# EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder

> **NIH NIH UH3** · YALE UNIVERSITY · 2021 · $1,788,163

## Abstract

Project Summary
Opioid use disorder (OUD), dependence on prescription opioids and heroin, is a major public health problem
taking a devastating toll on Americans, their families, and their communities. Three million Americans have or
have had OUD. Opioid overdose deaths have quadrupled in the United Sates since 1999 (33,000 in 2015).
Buprenorphine/naloxone (BUP), a partial opioid agonist combined with an antagonist, is a well-established
outpatient treatment for OUD that can only be prescribed by appropriately trained physicians. Patients with
untreated OUD often seek medical care in emergency departments (EDs). ED-initiated BUP doubles the rate
of engagement in addiction treatment in ED patients with OUD. However, the practice of initiating BUP in the
ED has not been implemented into ED care. Poor health information technology (HIT) usability is a major
challenge to implementation of evidence-based medicine. To improve the HIT user experience and uptake of
evidence-based medicine, HIT interventions should be developed using user-centered design. We propose a
multicenter, pragmatic, stepped wedge implementation trial to evaluate the effect of user-centered
computerized clinical decision support (CDS) for ED patients with OUD upon rates of ED-initiated BUP and
referral for ongoing medication assisted treatment (MAT). The aims for the UG3 Planning Phase (Year 1) are:
(1) Develop a pragmatic, user-centered CDS for ED-initiated BUP and referral for MAT in ED patients with
OUD which will automatically identify and facilitate management of potentially eligible patients and (2)
Establish the infrastructure for the proposed trial. In the UH3 Phase (Years 2-5) we will execute the trial with
the specific aim to: Compare the effectiveness of user-centered CDS for BUP to usual care on outcomes in ED
patients with OUD. We will test the primary implementation hypothesis that rates of ED-initiated BUP are
higher with user-centered CDS. This trial will be pragmatic and offer advantages over more actively collected
and distal outcomes by: (1) evaluating the effects of an intervention under the usual conditions in which it will
be applied, (2) utilizing structured data from the EHR that can be passively collected, and (3) requiring no
specific expertise or training of clinicians. Formative process evaluation, incremental cost effectiveness, and
return on investment analyses will be performed to optimize the context for implementation of the user-
centered CDS into routine ED practice and to evaluate its value. Given BUP's dramatic effect on engagement
in treatment, this trial will answer the critical implementation question in OUD care: “What is the best way to
maximize the rate of adoption of ED-initiated BUP and referral to MAT?" Our findings will have immediate and
lasting impact upon individuals with OUD. Our collaborative network between Yale, the Mayo Clinic, and UNC
is poised to efficiently carry out a trial of this design and magnitude. The study will be s...

## Key facts

- **NIH application ID:** 10129328
- **Project number:** 5UH3DA047003-04
- **Recipient organization:** YALE UNIVERSITY
- **Principal Investigator:** Gail D'Onofrio
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,788,163
- **Award type:** 5
- **Project period:** 2018-04-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10129328

## Citation

> US National Institutes of Health, RePORTER application 10129328, EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder (5UH3DA047003-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10129328. Licensed CC0.

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