Progress Report on EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder.

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.

A scalable, automated warm handoff from the emergency department to community sites offering continued medication for opioid use disorder: Lessons learned from the EMBED trial stakeholders.

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.

User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial.

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.