Measures to Improve Outcomes After an Opioid Overdose
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Opioid Related Emergency Department (ED) Visits
研究概览
简要总结
This is a pilot study that aims to develop good clinical practices to improve outcomes after an opioid overdose and transition of care from the Emergency Department (ED) into an Office Based Opioid Treatment (OBOT) clinic for patients with opioid overdose/Opioid Use Disorder (OUD). We intend to involve UVA Emergency Medicine and Medical Toxicology physicians with buprenorphine waiver or an interest in becoming waived at our institution to implement early initiation of buprenorphine protocol. We hope that this change in practice will result in better management of patients with OUD and opioid overdose, reduce relapse and improve engagement in addiction treatment.
Subjects who meet criteria will be consented in the ED and receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic. Subjects who consent to take part in this study will be entered in a database to track their involvement in treatment (s) at UVA and or any opioid related UVA health visits including OPIOID OVERDOSE.
详细描述
Every patient who is seen in the ED for opioid overdose and has received naloxone either by emergency medical services (EMS) or in the ED will be eligible to participate in this study. When patient is alert, they will be asked if they would be interested in participating in the study and consented when appropriate. Patients will receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic.
OBOT Follow-up The patient's follow-up care will take place at the OBOT clinic, supervised by an Addiction Medicine specialist (physician) with a buprenorphine-waiver and an license clinical social worker (LCSW). Scheduling of all OBOT visits during this study are in alignment with the OBOT standard of care, including frequency and duration of visits. A total of 10 visits will be scheduled over the course of 6 months.
Month 1:
Visit 1:
The first OBOT visit will last approximately 60 minutes and will entail the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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 or older
- •Person can read, write, and speak in English.
- •Presenting to the University of Virginia ED with opioid overdose and administration of naloxone either by EMS or in the ED.
- •Experiencing some withdrawal symptoms (COWS score of 12 or higher) or experiencing 3 of the following symptoms: tremor/twitching, irritability, joint or bone aches, bad chills or sweating, goose bumps
- •Express an interest in receiving a buprenorphine/naloxone induction with the goal to continue the same treatment outpatient
排除标准
- •Non-opioid substance overdose or overdose that does not respond to naloxone
- •Patients requiring admission secondary to medical or psychiatric complications
- •Patients on prescribed methadone
- •Women who are pregnant; This medication may precipitate opioid withdrawal in pregnant patients with opioid use disorder. Withdrawal can harm the placenta function, preterm labor, fetal convulsions (seizures), stunted fetal growth and fetal death during pregnancy.
- •Mothers who are breastfeeding
- •Persons under the age of 18
- •Persons not able to attend follow-up clinic visits
- •Persons not able to consent
- •Known allergy or sensitivity to buprenorphine
结局指标
主要结局
Opioid Related Emergency Department (ED) Visits
时间窗: up to 30 days
Reduce risk of opioid re-overdose following ED buprenorphine/naloxone induction protocol. This will be measured by calculating the percentage of opioid related visits to any ED at 7 days post discharge, at 30 days post discharge, and hospital admissions at 30 days discharge.
Treatment Engagement
时间窗: up to 6 months
Improve addiction treatment engagement for patients receiving ED buprenorphine/naloxone induction following opioid overdose. This will be measured by the number of ED patients scheduled for follow-up at the office based opioid treatment (OBOT) clinic versus number of patients that attend the scheduled first appointment and number of patients that continue to follow-up at the OBOT clinic at 30 days and at 6 months.
Clinical Opiate Withdrawal Scale (COWS)
时间窗: at screening
The COWS is an 11 item scale designed to be administered by a clinican. This tool is used to rate common signs and symptoms of opiate withdrawal and monitor these symptoms over time. Reduction in adverse events will be evaluated by the documentation of COWS scores right after administration of Naloxone, then buprenorphine/naloxone.
次要结局
- Urine Drug Screen(up to 6 months)
- HIV Risk-Taking Behavioral Scale HIV Risk-Taking Behavioral Scale(up to 6 months)
- Brief Addiction Monitor (BAM)(up to 6 months)
- Demographic Data(at screening)
研究者
Nassima Ait-Daoud Tiouririne
Associate Professor, Director of UVA Center for Leading Edge Addiction Research
University of Virginia