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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2026-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Push messages (standard)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Push messages (customized)

Intervention Type BEHAVIORAL

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

Control arm (Arm 3)

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No