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

Indiana University

Status: Invitation-only

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

Treatments: Behavioral: Push messages (standard); Behavioral: Push messages (customized)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06523985

R34DA058162 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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].

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

5,000 participants in 3 patient groups

Standard layperson messaging (Arm 1)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Push messages (standard)

Customized layperson messaging (Arm 2)

Experimental group

Description:

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.

Treatment:

Behavioral: Push messages (customized)

Control arm (Arm 3)

No Intervention group

Description:

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