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

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.

Keywords: change management; health informatics; quality in health care; substance misuse.

Figure 1

Schematic diagram of parallel, cluster randomised study design.

Figure 2

Clinical algorithm for ED initiation of buprenorphine. ED, emergency department; SL, sublingual.

Figure 3

Graphical user interface of the user-centred CDS EMBED intervention. CDS, clinical decision support; COWS, Clinical Opiate Withdrawal Scale; ED, emergency department; EMBED, Emergency Department-Initiated Buprenorphine for Opioid Use Disorder; OUD, opioid use disorder.

Figure 4

Number of study sites required as a function of coefficient of variation for site size assuming an ICC of 0.03. ICC, intraclass correlation coefficient.