Organizational perspectives on the impacts of scaling up overdose education and naloxone distribution in Kentucky

Freeman P.R., Walley A.Y., Winhusen T.J., Oga E.A., Villani J., Hunt T., Chandler R.K., Oyler D.R., Reilly B., Gelberg K., Douglas C., Lyons M.S., Holloway J., Vandergrift N.A., Adams J.W., et. al.

Objectives. To determine whether the Communities That HEAL (CTH) intervention is effective in increasing naloxone distribution compared with usual care. Methods. The HEALing (Helping to End Addiction Long-Term) Communities Study (HCS) is a cluster-randomized, parallel-arm, wait-list controlled implementation science trial testing the impact of the CTH intervention on increasing the use of evidence-based practices to lower opioid-related overdose deaths. Communities (n = 67) highly impacted by opioid overdose in Kentucky, Massachusetts, New York, and Ohio were allocated to CTH intervention (n = 34) or wait-list comparison (usual care; n = 33) arms. The primary outcome for this study was the number of naloxone units distributed in HCS communities during the comparison period (July 1, 2021‒June 30, 2022), examined using an intent-to-treat negative binomial regression model. Results. Naloxone distribution was 79% higher in the CTH intervention versus usual care arm (adjusted relative rate = 1.79; 95% confidence interval = 1.28, 2.51; P = .001; adjusted rates of naloxone distribution 3378 vs 1884 naloxone units per 100 000 residents), when controlling for urban‒rural status, state, baseline opioid-related overdose death rate, and baseline naloxone distribution rate. Conclusions. The CTH intervention increased naloxone distribution compared with usual care in communities highly impacted by the opioid crisis. Trial Registration. ClinicalTrials.gov identifier: NCT04111939. ( Am J Public Health. Published online ahead of print October 10, 2024:e1–e12. https://doi.org/10.2105/AJPH.2024.307845 )

Rivera B.D., Friedman S.R.

The high overdose mortality rates in the United States poses several questions: Why have they been increasing exponentially since 1979? Why are they so high? And how can they be greatly reduced? Building on past research, the causes of the increase seem to be deeply rooted in US social and economic structures and processes, rather than due only to opioid prescription patterns or the advent of synthetic opioids. Given this, we consider what changes might be needed to reverse the exponentially-increasing overdose mortality. We use a path dependency argument to argue that the United States political, economic, and public health systems have helped create this crisis and, unfortunately, continue to heighten it. These same systems suggest that proposals to expand harm reduction and drug treatment capacity, to decriminalize or legalize drugs, or to re-industrialize the country sufficiently to reduce "communities of despair" will not be enacted at a scale sufficient to end the overdose crisis. We thus suggest that in the United States serious improvements in overdose rates and related policies and structures require massive social movements with a broad social change agenda.

Glasgow L., Douglas C., Sprunger J.G., Campbell A.N., Chandler R., Dasgupta A., Holloway J., Marks K.R., Roberts S.M., Martinez L.S., Thompson K., Weiss R.D., Aldridge A., Asman K., Barbosa C., et. al.

The U.S. opioid overdose crisis persists. Outpatient behavioral health services (BHS) are essential components of a comprehensive response to opioid use disorder and overdose fatalities. The Helping End Addiction Long-Term (HEALing) Communities Study developed the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in 67 communities in Kentucky, Ohio, New York, and Massachusetts through the implementation of evidence-based practices (EBPs), including BHS. This paper compares the rate of individuals receiving outpatient BHS in Wave 1 intervention communities (n = 34) to waitlisted Wave 2 communities (n = 33). Medicaid data included individuals ≥18 years of age receiving any of five BHS categories: intensive outpatient, outpatient, case management, peer support, and case management or peer support. Negative binomial regression models estimated the rate of receiving each BHS for Wave 1 and Wave 2. Effect modification analyses evaluated changes in the effect of the CTH intervention between Wave 1 and Wave 2 by research site, rurality, age, sex, and race/ethnicity. No significant differences were detected between intervention and waitlisted communities in the rate of individuals receiving any of the five BHS categories. None of the interaction effects used to test the effect modification were significant. Several factors should be considered when interpreting results—no significant intervention effects were observed through Medicaid claims data, the best available data source but limited in terms of capturing individuals reached by the intervention. Also, the 12-month evaluation window may have been too brief to see improved outcomes considering the time required to stand-up BHS. Clinical Trials.gov http://www.clinicaltrials.gov: Identifier: NCT04111939

Irwin A.N., Gray M., Ventricelli D., Boggis J.S., Bratberg J., Floyd A.S., Silcox J., Hartung D.M., Green T.C.

Community pharmacies are well-positioned to improve the health of people with opioid use disorder and who use drugs by providing naloxone and other essential public health supplies. Respond to Prevent (R2P) is a clinical trial which sought to accelerate provision of harm reduction materials through a multicomponent intervention that included in-store materials, online training, and academic detailing. The objective of this study was to explore pharmacists’ attitudes, knowledge, and experiences in providing naloxone, dispensing buprenorphine, and selling nonprescription syringes following participation in the R2P program. Two online asynchronous focus groups were conducted with community-based chain pharmacists across Massachusetts, New Hampshire, Oregon, and Washington who had participated in the R2P program. Participants accessed an online repository of group interview items and responded to questions over a short period. Each pharmacist participated anonymously for approximately 30 min across over 2 ½ days. Pharmacists answered questions on experiences with pharmacy-based harm reduction care and R2P intervention implementation barriers and facilitators. Qualitative data analysis was conducted by a multidisciplinary team using an immersion-crystallization approach. A total of 32 pharmacists participated in the two focus groups. Most participants were female (n = 18, 56%), non-Hispanic (n = 29, 91%), and white (n = 17, 53%). Four major themes were identified related to (1) addressing bias and stigma toward people with opioid use disorder and who use drugs, (2) familiarity and comfort with naloxone provision, (3) perspective and practice shifts in nonprescription syringe sales, (4) structural challenges to harm reduction care in the pharmacy. Community pharmacists across the four states identified attitudes, knowledge, and experiences that create barriers to providing care to people with opioid use disorder and who use drugs. R2P approaches and tools were effective at reducing stigma and changing attitudes but were less effective at addressing structural challenges from the pharmacists’ perspective.

Westafer L.M., Beck S.A., Simon C., Potee B., Soares W.E., Schoenfeld E.M.

Study objectiveAlthough an increasing number of emergency departments (ED) offer opioid agonist treatment, naloxone, and other harm reduction measures, little is known about patient perspectives on harm reduction practices delivered in the ED. The objective of this study was to identify patient-focused barriers and facilitators to harm reduction strategies in the ED.MethodsWe conducted semistructured interviews with a convenience sample of individuals in Massachusetts diagnosed with opioid use disorder. We developed an interview guide, and interviews were recorded, transcribed, and analyzed in an iterative process using reflexive thematic analysis. After initial interviews and coding, we triangulated the results among a focus group of 4 individuals with lived experience.ResultsWe interviewed 25 participants with opioid use disorder, 6 recruited from 1 ED and 19 recruited from opioid agonist treatment clinics. Key themes included accessibility of harm reduction supplies, lack of self-care resulting from withdrawal and hopelessness, the impact of stigma on the likelihood of using harm reduction practices, habit and knowledge, as well as the need for user-centered harm reduction interventions.ConclusionIn this study, people with lived experience discussed the characteristics and need for user-centered harm reduction strategies in the ED that centered on reducing stigma, treatment of withdrawal, and availability of harm reduction materials. Although an increasing number of emergency departments (ED) offer opioid agonist treatment, naloxone, and other harm reduction measures, little is known about patient perspectives on harm reduction practices delivered in the ED. The objective of this study was to identify patient-focused barriers and facilitators to harm reduction strategies in the ED. We conducted semistructured interviews with a convenience sample of individuals in Massachusetts diagnosed with opioid use disorder. We developed an interview guide, and interviews were recorded, transcribed, and analyzed in an iterative process using reflexive thematic analysis. After initial interviews and coding, we triangulated the results among a focus group of 4 individuals with lived experience. We interviewed 25 participants with opioid use disorder, 6 recruited from 1 ED and 19 recruited from opioid agonist treatment clinics. Key themes included accessibility of harm reduction supplies, lack of self-care resulting from withdrawal and hopelessness, the impact of stigma on the likelihood of using harm reduction practices, habit and knowledge, as well as the need for user-centered harm reduction interventions. In this study, people with lived experience discussed the characteristics and need for user-centered harm reduction strategies in the ED that centered on reducing stigma, treatment of withdrawal, and availability of harm reduction materials.

Athey A., Kilmer B., Cerel J.

Oyler D.R., Knudsen H.K., Oser C.B., Walsh S.L., Roberts M., Nigam S.R., Westgate P.M., Freeman P.R.

Opioid overdoses differentially affect demographic groups. Strategies to reduce overdose deaths, specifically overdose education and naloxone distribution (OEND), are not consistently delivered equitably.The HEALing Communities StudySM (HCS) is a cluster-randomized trial designed to implement evidence-based practices, including OEND, to reduce overdose deaths across communities. Individuals receiving OEND in eight Kentucky counties between January 2020 and June 2022 provided demographics and overdose history. Recipient characteristics were compared to opioid overdose decedent characteristics to evaluate whether OEND was equitably delivered to the target population. Recipient characteristics were also analyzed based on whether OEND was delivered in criminal justice, behavioral health, or health care facilities.A total of 26,273 demographic records were analyzed from 137 partner agencies. Most agencies were in behavioral health (85.6 %) or criminal justice sectors (10.4 %). About half of OEND recipients were male (50.6 %), which was significantly lower than the 70.3 % of overdose decedents who were male, (p

Stopka T.J., Babineau D.C., Gibson E.B., Knott C.E., Cheng D.M., Villani J., Wai J.M., Blevins D., David J.L., Goddard-Eckrich D.A., Lofwall M.R., Massatti R., DeFiore-Hyrmer J., Lyons M.S., Fanucchi L.C., et. al.

ImportanceBuprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined.ObjectiveTo determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing.Design, Setting, and ParticipantsThis prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list–controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022.InterventionWaiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity.Main Outcomes and MeasuresThe rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100 000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed.ResultsA total of 8 166 963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10).Conclusions and RelevanceIn this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder.Trial RegistrationClinicalTrials.gov Identifier: NCT04111939

Fraimow-Wong L., Martín M., Thomas L., Giuliano R., Nguyen O.K., Knight K., Suen L.W.

ImportanceHarm reduction is associated with improved health outcomes among people who use substances. As overdose deaths persist, hospitals are recognizing the need for harm reduction services; however, little is known about the outcomes of hospital-based harm reduction for patients and staff.ObjectiveTo evaluate patient and staff perspectives on the impact and challenges of a hospital-based harm reduction program offering safer use education and supplies at discharge.Design, Setting, and ParticipantsThis qualitative study consisted of 40-minute semistructured interviews with hospitalized patients receiving harm reduction services and hospital staff at an urban, safety-net hospital in California from October 2022 to March 2023. Purposive sampling allowed inclusion of diverse patient racial and ethnic identities, substance use disorders (SUDs), and staff roles.ExposureReceipt of harm reduction education and/or supplies (eg, syringes, pipes, naloxone, and test strips) from an addiction consult team, or providing care for patients receiving these services.Main Outcomes and MeasuresInterviews were analyzed using thematic analysis to identify key themes.ResultsA total of 40 participants completed interviews, including 20 patients (mean [SD] age, 43 [13] years; 1 American Indian or Alaska Native [5%], 1 Asian and Pacific Islander [5%], 6 Black [30%]; 6 Latine [30%]; and 6 White [30%]) and 20 staff (mean [SD] age 37 [8] years). Patients were diagnosed with a variety of SUDs (7 patients with opioid and stimulant use disorder [35%]; 7 patients with stimulant use disorder [35%]; 3 patients with opioid use disorder [15%]; and 3 patients with alcohol use disorder [15%]). A total of 3 themes were identified; respondents reported that harm reduction programs (1) expanded access to harm reduction education and supplies, particularly for ethnically and racially minoritized populations; (2) built trust by improving the patient care experience and increasing engagement; and (3) catalyzed culture change by helping destigmatize care for individuals who planned to continue using substances and increasing staff fulfillment. Black and Latine patients, those who primarily used stimulants, and those with limited English proficiency (LEP) reported learning new harm reduction strategies. Program challenges included hesitancy regarding regulations, limited SUD education among staff, remaining stigma, and the need for careful assessment of patient goals.Conclusions and RelevanceIn this qualitative study, patients and staff believed that integrating harm reduction services into hospital care increased access for populations unfamiliar with harm reduction, improved trust, and reduced stigma. These findings suggest that efforts to increase access to harm reduction services for Black, Latine, and LEP populations, including those who use stimulants, are especially needed.

Rock P., Slavova S., Westgate P.M., Nakamura A., Walsh S.L.

Fatal overdoses involving fentanyl/fentanyl analogs (F/FA) have increased in the US, raising questions about naloxone doses for F/FA overdose reversal. Emergency medical services (EMS) data provide an opportunity to examine naloxone administration changes as fentanyl increases in the illicit opioid supply. Administered naloxone intranasal-equivalent total dose (INTD) in milligrams (mg) was calculated for Kentucky EMS suspected opioid overdose (SOO) encounters (n=33,846), 2018–2021, and patterns of administration were examined. County-level F/FA availability was measured as 1) proportion of fatal drug overdoses involving F/FA, and 2) F/FA police seizures. Linear mixed models estimated changes in INTD in relation to local F/FA availability accounting for patient characteristics. From 2018–2021, SOOs increased by 44% (6853 to 9888) with an average INTD increase from 4.5 mg to 4.7 mg, with more than 99% of encounters resulting in successful reversal each year. For SOO encounters examined by outcome at the scene (i.e., non-fatal fatal vs fatal), average INTD for non-fatal were 4.6 mg compared to 5.9 mg for fatal overdoses. Mixed modeling found no significant relationship between INTD and the two measures for local F/FA availability. As F/FA-involved overdose risk increased, we observed a modest increase in INTD administered in SOO EMS encounters – just slightly higher than the 4 mg standard dose. The lack of significant relationship between F/FA and naloxone dose suggests that naloxone utilization in SOO with EMS involvement remains effective for overdose reversal, and that EMS naloxone dosing patterns have not changed substantially.

Collins A.B., Kaplowitz E., Bastani P., McKee H., Whitaker D., Hallowell B.D., McKenzie M.

Davis A., Stringer K.L., Drainoni M., Oser C.B., Knudsen H.K., Aldrich A., Surratt H.L., Walker D.M., Gilbert L., Downey D.L., Gardner S.D., Tan S., Lines L.M., Vandergrift N., Mack N., et. al.

Community stigma toward people with opioid use disorder (OUD) can impede access to harm reduction services and treatment with medications for opioid use disorder (MOUD). Such community OUD stigma is partially rooted in community-level social and economic conditions, yet there remains a paucity of large-scale quantitative data examining community-level factors associated with OUD stigma. We examined whether rurality, social inequity, and racialized segregation across communities from four states in the HEALing Communities Study (HCS) were associated with 1) greater perceived community stigma toward people treated for OUD, 2) greater perceived intervention stigma toward MOUD, and 3) greater perceived intervention stigma toward naloxone by community stakeholders in the HCS. From November 2019-January 2020, a cross-sectional survey about community OUD stigma was administered to 801 members of opioid overdose prevention coalitions across 66 communities in four states prior to the start of HCS intervention activities. Bivariate analyses assessed pairwise associations between community rural/urban status and each of the three stigma variables, using linear mixed effect modeling to account for response clustering within communities, state, and respondent sociodemographic characteristics. We conducted similar bivariate analyses to assess pairwise associations between racialized segregation and social inequity. On average, the perceived community OUD stigma scale score of stakeholders from rural communities was 4% higher (β=1.57, SE=0.7, p≤0.05), stigma toward MOUD was 6% higher (β=0.28, SE=0.1, p≤0.05), and stigma toward naloxone was 10% higher (β=0.46, SE=0.1, p≤0.01) than among stakeholders from urban communities. No significant differences in the three stigma variables were found among communities based on racialized segregation or social inequity. Perceived community stigma toward people treated for OUD, MOUD, and naloxone was higher among stakeholders in rural communities than in urban communities. Findings suggest that interventions and policies to reduce community-level stigma, particularly in rural areas, are warranted.

Knudsen H.K., Freeman P.R., Oyler D.R., Oser C.B., Walsh S.L.

Abstract Background Scaling up overdose education and naloxone distribution (OEND), an evidence-based practice for reducing opioid overdose mortality, in communities remains a challenge. Novel models and intentional implementation strategies are needed. Drawing upon the EPIS model’s phases of Exploration, Preparation, Implementation, and Sustainment (Aarons et al. in Adm Policy Ment Health 38:4–23, 2011), this paper describes the development of the University of Kentucky’s unique centralized “Naloxone Hub with Many Spokes” approach to implementing OEND as part of the HEALing Communities Study (HCS-KY). Methods To scale up OEND in eight Kentucky counties, implementation strategies were utilized at two levels: a centralized university-based naloxone dispensing unit (“Naloxone Hub”) and adopting organizations (“Many Spokes”). Implementation strategies varied across the EPIS phases, but heavily emphasized implementation facilitation. The Naloxone Hub provided technical assistance, overdose education resources, and no-cost naloxone to partner organizations. Implementation outcomes across the EPIS phases were measured using data from internal study management trackers and naloxone distribution data submitted by partner organizations. Results Of 209 organizations identified as potential partners, 84.7% (n = 177) engaged in the Exploration/Preparation phase by participating in an initial meeting with an Implementation Facilitator about the HCS-KY OEND program. Adoption of the HCS-KY OEND program, defined as receipt of at least one shipment of naloxone, was achieved with 69.4% (n = 145) of all organizations contacted. During the Implementation phase, partner organizations distributed 40,822 units of naloxone, with partner organizations distributing a mean of 281.5 units of naloxone (SD = 806.2). The mean number of units distributed per county was 5102.8 (SD = 3653.3; range = 1057 − 11,053) and the mean county level distribution rate was 8396.5 units per 100,000 residents (SD = 8103.1; range = 1709.5–25,296.3). Of the partner organizations that adopted the HCS-KY OEND program, 87.6% (n = 127) attended a sustainability meeting with an Implementation Facilitator and agreed to transition to the state-funded naloxone program. Conclusions These data demonstrate the feasibility of this “Hub with Many Spokes” model for scaling up OEND in communities highly affected by the opioid epidemic. Trial registration ClinicalTrials.gov, NCT04111939. Registered 30 September 2019, https://clinicaltrials.gov/ct2/show/NCT04111939.

Kesich Z., Ibragimov U., Komro K., Lane K., Livingston M., Young A., Cooper H.L.

Abstract Background Overdoses have surged in rural areas in the U.S. and globally for years, but harm reduction interventions have lagged. Overdose education and naloxone distribution (OEND) programs reduce overdose mortality, but little is known about people who use drugs’ (PWUD) experience with these interventions in rural areas. Here, we analyze qualitative data with rural PWUD to learn about participants’ experiences with an OEND intervention, and about how participants’ perceptions of their rural risk environments influenced the interventions’ effects. Methods Twenty-nine one-on-one, semi-structured qualitative interviews were conducted with rural PWUD engaged in the CARE2HOPE OEND intervention in Appalachian Kentucky. Interviews were conducted via Zoom, audio-recorded, and transcribed verbatim. Thematic analysis was conducted, guided by the Rural Risk Environment Framework. Results Participants’ naloxone experiences were shaped by all domains of their rural risk environments. The OEND intervention transformed participants’ roles locally, so they became an essential component of the local rural healthcare environment. The intervention provided access to naloxone and information, thereby increasing PWUDs’ confidence in naloxone administration. Through the intervention, over half of participants gained knowledge on naloxone (access points, administration technique) and on the criminal-legal environment as it pertained to naloxone. Most participants opted to accept and carry naloxone, citing factors related to the social environment (responsibility to their community) and physical/healthcare environments (overdose prevalence, suboptimal emergency response systems). Over half of participants described recent experiences administering intervention-provided naloxone. These experiences were shaped by features of the local rural social environment (anticipated negative reaction from recipients, prior naloxone conversations). Conclusions By providing naloxone paired with non-stigmatizing health and policy information, the OEND intervention offered support that allowed participants to become a part of the healthcare environment. Findings highlight need for more OEND interventions; outreach to rural PWUD on local policy that impacts them; tailored strategies to help rural PWUD engage in productive dialogue with peers about naloxone and navigate interpersonal conflict associated with overdose reversal; and opportunities for rural PWUD to formally participate in emergency response systems as peer overdose responders. Trial registration The ClinicalTrials.gov ID for the CARE2HOPE intervention is NCT04134767. The registration date was October 19th, 2019.