Pilot Testing a Novel Remotely Delivered Intensive Outpatient Program for Individuals With Opioid Use Disorder Hospitalized With Serious Injection-related Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention program
研究概览
简要总结
This study aims to test a remotely delivered IOP program ("SmartIOP") for OUD patients who are hospitalized for serious injection-related infections. This will be a pilot trial to assess the feasibility of the IOP program and examine OUD-related outcomes following discharge from the hospital.
详细描述
The aim is to conduct a single-arm pilot study of 20 participants who are hospitalized for serious injection-related infections to complete the newly tailored program. The intervention to be developed and tested has two components: 1) the remotely delivered IOP ("Smart IOP"), and 2) a peer recovery coach who will provide support and accountability to the participant. The feasibility of the intervention will be established by evaluating recruitment and the acceptability of the program according to a priori benchmarks. The study team will assess the program's preliminary efficacy by evaluating OUD-related outcomes for up to 28 days after discharge from the hospital. The study will be conducted at Brigham and Women's Hospital (BWH), an urban, 793-bed academic medical center located in Boston, MA, and a major teaching hospital for Harvard Medical School.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •English-speaking adults aged 18 and above
- •Any DSM-5 substance use disorder
- •Can identify at least 2 individuals who can act as points of contact following discharge from the hospital
排除标准
- •Psychotic disorder, active suicidality, or homicidally
- •Condition likely to be terminal during the study period
- •Unable to perform consent due to impaired mental status
结局指标
主要结局
Feasibility of the intervention program
时间窗: Immediately Post Intervention
We expect the results to demonstrate adequate feasibility, as defined by exceeding the threshold for adequate recruitment feasibility and good program acceptability. Adequate recruitment feasibility is defined as enrolling more than 70% of those eligible individuals. Excellent program acceptability is defined as \>70% of the participants complete at least 70% of the Smart IOP intervention, and good program acceptability if \>60% of participants did.
次要结局
- Retention with MOUD treatment(7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up)
- Illicit opioid use(7-day Follow Up, 14-day Follow Up, 21-day Follow Up, and 28-Day Follow Up)
研究者
Joji Suzuki, MD
Director, Division of Addiction Psychiatry
Brigham and Women's Hospital