The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution

NCT06523985 | Active Not Recruiting

• 1 other identifier: R34DA058162
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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 \[only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research\].

Conditions

Carrying Naloxone/Narcan on Their Person or in Their Vehicle; Being Trained to Respond to an Opioid Overdose

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Standard layperson messaging (Arm 1)

ACTIVE COMPARATOR

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)

Customized layperson messaging (Arm 2)

EXPERIMENTAL

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)

Control arm (Arm 3)

NO INTERVENTION

Arm 3 functions as the control arm and will not receive any monthly recruitment messaging or encouragement.

Interventions

Push messages (standard) BEHAVIORAL

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.

Standard layperson messaging (Arm 1)

Push messages (customized) BEHAVIORAL

These messages are similar to content in the standard push messages but are customized to address common misperceptions about opioid overdose and naloxone.

Customized layperson messaging (Arm 2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Indiana University Bloomington

Bloomington, Indiana, 47405, United States

Location

Related Publications (2)

• Agley J, Henderson C, Nair M, Seo DC, Parker M, Golzarri-Arroyo L, Dickinson S, Tidd D. Recruiting a National Sample of First Response Agencies to Participate in an Overdose Prevention Research Project: Randomized Controlled Trial and Feasibility Study. JMIR Form Res. 2026 Apr 2;10:e81743. doi: 10.2196/81743.

  PMID: 41925721 BACKGROUND

• 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.

  PMID: 38551636 BACKGROUND

Related Links

• Open Science Framework Preregistration

Study Officials

• Jon Agley

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available in perpetuity once published.
• Access Criteria: Data will be fully anonymous (in ratio format) and access will not be curtailed.

Locations

US (1)