Organize and mobilize for implementation effectiveness to improve overdose education and naloxone distribution from syringe services programs: a randomized controlled trial

The United States (US) continues to face decades-long increases in opioid overdose mortality [1]. The Centers for Disease Control and Prevention (CDC) estimates nearly 775,000 people have died of an opioid overdose since 1999 [2]. Between 2020 and 2021, overdose mortality rates involving heroin and synthetic opioids, other than methadone, increased 22%. Overall, drug overdose deaths in the US increased for all genders; all age groups over the age of 25; American Indian/Alaskan Native, non-Hispanic White, non-Hispanic Black, Hispanic, and Native Hawaiian/Pacific Islander communities; all census regions; and urban, suburban, and rural settings [3].

Opioid overdoses involve a toxic dose of natural opioids like heroin, semisynthetic opioids like oxycodone, and/or synthetic opioids like fentanyl. Naloxone, an opioid antagonist, is an evidence-based biomedical intervention that effectively reverses opioid overdose when administered intranasally or intramuscularly [4‐7]. Opioid antagonists bind to the brain’s opioid receptor sites, which displaces any opioid currently in the system and temporarily negates their effects, saving the individual’s life. Use of naloxone does not cause dependence or tolerance and can, though not always, precipitate withdrawal [5‐8]. Naloxone can dramatically reduce opioid overdose mortality when distributed to people likely to experience or witness an opioid overdose and packaged with education on its use, known as overdose education and naloxone distribution (OEND) [9‐14].

Syringe services programs (SSPs) have a primary function of distributing safe drug use supplies, such as sterile syringes, pipes, and injection-related equipment, to facilitate the reduction of harms associated with drug use for their participants. Often, SSPs are the first to hear from their participants regarding changes in the unregulated drug market, drug use trends, and overdose experiences. Most SSPs provide a variety of other evidence-based interventions to improve the health of people who use drugs, including OEND [15‐18]. SSPs reach people at high risk for experiencing or witnessing an opioid overdose and pioneered the development of OEND [19‐21]. With staff who are culturally competent in providing services for people who use opioids and preexisting delivery systems designed to reach participants in their own environment, SSPs are an ideal venue for OEND.

Research documenting OEND’s effectiveness (i.e., intervention effectiveness) for reducing opioid overdose mortality emerged over 15 years ago [7]. Only recently have studies begun to assess elements of OEND implementation effectiveness within SSPs [22‐26]. As an organizational-level construct, implementation effectiveness can be defined as the aggregated consistency and quality of intervention use within an organization [27]. Findings from recent research identify factors from both the external and internal context of SSPs that shape effective implementation of OEND [22‐26]. Yet, to date, no studies have assessed whether implementation strategies (i.e., approaches to improve the adoption, implementation, or sustainment of evidence-based practices) can advance implementation effectiveness of OEND within SSPs.

External facilitation-based implementation strategies have been identified as a promising approach to advance implementation outcomes [28‐39]. Fundamentally, these approaches involve a person external to the organization providing interactive problem-solving and support to assist implementation efforts. Often, their work occurs in conjunction with other implementation strategies. Whether such an approach can help SSPs, which often face substantial community, financial, and legal constraints [40], effectively implement OEND remains an important area of inquiry. As such, we conducted a randomized controlled trial of 105 SSPs throughout the US to understand the effectiveness of a multifaceted, external facilitation-based implementation strategy at advancing OEND implementation effectiveness within SSPs.

We conducted a randomized controlled trial to understand whether the multicomponent OMIE approach improved OEND implementation effectiveness within 105 SSPs located throughout the United States. Compared to control SSPs, SSPs randomized to receive the OMIE approach reported a significant and meaningful increase in the number of people receiving naloxone and the number of naloxone doses distributed. These findings are particularly important as prior studies have directly linked higher levels of these two outcomes with reductions in opioid overdose mortality at the population level [17, 47, 48]. The multifaceted OMIE approach was modelled after the evidence-based ISF strategy [44, 51], and our findings contribute to the growing evidence base that supports facilitation-based implementation strategies [28‐39]. These findings are particularly encouraging given SSPs typically face substantial external barriers such as lack of adequate funding, fluctuating costs of naloxone, unsupportive legal environments, and community opposition or harassment which can restrict services [23]. Despite these barriers, our findings show that the OMIE approach can yield substantial and significant improvements in aspects of implementation effectiveness for naloxone.

In addition to the results of our intention to treat analysis, we observed a threshold effect where SSPs participating in 10 + sessions or receiving 12 + h had greater effect sizes with regard to the number of people given naloxone and the number of naloxone doses distributed. SSPs participating in fewer than 10 sessions or receiving less than 12 h did not experience significant changes in either the number of people receiving naloxone or the number of naloxone doses distributed. All OMIE SSPs were offered the ability to meet monthly with facilitators. Therefore, it could be that SSPs that were unable able to achieve the 10-session or 12-h threshold had less organizational capacity to engage with our approach. If an SSP does not have sufficient levels of funding or human resources, the challenges around creating time to reflect and plan intentionally with regard to improving implementation effectiveness could be difficult to surmount. Future initiatives should explore the resource needs for SSPs to engage with similar strategies and examine the intersection of improving financial resources for SSPs along with the OMIE approach [52, 53].

We did not observe significant or meaningful increases among OMIE SSPs regarding implementation quality, as measured by OEND best practice adoption. It is important to consider these findings in light of several factors. SSPs are comprised of a variety of organizational types, have various service delivery models, and have access to varying financial and human resources. Considering best practice implementation within and the measurement of implementation quality across this heterogeneous SSP landscape posed challenges. In addition, facilitators relied on distributing existing educational materials and resources as opposed to developing new resources, which could have been impactful during COVID-19. In many instances, SSPs’ external and internal setting constrained meaningful improvements in OEND best practice implementation. For example, our approach did not address the external contextual dynamics, such as funding availability, legal environment, or community harassment. Additionally, our approach could not shift staffing structures, budget size, or hiring polices within programs. With an average of 12 out of 19 best practices adopted at the onset of the trial, it is also important to remember that baseline levels were relatively high, and the remaining best practices could have been more challenging to implement during the COVID-19 pandemic when face-to-face interaction was limited.

Our findings must also be considered in the context of the emergence of the COVID-19 pandemic during the trial. With the onset of the COVID-19, organizational stress faced by SSPs was significant. Some organizations closed, while other SSPs quickly pivoted to service delivery modalities that involved less person-to-person contact. For our trial, we paused recruitment for 3 months as the initial phases of COVID-19 unfolded. We maintained contact with OMIE SSPs, allowing sessions to focus on understanding new challenges SSPs faced with a changing external context. As programs were adapting during the first few months of COVID-19, we relied primarily on email communication. In addition, specific best practice domains (i.e., “staff training and support”) [43], which had the most opportunity for improvement from baseline levels, could have been the most challenging domains to improve when in-person interaction was limited. As such, COVID-19 may have compromised SSPs’ abilities to improve some aspects of quality. Further, cost of operating programs likely increased with expenses due to personal protection equipment, ventilation, and shields to reduce contact between staff and participants, and the cost of naloxone increased during this period [54, 55]. Given the evidence base showing higher levels of naloxone distribution yield reductions in overdose mortality [17, 47, 48], SSPs may have prioritized making improvements with their consistency (i.e., number of people receiving naloxone, number of naloxone doses distribute) amid the intersecting overdose and COVID-19 crises. Nevertheless, future initiatives should consider additional strategies, such as developing educational materials, as potential adjuncts that might meaningfully improve implementation of newly defined best practices.

The generalizability of our findings requires careful consideration. First, this was a nationally based study of SSPs randomized to two study arms. As such, it follows logically that these findings would extend to SSPs meeting our inclusion criteria. It is also encouraging that budget levels of SSPs enrolled in the trial mirror budget levels from nationally representative samples of SSPs [53]. However, more caution should be applied when considering other evidence-based interventions that are common within SSPs, such as smoking supplies, drug checking, or clinical care as these are likely to be influenced by other external factors.

A noteworthy limitation with our trial is the reliance on self-report for the number of naloxone doses distributed, number of people receiving naloxone, and best practice implementation. Given this trial enrolled 105 SSPs across the US and its territories, it was not practical for the study team to visit each SSP and verify these metrics. However, SSPs routinely document naloxone distribution metrics to report to funders. We focused on the past 3 months of naloxone distribution to maximize the possibility of accurate records, and we also have no reason to believe reporting bias would differ by study arm. Yet, there is a possibility that we could have observed a different relationship if we could have accurately captured a longer timeframe. Furthermore, self-report of best practice implementation could have yielded socially desirable responses from programs or characterization of ideal scenarios as opposed to actual implementation experiences, which would bias our results toward the null. It also remains possible that our findings may not extend to SSPs experiencing a combination of outer and inner setting factors that constrain SSP services (e.g., limited financial resources, unsupportive legal environments, and high levels of community harassment).

In conclusion, we found evidence supporting the effectiveness of the multifaceted OMIE approach increasing naloxone distribution from SSPs. The OMIE approach was found to be effective despite substantial external shocks (i.e., impacts of COVID-19) during the trial. Our findings have major implications for addressing the overdose crisis, which has continued unabated for decades. Sustained funding from federal agencies and state health departments to support national networks and coalitions to employ OMIE practitioners could significantly improve naloxone distribution from SSPs. Organizations with the mission of capacity building and technical assistance within harm reduction should consider adding this approach. In addition, given our approach did not have a significant impact on best practice implementation, which was relatively high in both conditions, future efforts should seek to add other adjuncts that could assist with advancing implementation quality.