The Feasibility of Using the PulsePoint to Facilitate Overdose Education and Naloxone Distribution
Part of paid clinical trials in Bloomington, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06523985
- Status
- Enrolling By Invitation
Conditions
- Being Trained to Respond to an Opioid Overdose
- Carrying Naloxone/Narcan on Their Person or in Their Vehicle
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Push messages (standard) — BEHAVIORALPush 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.
- Push messages (customized) — BEHAVIORALThese messages are similar to content in the standard push messages but are customized to address common misperceptions about opioid overdose and naloxone.
Study Details
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 \[only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research\].
Key Dates
- Start date
- Aug 7, 2024
- Status verified
- Jun 2025
- Primary completion
- May 31, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 5,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- 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.
- 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.
- No Intervention: Control arm (Arm 3)Arm 3 functions as the control arm and will not receive any monthly recruitment messaging or encouragement.
Primary Outcome Measure
Certification of receiving OEND programming and naloxone carrying [ Time Frame: 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University Bloomington | Bloomington | Indiana | 47405 | - |