - Jackson Memorial Hospital — Miami, Florida, United States (Recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Recruiting)
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Utah Hospital — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Lisa R Metsch, PhD — Columbia University
- Study coordinator: Lauren K Gooden, PhD, MPH
- Email: lkg2129@columbia.edu
- Phone: 7867039819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.