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

Abstract

IntroductionThe 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).MethodsA 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 disseminationThe 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.

Interrupted Time Series of User‐centered Clinical Decision Support Implementation for Emergency Department–initiated Buprenorphine for Opioid Use Disorder

“…Given the additional burden of the consent process and to ensure the validity of the intervention's efficacy on changing routine care, clinician demographic information was not collected. 24,26 Therefore, all patient and physician identifiers were removed from EHR data by an honest broker and not shared with the investigative team. As a result of this deidentification process, it was not possible to match physician study data to our faculty roster to determine which physicians had an X-waiver to prescribe BUP.…”

“…This multisystem pragmatic trial will determine the effectiveness of the EMBED intervention on the adoption of ED-initiated BUP for OUD. 24…”

<p>Prescribing Buprenorphine for Opioid Use Disorders in the ED: A Review of Best Practices, Barriers, and Future Directions</p>

“…26 Among the research literature, there are variable inclusion and exclusion criteria for providing EDbased induction. Inclusion criteria have most often been a diagnosis of OUD, 13,19,[21][22][23]27 age over 16 21 or 18, 13,27 a positive urine test for opioids, 13 recent or multiple visits related to overdose, 23 intoxication, 23 or admission to an ED observation unit. 19 Exclusion criteria were pregnancy, 13,21,23,27 current enrollment in an OUD treatment program, 13,21,23,27 abuse of benzodiazepines or alcohol, 21,23 liver disease, 21 critically ill patients, 13 active suicidality, 13 police custody, 13 or an inability to communicate due to dementia or psychosis.…”

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

“…Full details of the study protocol are available in a May 2019 BMJ Open publication by Melnick et al [20].…”

“…To avoid patient identification based on date of ED service, all 5 healthcare systems were instructed to select a trial launch date within a two-week window. Enrollment with ongoing data collection, coordination, and management for the trial is underway per the trial protocol [20]. Data collection and submission will continue monthly for the duration of the trial over the next 18 months.…”