The Feasibility of Using the National PulsePoint Cardiopulmonary Resuscitation Responder Network to Facilitate Overdose Education and Naloxone Distribution: Protocol for a Randomized Controlled Trial.

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.

Developing the Opioid Rapid Response System™ for Lay Citizen Response to the Opioid Overdose Crisis: a Randomized Controlled Trial.

Emergency responders face challenges in arriving timely to administer naloxone in opioid overdoses. Therefore, interest in having lay citizens administer naloxone nasal spray has emerged. These citizens, however, must be recruited and trained, and be in proximity to the overdose. This study aimed to develop the Opioid Rapid Response System (ORRS)tm to meet this need by developing a system to recruit and train citizen responders and evaluate outcomes in a randomized clinical trial. ORRS recruitment messages and training platform were developed iteratively and then outcomes for each were evaluated in a randomized, unblinded two-arm waitlist-controlled trial. ORRS was field tested in 5 Indiana counties, recruiting adult citizen responders (age 18 or older) who did not self-identity as a certified first responder. Participants were recruited using either personal or communal messages and then randomly assigned to online naloxone training and waitlisted-control conditions. Pre- and post-surveys were administered online to measure the exposure to recruitment messages and training effects on knowledge of opioid overdose, confidence responding, concerns about responding, and intent to respond. Of the 220 randomized participants (114 training, 106 waitlisted-control), 140 were analyzed (59 training, 81 waitlisted-control). Recruited participants more frequently identified with communal appeal than with the personal appeal (chi-square = 53.5; p < 0.0001). Between-group differences for intervention effects were significant for knowledge of overdose signs (Cohen's d = 1.17), knowledge of overdose management (d = 1.72), self-efficacy (d = 1.39), and concerns (d = 1.31), but not for intent (d = 0.17), which suffered from a ceiling effect. ORRS provides stronger support for efficacy than that reported for other training interventions and the digital modality eases rapid dissemination.Trial Registration: NCT04589676.

Development of opioid rapid response system: Protocol for a randomized controlled trial.

BACKGROUND: Opioid overdoses require a rapid response, but emergency responders are limited in how quickly they can arrive at the scene for administering naloxone. If laypersons are trained to administer naloxone and are notified of overdoses, more lives can be saved. OBJECTIVE: This study aimed to examine the feasibility of the Opioid Rapid Response System (ORRS) that recruits, trains, and links citizen responders to overdose events in their community in real-time to administer naloxone. Aim of this paper is to present the protocols for recruiting participants through multiple communication channels; developing and evaluating the online training which has both interactive and asynchronous modules; randomly assigning laypersons to either online naloxone training or waitlist control group; measuring participants' knowledge, skills, and attitudes before and after the training; and distributing intranasal naloxone kits to participants for use in events of overdose in their community. METHODS: Sampling: Utilizing a combination of purposive sampling methods, laypersons from across five Indiana counties who did not self-identify as current first responders were invited to participate. DESIGN: In this two-arm randomized waitlist-controlled study (N = 220), individuals were assigned into either online training or waitlist control that received the training two weeks later. ANALYSIS: A linear mixed model will be used for determining the changes in targeted outcomes in the training group and accommodate for fixed and random effects. IMPLICATIONS: While ORRS can become a community-engaged, cost-effective model for technology-based emergency response for opioid overdoses, study protocols can be useful for other emergency response programs that involve laypersons. CLINICALTRIALS: gov Registration Number: NCT04589676.