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Early emergency department experience with 7-day extended-release injectable buprenorphine for opioid use disorder

D'Onofrio, Gail; Perrone, Jeanmarie; Hawk, Kathryn F; Cowan, Ethan; McCormack, Ryan; Coupet, Edouard; Owens, Patricia H; Martel, Shara H; Huntley, Kristen; Walsh, Sharon L; Lofwall, Michelle R; Herring, Andrew; ,
As the opioid overdose epidemic escalates, there is an urgent need for treatment innovations to address both patient and clinician barriers when initiating buprenorphine in the emergency department (ED). These include insurance status, logistical challenges such as the ability to fill a prescription and transportation, concerns regarding diversion, and availability of urgent referral sites. Extended-release buprenorphine (XR-BUP) preparations such as a new 7-day injectable could potentially solve some of these issues. We describe the pharmacokinetics of a new 7-day XR-BUP formulation and the feasibility of its use in the ED setting. We report our early experiences with this medication (investigational drug CAM2038), in the context of an ongoing clinical trial entitled Emergency Department-Initiated BUP VAlidaTION (ED INNOVATION), to inform emergency clinicians as they consider incorporating this medication into their practice. The medication was approved by the European Medicines Agency in 2018 and the U.S. Food and Drug Administration in 2023 for those 18 years or older for the treatment of moderate to severe opioid use disorder (OUD). We report our experience with approximately 800 ED patients with OUD who received the 7-day XR-BUP preparation in the ED between June 2020 and July 2023.
PMID: 37501652
ISSN: 1553-2712
CID: 5590962


Cowan, Ethan; Perrone, Jeanmarie; Dziura, James; Edelman, E Jennifer; Hawk, Kathryn; Herring, Andrew; McCormack, Ryan; Murphy, Alexandra; Phadke, Manali; Fiellin, David A; D'Onofrio, Gail
BACKGROUND:Opioid overdose deaths in 2021 were the highest ever, driven by fentanyl and polysubstance use. OBJECTIVE:The aim of the study was to characterize drug use, assessed by urine drug screens (UDSs), in patients with untreated opioid use disorder (OUD) presenting to 28 emergency departments (EDs) nationally and by region. METHODS:We analyzed UDSs from patients enrolled in the CTN-0099 ED-INNOVATION (Emergency Department-Initiated Buprenorphine Validation) trial between July 12, 2020 and March 9, 2022. Participants were adult ED patients with OUD not engaged in addiction treatment with a UDS positive for an opioid, but negative for methadone. Sites were divided into "East" and "West" regions. RESULTS:A UDS was available for all 925 enrolled participants, 543 from East and 382 from West. Fentanyl was in 702 specimens (76%) (n = 485 [89%] East vs. n = 217 [57%] West; p < 0.01) and was the only opioid in 269 (29%). After fentanyl, the most common opioids were morphine (presumably heroin; n = 411 [44%]; n = 192 [35%] East vs. n = 219 [57%] West; p < 0.01) and buprenorphine (n = 329 [36%]; n = 186 [35%] East vs. n = 143 [37%] West; p = 0.32). The most common drugs found with opioids were stimulants (n = 545 [59%]), tetrahydrocannabinol (n = 417 [45%]), and benzodiazepines (n = 151 [16%]). Amphetamine-type stimulants were more common in West (n = 209 [55%] vs. East (n = 125 [23%]). Cocaine was more common in East (n = 223 [41%]) vs. West (n = 82 [21%]). The presence of multiple drugs was common (n = 759 [82%]). CONCLUSIONS:Most participants had UDS specimens containing multiple substances; a high proportion had fentanyl, stimulants, and buprenorphine. Regional differences were noted. Given the increased risk of death with fentanyl and polysubstance use, ED providers should be providing risk reduction counseling, treatment, and referral.
PMID: 37716904
ISSN: 0736-4679
CID: 5593422

Implementing Programs to Initiate Buprenorphine for Opioid Use Disorder Treatment in High-Need, Low-Resource Emergency Departments: A Nonrandomized Controlled Trial

McCormack, Ryan P; Rotrosen, John; Gauthier, Phoebe; D'Onofrio, Gail; Fiellin, David A; Marsch, Lisa A; Novo, Patricia; Liu, David; Edelman, E Jennifer; Farkas, Sarah; Matthews, Abigail G; Mulatya, Caroline; Salazar, Dagmar; Wolff, Jeremy; Knight, Randolph; Goodman, William; Williams, Joseph; Hawk, Kathryn
STUDY OBJECTIVE/OBJECTIVE:We hypothesized that implementation facilitation would enable us to rapidly and effectively implement emergency department (ED)-initiated buprenorphine programs in rural and urban settings with high-need, limited resources and dissimilar staffing structures. METHODS:This multicenter implementation study employed implementation facilitation using a participatory action research approach to develop, introduce, and refine site-specific clinical protocols for ED-initiated buprenorphine and referral in 3 EDs not previously initiating buprenorphine. We assessed feasibility, acceptability, and effectiveness by triangulating mixed-methods formative evaluation data (focus groups/interviews and pre/post surveys involving staff, patients, and stakeholders), patients' medical records, and 30-day outcomes from a purposive sample of 40 buprenorphine-receiving patient-participants who met research eligibility criteria (English-speaking, medically stable, locator information, nonprisoners). We estimated the primary implementation outcome (proportion receiving ED-initiated buprenorphine among candidates) and the main secondary outcome (30-day treatment engagement) using Bayesian methods. RESULTS:Within 3 months of initiating the implementation facilitation activities, each site implemented buprenorphine programs. During the 6-month programmatic evaluation, there were 134 ED-buprenorphine candidates among 2,522 encounters involving opioid use. A total of 52 (41.6%) practitioners initiated buprenorphine administration to 112 (85.1%; 95% confidence interval [CI] 79.7% to 90.4%) unique patients. Among 40 enrolled patient-participants, 49.0% (35.6% to 62.5%) were engaged in addiction treatment 30 days later (confirmed); 26 (68.4%) reported attending one or more treatment visits; there was a 4-fold decrease in self-reported overdose events (odds ratio [OR] 4.03; 95% CI 1.27 to 12.75). The ED clinician readiness increased by a median of 5.02 (95% CI: 3.56 to 6.47) from 1.92/10 to 6.95/10 (n(pre)=80, n(post)=83). CONCLUSIONS:The implementation facilitation enabled us to effectively implement ED-based buprenorphine programs across heterogeneous ED settings rapidly, which was associated with promising implementation and exploratory patient-level outcomes.
PMID: 37140493
ISSN: 1097-6760
CID: 5504462

National Institute on Drug Abuse Clinical Trials Network Meeting Report: Advancing Emergency Department Initiation of Buprenorphine for Opioid Use Disorder

Cowan, Ethan; Perrone, Jeanmarie; Bernstein, Steven L; Coupet, Edouard; Fiellin, David A; Hawk, Kathryn; Herring, Andrew; Huntley, Kristen; McCormack, Ryan; Venkatesh, Arjun; D'Onofrio, Gail
Opioid use disorder and opioid overdose deaths are a major public health crisis, yet highly effective evidence-based treatments are available that reduce morbidity and mortality. One such treatment, buprenorphine, can be initiated in the emergency department (ED). Despite evidence of efficacy and effectiveness for ED-initiated buprenorphine, universal uptake remains elusive. On November 15 and 16, 2021, the National Institute on Drug Abuse Clinical Trials Network convened a meeting of partners, experts, and federal officers to identify research priorities and knowledge gaps for ED-initiated buprenorphine. Meeting participants identified research and knowledge gaps in 8 categories, including ED staff and peer-based interventions; out-of-hospital buprenorphine initiation; buprenorphine dosing and formulations; linkage to care; strategies for scaling ED-initiated buprenorphine; the effect of ancillary technology-based interventions; quality measures; and economic considerations. Additional research and implementation strategies are needed to enhance adoption into standard emergency care and improve patient outcomes.
PMID: 37178101
ISSN: 1097-6760
CID: 5503412

Substance use and pre-hospital crash injury severity among U.S. older adults: A five-year national cross-sectional study

Adeyemi, Oluwaseun; Bukur, Marko; Berry, Cherisse; DiMaggio, Charles; Grudzen, Corita R; Konda, Sanjit; Adenikinju, Abidemi; Cuthel, Allison; Bouillon-Minois, Jean-Baptiste; Akinsola, Omotola; Moore, Alison; McCormack, Ryan; Chodosh, Joshua
BACKGROUND:Alcohol and drug use (substance use) is a risk factor for crash involvement. OBJECTIVES:To assess the association between substance use and crash injury severity among older adults and how the relationship differs by rurality/urbanicity. METHODS:We pooled 2017-2021 cross-sectional data from the United States National Emergency Medical Service (EMS) Information System. We measured injury severity (low acuity, emergent, critical, and fatal) predicted by substance use, defined as self-reported or officer-reported alcohol and/or drug use. We controlled for age, sex, race/ethnicity, road user type, anatomical injured region, roadway crash, rurality/urbanicity, time of the day, and EMS response time. We performed a partial proportional ordinal logistic regression and reported the odds of worse injury outcomes (emergent, critical, and fatal injuries) compared to low acuity injuries, and the predicted probabilities by rurality/urbanicity. RESULTS:Our sample consisted of 252,790 older adults (65 years and older) road users. Approximately 67%, 25%, 6%, and 1% sustained low acuity, emergent, critical, and fatal injuries, respectively. Substance use was reported in approximately 3% of the population, and this proportion did not significantly differ by rurality/urbanicity. After controlling for patient, crash, and injury characteristics, substance use was associated with 36% increased odds of worse injury severity. Compared to urban areas, the predicted probabilities of emergent, critical, and fatal injuries were higher in rural and suburban areas. CONCLUSION:Substance use is associated with worse older adult crash injury severity and the injury severity is higher in rural and suburban areas compared to urban areas.
PMID: 37878571
ISSN: 1932-6203
CID: 5606472

ED-Home: Pilot feasibility study of a targeted homelessness prevention intervention for emergency department patients with drug or unhealthy alcohol use

Fazio, Daniela; Zuiderveen, Sara; Guyet, Dana; Reid, Andrea; Lalane, Monique; McCormack, Ryan P; Wall, Stephen P; Shelley, Donna; Mijanovich, Tod; Shinn, Marybeth; Doran, Kelly M
BACKGROUND:Housing insecurity is prevalent among emergency department (ED) patients. Despite a surge of interest in screening for patients' social needs including housing insecurity, little research has examined ED social needs interventions. We worked together with government and community partners to develop and pilot test a homelessness prevention intervention targeted to ED patients with drug or unhealthy alcohol use. METHODS:We approached randomly sampled patients at an urban public hospital ED, May to August 2019. Adult patients were eligible if they were medically stable, not incarcerated, spoke English, had unhealthy alcohol or any drug use, and were not currently homeless but screened positive for risk of future homelessness using a previously developed risk screening tool. Participants received a three-part intervention: (1) brief counseling and referral to treatment for substance use delivered through a preexisting ED program; (2) referral to Homebase, an evidence-based community homelessness prevention program; and (3) up to three troubleshooting phone calls by study staff. Participants completed surveys at baseline and 6 months. RESULTS:Of 2183 patients screened, 51 were eligible and 40 (78.4%) participated; one later withdrew, leaving 39 participants. Participants were diverse in age, gender, race, and ethnicity. Of the 32 participants reached at 6 months, most said it was very or extremely helpful to talk to someone about their housing situation (n = 23, 71.9%) at the baseline ED visit. Thirteen (40.6%) said their housing situation had improved in the past 6 months and 16 (50.0%) said it had not changed. Twenty participants (62.5%) had made contact with a Homebase office. Participants shared ideas of how to improve the intervention. CONCLUSIONS:This pilot intervention was feasible and well received by participants though it required a large amount of screening to identify potentially eligible patients. Our findings will inform a larger future trial and may be informative for others seeking to develop similar interventions.
PMID: 36268815
ISSN: 1553-2712
CID: 5360592

A randomized clinical trial of strengths-based case management to link emergency department patients to opioid use disorder treatment

Bogenschutz, Michael P; McCormack, Ryan; Rapp, Richard; Meyers-Ohki, Sarah; Mennenga, Sarah E; Regis, Amber; Kolaric, Rhonda; Glisker, Richard; Greco, Peter P
BACKGROUND:Despite the existence of effective pharmacotherapies, rates of opioid use disorder and opioid overdose deaths have continued to increase. Emergency department (ED) visits provide an important opportunity to engage in treatment patients with untreated opioid use disorder (OUD). Case management implemented in other settings is effective in linking those with opioid and other drug use disorders to longer-term treatment, but research has not established its efficacy in the ED. Here we report the results of a trial of Strengths-Based Case Management (SBCM) for people with untreated OUD who are identified during ED visits, with the primary goal of linking them to pharmacologic treatment. METHODS:The study identified patients with untreated OUD during a treatment episode at a large urban ED. The study randomly assigned three hundred participants in 1:1 ratio to receive SBCM or screening, assessment, and referral (SAR) to OUD treatment. Those assigned to SBCM received up to six sessions of SBCM with the primary goal of linkage to treatment. Primary outcomes were initiation of treatment and engagement in pharmacotherapy for OUD. The study defined a "successful outcome" for opioid use as a 3-month urine negative for illicit opioids and no more than 2 days of self-reported opioid misuse in the 4 weeks prior to the 3-month interview. RESULTS:Rates of treatment initiation were not significantly different in the SBCM and SAR groups (57.4% vs. 49.7%, respectively, p > 0.05), nor did engagement in pharmacotherapy differ significantly between groups (p > 0.05). During the 90 days following the index ED visit, SBCM and SAR participants engaged in pharmacotherapy for a mean of 21.8% (SD = 35.1%) versus 17.7% (SD = 31.0%) of days, respectively. Likewise, no significant difference occurred between groups in rates of "successful opioid use outcome" as defined a priori (p > 0.05), although self-reported opioid use over the entire 6-month follow-up period was lower in the SBCM group (10.8 vs. 13.4 days/month, p = 0.042). CONCLUSIONS:SBCM-ED did not improve OUD treatment initiation and engagement in this ED study. Although these findings do not necessarily generalize to all EDs, other approaches, such as direct referral or initiation of treatment in the ED, have considerable empirical support, and should be implemented where they are feasible.
PMID: 35341615
ISSN: 1873-6483
CID: 5200842

Perspectives About Emergency Department Care Encounters Among Adults With Opioid Use Disorder

Hawk, Kathryn; McCormack, Ryan; Edelman, E Jennifer; Coupet, Edouard; Toledo, Nicolle; Gauthier, Phoebe; Rotrosen, John; Chawarski, Marek; Martel, Shara; Owens, Patricia; Pantalon, Michael V; O'Connor, Patrick; Whiteside, Lauren K; Cowan, Ethan; Richardson, Lynne D; Lyons, Michael S; Rothman, Richard; Marsch, Lisa; Fiellin, David A; D'Onofrio, Gail
Importance/UNASSIGNED:Emergency departments (EDs) are increasingly initiating treatment for patients with untreated opioid use disorder (OUD) and linking them to ongoing addiction care. To our knowledge, patient perspectives related to their ED visit have not been characterized and may influence their access to and interest in OUD treatment. Objective/UNASSIGNED:To assess the experiences and perspectives regarding ED-initiated health care and OUD treatment among US patients with untreated OUD seen in the ED. Design, Setting, and Participants/UNASSIGNED:This qualitative study, conducted as part of 2 studies (Project ED Health and ED-CONNECT), included individuals with untreated OUD who were recruited during an ED visit in EDs at 4 urban academic centers, 1 public safety net hospital, and 1 rural critical access hospital in 5 disparate US regions. Focus groups were conducted between June 2018 and January 2019. Main Outcomes and Measures/UNASSIGNED:Data collection and thematic analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework with evidence (perspectives on ED care), context (ED), and facilitation (what is needed to promote change) elements. Results/UNASSIGNED:A total of 31 individuals (mean [SD] age, 43.4 [11.0] years) participated in 6 focus groups. Twenty participants (64.5%) identified as male and most 13 (41.9%) as White; 17 (54.8%) reported being unemployed. Themes related to evidence included patients' experience of stigma and perceived minimization of their pain and medical problems by ED staff. Themes about context included the ED not being seen as a source of OUD treatment initiation and patient readiness to initiate treatment being multifaceted, time sensitive, and related to internal and external patient factors. Themes related to facilitation of improved care of patients with OUD seen in the ED included a need for on-demand treatment and ED staff training. Conclusions and Relevance/UNASSIGNED:In this qualitative study, patients with OUD reported feeling stigmatized and minimized when accessing care in the ED and identified several opportunities to improve care. The findings suggest that strategies to address stigma, acknowledge and treat pain, and provide ED staff training should be implemented to improve ED care for patients with OUD and enhance access to life-saving treatment.
PMID: 35076700
ISSN: 2574-3805
CID: 5154372

Association of substance use characteristics and future homelessness among emergency department patients with drug use or unhealthy alcohol use: Results from a linked data longitudinal cohort analysis

Yoo, Ruth; Krawczyk, Noa; Johns, Eileen; McCormack, Ryan P; Rotrosen, John; Mijanovich, Tod; Gelberg, Lillian; Doran, Kelly M
PMID: 35499455
ISSN: 1547-0164
CID: 5215872

The Perceived Impact of the COVID-19 Pandemic on the Social Needs of Adult Emergency Department Patients

Gallagher, Timothy H; Doran, Kelly M; Samuels, Elizabeth A; McCormack, Ryan P
Objectives/UNASSIGNED:We aim to assess the influence of COVID-19 on the social needs of emergency department (ED) patients, and assess patients' access to social services. Methods/UNASSIGNED:We conducted a cross-sectional survey of 175 purposively sampled adult ED patients. Results/UNASSIGNED:Approximately half of participants stated that COVID-19 negatively impacted their social needs with statistically significant differences observed for race, ethnicity, and insurance status. Many participants did not know of available social services, and a majority welcomed assistance from the ED. Conclusion/UNASSIGNED:This study suggests that unmet social needs have risen because of COVID-19, and EDs may be positioned to identify and assist affected patients.
PMID: 36186619
ISSN: 2473-1242
CID: 5361502