NIDA CTN-0107 Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission
研究概览
简要总结
The purpose of the Peer Intervention to Link Overdose Survivors to Treatment (PILOT) study is to improve outcomes for individuals after surviving an overdose involving opioids. This study will be comparing the enhanced peer intervention known as PILOT for overdose survivors with treatment as usual (TAU) provided in the Emergency Department.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •To be included in this study participants must:
- •Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion).
- •Meet one of the following non-fatal overdose involving opioids (NFOO) criteria:
- •Having presented to the Emergency Department for any health issue within the past 48 hours AND self-report having a known or suspected overdose involving opioids in the past 72 hours, OR
- •Having presented to the Emergency Department within the past 48 hours for any SUD-related health issue, self-report having a known or suspected overdose involving opioids in the past 30 days
- •Be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant.
- •Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study as determined by research staff.
- •Be willing and able to confirm future SUD treatment receipt as evidenced by 2 out of 3 of the following: (a) signing appropriate releases to for study staff to confirm treatment with follow-up provider; (b) having technology necessary to visualize medication bottles and transmit to study team utilizing HIPAA-compliant platform; and/or (c) able and willing to undergo toxicology tests (in person or via HIPAA-compliant videoconferencing).
排除标准
- •include those who are:
- •Identified as having had an intentional overdose as the Index NFOO.
- •Actively suicidal at the time of screening (defined as current intention and/or plan for suicide attempt).
- •Unable to complete study baseline procedures due to medical or psychiatric condition.
- •Currently in jail, prison or in police custody at the time of the index ED visit or under current terms of civil commitment or guardianship (i.e., OHRP-defined prisoner status).
- •Previously randomized as a participant in this study - individuals may only be enrolled and randomized once.
- •Unwilling to follow study procedures (e.g., unable to provide sufficient locator information [defined as two contacts] or unavailable for follow-up assessments).
研究组 & 干预措施
Treatment As Usual Peer
干预措施: Treatment As Usual Peer (Behavioral)
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
干预措施: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer (Behavioral)
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
干预措施: Treatment As Usual Peer (Behavioral)
结局指标
主要结局
Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission
时间窗: 180 days (6 months)
Past month total score on the modified Overdose Risk Behavior Checklist (OBRC) at 180 days (6 months post-randomization) compared between experimental groups. The ORBC was a 13-item scale with 11 of the items used to generate a total score (ranging from 0-44); higher scores indicate greater frequency and number of overdose risk behaviors.
次要结局
- Number of Steps Achieved Along a Modified SUD Cascade of Care(180 days (6 months))
研究者
Kelly Barth
Professor
Medical University of South Carolina