Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Implementation Trial of High Intensity Versus Low Intensity Strategy for Supporting Hospital-Based Opioid Use Disorder Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Gavin Bart
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Engagement with MOUD
研究概览
简要总结
This study is a multi-site, cluster randomized, two group implementation trial comparing a low- versus high-intensity implementation strategy for supporting hospital-based opioid use disorder treatment (HBOT) in community hospital settings where medication for opioid use disorder (MOUD) treatment has not been implemented.
详细描述
The study will randomize approximately 24 community hospitals meeting defined eligibility requirements, including a desire to address OUD among inpatients through the use of MOUD. Community hospitals will be randomized 1:1 to implement a low- or high-intensity strategy. Hospitals will be randomized with intervention implementation and oversight assigned to one of 3-4 geographically diverse hub academic medical centers with existing clinical and research expertise in HBOT. The randomization will be stratified by site/hub. Participants will be assessed for "engagement with MOUD", measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention. Further outcomes will be assessed during the entire 4-year study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a community hospital deemed by the lead investigators to be in the region of a site/hub. Region will usually be defined as state unless a compelling case can be made as to geographic feasibility of implementing the intervention and access to relevant Medicaid data.
- •Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients.
- •Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge.
- •Commit to having buprenorphine-waivered prescribers willing and able to write prescriptions to bridge discharged patients to post-discharge OUD treatment, or available direct entry into outpatient MOUD with methadone or buprenorphine.
- •Have hospital staff who express willingness to engage with a site/hub team for training and for data collection.
- •Be willing to be randomized to low-intensity or high-intensity implementation support.
- •Provide inpatient general medical care.
- •Have sufficient numbers of Medicaid OUD discharges (any listed diagnosis; sufficient is defined as at least enough such that when added to the other hospitals in the region there are on average 100 discharges per year). Medicaid data must capture at least 3 discharge diagnoses, outpatient MOUD, and be available within no more than 12 months of discharge.
排除标准
- •Have an ACS routinely prescribing MOUD at discharge.
- •Have an existing, functioning HBOT program or be imminently starting an HBOT initiative, as confirmed by the investigator team.
- •Be a Veterans Affairs hospital.
研究组 & 干预措施
Low Intensity
MOUD training and support through the use of educational materials.
干预措施: Low Intensity (Other)
High Intensity
MOUD training and support through the use of educational materials in addition to practice facilitation.
干预措施: High Intensity (Other)
结局指标
主要结局
Engagement with MOUD
时间窗: 34 days following hospital discharge
measured as the proportion of community hospital OUD discharges engaged with MOUD within 34 days following hospital discharge during months 13-24 of the intervention.
次要结局
未报告次要终点
研究者
Gavin Bart
Gavin Bart, MD PhD FACP DFASAM
Hennepin Healthcare Research Institute