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1.
Acad Emerg Med ; 30(12): 1264-1271, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37501652

ABSTRACT

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.


Subject(s)
Buprenorphine , Opioid-Related Disorders , Humans , Buprenorphine/therapeutic use , Narcotic Antagonists/therapeutic use , Opioid-Related Disorders/drug therapy , Opioid-Related Disorders/epidemiology , Emergency Service, Hospital , Analgesics, Opioid/therapeutic use
2.
J Subst Use Addict Treat ; 155: 209058, 2023 12.
Article in English | MEDLINE | ID: mdl-37149149

ABSTRACT

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.


Subject(s)
Buprenorphine , Opioid-Related Disorders , Humans , Buprenorphine/therapeutic use , Pharmacists , Opiate Substitution Treatment , Opioid-Related Disorders/drug therapy , Emergency Service, Hospital
3.
JAMA Netw Open ; 6(4): e235439, 2023 04 03.
Article in English | MEDLINE | ID: mdl-37017967

ABSTRACT

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.


Subject(s)
Buprenorphine , Opioid-Related Disorders , Humans , Male , Adult , Female , Buprenorphine/therapeutic use , Narcotic Antagonists/therapeutic use , Opiate Substitution Treatment/methods , Opioid-Related Disorders/drug therapy , Naloxone/therapeutic use , Emergency Service, Hospital
4.
Ann Emerg Med ; 80(5): 410-419, 2022 11.
Article in English | MEDLINE | ID: mdl-35752520

ABSTRACT

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.


Subject(s)
Buprenorphine , Opioid-Related Disorders , Humans , Buprenorphine/therapeutic use , Opiate Substitution Treatment , Narcotic Antagonists/therapeutic use , Patient Discharge , Emergency Service, Hospital , Opioid-Related Disorders/drug therapy , Referral and Consultation
5.
JAMA Netw Open ; 5(1): e2144955, 2022 01 04.
Article in English | MEDLINE | ID: mdl-35076700

ABSTRACT

Importance: 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: 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: 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: 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: 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: 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.


Subject(s)
Emergency Service, Hospital , Opioid-Related Disorders/psychology , Patient Acceptance of Health Care/psychology , Social Stigma , Stereotyping , Adult , Female , Focus Groups , Humans , Male , Qualitative Research , United States
6.
Contemp Clin Trials ; 104: 106359, 2021 05.
Article in English | MEDLINE | ID: mdl-33737199

ABSTRACT

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.


Subject(s)
Buprenorphine , Opioid-Related Disorders , Buprenorphine/therapeutic use , Delayed-Action Preparations/therapeutic use , Emergency Service, Hospital , Humans , Narcotic Antagonists/therapeutic use , Opioid-Related Disorders/drug therapy
7.
Drug Alcohol Depend ; 219: 108428, 2021 02 01.
Article in English | MEDLINE | ID: mdl-33307301

ABSTRACT

BACKGROUND Little is known regarding the sociodemographic and clinical characteristics of emergency department (ED) patients with untreated opioid use disorder (OUD) and the relationship of those characteristics with whether they were seeking a referral to substance use treatment at the time of their ED visit. METHODS Using data collected from 2/2017-1/2019 from participants enrolled in Project ED Health (CTN-0069), we conducted a cross-sectional analysis of patients with untreated moderate to severe OUD presenting to one of four EDs in Baltimore, New York City, Cincinnati, or Seattle. Sociodemographic and clinical correlates, and International Classification of Diseases Tenth Revision (ICD-10) diagnosis codes related to opioid withdrawal, injection-related infection, other substance use, overdose, and OUD of those seeking and not seeking a referral to substance use treatment on presentation were compared using univariate analyses. RESULTS Among 394 study participants, 15.2 % (60/394) came to the ED seeking a referral to substance use treatment. No differences in age, gender, education, health insurance status or housing stability were detected between those seeking and not seeking referral to substance use treatment. Those seeking a referral to substance use treatment were less likely to have urine toxicology testing positive for amphetamine [17 % (10/60) vs 31 % (104/334), p = 0.023] and methamphetamine [23 % (14/60) vs 40 % (132/334), p = 0.017] compared to those not seeking a referral. CONCLUSION Most patients with untreated OUD seen in the EDs were not seeking a referral to substance use treatment. Active identification, treatment initiation, and coding may improve ED efforts to address untreated OUD.


Subject(s)
Opioid-Related Disorders/drug therapy , Referral and Consultation/statistics & numerical data , Adult , Amphetamine/therapeutic use , Baltimore/epidemiology , Cross-Sectional Studies , Drug Overdose/drug therapy , Emergency Service, Hospital/statistics & numerical data , Female , Humans , International Classification of Diseases , Male , Methamphetamine , Middle Aged , New York City/epidemiology , Opioid-Related Disorders/epidemiology , Surveys and Questionnaires , Young Adult
8.
Ann Emerg Med ; 76(6): 782-787, 2020 12.
Article in English | MEDLINE | ID: mdl-32782084

ABSTRACT

STUDY OBJECTIVE: Concurrent use of amphetamine-type stimulants among individuals with opioid use disorder can exacerbate social and medical harms, including overdose risk. The study evaluated rates of amphetamine-type stimulant use among patients with untreated opioid use disorder presenting at emergency departments in Baltimore, MD; New York, NY; Cincinnati, OH; and Seattle, WA. METHODS: Emergency department (ED) patients with untreated opioid use disorder (N=396) and enrolled between February 2017 and January 2019 in a multisite hybrid type III implementation science study were evaluated for concurrent amphetamine-type stimulant use. Individuals with urine tests positive for methamphetamine, amphetamine, or both were compared with amphetamine-type stimulant-negative patients. RESULTS: Overall, 38% of patients (150/396) were amphetamine-type stimulant positive; none reported receiving prescribed amphetamine or methamphetamine medications. Amphetamine-type stimulant-positive versus -negative patients were younger: mean age was 36 years (SD 10 years) versus 40 years (SD 12 years), 69% (104/150) versus 46% (114/246) were white, 65% (98/150) versus 54% (132/246) were unemployed, 67% (101/150) versus 49 (121/246) had unstable housing, 47% (71/150) versus 25% (61/245) reported an incarceration during 1 year before study admission, 60% (77/128) versus 45% (87/195) were hepatitis C positive, 79% (118/150) versus 47% (115/245) reported drug injection during 1 month before the study admission, and 42% (62/149) versus 29% (70/244) presented to the ED for an injury. Lower proportions of amphetamine-type stimulant-positive patients had cocaine-positive urine test results (33% [50/150] versus 52% [129/246]) and reported seeking treatment for substance use problems as a reason for their ED visit (10% [14/148] versus 19% [46/246]). All comparisons were statistically significant at P<.05 with the false discovery rate correction. CONCLUSION: Amphetamine-type stimulant use among ED patients with untreated opioid use disorder was associated with distinct sociodemographic, social, and health factors. Improved ED-based screening, intervention, and referral protocols for patients with opioid use disorder and amphetamine-type stimulant use are needed.


Subject(s)
Amphetamine/adverse effects , Central Nervous System Stimulants/adverse effects , Methamphetamine/adverse effects , Opioid-Related Disorders/diagnosis , Adult , Amphetamine/therapeutic use , Amphetamine/urine , Amphetamine-Related Disorders/diagnosis , Amphetamine-Related Disorders/epidemiology , Case-Control Studies , Central Nervous System Stimulants/therapeutic use , Central Nervous System Stimulants/urine , Drug Overdose/etiology , Emergency Service, Hospital/statistics & numerical data , Female , Hepatitis C/epidemiology , Humans , Male , Methamphetamine/therapeutic use , Methamphetamine/urine , Middle Aged , Opioid-Related Disorders/complications , Opioid-Related Disorders/epidemiology , Opioid-Related Disorders/urine , Substance Abuse Detection , United States/epidemiology
9.
JAMA Netw Open ; 3(5): e204561, 2020 05 01.
Article in English | MEDLINE | ID: mdl-32391893

ABSTRACT

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.


Subject(s)
Buprenorphine/therapeutic use , Emergency Service, Hospital/statistics & numerical data , Opiate Substitution Treatment , Opioid-Related Disorders/drug therapy , Practice Patterns, Physicians' , Referral and Consultation , Adult , Buprenorphine/administration & dosage , Female , Focus Groups , Humans , Male , Middle Aged , Opioid Epidemic/prevention & control , Surveys and Questionnaires , United States
10.
Article in English | MEDLINE | ID: mdl-32309637

ABSTRACT

Buprenorphine (BUP) can safely and effectively reduce craving, overdose, and mortality rates in people with opioid use disorder (OUD). However, adoption of ED-initiation of BUP has been slow partly due to physician perception this practice is too complex and disruptive. We report progress of the ongoing EMBED (EMergency department-initiated BuprenorphinE for opioid use Disorder) project. This project is a five-year collaboration across five healthcare systems with the goal to develop, integrate, study, and disseminate user-centered Clinical Decision Support (CDS) to promote the adoption of Emergency Department (ED)-initiation of buprenorphine/naloxone (BUP) into routine emergency care. Soon to enter its third year, the project has already completed multiple milestones to achieve its goals including (1) user-centered design of the CDS prototype, (2) integration of the CDS into an automated electronic health record (EHR) workflow, (3) data coordination including derivation and validation of an EHR-based computable phenotype, (4) meeting all ethical and regulatory requirements to achieve a waiver of informed consent, (5) pilot testing of the intervention at a single site, and (6) launching a parallel group-randomized 18-month pragmatic trial in 20 EDs across 5 healthcare systems. Pilot testing of the intervention in a single ED was associated with increased rates of ED-initiated BUP and naloxone prescribing and a doubling of the number of unique physicians adopting the practice. The ongoing multi-center pragmatic trial will assess the intervention's effectiveness, scalability, and generalizability with a goal to shift the emergency care paradigm for OUD towards early identification and treatment. TRIAL REGISTRATION: Clinicaltrials.gov # NCT03658642.

11.
J Subst Abuse Treat ; 102: 47-52, 2019 07.
Article in English | MEDLINE | ID: mdl-31202288

ABSTRACT

BACKGROUND: In order to streamline the emergency department (ED) referral process in a multi-network automated opioid treatment referral program, we performed a needs assessment of community providers for Medication for Opioid Use Disorder (MOUD) in the EMergency department-initiated BuprenorphinE for opioid use Disorder (EMBED) trial network. METHODS: A needs assessment was conducted in two phases: (1) key stakeholder meetings and (2) a survey of community sites offering MOUD. Stakeholder meetings were conducted with five key stakeholder groups: 1) ED clinicians and staff, 2) community sites offering MOUD, 3) the investigative team, 4) health system IT staff, and 5) medical ethics experts. Meetings continued until each stakeholder group stated that their priorities and needs were understood. Major categories of needs were extracted pragmatically based on recurrence across stakeholder groups. Informed by needs expressed by IT and MOUD site stakeholders, nineteen MOUD sites were surveyed to better characterize information needs of community sites offering MOUD when receiving an ED referral. RESULTS: Three major categories of needs for referral system were identified: 1) The system to be automated, flexible and allow multiple channels of referral, 2) Referral metrics are retrievable in a HIPAA compliant manner, 3) Patients are scheduled into community sites offering MOUD as urgently as possible. Of the MOUD sites surveyed, 68.4% (13/19) responded. Based on the responses, specific patient identifiers were required for most MOUD site referrals, and encrypted emails and EHR were the preferred methods of communication for the handoff. 53.8% (7/13) of the sites were able to accept patients within 3 days with only 1 site requiring >7 days. CONCLUSION: These findings can inform IT solutions to address the discordant priorities of the ED (rapid and flexible referral process) and the community sites offering (referrals minimize variability and overbooking). To prevent drop-out in the referral cascade, our findings emphasize the need for increased availability and accessibility to MOUD on demand and protected communication channels between EDs and community providers of MOUD.


Subject(s)
Community Health Services/organization & administration , Opioid-Related Disorders/rehabilitation , Patient Handoff/organization & administration , Referral and Consultation/organization & administration , Automation , Buprenorphine/administration & dosage , Communication , Emergency Service, Hospital/organization & administration , Humans , Needs Assessment , Opiate Substitution Treatment/methods , Surveys and Questionnaires
12.
BMJ Open ; 9(5): e028488, 2019 05 30.
Article in English | MEDLINE | ID: mdl-31152039

ABSTRACT

INTRODUCTION: The goal of this trial is to determine whether implementation of a user-centred clinical decision support (CDS) system can increase adoption of initiation of buprenorphine (BUP) into the routine emergency care of individuals with opioid use disorder (OUD). METHODS: A pragmatic cluster randomised trial is planned to be carried out in 20 emergency departments (EDs) across five healthcare systems over 18 months. The intervention consists of a user-centred CDS integrated into ED clinician electronic workflow and available for guidance to: (1) determine whether patients presenting to the ED meet criteria for OUD, (2) assess withdrawal symptoms and (3) ascertain and motivate patient willingness to initiate treatment. The CDS guides the ED clinician to initiate BUP and facilitate follow-up. The primary outcome is the rate of BUP initiated in the ED. Secondary outcomes are: (1) rates of receiving a referral, (2) fidelity with the CDS and (3) rates of clinicians providing any ED-initiated BUP, referral for ongoing treatment and receiving Drug Addiction Act of 2000 training. Primary and secondary outcomes will be analysed using generalised linear mixed models, with fixed effects for intervention status (CDS vs usual care), prespecified site and patient characteristics, and random effects for study site. ETHICS AND DISSEMINATION: The protocol has been approved by the Western Institutional Review Board. No identifiable private information will be collected from patients. A waiver of informed consent was obtained for the collection of data for clinician prescribing and other activities. As a minimal risk implementation study of established best practices, an Independent Study Monitor will be utilised in place of a Data Safety Monitoring Board. Results will be reported in ClinicalTrials.gov and published in open-access, peer-reviewed journals, presented at national meetings and shared with the clinicians at participating sites via a broadcast email notification of publications. TRIAL REGISTRATION NUMBER: NCT03658642; Pre-results.


Subject(s)
Buprenorphine/administration & dosage , Decision Support Systems, Clinical/statistics & numerical data , Emergency Service, Hospital , Narcotic Antagonists/administration & dosage , Opioid-Related Disorders/drug therapy , Adult , Cluster Analysis , Female , Humans , Male , Middle Aged , Multicenter Studies as Topic , Opiate Substitution Treatment , Opioid-Related Disorders/epidemiology , Pragmatic Clinical Trials as Topic , Randomized Controlled Trials as Topic , United States/epidemiology , Young Adult
13.
Implement Sci ; 14(1): 48, 2019 05 07.
Article in English | MEDLINE | ID: mdl-31064390

ABSTRACT

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.


Subject(s)
Buprenorphine/therapeutic use , Emergency Medicine/education , Emergency Service, Hospital/organization & administration , Narcotic Antagonists/therapeutic use , Opiate Substitution Treatment/methods , Opioid-Related Disorders/drug therapy , Adult , Evidence-Based Medicine , Female , Focus Groups , Humans , Inservice Training , Male , Program Development , Program Evaluation , Research Design , United States
14.
JMIR Hum Factors ; 6(1): e13121, 2019 Feb 27.
Article in English | MEDLINE | ID: mdl-30810531

ABSTRACT

BACKGROUND: Emergency departments (EDs) frequently care for individuals with opioid use disorder (OUD). Buprenorphine (BUP) is an effective treatment option for patients with OUD that can safely be initiated in the ED. At present, BUP is rarely initiated as a part of routine ED care. Clinical decision support (CDS) could accelerate adoption of ED-initiated BUP into routine emergency care. OBJECTIVE: This study aimed to design and formatively evaluate a user-centered decision support tool for ED initiation of BUP for patients with OUD. METHODS: User-centered design with iterative prototype development was used. Initial observations and interviews identified workflows and information needs. The design team and key stakeholders reviewed prototype designs to ensure accuracy. A total of 5 prototypes were evaluated and iteratively refined based on input from 26 attending and resident physicians. RESULTS: Early feedback identified concerns with the initial CDS design: an alert with several screens. The timing of the alert led to quick dismissal without using the tool. User feedback on subsequent iterations informed the development of a flexible tool to support clinicians with varied levels of experience with the intervention by providing both one-click options for direct activation of care pathways and user-activated support for critical decision points. The final design resolved challenging navigation issues through targeted placement, color, and design of the decision support modules and care pathways. In final testing, users expressed that the tool could be easily learned without training and was reasonable for use during routine emergency care. CONCLUSIONS: A user-centered design process helped designers to better understand users' needs for a Web-based clinical decision tool to support ED initiation of BUP for OUD. The process identified varying needs across user experience and familiarity with the protocol, leading to a flexible design supporting both direct care pathways and user-initiated decision support.

15.
J Adolesc Health ; 63(3): 327-334, 2018 09.
Article in English | MEDLINE | ID: mdl-30097347

ABSTRACT

PURPOSE: To evaluate a screening, brief intervention and referral to treatment curriculum for alcohol and other substance use developed, implemented and integrated into a pediatric residency program. METHODS: During a 1-month adolescent medicine rotation, pediatric, and medicine/pediatric residents in an urban teaching hospital completed a 2 1/2-hour formal curriculum including a didactic lecture, a 40-minute video describing the Brief Negotiation Interview (BNI), and a skill-based session practicing the BNI and receiving individualized feedback. Access to a website with didactic material was provided. Outcome measures were pre- and post-training knowledge, BNI performance measured with a standardized patient using a validated BNI adherence scale, satisfaction with training, and adoption of BNI into clinical practice. RESULTS: Of the 106 residents trained, 92(87%) completed both pre- and post-test evaluations. Significant improvements were found in pre- versus post-test scores of knowledge, (20.0 [2.4 SD] vs. 24.1 [3.5 SD], p <.001) and BNI performance comparing pre- and post BNI adherence scale total scores, (5.14 [1.8 S.D.] vs. 11.5 [.96], p<.001). Residents reported high satisfaction with training, [1.4, SD .5, immediately and 1.6, SD .6, 30-days post training)with scores ranging from 1 to 5 with lower score=greater satisfaction. During the 12-month follow-up period, we received 83 responses from residents reporting a total of 129 BNIs in actual clinical settings. CONCLUSIONS: A screening, brief intervention and referral to treatment curriculum was successfully integrated into an adolescent medicine elective in a pediatric residency program. Residents demonstrated significant improvements in knowledge and skills performing the BNI, with high satisfaction and adoption of the BNI into clinical practice.


Subject(s)
Curriculum , Internship and Residency , Mass Screening , Pediatrics/education , Referral and Consultation , Substance-Related Disorders/therapy , Adolescent , Clinical Competence , Education, Medical, Graduate , Humans
16.
Subst Abus ; 33(3): 251-60, 2012.
Article in English | MEDLINE | ID: mdl-22738002

ABSTRACT

The objective of this study was to evaluate the integration of a screening, brief intervention, and referral to treatment (SBIRT) curriculum for alcohol and other drug use into a pediatric residency program. Pediatric and medicine/pediatric residents in an adolescent medicine rotation located in an urban teaching hospital participated in the study. Main outcome measures were pre- and post-training knowledge scores, performance of the Brief Negotiation Interview (BNI), training satisfaction, and adoption of the BNI into clinical practice. Thirty-four residents were trained. Significant pre- to post-training improvements were seen in knowledge scores (P < .001) and performance as measured by the BNI Adherence Scale (P < .001). Residents reported high satisfaction immediately post-training and at 30 days on a 1-5 Likert scale: mean 1.41 to 1.59 (1 = very satisfied) (P = 0.23). Over a 9-month period, 53% of residents documented performing at least 1 BNI, of which 2/3 reported ≥2 BNIs in a subsequent clinical setting. The results show that integrating a SBIRT curriculum into a pediatric residency program increases residents' knowledge and skills.


Subject(s)
Adolescent Behavior/psychology , Curriculum/standards , Internship and Residency/methods , Pediatrics/education , Psychotherapy, Brief/education , Referral and Consultation , Substance Abuse Detection , Adolescent , Adult , Clinical Competence , Female , Humans , Internship and Residency/standards , Male , Program Development
17.
Subst Abus ; 33(2): 168-81, 2012.
Article in English | MEDLINE | ID: mdl-22489589

ABSTRACT

The authors sought to evaluate the feasibility and acceptability of initiating a Screening, Brief Intervention, and Referral to Treatment (SBIRT) for alcohol and other drug use curriculum across multiple residency programs. SBIRT project faculty in the internal medicine (traditional, primary care internal medicine, medicine/pediatrics), psychiatry, obstetrics and gynecology, emergency medicine, and pediatrics programs were trained in performing and teaching SBIRT. The SBIRT project faculty trained the residents in their respective disciplines, accommodating discipline-specific implementation issues and developed a SBIRT training Web site. Post-training, residents were observed performing SBIRT with a standardized patient. Measurements included number of residents trained, performance of SBIRT in clinical practice, and training satisfaction. One hundred and ninety-nine residents were trained in SBIRT: 98 internal medicine, 35 psychiatry, 18 obstetrics and gynecology, 21 emergency medicine, and 27 pediatrics residents. To date, 338 self-reported SBIRT clinical encounters have occurred. Of the 196 satisfaction surveys completed, the mean satisfaction score for the training was 1.60 (1 = very satisfied to 5 = very dissatisfied). Standardized patient sessions with SBIRT project faculty supervision were the most positive aspect of the training and length of training was a noted weakness. Implementation of a graduate medical education SBIRT curriculum in a multispecialty format is feasible and acceptable. Future efforts focusing on evaluation of resident SBIRT performance and sustainability of SBIRT are needed.


Subject(s)
Alcoholism/diagnosis , Curriculum , Education, Medical, Graduate/methods , Internship and Residency/methods , Mass Screening/organization & administration , Substance-Related Disorders/diagnosis , Alcoholism/therapy , Feasibility Studies , Humans , Program Evaluation , Referral and Consultation , Substance-Related Disorders/prevention & control , United States , United States Substance Abuse and Mental Health Services Administration
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