Leveraging a Learning Collaborative Model to Develop and Pilot Quality Measures to Improve Opioid Prescribing in the Emergency Department.

The American College of Emergency Physicians (ACEP) Emergency Medicine Quality Network (E-QUAL) Opioid Initiative was launched in 2018 to advance the dissemination of evidence-based resources to promote the care of emergency department (ED) patients with opioid use disorder. This virtual platform-based national learning collaborative includes a low-burden, structured quality improvement project, data benchmarking, tailored educational content, and resources designed to support a nationwide network of EDs with limited administrative and research infrastructure. As a part of this collaboration, we convened a group of experts to identify and design a set of measures to improve opioid prescribing practices to provide safe analgesia while reducing opioid-related harms. We present those measures here, alongside initial performance data on those measures from a sample of 370 nationwide community EDs participating in the 2019 E-QUAL collaborative. Measures include proportion of opioid administration in the ED, proportion of alternatives to opioids as first-line treatment, proportion of opioid prescription, opioid pill count per prescription, and patient medication safety education among ED visits for atraumatic back pain, dental pain, or headache. The proportion of benzodiazepine and opioid coprescribing for ED visits for atraumatic back pain was also evaluated. This project developed and effectively implemented a collection of 6 potential measures to evaluate opioid analgesic prescribing across a national sample of community EDs, representing the first feasibility assessment of opioid prescribing-related measures from rural and community EDs.

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

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.

Perspectives of Clinicians and Staff at Community-Based Opioid Use Disorder Treatment Settings on Linkages With Emergency Department-Initiated Buprenorphine Programs.

Importance: An increasing number of emergency departments (EDs) are initiating buprenorphine for opioid use disorder (OUD) and linking patients to ongoing community-based treatment, yet community-based clinician and staff perspectives regarding this practice have not been characterized. Objective: To explore perspectives and experiences regarding ED-initiated buprenorphine among community-based clinicians and staff in geographically distinct regions. Design, Setting, and Participants: This qualitative study reports findings from Project ED Health, a hybrid type 3 effectiveness-implementation study designed to evaluate the impact of implementation facilitation on ED-initiated buprenorphine with referral to ongoing medication treatment. Clinicians and staff from community-based treatment programs were identified by urban academic EDs as potential referral sites for ongoing OUD treatment in 4 cities across the US in a formative evaluation as having the capability to continue medication treatment. Focus groups were held from April 1, 2018, to January 11, 2019, to examine community OUD treatment clinician and staff perspectives on accepting patients who have received ED-initiated buprenorphine. Data were analyzed from August 2020 to August 2022. Main Outcomes and Measures: Data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) implementation science framework, focusing on domains including evidence, context, and facilitation. Results: A total of 103 individuals (mean [SD] age, 45.3 [12.0] years; 76 female and 64 White) participated in 14 focus groups (groups ranged from 3-22 participants). Participants shared negative attitudes toward buprenorphine and variable attitudes toward ED-initiated buprenorphine. Prominent barriers included the community site treatment capacity and structure as well as payment and regulatory barriers. Perceived factors that could facilitate this model included additional substance use disorder training for ED staff, referrals and communication, greater inclusion of peer navigators, and addressing sociostructural marginalization that patients faced. Conclusions and Relevance: In this study of community-based clinicians and staff positioned to deliver OUD treatment, participants reported many barriers to successful linkages for patients who received ED-initiated buprenorphine. Strategies to improve these linkages included educating communities and programs, modeling low-barrier philosophies, and using additional staff trained in addiction as resources to improve transitions from EDs to community partners.

Perspectives on and experiences of emergency department-initiated buprenorphine among clinical pharmacists: A multi-site qualitative study.

INTRODUCTION: Clinical pharmacists are well positioned to enhance efforts to promote emergency department (ED)-initiated buprenorphine to treat opioid use disorder (OUD). Among clinical pharmacists in urban EDs, we sought to characterize barriers and facilitators for ED-initiated buprenorphine to inform future implementation efforts and enhance access to this highly effective OUD treatment. METHODS: This study was conducted as a part of Project ED Health (CTN-0069, NCT03023930), a multisite effectiveness-implementation study aimed at promoting ED-initiated buprenorphine that was conducted between April 2017 and July 2020. Data collection and analysis were grounded in the Promoting Action on Research Implementation in Health Services (PARIHS) framework to assess perspectives on the relationship between 3 elements: evidence for buprenorphine, the ED context, and facilitation needs to promote ED-initiated buprenorphine. The study used an iterative coding process to identify overlapping themes within these 3 domains. RESULTS: The study conducted eight focus groups/interviews across four geographically disparate EDs with 15 pharmacist participants. We identified six themes. Themes related to evidence included (1) varied levels of comfort and experience among pharmacists with ED-initiated buprenorphine that increased over time and (2) a perception that patients with OUD have unique challenges that require guidance to optimize ED care. With regards to context, clinical pharmacists identified: (3) their ability to clarify scope of ED care in the context of unique pharmacology, formulations, and regulations of buprenorphine to ED staff, and that (4) their presence promotes successful program implementation and quality improvement. Participants identified facilitation needs including: (5) training to promote practice change and (6) ways to leverage already existing pharmacy resources outside of the ED. CONCLUSION: Clinical pharmacists play a unique and critical role in the efforts to promote ED-initiated buprenorphine. We identified 6 themes that can inform pharmacist-specific interventions that could aid in the successful implementation of this practice.

Implementation Facilitation to Promote Emergency Department-Initiated Buprenorphine for Opioid Use Disorder.

Importance: Emergency department (ED)-initiated buprenorphine for the treatment of opioid use disorder (OUD) is underused. Objective: To evaluate whether provision of ED-initiated buprenorphine with referral for OUD increased after implementation facilitation (IF), an educational and implementation strategy. Design, Setting, and Participants: This multisite hybrid type 3 effectiveness-implementation nonrandomized trial compared grand rounds with IF, with pre-post 12-month baseline and IF evaluation periods, at 4 academic EDs. The study was conducted from April 1, 2017, to November 30, 2020. Participants were ED and community clinicians treating patients with OUD and observational cohorts of ED patients with untreated OUD. Data were analyzed from July 16, 2021, to July 14, 2022. Exposure: A 60-minute in-person grand rounds was compared with IF, a multicomponent facilitation strategy that engaged local champions, developed protocols, and provided learning collaboratives and performance feedback. Main Outcomes and Measures: The primary outcomes were the rate of patients in the observational cohorts who received ED-initiated buprenorphine with referral for OUD treatment (primary implementation outcome) and the rate of patients engaged in OUD treatment at 30 days after enrollment (effectiveness outcome). Additional implementation outcomes included the numbers of ED clinicians with an X-waiver to prescribe buprenorphine and ED visits with buprenorphine administered or prescribed and naloxone dispensed or prescribed. Results: A total of 394 patients were enrolled during the baseline evaluation period and 362 patients were enrolled during the IF evaluation period across all sites, for a total of 756 patients (540 [71.4%] male; mean [SD] age, 39.3 [11.7] years), with 223 Black patients (29.5%) and 394 White patients (52.1%). The cohort included 420 patients (55.6%) who were unemployed, and 431 patients (57.0%) reported unstable housing. Two patients (0.5%) received ED-initiated buprenorphine during the baseline period, compared with 53 patients (14.6%) during the IF evaluation period (P < .001). Forty patients (10.2%) were engaged with OUD treatment during the baseline period, compared with 59 patients (16.3%) during the IF evaluation period (P = .01). Patients in the IF evaluation period who received ED-initiated buprenorphine were more likely to be in treatment at 30 days (19 of 53 patients [35.8%]) than those who did not 40 of 309 patients (12.9%; P < .001). Additionally, there were increases in the numbers of ED clinicians with an X-waiver (from 11 to 196 clinicians) and ED visits with provision of buprenorphine (from 259 to 1256 visits) and naloxone (from 535 to 1091 visits). Conclusions and Relevance: In this multicenter effectiveness-implementation nonrandomized trial, rates of ED-initiated buprenorphine and engagement in OUD treatment were higher in the IF period, especially among patients who received ED-initiated buprenorphine. Trial Registration: ClinicalTrials.gov Identifier: NCT03023930.

Incidence of Precipitated Withdrawal During a Multisite Emergency Department-Initiated Buprenorphine Clinical Trial in the Era of Fentanyl.

This cohort study examines the incidence of precipitated withdrawal comparing traditional sublingual buprenorphine with a 7-day extended-release injectable initiated in the emergency department (ED).

Improving Uptake of Emergency Department-initiated Buprenorphine: Barriers and Solutions.

Emergency departments (ED) are increasingly providing buprenorphine to persons with opioid use disorder. Buprenorphine programs in the ED have strong support from public health leaders and emergency medicine specialty societies and have proven to be clinically effective, cost effective, and feasible. Even so, few ED buprenorphine programs currently exist. Given this imbalance between evidence-based practice and current practice, proven behavior change approaches can be used to guide local efforts to expand ED buprenorphine capacity. In this paper, we use the theory of planned behavior to identify and address the 1) clinician factors, 2) institutional factors, and 3) external factors surrounding ED buprenorphine implementation. By doing so, we seek to provide actionable and pragmatic recommendations to increase ED buprenorphine availability across different practice settings.

Models for Implementing Emergency Department-Initiated Buprenorphine With Referral for Ongoing Medication Treatment at Emergency Department Discharge in Diverse Academic Centers.

There has been a substantial rise in the number of publications and training opportunities on the care and treatment of emergency department (ED) patients with opioid use disorder over the past several years. The American College of Emergency Physicians recently published recommendations for providing buprenorphine to patients with opioid use disorder, but barriers to implementing this clinical practice remain. We describe the models for implementing ED-initiated buprenorphine at 4 diverse urban, academic medical centers across the country as part of a federally funded effort termed "Project ED Health." These 4 sites successfully implemented unique ED-initiated buprenorphine programs as part of a comparison of implementation facilitation to traditional educational dissemination on the uptake of ED-initiated buprenorphine. Each site describes the elements central to the ED process, including screening, treatment initiation, referral, and follow-up, while harnessing organizational characteristics, including ED culture. Finally, we discuss common facilitators to program success, including information technology and electronic medical record integration, hospital-level support, strong connections with outpatient partners, and quality improvement processes.

High-Dose Buprenorphine Induction in the Emergency Department for Treatment of Opioid Use Disorder.

Importance: Emergency departments (EDs) sporadically use a high-dose buprenorphine induction strategy for the treatment of opioid use disorder (OUD) in response to the increasing potency of the illicit opioid drug supply and commonly encountered delays in access to follow-up care. Objective: To examine the safety and tolerability of high-dose (>12 mg) buprenorphine induction for patients with OUD presenting to an ED. Design, Setting, and Participants: In this case series of ED encounters, data were manually abstracted from electronic health records for all ED patients with OUD treated with buprenorphine at a single, urban, safety-net hospital in Oakland, California, for the calendar year 2018. Data analysis was performed from April 2020 to March 2021. Interventions: ED physicians and advanced practice practitioners were trained on a high-dose sublingual buprenorphine induction protocol, which was then clinically implemented. Main Outcomes and Measures: Vital signs; use of supplemental oxygen; the presence of precipitated withdrawal, sedation, and respiratory depression; adverse events; length of stay; and hospitalization during and 24 hours after the ED visit were reported according to total sublingual buprenorphine dose (range, 2 to >28 mg). Results: Among a total of 391 unique patients (median [interquartile range] age, 36 [29-48] years), representing 579 encounters, 267 (68.3%) were male and 170 were (43.5%) Black. Homelessness (88 patients [22.5%]) and psychiatric disorders (161 patients [41.2%]) were common. A high dose of sublingual buprenorphine (>12 mg) was administered by 54 unique clinicians during 366 (63.2%) encounters, including 138 doses (23.8%) greater than or equal to 28 mg. No cases of respiratory depression or sedation were reported. All 5 (0.8%) cases of precipitated withdrawal had no association with dose; 4 cases occurred after doses of 8 mg of buprenorphine. Three serious adverse events unrelated to buprenorphine were identified. Nausea or vomiting was rare (2%-6% of cases). The median (interquartile range) length of stay was 2.4 (1.6-3.75) hours. Conclusions and Relevance: These findings suggest that high-dose buprenorphine induction, adopted by multiple clinicians in a single-site urban ED, was safe and well tolerated in patients with untreated OUD. Further prospective investigations conducted in multiple sites would enhance these findings.

The design and conduct of a randomized clinical trial comparing emergency department initiation of sublingual versus a 7-day extended-release injection formulation of buprenorphine for opioid use disorder: Project ED Innovation.

ED-INNOVATION (Emergency Department-INitiated bupreNOrphine VAlidaTION) is a Hybrid Type-1 Implementation-Effectiveness multisite emergency department (ED) study funded through The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM efforts to increase access to medications for opioid use disorder (OUD). We use components of Implementation Facilitation to enhance adoption of ED-initiated buprenorphine (BUP) at approximately 30 sites. Subsequently we compare the effectiveness of two BUP formulations, sublingual (SL-BUP) and 7-day extended-release injectable (CAM2038, XR-BUP) in a randomized clinical trial (RCT) of approximately 2000 patients with OUD on the primary outcome of engagement in formal addiction treatment at 7 days. Secondary outcomes assessed at 7 and 30 days include self-reported opioid use, craving and satisfaction, health service utilization, overdose events, and engagement in formal addiction treatment (30 days) and receipt of medications for OUD (at 7 and 30 days). A sample size of 1000 per group provides 90% power at the 2-sided significance level to detect a difference in the primary outcome of 8% and accommodates a 15% dropout rate. We will compare the cost effectiveness of the two treatments on the primary outcome using the incremental cost-effectiveness ratio. We will also conduct an ancillary study in approximately 75 patients experiencing minimal to no opioid withdrawal who will undergo XR-BUP initiation. If the ancillary study demonstrates safety, we will expand the eligibility criteria for the RCT to include individuals with minimal to no opioid withdrawal. The results of these studies will inform implementation of ED-initiated BUP in diverse EDs which has the potential to improve treatment access.

Barriers and Facilitators to Clinician Readiness to Provide Emergency Department-Initiated Buprenorphine.

Importance: Treatment of opioid use disorder (OUD) with buprenorphine decreases opioid use and prevents morbidity and mortality. Emergency departments (EDs) are an important setting for buprenorphine initiation for patients with untreated OUD; however, readiness varies among ED clinicians. Objective: To characterize barriers and facilitators of readiness to initiate buprenorphine for the treatment of OUD in the ED and identify opportunities to promote readiness across multiple clinician types. Design, Setting, and Participants: Using data collected from April 1, 2018, to January 11, 2019, this mixed-methods formative evaluation grounded in the Promoting Action on Research Implementation in Health Services framework included 4 geographically diverse academic EDs. Attending physicians (n = 113), residents (n = 107), and advanced practice clinicians (APCs) (n = 48) completed surveys electronically distributed to all ED clinicians (n = 396). A subset of participants (n = 74) also participated in 1 of 11 focus group discussions. Data were analyzed from June 1, 2018, to February 22, 2020. Main Outcomes and Measures: Clinician readiness to initiate buprenorphine and provide referral for ongoing treatment for patients with OUD treated in the ED was assessed using a visual analog scale. Responders (268 of 396 [67.7%]) were dichotomized as less ready (scores 0-6) or most ready (scores 7-10). An ED-adapted Organizational Readiness to Change Assessment (ORCA) and 11 focus groups were used to assess ratings and perspectives on evidence and context-related factors to promote ED-initiated buprenorphine with referral for ongoing treatment, respectively. Results: Among the 268 survey respondents (153 of 260 were men [58.8%], with a mean [SD] of 7.1 [9.8] years since completing formal training), 56 (20.9%) indicated readiness to initiate buprenorphine for ED patients with OUD. Nine of 258 (3.5%) reported Drug Addiction Treatment Act of 2000 training completion. Compared with those who were less ready, clinicians who were most ready to initiate buprenorphine had higher mean scores across all ORCA Evidence subscales (3.50 [95% CI, 3.35-3.65] to 4.33 [95% CI, 4.13-4.53] vs 3.11 [95% CI, 3.03-3.20] to 3.60 [95% CI, 3.49-3.70]; P < .001) and on the Slack Resources of the ORCA Context subscales (3.32 [95% CI, 3.08-3.55] vs 3.0 [95% CI, 2.87-3.12]; P = .02). Barriers to ED-initiated buprenorphine included lack of training and experience in treating OUD with buprenorphine, concerns about ability to link to ongoing care, and competing needs and priorities for ED time and resources. Facilitators to ED-initiated buprenorphine included receiving education and training, development of local departmental protocols, and receiving feedback on patient experiences and gaps in quality of care. Conclusions and Relevance: Only a few ED clinicians had a high level of readiness to initiate buprenorphine; however, many expressed a willingness to learn with sufficient supports. Efforts to promote adoption of ED-initiated buprenorphine will require clinician and system-level changes.

Implementation facilitation to promote emergency department-initiated buprenorphine for opioid use disorder: protocol for a hybrid type III effectiveness-implementation study (Project ED HEALTH).

BACKGROUND: Patients with opioid use disorder (OUD) frequently present to the emergency department (ED) after overdose, or seeking treatment for general medical conditions, their addiction, withdrawal symptoms, or complications of injection drug use, such as soft tissue infections. ED-initiated buprenorphine has been shown to be effective in increasing patient engagement in treatment compared with brief intervention with a facilitated referral or referral alone. However, adoption into practice has lagged behind need. To address this implementation challenge, we are evaluating the impact of implementation facilitation (IF) on the adoption of ED-initiated buprenorphine for OUD into practice. METHODS: This protocol describes a study that is being conducted through the National Institute on Drug Abuse's Center for the Clinical Trials Network. A hybrid type III effectiveness-implementation study design is used to evaluate the effectiveness of a standard educational dissemination strategy versus IF on implementation (primary) and effectiveness (secondary) outcomes in four urban, academic EDs. Sites start with a standard 60-min "Grand Rounds" educational intervention describing the prevalence of ED patients with OUD, the evidence for opioid agonist treatment and for innovative interventions with ED-initiated buprenorphine; followed by a 1-year baseline evaluation period. Using a modified stepped wedge design, sites are randomly assigned to the IF intervention which is guided by the Promoting Action on Research Implementation in Health Services (PARiHS) framework to assess evidence, context, and facilitation-related factors impacting the adoption of ED-initiated buprenorphine. During the 6 months of IF through the 1-year IF evaluation period, external facilitators work with local stakeholders to tailor and refine a bundle of activities to meet the site's needs. The primary analyses compare the baseline evaluation period to the IF evaluation period (n = 120 patients with untreated OUD enrolled during each period) on (1) rates of provision of ED-initiated buprenorphine by ED providers with referral for ongoing medication (implementation outcome) and (2) rates of patient engagement in addiction treatment on the 30th day after the ED visit (effectiveness outcome). Finally, we will perform a cost-effectiveness analysis (CEA) to determine if the effectiveness benefits are worth the additional costs. DISCUSSION: Results will generate novel information regarding the impact of IF as a strategy to promote ED-initiated buprenorphine. TRIAL REGISTRATION: ClinicalTrials.gov NCT03023930 first posted 1/10/2017, https://clinicaltrials.gov/ct2/show/NCT03023930?term=0069&rank=1.

Emergency Medicine Research Priorities for Early Intervention for Substance Use Disorders.

INTRODUCTION: Patients with substance use disorders (SUDs) frequently seek emergency care, and the emergency department (ED) may be their only point of contact with the healthcare system. While the ED visit has been increasingly recognized as providing opportunity for interventions around substance use, many questions remain. METHODS: In December 2016 the Coalition on Psychiatric Emergencies (CPE) convened the first Research Consensus Conference on Acute Mental Illness, which consisted of clinical researchers, clinicians from emergency medicine, emergency psychiatry, emergency psychology, representatives from governmental agencies and patient advocacy groups. Background literature review was conducted prior to the meeting, and questions were iteratively focused, revised, voted on and ranked by perceived importance using nominal group method. RESULTS: The main goal of the SUD workgroup was to identify research priorities and develop a research agenda to improve the early identification of and management of emergency department (ED) patients with SUDs with the goal of improving outcomes. This article is the product of a breakout session on "Special Populations: Substance Use Disorder." The workgroup identified with high consensus six research priorities for their importance related to the care of ED patients with SUDs in these overall domains: screening; ED interventions; the role of peer navigators; initiation of SUD management in the ED; specific patient populations that may impact the effectiveness of interventions including sociogenerational and cultural factors; and the management of the acutely intoxicated patient. CONCLUSION: Emergency providers are increasingly recognizing the important role of the ED in reducing adverse outcomes associated with untreated SUDs. Additional research is required to close identified knowledge gaps and improve care of ED patients with SUD.

Multiple Fentanyl Overdoses - New Haven, Connecticut, June 23, 2016.

On the evening of June 23, 2016, a white powder advertised as cocaine was purchased off the streets from multiple sources and used by an unknown number of persons in New Haven, Connecticut. During a period of less than 8 hours, 12 patients were brought to the emergency department (ED) at Yale New Haven Hospital, experiencing signs and symptoms consistent with opioid overdose. The route of intoxication was not known, but presumed to be insufflation ("snorting") in most cases. Some patients required doses of the opioid antidote naloxone exceeding 4 mg (usual initial dose = 0.1-0.2 mg intravenously), and several patients who were alert after receiving naloxone subsequently developed respiratory failure. Nine patients were admitted to the hospital, including four to the intensive care unit (ICU); three required endotracheal intubation, and one required continuous naloxone infusion. Three patients died. The white powder was determined to be fentanyl, a drug 50 times more potent than heroin, and it included trace amounts of cocaine. The episode triggered rapid notification of public health and law enforcement agencies, interviews of patients and their family members to trace and limit further use or distribution of the fentanyl, immediate naloxone resupply and augmentation for emergency medical services (EMS) crews, public health alerts, and plans to accelerate naloxone distribution to opioid users and their friends and families. Effective communication and timely, coordinated, collaborative actions of community partners reduced the harm caused by this event and prevented potential subsequent episodes.

Reducing Fatal Opioid Overdose: Prevention, Treatment and Harm Reduction Strategies.

The opioid overdose epidemic is a major threat to the public's health, resulting in the development and implementation of a variety of strategies to reduce fatal overdose. Many strategies are focused on primary prevention and increased access to effective treatment, although the past decade has seen an exponential increase in harm reduction initiatives. To maximize identification of opportunities for intervention, initiatives focusing on prevention, access to effective treatment, and harm reduction are examined independently, although considerable overlap exists. Particular attention is given to harm reduction approaches, as increased public and political will have facilitated widespread implementation of several initiatives, including increased distribution of naloxone and policy changes designed to increase bystander assistance during a witnessed overdose.