Developing and Testing the Opioid Rapid Response System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 773
- 试验地点
- 1
- 主要终点
- The Number of Days Per Week, on Average, to Carry Narcan
研究概览
简要总结
The pervasive impact of the opioid epidemic has touched all layers of society for the past two decades, resulting in over 115 deaths daily and imposing annual costs of $78.5 billion. Responding swiftly to overdoses, akin to various medical emergencies, poses a significant challenge, particularly in geographically dispersed rural areas and densely populated urban settings. Effectively delivering the life-saving drug naloxone, which counteracts the effects of overdoses, necessitates a well-coordinated and cost-efficient response system.
Simply opting for widespread distribution of naloxone, even with citizen involvement, proves to be a financially burdensome approach when compared to more targeted strategies. Moreover, obstacles such as limited access, inadequate or unavailable naloxone training, and delayed response times from emergency responders compound the problem. Addressing these issues, the proposed Opioid Rapid Response System (ORRS) project seeks to advance prevention science by adopting an innovative approach that incorporates technology and contemporary communication theory.
The primary objective of the ORRS project is to mitigate opioid overdose deaths by enlisting and training citizens to administer naloxone in response to such events. Leveraging the PulsePoint health app, which connects citizens to cardiac events, the ORRS project will extend its capabilities to respond to overdose incidents. This initiative involves comprehensive development of ORRS, followed by a randomized clinical trial on a national scale to assess its effectiveness. The study aims to contribute to both prevention and implementation science by identifying optimal recruitment strategies and testing a model of online training. In pursuit of these objectives, the study is guided by the following Specific Aims:
SA 1: Refine and complete the development of ORRS. SA 2: Conduct a randomized clinical trial to evaluate the effectiveness of the intervention. SA 3: Prepare ORRS for dissemination.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Citizens who live in participating PulsePoint communities
- •Must to be 18 and older
- •Must be fluent in English
- •Must have access to the mobile data and able to download and use apps in a smartphone
排除标准
- •Citizens who do not live in participating PulsePoint communities
- •Under 18-year-old
- •Citizens who are not fluent in English
- •Citizens who do not have access to mobile data and unable to download and use apps in a smartphone.
研究组 & 干预措施
Waitlist group
Participants will receive non-active opioid overdose response training. Investigators will provide online training about opioid prevalence in US, opioid mechanism, side effect, and addiction. However, Investigators do not provide any knowledge about opioid overdose management and naloxone in this training.
Once the project is completed, participants will receive online Naloxone training.
干预措施: Non-active opioid overdose response training (Behavioral)
ORRS training group
Online Naloxone training
干预措施: Opioid Rapid Resonse System (ORRS) training (Behavioral)
结局指标
主要结局
The Number of Days Per Week, on Average, to Carry Narcan
时间窗: Up to 6 months
Single item: how many days per week, on average, participants carry Narcn
Knowledge of Overdose Sign
时间窗: up to 2 weeks
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose sign.
Knowledge of Overdose Management
时间窗: up to 2 weeks
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose management.
Self-Efficacy Toward Intervening Opioid Overdose
时间窗: up to 2 weeks
Investigators will modify self-efficacy scale developed and theorized by Bandura (2005). Response options are from 0 (no confident) to 100 (highly confident). Higher score indicates greater self-efficacy
Response Efficacy About Intervening Opioid Overdose
时间窗: up to 2 weeks
Investigators will develop and measure how participants perceive the effectiveness of activities to intervene opioid overdose events in communities. Response options are from 0 (not effective) to 100 (highly effective). Higher score indicate greater response efficacy.
Concerns Related to Overdose Management
时间窗: up to 2 weeks
Investigators will use a subset of Opioid Overdose Attitude Scale (OOAS) with 5 point scale (1: strongly disagree \~5: strongly agree). Higher score indicates the greater concerns.
Intent to Intervene Opioid Overdose Events in Communities
时间窗: up to 2 weeks
Investigators will use behavioral intention scale developed by in the opioid training literature (Hecht et al., 2023) to measure intent to intervene opioid overdose events in communities (e.g., administering Narcan). Response options are from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicates grater intention to intervene opioid overdose events in communities.
Number of Participants to Response to Overdose Events From PulsePoint App.
时间窗: Up to 6 months
Single item: whether participant response to overdose events from PulsePoint notifications/alerts
Number of Participants to Administer Narcan
时间窗: Up to 6 months
Single item: Whether participant administer Narcan to respond opioid overdose events in communities.
Knowledge of overdose sign
时间窗: up to 2 weeks
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose sign.
Knowledge of overdose management
时间窗: up to 2 weeks
Investigators will use a subset of Opioid Overdose Knowledge Scale (OOKS) to measure through a forced choice scale with each choice coded as correct (=1) or incorrect (=0). Higher score indicated greater knowledge of overdose management.
Self-Efficacy toward intervening opioid overdose
时间窗: up to 2 weeks
Investigators will modify self-efficacy scale developed and theorized by Bandura (2005). Response options are from 0 (no confident) to 100 (highly confident). Higher score indicates greater self-efficacy
Response efficacy about intervening opioid overdose
时间窗: up to 2 weeks
Investigators will develop and measure how participants perceive the effectiveness of activities to intervene opioid overdose events in communities. Response options are from 0 (not effective) to 100 (highly effective). Higher score indicate greater response efficacy.
Concerns related to overdose management
时间窗: up to 2 weeks
Investigators will use a subset of Opioid Overdose Attitude Scale (OOAS) with 5 point scale (1: strongly disagree \~5: strongly agree). Higher score indicates the greater concerns.
Intent to intervene opioid overdose events in communities
时间窗: up to 2 weeks
Investigators will use behavioral intention scale developed by in the opioid training literature (Hecht et al., 2023) to measure intent to intervene opioid overdose events in communities (e.g., administering Narcan). Response options are from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicates grater intention to intervene opioid overdose events in communities.
The number of days per week, on average, to carry Narcan
时间窗: Up to 6 months
Single item: how many days per week, on average, participants carry Narcn
Number of Participants to response to overdose events from PulsePoint app.
时间窗: Up to 6 months
Single item: whether participant response to overdose events from PulsePoint notifications/alerts
Number of participants to administer Narcan
时间窗: Up to 6 months
Single item: Whether participant administer Narcan to respond opioid overdose events in communities.
次要结局
未报告次要终点
研究者
Hye Jeong Choi
Associate Professor
University of Missouri-Columbia