Emergency Medical Services (EMS)-Initiated Buprenorphine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 495
- 试验地点
- 6
- 主要终点
- Primary Outcome Measure for Pragmatic Field Study
研究概览
简要总结
This is a multisite EMS study that will first conduct a sequence of pragmatic, prehospital field studies to provide preliminary feasibility, acceptability, and safety data for refinement and enhancement of a subsequent single-arm prospective trial that will provide preliminary effectiveness data, from which to build a larger randomized control trail (RCT) trial.
详细描述
Evaluating the EMS clinical protocol details and subsequent research procedures will be accomplished by enrolling approximately five EMS-initiated BUP encounters per site. Subsequently, a pragmatic field study will engage approximately thirty successful BUP initiations to assess the feasibility, acceptability, and safety of the EMS clinical protocol and follow up procedures. Investigators will also enroll a cohort of up to thirty patients per site who are eligible for BUP but refuse for informative purposes only, to understand reasons for refusal. Qualitative data on the refusal cohort will be analyzed separately. The outcomes of the pragmatic studies will inform revisions to the EMS clinical protocol.
A single-arm prospective trial of approximately 100 patients per site will subsequently be conducted to collect preliminary data on the effectiveness of EMS-initiated BUP on engagement in MOUD treatment within 10 and 30 days after the EMS-initiated BUP encounter.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Treated by the EMS-Initiated buprenorphine clinical protocol which includes:
- •Patients that accept EMS-Initiated BUP protocol. Patients offered the EMS-Initiated BUP protocol but declined.1
- •Willing to follow study procedures.
- •Able to speak English sufficiently to understand study procedures, and to provide verbal and electronic/written consent.
排除标准
- •Patients who lack decision making capacity
- •Patients who are in police or protective custody
研究组 & 干预措施
Participants
Individuals with opioid use disorder (OUD) who encounter Emergency Medical Services (EMS) in the prehospital setting under one of two circumstances: (1) They have experienced an overdose requiring naloxone reversal or (2) They are in acute opioid abstinence withdrawal and are offered an EMS-initiated BUP clinical protocol.
结局指标
主要结局
Primary Outcome Measure for Pragmatic Field Study
时间窗: Baseline
Feasibility and acceptability will be measured by the proportion of patients who accept EMS-initiated BUP among all patients who are offered the EMS-initiated BUP clinical protocol.
Primary Outcome Measure for the Single Arm Prospective Trial
时间窗: Within 10 days after EMS encounter
The proportion of participants engaged in MOUD within 10 days post EMS-initiated BUP among participants who received BUP and consented to be followed
次要结局
- Engagement in Treatment (30)(Within 30 days after EMS encounter)
- Precipitated Withdrawal(Baseline)
- ED Visits and Hospitalizations(Within 30 days after EMS encounter)
- Adverse Events(Within 30 days after EMS-BUP encounter)