Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 253
- 试验地点
- 2
- 主要终点
- Number of Opioid-related Adverse Events
研究概览
简要总结
The New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has implemented Relay, a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. The proposed randomized controlled trial will evaluate the impact of Relay on preventing subsequent opioid-related adverse events. A total of 350 eligible individuals with nonfatal opioid OD presenting to one of four participating EDs will be enrolled and randomized to one of two arms: 1) site-directed care (SDC) or 2) Relay-peer-delivered OD education and treatment linkage, including 90 days of peer navigation. Outcomes will be measured for 12 months through interviews and administrative health data.
详细描述
Relay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years)
- •English- or Spanish-speaking
- •Patient at a participating ED with nonfatal opioid OD.
- •Currently residing in NYC
排除标准
- •Unable to provide informed consent
- •Currently incarcerated, currently living in another controlled environment prohibiting research contacts, or currently in police custody
- •Known to be currently pregnant
- •Already participating in the study (patients will only be enrolled into the study once)
- •Already actively engaged in the Relay program (within the 90-day program window)
- •Speaks only Spanish, at a site and time period when no Spanish-speaking RA is available
结局指标
主要结局
Number of Opioid-related Adverse Events
时间窗: Up to Month 12
Opioid-related adverse events includes fatal and non-fatal opioid-involved overdose as well as substance use-related emergency department (ED) visits. ED visits and fatal overdoses in the 12-month period after baseline will be captured in administrative data sources. Other non-fatal opioid-involved overdose events will be captured by self-report in follow-up interviews through six months after baseline, and estimated for the second half of the 12-month follow-up period.
次要结局
- Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)(Up to Month 3)
- Overdose Risk Behavior Questionnaire Score(Month 6)
- Time to Next Opioid-Involved Overdose(Up to Month 6)
- Number of Emergency Deparment (ED) Visits for Any Cause(Up to Month 12)
- Number of ED Visits for Other (Non-OD) Substance Use Reasons(Up to Month 12)
- Number of Opioid Overdose-Related ED Visits(Up to Month 12)
- Percentage of Participants Who Self-Report Opioid-Involved Overdose(Month 6)