UH3 Project: Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED)
Overview
Principal Investigators:
Sponsoring Institution: Yale University
Collaborators:
- University of North Carolina at Chapel Hill
- University of Alabama at Birmingham
- University of Colorado Denver
- UMass Chan Medical School-Baystate
NIH Institute Providing Oversight: National Institute on Drug Abuse (NIDA)
Program Official: Sarah Duffy, PhD (NIDA)
Project Scientist: Shelley Su, PhD (NIDA)
ClinicalTrials.gov Identifier: NCT03658642
Trial Status: Enrollment completed
Trial Summary
Study question and significance: Patients with untreated opioid use disorder often seek medical care in emergency departments (EDs). ED-initiated buprenorphine doubles the rate of engagement in addiction treatment by these patients. However, the practice of initiating buprenorphine in the ED has not been implemented into ED care. One major challenge for implementing evidence-based medicine has been the poor usability of health information technology. User-centered design of health information technology interventions can improve the user experience and the uptake of evidence-based medical care.
Design and setting: Pragmatic cluster randomized controlled trial with 599 attending emergency physicians caring for 5047 adult patients who presented with opioid use disorder in 18 ED clusters across 5 healthcare systems in 5 states between November 2019 and May 2021.
Intervention and methods: The study seamlessly integrated a user-centered, physician-facing clinical decision support system into user workflows in the electronic health record (EHR) to support initiation of buprenorphine in the ED. The system was designed to help clinicians diagnose opioid use disorder, assess withdrawal severity, motivate patients to accept treatment, and complete EHR tasks by automating clinical and after-visit documentation, order entry, prescribing, and referral. The primary study outcome was the rate of buprenorphine administration or prescription in the ED among patients with opioid use disorder. Secondary implementation outcomes were measured using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework.
Findings: Assessment of 1,413,693 ED visits for study eligibility identified 5047 patients with opioid use disorder (2787 in the intervention arm, 2260 in the usual care arm) under the care of 599 attending physicians (340 in the intervention arm, 259 in the usual care arm) for analysis. Buprenorphine was initiated in 347 patients (12.5%) in the intervention arm and 271 patients (12.0%) in the usual care arm (odds ratio [OR] from adjusted generalized estimating equations, 1.22; 95% CI, 0.61-2.43; P = .58). Buprenorphine was initiated at least once by 151 physicians (44.4%) in the intervention arm and 88 physicians (34.0%) in the usual care arm (OR, 1.83; 95% CI, 1.16-2.89; P = .01).
Conclusions and relevance: Although user-centered clinical decision support did not increase patient-level rates of buprenorphine initiation in the ED, when used, EMBED was associated with high rates of initiation of buprenorphine. EMBED also increased the number of unique physicians who provided initiation of buprenorphine in the ED and prescribed naloxone. Clinical decision support that streamlines and automates electronic workflows can increase physician adoption of complex, unfamiliar evidence-based practices. More interventions are needed to examine other barriers to the treatment of addiction at the patient level in the ED for patients with opioid use disorder.
Data and Resource Sharing
- EMBED Data Submission Specs
EMBED Data Submission Specs
- EMBED Data Dictionary
EMBED Data Dictionary
- EMBED SAS Code
EMBED SAS Code
- EMBED-2019-UH3 Follow-up
EMBED-Ethics and Regulatory UH3 Follow-up
- EMBED Ethics and Regulatory Discussion
EMBED Ethics and Regulatory Discussion
Featured Interviews
Dr. Melnick discusses the EMBED NIH Collaboratory Trial.
News and Interviews
- News_A Year of New Insights From the NIH Pragmatic Trials Collaboratory
December 12, 2023: A Year of New Insights From the NIH Pragmatic Trials Collaboratory
- News_EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder
May 22, 2023: EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder
- News_EMBED Offers Lessons for Intervention Implementation
May 15, 2023: EMBED Offers Lessons for Intervention Adoption, Implementation, and Maintenance
- News_Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
December 13, 2022: In Our Tenth Year, a Wealth of New Insights From the NIH Pragmatic Trials Collaboratory
- Video_Update on the EMBED Demonstration Project
Video Interview: Update on the EMBED NIH Collaboratory Trial
- News_Pragmatic Trials in Emergency Medicine
July 18, 2022: New Article Offers Recommendations for Pragmatic Trials in Emergency Medicine
- News_EMBED Publishes Results
June 27, 2022: EMBED Publishes Results From Study of Buprenorphine Initiation in Emergency Departments
- News_A Year of New Insights From the NIH Collaboratory
December 14, 2021: A Year of New Insights From the NIH Collaboratory
- News_EMBED team findinings
March 23, 2021: EMBED Team Reports Widespread Worsening of the Opioid Epidemic in 2020
- News_A Year of Results and New Insights From the NIH Collaboratory
December 15, 2020: A Year of Results and New Insights From the NIH Collaboratory
Publications
- Sangal et al Mayo Clin Proc 2023
Clinical decision support: moving beyond interruptive "pop-up" alerts
- Jeffery et al N Engl J Med 2023
Fentanyl-associated overdose deaths outside the hospital
- Holland et al Acad Emerg Med 2023
Racial and ethnic disparities in emergency department-initiated buprenorphine across five health care systems
- Simpson et al Implement Sci Commun 2023
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
- Samuels and Doran Ann Emerg Med 2022
Moving upstream: a social emergency medicine approach to opioid use disorder
- EMBED Study Snapshot
EMBED Study Snapshot
- Stevens et al JAMA Netw Open 2022
Trends and disparities in access to buprenorphine treatment following an opioid-related emergency department visit among an insured cohort, 2014-2020
- Gettel et al Acad Emerg Med 2022
Pragmatic clinical trial design in emergency medicine: study considerations and design types
- Melnick et al BMJ 2022
EMBED Main Outcome Paper
- Melnick et al J Am Med Inform Assoc 2021
The association between perceived electronic health record usability and professional burnout among US nurses
- Richesson et al J Am Med Inform Assoc 2021
Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory
- Soares et al Ann Emerg Med 2021
Emergency department visits for nonfatal opioid overdose during the COVID-19 pandemic across 6 US healthcare systems
- Melnick et al J Med Internet Res 2020
Perceived electronic health record usability as a predictor of task load and burnout among US physicians: mediation analysis
- Melnick et al JAMA Netw Open 2020
Association of perceived electronic health record usability with patient interactions and work-life integration among US physicians
- Li et al Int J Epidemiol 2020
Commentary: Right truncation in cluster randomized trials can attenuate the power of a marginal analysis
- Jeffery et al JAMA Intern Med 2020
Trends in emergency department visits and hospital admissions in health care systems in 5 states in the first months of the COVID-19 pandemic in the US
- Li et al Stat Methods Med Res 2020
Mixed-effects models for the design and analysis of stepped wedge cluster randomized trials: an overview
- Living Textbook Chapter_Clinical Decision Support
Living Textbook Chapter: Clinical Decision Support
- Living Textbook_The Embedded Pragmatic Trials Ecosystem
Living Textbook: The Embedded Pragmatic Clinical Trial Ecosystem
- Holland et al Acad Emerg Med 2020
Interrupted time series of user-centered clinical decision support implementation for emergency department-initiated buprenorphine for opioid use disorder
- Melnick et al J Psychiatr Brain Sci
Progress report on EMBED: a Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder
- Li Stat Med 2020
Design and analysis considerations for cohort stepped wedge cluster randomized trials with a decay correlation structure
- EMBED-Study Snapshot-2019
EMBED Study Snapshot
- Chartash et al JMIR Med Inform 2019
Identifying opioid use disorder in the emergency department: multi-system electronic health record–based computable phenotype derivation and validation study
- Melnick et al JAMIA Open 2019
An integrated web application for decision support and automation of EHR workflow: a case study of current challenges to standards-based messaging and scalability from the EMBED trial
- Ahmed et al J Subst Abuse Treat 2019
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
- Melnick et al BMJ Open 2019
EMBED Study Design Paper
- Ray et al JMIR Hum Factors 2019
Computerized clinical decision support system for emergency department–initiated buprenorphine for opioid use disorder: user-centered design
Presentations
- Alabama ACEP_EMBED
Buprenorphine and Chronic Opioid Patients’ Health Services Utilization during the COVID-19 Pandemic
- National Trends_Academy Health_05Jun2022
National Trends and Disparities in Timely Buprenorphine Treatment Following an Opioid-Related Emergency Department Visit Among Commercial and Medicare Advantage Enrollees, 2014 to 2020
- Wesley Holland NERDS22 Presentation 11May2022
Observed Disparities in ED Initiated Buprenorphine Across 5 Healthcare Systems From the EMBED Pragmatic Trial
- NERDS22_SAEM New England Regional Meeting_Holland
Racial and Ethnic Disparities in Emergency Department-Initiated Buprenorphine Across Five Healthcare Systems
- ACEP21 Scientific Assembly_Melnick
Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder
- GR-Video-01-28-22
EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (GR Video 2022)
- GR-Slides-01-28-22
EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (GR Slides 2022)
- 2022 NIH Workshop_D’Onofrio
2022 NIH Workshop: EMBED Presentation
- SC-Mtg-2022-Day-2-Melnick-Unanticipated-Challenges
EMBED Unanticipated Challenges Presentation at 2022 Steering Committee Meeting
- SC-Mtg-2022-Day-2-Melnick
EMBED Presentation at 2022 Steering Committee Meeting
- The Opioid Crisis (Keynote 2020)
The Opioid Crisis (Keynote 2020
- Poster_EMBED_AMIA_2020_c
Interrupted Time Series of User-Centered CDS Implementation for ED-Initiated Buprenorphine for Opioid Use Disorder (AMIA 2020)
- GR-Video-12-13-19
EMBED Update: Challenges and Solutions (GR Video 2019)
- Presentation_EMBED_AMIA_2019_c
A Pragmatic Multi-system Opioid Use Disorder Computable Phenotype for the ED (AMIA 2019)
- Presentation_EMBED_SAEM_2019_c
Requirements for an Automated Warm Handoff from the ED to Opioid Treatment Centers (SAEM 2019)
- Poster_EMBED_SAEM_2019_c
EMR Phenotyping Accurately Identifies Opioid Use Disorder in the ED (SAEM 2019)
- Workshop Design and Analysis of PCT_Panel 3_Choosing a Parallel Group or Stepped-Wedge Design
Workshop Design and Analysis of PCT: Panel 3: Choosing a Parallel Group or Stepped-Wedge Design
- SC-2019-UG3-EMBED
UG3 Updates at the 2019 SC Meeting-EMBED
- Poster_EMBED_SEAM_2019_2_c
Formative Evaluation for ED-initiated Buprenorphine User-Centered Decision Support (SAEM 2019)
- GR-Slides-12-13-19
EMBED Update: Challenges and Solutions (GR Slides 2019)
- Presentation_EMBED_Webinar_2019_c
Developing an ED-Initiated Buprenorphine Program (Webinar 2019)
- GR-Slides-11-02-18
EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (GR Slides 2018)
- GR-Video-11-02-18
EMBED: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (GR Video 2018)
- 2.-Melnick_15min_FINAL_revised
Discussion from New UG3 EMBED for NIH Collaboratory Steering Committee Meeting
- 11.-Melnick_5min_FINAL_updated
Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opiod Use Disorder (EMBED) Overview