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
Background: US overdose deaths continue to exceed 77,000 per year, the majority of which involve opioids. One evidence-based response to this crisis is overdose education and naloxone distribution (OEND). There is a large national (US) network of citizens and first response agencies connected through an app called , who are engaged in facilitating rapid layperson cardiopulmonary resuscitation administration in cases of public emergencies. Our goal is to recruit these first response agencies to provide targeted messaging about OEND to this large subpopulation of motivated layperson responders. This study focuses on the first step: the feasibility of our national efforts to recruit first response agencies to participate in our project. Objective: This study aimed to determine whether more first response agencies were successfully recruited using materials that included preemptive correction of misperceptions about overdose and naloxone than with standard recruitment materials and to investigate the recruitment parameters observed when agencies were successfully recruited. Methods: The overall study was a randomized controlled trial in which we randomly sampled 180 first response agencies from the total set of agencies subscribing to (n=773). Agencies were randomly allocated to 3 study arms (1:1:1) with stratification for rural status. Arm 1 received standard recruitment materials, arm 2 received similar materials that directly addressed common misperceptions about overdose and naloxone, and arm 3 was recruited to serve as a control arm for later parts of the study. The primary analysis of recruitment approaches used logistic regression, contrasting arms 1 and 2. Exploratory analyses included descriptive statistics and other logistic regression models. Results: A total of 40 agencies signed memoranda of understanding to participate in the project (n=176, 22.7% of contacted agencies; n=151, 26.5% of the agencies where a point of contact had been established). We did not find evidence that the messaging contained in arm 2 significantly affected recruitment success (odds ratio 0.754, 95% CI 0.298‐1.904; =.55). Likewise, arm assignment (3-way comparison) did not significantly affect the likelihood of an agency agreeing to participate. The recruitment process took a mean of 159.08 (SD 104.74) days per agency and involved 8.38 emails, 1.98 voicemails, 0.83 phone calls, and 1.23 video calls. Conclusions: Recruiting first response agencies that subscribe to for participation in a national-level OEND project appears feasible, with an anticipated participation rate between 23% and 27% of agencies solicited. Successful recruitment timelines can be lengthy and involve extensive correspondence. Since the language used in our different study arms did not have a significant effect on agency recruitment, other factors (such as individual citizen responses to messaging) could reasonably be used to select the overall language used in subsequent project recruitment materials. Trial Registration: OSF Registries osf.io/egn3z; https://osf.io/egn3z International Registered Report Identifier (IRRID): RR2-10.2196/57280