NCT03658642: EMBED

Clinical Decision Support to Implement ED-initiated Buprenorphine for OUD

Completed NA Results posted Last updated 28 June 2022

What this trial tests

NA trial testing Clinical Decision Support (CDS) in Clinical Decision Support in 5,047 participants. Completed in 15 September 2021.

Timeline

15 November 2019

Primary endpoint
14 May 2021

15 September 2021

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	5,047
Start date	15 November 2019
Primary completion	14 May 2021
Estimated completion	15 September 2021
Sites	22 locations across United States

Drugs / interventions tested

• Clinical Decision Support (CDS)

Conditions studied

• Clinical Decision Support — all drugs for Clinical Decision Support →
• Buprenorphine — all drugs for Buprenorphine →
• Opioid-use Disorder — all drugs for Opioid-use Disorder →

Sponsor

Yale University

Who can join

18 and older, any sex, with Clinical Decision Support or Buprenorphine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Count of Initiating BUP in the ED With Referral for Ongoing MOUD With User-centered CDS Compared With Usual Care Primary · Upon discharge (Up to 1 day)

The primary outcome will be Buprenorphine (BUP) initiation in the Emergency Department (ED), defined as whether or not an eligible patient is administered BUP in the ED and/or prescribed BUP upon discharge from the ED. Although this is not a patient-centered outcome, it is a pragmatic and meaningful surrogate that will serve as a lead indicator of the CDS intervention's effect on engaging more OUD patients in treatment. Medications for Opioid Use Disorder (MOUD)

Group	Value	95% CI
Clinical Decision Support for BUP	347
Usual Care	271

Count of Those With Referral to Follow-up for Ongoing MOUD Treatment (Patient Level) Secondary · Upon discharge (Up to 1 day)

The count of enrolled patients who receive an Medication Assisted Therapy (MAT) appointment. Medications for Opioid Use Disorder (MOUD)

Group	Value	95% CI
Clinical Decision Support for BUP	367
Usual Care	226

Number of Clinicians Providing ED-initiated BUP Secondary · 18 months

Number of clinicians providing ED-initiated BUP regardless of CDS

Group	Value	95% CI
Clinical Decision Support for BUP	151
Usual Care	88

Number of Clinicians Providing Referral of Any Ongoing MOUD Treatment Secondary · 18 months

Number of clinicians that refer patients with OUD regardless of CDS

Group	Value	95% CI
Clinical Decision Support for BUP	141
Usual Care	100

Number of Clinicians Who Have Received Drug Addiction Treatment Act (DATA) of 2000 Training Secondary · 18 months

Number of clinicians that obtained DATA waiver

Group	Value	95% CI
Clinical Decision Support for BUP	50
Usual Care	30

Sponsor's own description

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) represents a potential approach to accelerate adoption of this best practice into routine emergency care. The goal of this trial is to determine whether implementation of a user-centered clinical decision support (CDS) system can increase adoption of initiation of BUP into the routine emergency care of individuals with OUD.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Emergency Department Visits for Nonfatal Opioid Overdose During the COVID-19 Pandemic Across Six US Health Care Systems.
   Soares WE, Melnick ER, Nath B, D'Onofrio G, et al · · 2022 · cited 106× · PMID 34119326 · DOI 10.1016/j.annemergmed.2021.03.013
2. Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory.
   Richesson RL, Marsolo KS, Douthit BJ, Staman K, et al · · 2021 · cited 41× · PMID 34597383 · DOI 10.1093/jamia/ocab202
3. User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial.
   Melnick ER, Nath B, Dziura JD, Casey MF, et al · · 2022 · cited 39× · PMID 35760423 · DOI 10.1136/bmj-2021-069271
4. User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial.
   Melnick ER, Jeffery MM, Dziura JD, Mao JA, et al · · 2019 · cited 31× · PMID 31152039 · DOI 10.1136/bmjopen-2018-028488
5. The impact of COVID-19 on pragmatic clinical trials: lessons learned from the NIH Health Care Systems Research Collaboratory.
   O'Brien EC, Sugarman J, Weinfurt KP, Larson EB, et al · · 2022 · cited 9× · PMID 35597988 · DOI 10.1186/s13063-022-06385-8
6. Progress Report on EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder.
   Melnick ER, Nath B, Ahmed OM, Brandt C, et al · · 2020 · cited 9× · PMID 32309637 · DOI 10.20900/jpbs.20200003
7. Implementation strategies to address the determinants of adoption, implementation, and maintenance of a clinical decision support tool for emergency department buprenorphine initiation: a qualitative study.
   Simpson MJ, Ritger C, Hoppe JA, Holland WC, et al · · 2023 · cited 6× · PMID 37081581 · DOI 10.1186/s43058-023-00421-7
8. Monitoring in pragmatic trials lessons from the NIH pragmatic trials collaboratory.
   Curtis LH, Morain S, O'Rourke PP, Staman K, et al · · 2025 · cited 2× · PMID 40015598 · DOI 10.1016/j.cct.2025.107866