Integrated Care and Treatment for Severe Infectious Diseases and Substance Use Disorders Among Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 12
- 主要终点
- Mortality and Hospital Readmissions
研究概览
简要总结
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.
详细描述
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. The SIRI Team intervention will be grounded in a harm reduction approach. The intervention duration is approximately 4 months. Participants will complete follow-up visits at 4-, 8-, and 12-months post-randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mortality and Hospital Readmissions
时间窗: 4 months post-randomization
Binary: A participant is alive with no hospital readmission 4 months post-randomization vs. a participant has died or been readmitted to the hospital within 4 months post-randomization
次要结局
- Initiation of treatment before hospital discharge(Course of hospital visit (expected to be within 1 month of randomization))
- Receipt of post-discharge treatment(This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.)
- Completion of planned antibiotic course for the index infection(Course of antibiotic treatment (Length varies by severity of infection); Assessed at the 4 month follow-up time)
- Patient-directed discharge from index hospitalization(Course of hospital visit (expected to be within 1 month of randomization))
- Post-discharge hospital visits(This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.)
- New or recurrent acute bacterial or fungal infection post-index hospitalization(This will be a repeated assessment at each of the follow-up times. The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.)
- Substance use severity(The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.)
- Alcohol use severity(The main test of the secondary hypothesis is at the 4th month. An additional contrast will assess if this maintains on average at the 8th and 12th month.)
- All-cause mortality(At each of the follow-up times (4, 8 and 12 months))
研究者
Lisa Metsch
Dean of Columbia University School of General Studies, Professor in Department of Sociomedical Sciences
Columbia University