Opioid Rapid Response System: Naloxone Training in Communities

Opioid Overdose Clinical Trial

Official title:

Developing and Testing the Opioid Rapid Response System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06238128
• Other study ID #: 2097714
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2024
• Source: University of Missouri-Columbia
• Contact: Hye Jeong Choi
• Phone: 5738844592
• Email: choihyej[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1600
• Est. completion date: July 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Opiate Overdose
• Opioid Overdose

Intervention

Behavioral:
• Opioid Rapid Resonse System (ORRS) training
ORRS is on online system to train citizen responders to administer NARCAN to save the lives of opioid overdose victims. It capitalizes on the innovative PulsePoint technology to connect responders to overdose events. PulsePoint is an app that connects 911 requesting assistance for cardiac arrests to responders with Cardiopulmonary Resuscitation (CPR) training. ORRS allows us to partner with PulsePoint users to expand its reach to opioid overdoses, which share the need for a quick response that emergency responders are often unable to provide. ORRS has the advantage of expanding the population of responders with NARCAN, rescue breathing, and CPR training that can be connected to overdose events, increasing the likelihood of saving overdose victims' lives through a quick, efficient response. ORRS is delivered through an interactive, digital platform containing sequential, multi-media modules.
• 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.

Locations

Country	Name	City	State
United States	Ewald & Wasserman Research Consultants, LLC	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge of overdose sign	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.	up to 24 hours
Primary	Knowledge of overdose management	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.	up to 24 hours
Primary	Self-Efficacy toward intervening opioid overdose	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	up to 24 hours
Primary	Response efficacy about intervening opioid overdose	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.	up to 24 hours
Primary	Concerns related to overdose management	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.	up to 24 hours
Primary	Intent to intervene opioid overdose events in communities	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.	up to 1 month
Primary	The number of days per week, on average, to carry Narcan	Single item: how many days per week, on average, participants carry Narcn	Up to 6 months
Primary	Number of Participants to response to overdose events from PulsePoint app.	Single item: whether participant response to overdose events from PulsePoint notifications/alerts	Up to 6 months
Primary	Number of participants to administer Narcan	Single item: Whether participant administer Narcan to respond opioid overdose events in communities.	Up to 6 months