Background
The use of naloxone, an opioid antagonist, is a critical component of the US response to fatal opioid-involved overdoses. The importance and utility of naloxone in preventing fatal overdoses have been widely declaimed by medical associations and government officials and are supported by strong research evidence. Still, there are gaps in the current US national strategy because many opioid-involved overdose fatalities have no evidence of naloxone administration. Improving the likelihood that naloxone will be used to prevent fatal overdoses is predicated on facilitating an environment wherein naloxone is available near each overdose and can be accessed by someone who is willing and able to use it. How to accomplish this on a national scale has been unclear. However, there exists a national network of >1 million cardiopulmonary resuscitation (CPR) layperson responders and 4800 emergency responder agencies linked through a mobile phone app called PulsePoint Respond. PulsePoint responders certify that they are trained to administer CPR and are willing to respond to possible cardiac events in public. When such an event occurs near their mobile phone’s location, they receive an alert to respond. These motivated citizens are ideally positioned to carry naloxone and reverse overdoses that occur in public.
Objective
This randomized controlled trial will examine the feasibility of recruiting first responder agencies and layperson CPR responders who already use PulsePoint to obtain overdose education and carry naloxone.
Methods
This will be a 3-arm parallel-group randomized controlled trial. We will randomly select 180 first responder agencies from the population of agencies contracting with the PulsePoint Foundation. The 3 study arms will include a standard recruitment arm, a misperception-correction recruitment arm, and a control arm (1:1:1 allocation, with random allocation stratified by zip code designation [rural or nonrural]). We will study agency recruitment and, among the agencies we successfully recruit, responder certification of receiving overdose and naloxone education, carrying naloxone, or both. Hypothesis 1 contrasts agency recruitment success between arms 1 and 2, and hypothesis 2 contrasts the ratios of layperson certification across all 3 arms. The primary analyses will be a logistic regression comparing the recruitment rates among the arms, adjusting for rural or nonrural zip code designation.
Results
This study was reviewed by the Indiana University Institutional Review Board (20218 and 20219). This project was funded beginning September 14, 2023, by the National Institute on Drug Abuse.
Conclusions
The hypotheses in this study will test whether a specific type of messaging is particularly effective in recruiting agencies and layperson responders. Although we hypothesize that arm 2 will outperform the other arms, our intention is to use the best-performing approach in the next phase of this study if any of our approaches demonstrates feasibility.
Trial Registration
OSF Registries osf.io/egn3z; https://osf.io/egn3z
International Registered Report Identifier (IRRID)
PRR1-10.2196/57280