June 22, 2023: EMBED Team Documents Rise in Fentanyl-Associated Overdose Deaths

EMBED logoResearchers from EMBED, an NIH Pragmatic Trials Collaboratory Trials, found a sharp rise in out-of-hospital overdose deaths in the early years of the COVID-19 pandemic, attributable largely to increasing involvement of fentanyl.

The findings were published online ahead of print this week in the New England Journal of Medicine.

EMBED was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial evaluated a clinical decision support system for initiating buprenorphine in emergency department settings. Since completing the trial, the research team has pursued multiple health services research studies to describe the environment in which the EMBED clinical decision support tools are being implemented.

Using data from the National Center for Health Statistics from 2016 through 2021, the research team compared overdose deaths outside the hospital in the years before the COVID-19 pandemic to those in the early years of the pandemic. Out-of-hospital overdose deaths increased significantly during the early pandemic period and were driven primarily by deaths associated with fentanyl.

Read the full report.

EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.

May 22, 2023: EMBED Finds Racial and Ethnic Differences in Buprenorphine Initiation for Opioid Use Disorder

EMBED logoIn a secondary analysis from the EMBED pragmatic clinical trial, Black patients with opioid use disorder were less likely than White patients to be initiated on buprenorphine in the emergency department.

The study’s findings were published recently in Academic Emergency Medicine.

EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial evaluated a clinical decision support system for initiating buprenorphine in emergency department settings.

The racial disparity in buprenorphine initiation remained after adjustment for patient, clinician, and site characteristics. Even in emergency departments in academic hospitals, where rates of buprenorphine were higher overall, Black patients received proportionally less buprenorphine initiations than White patients. Hispanic patients were more likely to receive buprenorphine than non-Hispanic patients in both community and academic emergency departments. However, adjustment for discharge diagnosis attenuated the association between ethnicity and buprenorphine initiation.

“Attention should be focused on identifying continued disparities in [emergency department] treatment of opioid use disorder by race and ethnicity,” the authors concluded, “as well as the barriers and inequities that continue to limit patients’ ability to access the [emergency department] for treatment of opioid use disorder.”

EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.

Read the full report.

May 15, 2023: EMBED Offers Lessons for Intervention Adoption, Implementation, and Maintenance

EMBED logoOrganizational culture, clinician training and support, the ability to link patients to ongoing treatment, and the ability to tailor implementation to each clinical site were key determinants of successful implementation of an intervention to promote buprenorphine initiation in emergency departments, according to a qualitative study conducted as part of the EMBED pragmatic clinical trial.

The study’s findings were published recently in Implementation Science Communications.

EMBED, an NIH Collaboratory Trial, was a cluster randomized trial across 21 emergency departments in 5 healthcare systems in the United States. The trial tested the effectiveness of a clinical decision support tool integrated into the electronic health record in improving rates of buprenorphine initiation in the emergency department for the treatment of opioid use disorder. The intervention led to a modest increase in buprenorphine initiation and little impact on patient outcomes.

A secondary aim of the study was to identify determinants of adopting, implementing, and maintaining the clinical decision support tool at the trial sites. Among the key determinants were:

  • establishing buprenorphine initiation as a cultural norm within healthcare organizations;
  • organizational commitment to implementing and sustaining the intervention;
  • clinician training and support on opioid use disorder and buprenorphine initiation in emergency departments;
  • availability of referral resources to link patients who were initiated on buprenorphine in the emergency to ongoing treatment; and
  • the ability to tailor the intervention to clinic workflows that fit the resources and characteristics of the local clinic.

EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and received logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn about the other NIH Collaboratory Trials.

Read the full report.

July 18, 2022: New Article Offers Recommendations for Pragmatic Trials in Emergency Medicine

Dr. Edward Melnick, Co-PI of EMBED, and Dr. Corita Grudzen, PI of PRIM-ER
(From left) Dr. Edward Melnick, Co-PI of EMBED, and Dr. Corita Grudzen, PI of PRIM-ER

Investigators planning emergency department (ED)­–based pragmatic clinical trials (PCTs) face multiple decisions during the planning phase to ensure robust and meaningful study findings in this unique setting; however, there is no guide for planning and conducting these studies.

A new article in Academic Emergency Medicine fills the gap by providing recommendations for the design of PCTs in emergency settings. Among the authors are investigators from EMBED and PRIM-ER, both NIH Pragmatic Trials Collaboratory Trials.

The authors recommend that investigators planning ED-based PCTs should strongly consider the use of the PRECIS-2 wheel diagram during the study design phase to increase chances that the results of the trial are generalizable across the intended practice settings. The PRECIS tool was developed to help investigators work through study design decisions to avoid designing a trial that does not meet their own intentions.

The authors expand upon the 9 domains within the PRECIS-2 framework to identify points for investigators to consider in the design of ED-based PCTs, and they provide examples of successful studies. Using the PRECIS-2 framework can help investigators navigate unique challenges in the ED setting, including time-sensitive conditions, limited availability of electronic health data for the patient population, and added complexity surrounding capacity and consent for certain vulnerable ED populations with mental illness or substance use disorder.

The authors also address special considerations for randomization, human subjects concerns, and electronic health record integration.

Finally, the authors provide an analysis that highlights the advantages, disadvantages, and rationale for the use of 4 common randomized PCT study design types and examples of similar trials set in the ED.

Read the full text of the article.

July 14, 2022: Solving Unexpected Challenges in Pragmatic Trial Data Collection

Headshot of Dr. Keith MarsoloDuring the NIH Pragmatic Trials Collaboratory Steering Committee meeting and 10th anniversary celebration, Dr. Keith Marsolo, Co-chair of the Electronic Health Records Core, moderated a panel on “Barriers and Challenges: Data Collection and Merging Datasets.” Four panelists shared their experiences collecting and aggregating data from diverse data sets and how they solved unexpected challenges.

The panelists included Drs. Ted Melnick (EMBED), Holt Oliver (ICD-Pieces), Margaret Kuklinski (GGC4H), and Andrea Cheville (NOHARM).

During the discussion, panelists shared lessons learned from collecting electronic health record (EHR) data during large pragmatic clinical trials across multiple health systems. Common challenges included:

  • Privacy concerns and not having the ability to collect deidentified patient or clinician demographic information
  • Working across health systems that use different EHR platforms and collecting data consistently across sites
  • Turnover of IT staff at participating sites and changes in site data agencies during the study period
  • Updates to the EHR that affect study algorithms and other issues with algorithms not identifying data as expected
  • Overcoming technical barriers with practice workflows and integrating with IT systems

The panelists shared solutions and possible best practices for future studies, including the need for planning, coordinating, and testing before study launch, the importance of being able to pivot and change directions as problems arise, being open to alternative data collection methods such as surveys to augment findings, and having the right team at the right time to be responsive to problems, which for one study meant having informaticists and expert EHR builders embedded in the trial team.

Panelists identified two key policy and infrastructure changes that would help trials be successful in the future. These changes include development of a national unique patient identifier across health systems and incentivizing EHR vendors to find common ground to better support research.

The Electronic Health Records Core continues to learn from experiences of the program’s NIH Collaboratory Trials and shares emerging information, resources, and EHR-related recommendations to improve future pragmatic research.

View slides from the discussion panel.

Learn more

View video collection that highlights advances in Electronic Health Records for pragmatic research.

Watch the August 2021 Interview with Electronic Health Record Core leaders Drs. Rachel Richesson and Keith Marsolo

June 27, 2022: EMBED Publishes Results From Study of Buprenorphine Initiation in Emergency Departments

Headshots of Dr. Edward Melnick and Dr. Gail D'Onofrio
Dr. Ted Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED

Implementation of a user-centered clinical decision support tool did not increase the rate of patients receiving buprenorphine for treatment of opioid use disorder in the emergency department (ED) when compared to usual care.

When the tool was used, it was associated with high rates of buprenorphine initiation, and the tool increased the number of physicians who provided ED-initiated buprenorphine and naloxone prescriptions.

The findings of EMBED were published in the BMJ on June 27.

From November 2019 to May 2021, researchers conducted EMBED, an NIH Pragmatic Trials Collaboratory Trial, in 18 clusters across 5 healthcare systems in 5 states, representing the Northeast, Southeast, and Western regions of the United States.

The 18 clusters included 21 EDs, with 3 sites paired with a second ED within the same healthcare system due to low patient volume or high physician crossover rates between the 2 sites. Each cluster received either the intervention or maintained usual care.

The study sample was made up of all patient visits to the ED during the study period. Eligible patient encounters were identified using criteria in the electronic health record. For patients with multiple ED visits during the trial, only the first ED visit was included in the analysis.

ED attending physicians caring for patients who met the trial’s inclusion criteria were the primary study subjects, but all ED clinicians practicing at intervention sites had access to the EMBED tool for all patients in their care at that site. A total of 5,047 patients (2,787 intervention and 2,260 usual care) were eligible for analysis along with the 599 physicians who cared for them (340 intervention, 259 usual care).

The intervention did not affect the patient-level rate of ED-initiated buprenorphine (which was 12.5% in the intervention arm and 12.0% in the usual care arm). The proportion of physicians who initiated buprenorphine in the ED at least once was higher at intervention sites compared to usual care sites (44.4% vs 34.0%).

In the intervention arm, the EMBED tool was launched by physicians for 261 of 2,787 eligible patients. When the tool was launched, buprenorphine was ordered for 161 patients (67% of 261 encounters).

“We built tools that work within the electronic health record that make it easier for clinicians to treat patients with addiction, using medications that physicians may initially find complex and unfamiliar,” said Dr. Edward Melnick of Yale University, co–principal investigator of the study. “We’ve tried to make that easier for clinicians to allow this practice to be adopted into routine care.”

“EMBED offers a major opportunity to accelerate adoption by offering a simple, automated, rapid solution to initiating treatment and referral for people suffering from opioid use disorder,” said Dr. Gail D’Onofrio of Yale University, co–principal investigator of the study. “Additional prompts and interventions will be needed to increase more universal implementation into the routine care of ED patients with opioid use disorder.”

Watch Dr. Melnick discuss the EMBED project in this NIH Pragmatic Trials Collaboratory interview from April 2022.

EMBED was supported within the NIH Pragmatic Trials Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

January 28, 2022: EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder

Speaker

Edward R Melnick, MD, MHS
Associate Professor of Emergency Medicine, Yale School of Medicine
Associate Professor of Biostatistics (Health Informatics), Yale School of Public Health
Program Director, Yale-VA Clinical Informatics Fellowship Program

Gail D’Onofrio, MD, MS
Albert E. Kent Professor of Emergency Medicine
Yale School of Medicine
Professor of Public Health, Chronic Disease & Epidemiology
Yale School of Public Health

 

 

Keywords

EMBED; Opioid use disorder; Buprenorphine; EHR workflow

 

Key Points

  • The epidemic of opioid misuse continues to escalate with almost 70 thousand deaths attributed to prescription and illicit opioids in 2020.
  • Medications for opioid use disorder, including Buprenorphine, are available and can be prescribed to patients in the emergency department, but less than 30% of patients who are eligible for BUP receive the medication. Buprenorphine/naloxone (BUP) is safe, effective, decreases withdrawal, and decreases opioid overdose events.
  • EMBED was started to address the barriers and promote the facilitators to initiating BUP in the emergency department. Common barriers included complex protocols, knowledge gaps, and poor usability of health IT systems. Promoting a proper learning tool was a helpful facilitator for initiating BUP.
  • EMBED was an 18-month pragmatic, parallel, group randomized trial conducted in 18 emergency department clusters in 5 healthcare systems.
  • EMBED created a user centered design to simplify the clinician’s role in initiating BUP to an automatic 5-minute process that included diagnosing opioid use disorder, assessing withdrawal severity, motivating patients to accept treatment, and an automatic EHR workflow for prescribing and referral.
  • EMBED increased Naloxone prescriptions at discharge for intervention patients (18.6%) compared with control patients (6.0%). Of the patients eligible, BUP was initiated using EMBED for 42.5%. Physicians in the intervention group initiated BUP (39.7%) and prescribed naloxone (52.1%) at a higher rate than physicians in the control group (initiated BUP 30.1%; prescribed naloxone, 27.4%).
  • EMBED increased provider adoption of complex, unfamiliar evidence-based practices in the emergency department. EMBED can help improve consistency and quality of care for patients with opioid use disorder.

Discussion Themes

– Gentle nudges to encourage clinicians to use the health IT, may increase use. Incentives to use the health IT may also lead to greater use.

– The explosion of health information, especially with regard to emergency department care, has increased acceptance of the use of health IT pathways that give the most updated evidence for care.

 

Learn more about the EMBED project and read about the findings from EMBED.

Tags

#pctGR, @Collaboratory1

January 26, 2022: PCT Grand Rounds to Highlight Primary Results of EMBED Trial

Headshots of Dr. Edward Melnick and Dr. Gail D'Onofrio
Dr. Edward Melnick and Dr. Gail D’Onofrio, co–principal investigators of EMBED

In this Friday’s PCT Grand Rounds, the principal investigators of EMBED, an NIH Collaboratory Trial, will announce the study’s primary results.

Co–principal investigators Dr. Edward Melnick and Dr. Gail D’Onofrio of Yale University will present “EMBED Trial Results: Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder.” The Grand Rounds session will be held on Friday, January 28, at 1:00 pm eastern.

EMBED is a pragmatic trial to evaluate the effect of user-centered computerized clinical decision support on rates of emergency department–initiated buprenorphine and referral for ongoing medication-assisted treatment for patients with opioid use disorder.

Join the online meeting.

EMBED is supported within the NIH Collaboratory by the NIH Common Fund and by a cooperative agreement from the National Institute on Drug Abuse.

December 14, 2021: A Year of New Insights From the NIH Collaboratory

Collage of journal coversNIH Collaboratory researchers in 2021 shared study results, generated new knowledge, and developed innovative research methods in pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups, analyses from the NIH Collaboratory Distributed Research Network, and results and methodological approaches from the NIH Collaboratory Trials.

So far this year, the NIH Collaboratory has produced 3 dozen articles in the peer-reviewed literature, including the primary results of the PPACT and TSOS trials, the study design of the Nudge and OPTIMUM studies, insights into the COVID-19 pandemic from the EMBED and ACP PEACE studies, and more:

NIH Collaboratory Coordinating Center

NIH Collaboratory Distributed Research Network

ACP PEACE NIH Collaboratory Trial

BackInAction NIH Collaboratory Trial

EMBED NIH Collaboratory Trial

GRACE NIH Collaboratory Trial

HiLo NIH Collaboratory Trial

LIRE NIH Collaboratory Trial

Nudge NIH Collaboratory Trial

OPTIMUM NIH Collaboratory Trial

PPACT NIH Collaboratory Trial

PRIM-ER NIH Collaboratory Trial

PROVEN NIH Collaboratory Trial

SPOT NIH Collaboratory Trial

TSOS NIH Collaboratory Trials

March 23, 2021: EMBED Team Reports Widespread Worsening of the Opioid Epidemic in 2020

In an analysis of data collected as part of EMBED, an NIH Collaboratory Demonstration Project, the rate of opioid overdose visits per 100 all-cause visits to emergency departments rose nearly 30% in 2020. The absolute number of opioid overdose visits increased by more than 10%, even while visits for other life-threatening conditions declined. The findings provide insight into the widespread worsening of the opioid epidemic during the COVID-19 pandemic in the United States.

The paper was published ahead of print this month in the Annals of Emergency Medicine.

The study accessed data from 25 emergency departments in Alabama, Colorado, Connecticut, Massachusetts, North Carolina, and Rhode Island. Five of the 6 healthcare systems in the study are participating in EMBED, a pragmatic trial of prescribing practices for opioid use disorder in emergency departments. An amended study protocol enabled the researchers to collect the data as part of an effort to better understand the impact of the COVID-19 pandemic on trial enrollment.

EMBED is supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse and receives logistical and technical support from the NIH Collaboratory Coordinating Center. Read more about EMBED in the Living Textbook, and learn more about the NIH Collaboratory Demonstration Projects.

For more news and resources related to the COVID-19 public health emergency, see our COVID-19 Resources page.