Continuum of Care in Hospitalized Patients With Opioid or Stimulant Use Disorder and Infectious Complications of Drug Use - Substance Use/ID Integrated Clinic vs. TAU to Prevent Infection Related Readmission
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 304
- 试验地点
- 8
- 主要终点
- Infection Rehospitalization
研究概览
简要总结
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.
详细描述
This is a phase III two arm randomized controlled trial to determine the impact and Integrated infectious diseases (ID) and Substance Use Disorder outpatient clinic (IC) compared to treatment as usual on infection related rehospitalization in individuals hospitalized with infections due to injecting opioids or Stimulants, in the 6 month time period after discharge. This study includes both cost effectiveness and implementation outcomes.
(1) IC will provide facilitated linkage to a clinic providing medical treatment aimed at treating substance use disorder (SUD), resolving the index infection, treating existing ID complications of OUD (HIV, HCV, wounds) and preventing subsequent infections by providing accessible care for infectious diseases and medication for OUD (MOUD) treatment that is integrated into a single appointment and co-located at a single site (either in person or via telemedicine) for a minimum of monthly appointments over a 6 month time period. A feature of the IC will be weekly care coordination meetings between the ID and MOUD providers.
The study will recruit patients during hospitalization for an infection due to injecting opioids or stimulants at four hospital systems (five hospitals) and randomly assign approximately 304 inpatients in 1:1 ratio to IC vs TAU.
Participants will be followed for 12 months.
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
- •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.
- •Qualifying infections:
- •Non-vertebral osteomyelitis
- •Vertebral osteomyelitis or discitis
- •Epidural, subdural, or extradural abscess
- •Intracranial or intraspinal abscess
- •Native joint septic arthritis
- •Prosthetic joint septic arthritis
- •Blood stream infection (bacterial or fungal)
- •Native valve Endocarditis
- •Prosthetic valve endocarditis
- •Cardiac Implantable electronic device infection
- •Infectious pseudoaneurysm and aneurysm
- •Infected vascular graft
- •Septic venous thrombosis
- •Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis)
- •Infected skin ulcer
- •Orthopedic hardware infection
- •Muscle abscess/myositis
- •Central nervous system infection (bacterial or fungal)
- •Bacterial or fungal ophthalmologic infection
- •Other abscess
- •Pulmonary septic emboli
- •Other acute bacterial or fungal infection deemed appropriate by site study team
排除标准
- •1. Infection due to a cause other than injection drug use, per determination of a site PI.
- •2. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.
- •3. Unwilling to provide informed consent
- •Unable to receive potential interventions due to geography
- •On comfort measures or planned for discharge to hospice care
- •Incarcerated at the time of hospitalization
- •Other criteria at the discretion of the site investigator
结局指标
主要结局
Infection Rehospitalization
时间窗: 6 months after discharge for index hospitalization
New hospitalization due to infection following discharge for index hospitalization
次要结局
- Time to first infection related readmission(12 months after discharge for index hospitalization)
- Reason for infection related readmission(12 months after discharge for index hospitalization)
- Hospital services utilization(12 months after discharge for index hospitalization)
- Mortality(12 months after discharge for index hospitalization)
- Index infection(3 months after discharge for index hospitalization)
- Other Infections(12 months after discharge for index hospitalization)
- Skin and soft tissue wounds(12 months after discharge for index hospitalization)
- New infections not requiring hospitalization(12 months after discharge for index hospitalization)
- Outpatient linkage and retention(12 months after discharge for index hospitalization)
- Medication for Opioid Use (MOUD)(12 months after discharge for index hospitalization)
- Medication for stimulant use (MStUD)(12 months after discharge for index hospitalization)
- Substance Use-Opioid(12 months after discharge for index hospitalization)
- Substance Use - Stimulant(12 months after discharge for index hospitalization)
- Cost Effectiveness(12 months after discharge for index hospitalization)
研究者
Elana Rosenthal
Associate Professor
University of Maryland, Baltimore