The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution (PP-OD)

The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution

This study is a feasibility trial to assess whether, in a random sample of 180 agencies where PulsePoint is already active, revised procedures (hereinafter PulsePoint-OD) to facilitate opioid overdose and naloxone distribution (OEND) can successfully recruit first responder agencies and layperson responders. For this study, agency refers to a single implementation site where PulsePoint is active and that is bound by the service area or jurisdiction of the first responder agency collaborating with PulsePoint.

The study will test the following hypotheses:

H1: more first responder agencies will be successfully recruited by arm 2 than by arm 1.

H2: more layperson responders will report engaging with OEND programming in arm 2 than in arms 1 or 3 and in arm 1 than in arm 3 [only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research].

Study Overview

• Status: Enrolling by invitation
• Conditions: Carrying Naloxone/Narcan on Their Person or in Their Vehicle; Being Trained to Respond to an Opioid Overdose
• Intervention / Treatment: Behavioral: Push messages (standard); Behavioral: Push messages (customized)

Detailed Description

A full, detailed description of the study protocol and preregistered procedures is located in our formal protocol paper (https://doi.org/10.2196/57280) which is also cited at the end of this specific registration.

All specific language throughout this document is derived directly (verbatim) from the protocol paper, which is our controlling, planned preregistration document for this project.

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University Bloomington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Layperson responders who are part of the PulsePoint system register with a local first responder agency using their smartphone. Anyone who is registered with a PulsePoint agency randomly selected for this project is included. Most layperson responders (eg, those who are not also off-duty first responders themselves) are only alerted to incidents in public spaces. No identifying information is collected from these users except the unique ID of the device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard layperson messaging (Arm 1); Users randomized to arm 1 will receive standard monthly recruitment push messages. These push messages will differ from the certification messages because they will contain language intended to foster engagement with OEND services (eg, to get trained and carry naloxone) alongside the link to a landing page.	Behavioral: Push messages (standard); Push messages will be developed based on best practice recruitment principles in cooperation with an external marketing team and then reviewed and finalized by the study team. Messages will be different each month and sent across 12 months. The monthly time frame was selected based on our need to balance contact with responders and research or expert opinions on push messaging saturation.
Experimental: Customized layperson messaging (Arm 2); Arm 2 will follow the same procedures that are described for arm 1 but will use separate messaging. Specifically, the push messages and landing page will contain additional, brief messages that specifically provide factual information that counteracts misperceptions about overdose and naloxone.	Behavioral: Push messages (customized); These messages are similar to content in the standard push messages but are customized to address common misperceptions about opioid overdose and naloxone.
No Intervention: Control arm (Arm 3); Arm 3 functions as the control arm and will not receive any monthly recruitment messaging or encouragement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Certification of receiving OEND programming and naloxone carrying	At baseline, we will calculate the ratio of persons certifying that they are trained (numeric count of N) compared to the total number of push message recipients (T), the ratio of persons certifying that they carry naloxone (numeric count of C) compared to the total number of push message recipients (T), and the ratio of individuals who clicked on the link (O) compared to the total number of push message recipients (T). Separately at 6- and 12-month follow-ups, the numbers of certifications of training and carrying naloxone (N and C, respectively) that were submitted compared to the numbers of push recipients (T) in each period (tracked by D) and the ratio of individuals who clicked on the link (O) each month compared to the number of total push message recipients (T). Our outcome variables are ratios: X = (N / T) for each value of D (0, 1, or 2) and Y = (C / T) for each value of D. The ratio Z = (O / T) is a covariate representing engagement with push messages at each value of D.	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Jon Agley, Indiana University

Publications and helpful links

General Publications

• Agley J, Henderson C, Seo DC, Parker M, Golzarri-Arroyo L, Dickinson S, Tidd D. The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 29;13:e57280. doi: 10.2196/57280.

Helpful Links

• Open Science Framework Preregistration

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Drug Misuse; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Prescription Drug Misuse; Opioid-Related Disorders; Opiate Overdose; Drug Overdose
• Other Study ID Numbers: R34DA058162 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified raw data will be provided alongside publications using those data.
• IPD Sharing Time Frame: Data will be available in perpetuity once published.
• IPD Sharing Access Criteria: Data will be fully anonymous (in ratio format) and access will not be curtailed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No