Being Trained to Respond to an Opioid Overdose, Carrying Naloxone/Narcan on Their Person or in Their Vehicle
Conditions
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 \[only this hypothesis is covered by the IRB, hypothesis 1 is not human subjects research\].
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.
Interventions
BEHAVIORALPush 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.
BEHAVIORALPush 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.
Sponsors
Indiana University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Certification of receiving OEND programming and naloxone carrying | 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJon Agley
Indiana University
Outcome results
None listed