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阿片类药物快速反应系统的开发:一项随机对照试验方案。

Development of opioid rapid response system: Protocol for a randomized controlled trial.

机构信息

Institute for Research on Addictive Behavior, Prevention Insights, School of Public Health-Bloomington, Indiana University, United States.

REAL Prevention, LLC, Clifton, NJ, United States.

出版信息

Contemp Clin Trials. 2022 Apr;115:106727. doi: 10.1016/j.cct.2022.106727. Epub 2022 Mar 13.

DOI:10.1016/j.cct.2022.106727
PMID:35296414
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9427328/
Abstract

BACKGROUND

Opioid overdoses require a rapid response, but emergency responders are limited in how quickly they can arrive at the scene for administering naloxone. If laypersons are trained to administer naloxone and are notified of overdoses, more lives can be saved.

OBJECTIVE

This study aimed to examine the feasibility of the Opioid Rapid Response System (ORRS) that recruits, trains, and links citizen responders to overdose events in their community in real-time to administer naloxone. Aim of this paper is to present the protocols for recruiting participants through multiple communication channels; developing and evaluating the online training which has both interactive and asynchronous modules; randomly assigning laypersons to either online naloxone training or waitlist control group; measuring participants' knowledge, skills, and attitudes before and after the training; and distributing intranasal naloxone kits to participants for use in events of overdose in their community.

METHODS

Sampling: Utilizing a combination of purposive sampling methods, laypersons from across five Indiana counties who did not self-identify as current first responders were invited to participate.

DESIGN

In this two-arm randomized waitlist-controlled study (N = 220), individuals were assigned into either online training or waitlist control that received the training two weeks later.

ANALYSIS

A linear mixed model will be used for determining the changes in targeted outcomes in the training group and accommodate for fixed and random effects.

IMPLICATIONS

While ORRS can become a community-engaged, cost-effective model for technology-based emergency response for opioid overdoses, study protocols can be useful for other emergency response programs that involve laypersons.

CLINICALTRIALS

gov Registration Number: NCT04589676.

摘要

背景

阿片类药物过量需要快速反应,但急救人员到达现场给予纳洛酮的速度有限。如果对非专业人员进行培训并通知他们发生过量用药事件,就可以挽救更多生命。

目的

本研究旨在检验 Opioid Rapid Response System(ORRS)的可行性,该系统招募、培训公民响应者,并实时将他们与社区中的过量用药事件联系起来,以便给予纳洛酮。本文旨在介绍通过多种沟通渠道招募参与者的方案;开发和评估具有互动和异步模块的在线培训;将非专业人员随机分配到在线纳洛酮培训或候补对照组;在培训前后测量参与者的知识、技能和态度;并向参与者分发鼻腔内纳洛酮试剂盒,以便在社区中发生过量用药事件时使用。

方法

采用多种目的抽样方法,邀请来自印第安纳州五个县的非自我认定为当前急救人员的非专业人员参与研究。

设计

在这项两臂随机候补对照研究(N=220)中,参与者被分配到在线培训或候补对照组,两周后接受培训。

分析

线性混合模型将用于确定培训组中目标结果的变化,并适应固定和随机效应。

意义

虽然 ORRS 可以成为一种基于技术的社区参与、具有成本效益的阿片类药物过量急救模型,但研究方案对于涉及非专业人员的其他急救响应计划可能有用。

临床试验

gov 注册号:NCT04589676。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc2d/9427328/9042ec07c1b9/nihms-1790154-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc2d/9427328/966e6229722c/nihms-1790154-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc2d/9427328/e29fd38f2422/nihms-1790154-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc2d/9427328/9042ec07c1b9/nihms-1790154-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc2d/9427328/966e6229722c/nihms-1790154-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc2d/9427328/e29fd38f2422/nihms-1790154-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fc2d/9427328/9042ec07c1b9/nihms-1790154-f0003.jpg

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