- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06238128
Opioid Rapid Response System: Naloxone Training in Communities
Developing and Testing the Opioid Rapid Response System
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hye Jeong Choi
- Phone Number: 5738844592
- Email: choihyej@health.missouri.edu
Study Contact Backup
- Name: Michael Hecht
- Phone Number: 8143601893
- Email: hechtpsu@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ORRS training group
Online Naloxone 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.
|
Sham Comparator: 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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of overdose sign
Time Frame: up to 24 hours
|
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
|
Knowledge of overdose management
Time Frame: up to 24 hours
|
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
|
Self-Efficacy toward intervening opioid overdose
Time Frame: up to 24 hours
|
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
|
Response efficacy about intervening opioid overdose
Time Frame: up to 24 hours
|
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
|
Concerns related to overdose management
Time Frame: up to 24 hours
|
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
|
Intent to intervene opioid overdose events in communities
Time Frame: up to 1 month
|
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
|
The number of days per week, on average, to carry Narcan
Time Frame: Up to 6 months
|
Single item: how many days per week, on average, participants carry Narcn
|
Up to 6 months
|
Number of Participants to response to overdose events from PulsePoint app.
Time Frame: Up to 6 months
|
Single item: whether participant response to overdose events from PulsePoint notifications/alerts
|
Up to 6 months
|
Number of participants to administer Narcan
Time Frame: Up to 6 months
|
Single item: Whether participant administer Narcan to respond opioid overdose events in communities.
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Drug Overdose
- Prescription Drug Misuse
- Drug Misuse
- Opiate Overdose
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Narcotics
- Analgesics, Opioid
Other Study ID Numbers
- 2097714
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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