Dataset Information

Implementation facilitation to introduce and support emergency department-initiated buprenorphine for opioid use disorder in high need, low resource settings: protocol for multi-site implementation-feasibility study

ABSTRACT:

Background

For many reasons, the emergency department (ED) is a critical venue to initiate OUD interventions. The prevailing culture of the ED has been that substance use disorders are non-emergent conditions better addressed outside the ED where resources are less constrained. This study, its rapid funding mechanism, and accelerated timeline originated out of the urgent need to learn whether ED-initiated buprenorphine (BUP) with referral for treatment of OUD is generalizable, as well as to develop strategies to facilitate its adoption across a variety of ED settings and under real-world conditions. It both complements and uses methods adapted from Project ED Health (CTN-0069), a Hybrid Type 3 implementation-effectiveness study of using Implementation Facilitation (IF) to integrate ED-initiated BUP and referral programs.

Methods

ED-CONNECT (CTN 0079) was a three-site implementation study exploring the feasibility, acceptability, and impact of introducing ED-initiated BUP in rural and urban settings with high-need, limited resources, and different staffing structures. We used a multi-faceted approach to develop, introduce and iteratively refine site-specific ED clinical protocols and implementation plans for opioid use disorder (OUD) screening, ED-initiated BUP, and referral for treatment. We employed a participatory action research approach and use mixed methods incorporating data derived from abstraction of medical records and administrative data, assessments of recruited ED patient-participants, and both qualitative and quantitative inquiry involving staff from the ED and community, patients, and other stakeholders.

Discussion

This study was designed to provide the necessary, time-sensitive understanding of how to identify OUD and initiate treatment with BUP in the EDs previously not providing ED-initiated BUP, in communities in which this intervention is most needed: high need, low resource settings. Trial registration: The study was prospectively registered on ClinicalTrials.gov (NCT03544112) on June 01, 2018: https://clinicaltrials.gov/ct2/show/NCT03544112.

SUBMITTER: McCormack R

PROVIDER: S-EPMC7941881 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceEmergency department (ED)-initiated buprenorphine for the treatment of opioid use disorder (OUD) is underused.ObjectiveTo evaluate whether provision of ED-initiated buprenorphine with referral for OUD increased after implementation facilitation (IF), an educational and implementation strategy.Design, setting, and participantsThis 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.ExposureA 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 measuresThe 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.ResultsA 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 relevanceIn 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 registrationClinicalTrials.gov Identifier: NCT03023930.

Project description:BackgroundPatients 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.MethodsThis 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.DiscussionResults will generate novel information regarding the impact of IF as a strategy to promote ED-initiated buprenorphine.Trial registrationClinicalTrials.gov NCT03023930 first posted 1/10/2017, https://clinicaltrials.gov/ct2/show/NCT03023930?term=0069&rank=1.

Project description:ObjectivesAdoption of emergency department (ED) initiation of buprenorphine (BUP) for opioid use disorder (OUD) into routine emergency care has been slow, partly due to clinicians' unfamiliarity with this practice and perceptions that it is complicated and time-consuming. To address these barriers and guide emergency clinicians through the process of BUP initiation, we implemented a user-centered computerized clinical decision support system (CDS). This study was conducted to assess the feasibility of implementation and to evaluate the preliminary efficacy of the intervention to increase the rate of ED-initiated BUP.MethodsAn interrupted time series study was conducted in an urban, academic ED from April 2018 to February 2019 (preimplementation phase), March 2019 to August 2019 (implementation phase), and September 2019 to December 2019 (maintenance phase) to study the effect of the intervention on adult ED patients identified by a validated electronic health record (EHR)-based computable phenotype consisting of structured data consistent with potential cases of OUD who would benefit from BUP treatment. The intervention offers flexible CDS for identification of OUD, assessment of opioid withdrawal, and motivation of readiness to start treatment and automates EHR activities related to ED initiation of BUP (including documentation, orders, prescribing, and referral). The primary outcome was the rate of ED-initiated BUP. Secondary outcomes were launch of the intervention, prescription for naloxone at ED discharge, and referral for ongoing addiction treatment.ResultsOf the 141,041 unique patients presenting to the ED over the preimplementation and implementation phases (i.e., the phases used in primary analysis), 906 (574 preimplementation and 332 implementation) met OUD phenotype and inclusion criteria. The rate of BUP initiation increased from 3.5% (20/574) in the preimplementation phase to 6.6% (22/332) in the implementation phase (p = 0.03). After the temporal trend of the number of physician's with X-waiver training and other covariates were adjusted for, the relative risk of BUP initiation rate was 2.73 (95% confidence interval [CI] = 0.62 to 12.0, p = 0.18). Similarly, the number of unique attendings who initiated BUP increased modestly 7/53 (13.0%) to 13/57 (22.8%, p = 0.10) after offering just-in-time training during the implementation period. The rate of naloxone prescribed at discharge also increased (6.5% preimplementation and 11.5% implementation; p < 0.01). The intervention received a system usability scale score of 82.0 (95% CI = 76.7 to 87.2).ConclusionImplementation of user-centered CDS at a single ED was feasible, acceptable, and associated with increased rates of ED-initiated BUP and naloxone prescribing in patients with OUD and a doubling of the number of unique physicians adopting the practice. We have implemented this intervention across several health systems in an ongoing trial to assess its effectiveness, scalability, and generalizability.

Project description:ImportanceAn 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.ObjectiveTo explore perspectives and experiences regarding ED-initiated buprenorphine among community-based clinicians and staff in geographically distinct regions.Design, setting, and participantsThis 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 measuresData 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.ResultsA 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 relevanceIn 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.

Project description:IMPORTANCE:Opioid-dependent patients often use the emergency department (ED) for medical care. OBJECTIVE:To test the efficacy of 3 interventions for opioid dependence: (1) screening and referral to treatment (referral); (2) screening, brief intervention, and facilitated referral to community-based treatment services (brief intervention); and (3) screening, brief intervention, ED-initiated treatment with buprenorphine/naloxone, and referral to primary care for 10-week follow-up (buprenorphine). DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial involving 329 opioid-dependent patients who were treated at an urban teaching hospital ED from April 7, 2009, through June 25, 2013. INTERVENTIONS:After screening, 104 patients were randomized to the referral group, 111 to the brief intervention group, and 114 to the buprenorphine treatment group. MAIN OUTCOMES AND MEASURES:Enrollment in and receiving addiction treatment 30 days after randomization was the primary outcome. Self-reported days of illicit opioid use, urine testing for illicit opioids, human immunodeficiency virus (HIV) risk, and use of addiction treatment services were the secondary outcomes. RESULTS:Seventy-eight percent of patients in the buprenorphine group (89 of 114 [95% CI, 70%-85%]) vs 37% in the referral group (38 of 102 [95% CI, 28%-47%]) and 45% in the brief intervention group (50 of 111 [95% CI, 36%-54%]) were engaged in addiction treatment on the 30th day after randomization (P?<?.001). The buprenorphine group reduced the number of days of illicit opioid use per week from 5.4 days (95% CI, 5.1-5.7) to 0.9 days (95% CI, 0.5-1.3) vs a reduction from 5.4 days (95% CI, 5.1-5.7) to 2.3 days (95% CI, 1.7-3.0) in the referral group and from 5.6 days (95% CI, 5.3-5.9) to 2.4 days (95% CI, 1.8-3.0) in the brief intervention group (P?<?.001 for both time and intervention effects; P?=?.02 for the interaction effect). The rates of urine samples that tested negative for opioids did not differ statistically across groups, with 53.8% (95% CI, 42%-65%) in the referral group, 42.9% (95% CI, 31%-55%) in the brief intervention group, and 57.6% (95% CI, 47%-68%) in the buprenorphine group (P?=?.17). There were no statistically significant differences in HIV risk across groups (P?=?.66). Eleven percent of patients in the buprenorphine group (95% CI, 6%-19%) used inpatient addiction treatment services, whereas 37% in the referral group (95% CI, 27%-48%) and 35% in the brief intervention group (95% CI, 25%-37%) used inpatient addiction treatment services (P?<?.001). CONCLUSIONS AND RELEVANCE:Among opioid-dependent patients, ED-initiated buprenorphine treatment vs brief intervention and referral significantly increased engagement in addiction treatment, reduced self-reported illicit opioid use, and decreased use of inpatient addiction treatment services but did not significantly decrease the rates of urine samples that tested positive for opioids or of HIV risk. These findings require replication in other centers before widespread adoption. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00913770.

Project description: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.

Project description:ImportanceEmergency department (ED) initiation of buprenorphine is safe and effective but underutilized in practice. Understanding the factors affecting adoption of this practice could inform more effective interventions.ObjectiveTo quantify the factors, including social contagion, associated with the adoption of the practice of ED initiation of buprenorphine for patients with opioid use disorder.Design, setting, and participantsThis is a secondary analysis of the EMBED (Emergency Department-Initiated Buprenorphine For Opioid Use Disorder) trial, a multicentered, cluster randomized trial of a clinical decision support intervention targeting ED initiation of buprenorphine. The trial occurred from November 2019 to May 2021. The study was conducted at ED clusters across health care systems from the northeast, southeast, and western regions of the US and included attending physicians, resident physicians, and advanced practice practitioners. Data analysis was performed from August 2022 to June 2023.ExposuresThis analysis included both the intervention and nonintervention groups of the EMBED trial. Graph methods were used to construct the network of clinicians who shared in the care of patients for whom buprenorphine was initiated during the trial before initiating the practice themselves, termed exposure.Main outcomes and measuresCox proportional hazard modeling with time-dependent covariates was performed to assess the association of the number of these exposures with self-adoption of the practice of ED initiation of buprenorphine while adjusting for clinician role, health care system, and intervention site status.ResultsA total of 1026 unique clinicians in 18 ED clusters across 5 health care systems were included. Analysis showed associations of the cumulative number of exposures to others initiating buprenorphine with the self-practice of buprenorphine initiation. This increased in a dose-dependent manner (1 exposure: hazard ratio [HR], 1.31; 95% CI, 1.16-1.48; 5 exposures: HR, 2.85; 95% CI, 1.66-4.89; 10 exposures: HR, 3.55; 95% CI, 1.47-8.58). Intervention site status was associated with practice adoption (HR, 1.50; 95% CI, 1.04-2.18). Health care system and clinician role were also associated with practice adoption.Conclusions and relevanceIn this secondary analysis of a multicenter, cluster randomized trial of a clinical decision support tool for buprenorphine initiation, the number of exposures to ED initiation of buprenorphine and the trial intervention were associated with uptake of ED initiation of buprenorphine. Although systems-level approaches are necessary to increase the rate of buprenorphine initiation, individual clinicians may change practice of those around them.Trial registrationClinicalTrials.gov Identifier: NCT03658642.

Project description:Study objectiveThere is strong evidence supporting emergency department (ED)-initiated buprenorphine for opioid use disorder, but less is known about how to implement this practice. Our aim was to describe implementation, maintenance, and provider adoption of a multicomponent strategy for opioid use disorder treatment in 3 urban, academic EDs.MethodsWe conducted a retrospective analysis of electronic health record data for adult patients with opioid use disorder-related visits before (March 2017 to November 2018) and after (December 2018 to July 2020) implementation. We describe patient characteristics, clinical treatment, and process measures over time and conducted an interrupted time series analysis using a patient-level multivariable logistic regression model to assess the association of the interventions with buprenorphine use and other outcomes. Finally, we report provider-level variation in prescribing after implementation.ResultsThere were 2,665 opioid use disorder-related visits during the study period: 28% for overdose, 8% for withdrawal, and 64% for other conditions. Thirteen percent of patients received medications for opioid use disorder during or after their ED visit overall. Following intervention implementation, there were sustained increases in treatment and process measures, with a net increase in total buprenorphine of 20% in the postperiod (95% confidence interval 16% to 23%). In the adjusted patient-level model, there was an immediate increase in the probability of buprenorphine treatment of 24.5% (95% confidence interval 12.1% to 37.0%) with intervention implementation. Seventy percent of providers wrote at least 1 buprenorphine prescription, but provider-level buprenorphine prescribing ranged from 0% to 61% of opioid use disorder-related encounters.ConclusionA combination of strategies to increase ED-initiated opioid use disorder treatment was associated with sustained increases in treatment and process measures. However, adoption varied widely among providers, suggesting that additional strategies are needed for broader uptake.