Clinical trial NCT06238128: Opioid Rapid Response System: Naloxone Training in Communities
Official title: Developing and Testing the Opioid Rapid Response System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Overdose
Keywords: naloxone training
Community-engagement
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Knowledge of overdose sign
timeFrame: up to 2 weeks
measure: Knowledge of overdose management
timeFrame: up to 2 weeks
measure: Self-Efficacy toward intervening opioid overdose
timeFrame: up to 2 weeks
measure: Response efficacy about intervening opioid overdose
timeFrame: up to 2 weeks
measure: Concerns related to overdose management
timeFrame: up to 2 weeks
measure: Intent to intervene opioid overdose events in communities
timeFrame: up to 2 weeks
measure: The number of days per week, on average, to carry Narcan
timeFrame: Up to 6 months
measure: Number of Participants to response to overdose events from PulsePoint app.
timeFrame: Up to 6 months
measure: Number of participants to administer Narcan
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Ewald & Wasserman Research Consultants, LLC
state: California
Study officials:
affiliation: Univeristy of Missouri
name: Hye Jeong Choi
role: PRINCIPAL_INVESTIGATOR
affiliation: Real Prevention
name: Michael Hecht
role: PRINCIPAL_INVESTIGATOR
References: