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临床试验/NCT03526380
NCT03526380已完成不适用

Translation of Opiate Overdose Prevention Strategies

University of Michigan2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2018年10月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
2
主要终点
Overdose Risk Behaviors (ORB)

研究概览

简要总结

Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use.

The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.

详细描述

Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Speaks English Fluently
  • Receiving services at one of the investigator's partner sites
  • History of opioid use

排除标准

  • Medically unstable
  • Prisoners
  • Inability to speak and understand English
  • Inability to give informed, voluntary, written consent for any reason

结局指标

主要结局

Overdose Risk Behaviors (ORB)

时间窗: 3 months post-baseline

The ORB measures change over time for prescription opioid use, specific to type of opioid use, combination with other substances, route, and if they use alone. This scale is a total sum of 9 items assessing participant's self-report of engaging in behavior that increases risk for overdose. Higher scores indicate greater risk for overdose. The range for this measure is 0 to 32 in one assessment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy S.B. Bohnert

Associate Professor

University of Michigan

研究点 (2)

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The OPT-IN Project | 临床试验