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

October 21, 2021: NIH Collaboratory Launches IMPACt-LBP NIH Collaboratory Trial

IMPACt-LBP investigatorsThe NIH Collaboratory is excited to announce the addition of a new large-scale pragmatic clinical trial to its portfolio: Implementation of the American College of Physicians Guideline for Low Back Pain (IMPACt‑LBP). Co-led by investigators at the Duke Clinical Research Institute, IMPACt-LBP is a pragmatic, multisite, 2-arm cluster randomized trial that will evaluate the effect of a multidisciplinary collaborative team approach for low back pain (LBP) versus usual care. In the intervention arm, patients with a primary complaint of LBP will be referred to physical therapists and chiropractic doctors—or primary spine practitioners (PSPs)—as first-line providers.

This study aims to determine if initial contact with PSP clinicians will improve physical function, decrease pain, decrease opioid prescriptions, improve patient satisfaction, and decrease costs and utilization of health care services in patients with a primary complaint of LBP, when compared with usual medical care.

NIH Collaboratory Trials are multicenter, pragmatic trials that are embedded in healthcare delivery systems to gather real-world evidence and answer clinical questions of major public health importance. In its first 10 years, the NIH Collaboratory successfully engaged with 21 complex NIH Collaboratory Trials. IMPACt-LBP will join 6 other NIH Collaboratory Trials that focus on pain as part of a broader effort to reduce opioid prescribing and inform policy.

The results from this study will directly inform implementation and policy efforts to improve the quality of pain management for patients suffering from LBP while simultaneously reducing opioid prescriptions, health care costs and utilization of services.

The study is supported within the NIH Collaboratory by the National Center for Complementary and Integrative Health, with additional support from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Child Health and Human Development.

 

 

April 27, 2020: NIH Announces Supplemental Funding Opportunity for Research on Stigma in Pain Management, Opioid Use, and Opioid Use Disorder

The NIH Office of Behavioral and Social Sciences Research, with other NIH Institutes, Centers, and Offices, has issued a notice of special interest calling for research on stigma in the context of chronic pain management and opioid use or opioid use disorder. The NIH will support administrative supplements to current awards and cooperative agreements under the Helping to End Addiction Long Term (HEAL) Initiative. A total of up to $3.5 million is available for the supplemental awards. Applications will be accepted through May 29, 2020.

This funding opportunity will give high priority to projects that analyze strategies to reduce stigma, discrimination, and prejudice related to chronic pain management and/or opioid use disorder; and to projects that use existing psychometrically validated tools to measure stigma (or that support the development of new measurement tools, if there is compelling rationale). Specific areas of interest include:

  • The impact of internalized and anticipated stigma on prevention, management, treatment, and recovery.
  • Prejudice by care providers that undermine treatment and health-related quality of life.
  • Strategies to address stigma among healthcare providers, workplace colleagues, emergency responders, family and friends, and others.
  • Strategies to address internalized stigma.
  • The adaption and application of existing theories of health-related stigma to chronic pain and/or opioid use disorder in reducing stigma.
  • Analyses of combinations of approaches that are known to reduce discrimination and prejudice.
  • Approaches to build resilience to discrimination and prejudice.
  • First-stage development of multicomponent approaches that could be expanded and implemented for large-scale multicomponent research projects.

Application and submission information is available in the full notice of special interest.

April 9, 2019: EMBED Awarded Continuation From Planning to Implementation Phase

The investigators of EMBED, an NIH Collaboratory Trial, have received approval to move from the planning phase to the implementation phase of their study. Congratulations to Dr. Ted Melnick, Dr. Gail D’Onofrio, and the EMBED study team for their excellent work!

“The opioid crisis is taking a devastating toll on Americans, their families, and their communities. The EMBED project leverages the urgency of our nation’s opioid crisis to bring together leaders in human-centered design, clinical informatics, data coordination, emergency medicine, and addiction medicine to provide an integrated, user-friendly solution to emergency clinicians caring for people with opioid addiction.”   —Dr. Edward Melnick, Co-PI of EMBED

EMBED (Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder) is designed to evaluate the effect of computerized clinical decision support on rates of emergency department-initiated buprenorphine/naloxone (BUP), which is a well-established outpatient treatment for people with opioid use disorder. BUP can only be prescribed by appropriately trained physicians. Although patients with opioid use disorder often seek medical care in emergency departments, the practice of initiating BUP in the emergency department is not common.

“Initiating buprenorphine in the emergency department has the potential to improve and save so many lives, but currently adoption rates are close to 0%. We believe that the EMBED intervention will be a crucial part of getting this evidence-based practice into routine emergency care.”   —Dr. Edward Melnick, Co-PI of EMBED

NIH Collaboratory Trials begin with a 1-year, milestone-driven planning phase. Projects become eligible to move to the implementation phase after an administrative review of progress toward scientific milestones and feasibility requirements.

In the planning phase, the EMBED study team developed the clinician decision support tools intended to facilitate the management of people with untreated opioid use disorder who seek care in emergency departments. In the next phase, the team will implement the trial and test the effect of the clinical decision support tool compared to usual care on outcomes in patients with opioid use disorder who seek care in emergency departments.

EMBED was supported within the NIH Collaboratory by a cooperative agreement from the National Institute on Drug Abuse. The study also received logistical and technical support from the NIH Collaboratory Coordinating Center through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.

 

February 13, 2019: Proposals Due for Pragmatic Trials of Acupuncture Treatment in Older Adults With Chronic Low Back Pain

Proposals are due March 15 in response to an NIH funding opportunity announcement for embedded pragmatic clinical trials that address pain management and the opioid crisis. The NIH will support 1 to 2 pragmatic trials that evaluate acupuncture treatment in older adults with chronic low back pain. The projects will join the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research.

Read the full announcement: Pragmatic Randomized Controlled Trial of Acupuncture for Management of Chronic Low Back Pain in Older Adults

The request for applications is part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

December 11, 2018: Two New NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced two new funding opportunity announcements (FOAs) for 7 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research.

The two announcements are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

November 20, 2018: Upcoming NIH Funding Opportunity Announcements for Pragmatic Trials Address the Opioid Crisis

The NIH has announced an intent to publish new funding opportunity announcements (FOAs) for 5 or more embedded pragmatic clinical trials that address pain management and the opioid crisis. These projects will become part of the NIH Health Care Systems Research Collaboratory as phased UG3/UH3 cooperative research. Both FOAs will be published in early December with applications due as early as February 2019.

The two notices are:

The announcements are part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

November 2, 2018: EMBED Pragmatic Trial of User-Centered Clinical Decision Support to Implement Emergency Department-Initiated Buprenorphine for Opioid Use Disorder (Ted Melnick, MD, Gail D’Onofrio, MD)

Speakers

Ted Melnick, MD, MHS
Assistant Professor of Emergency Medicine
Program Director, ACGME Clinical Informatics Fellowship
Yale School of Medicine

Gail D’Onofrio, MD
Professor and Chair of Emergency Medicine, Yale School of Medicine
Physician-in-Chief of Emergency Services Yale-New Haven Hospital

Topic

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

Keywords

EMBED; Embedded PCT; Pragmatic clinical trial; Opioid use disorder; Clinical decision support; Emergency department; Buprenorphine

Key Points

  • The EMBED pragmatic trial is evaluating a clinical decision support tool designed to automatically identify and facilitate management of eligible patients with opioid use disorder in the emergency department (ED).
  • From July 2016 to Sep 2017, there was a 30% increase in visits to the ED for opioid overdose (Morbidity and Mortality Weekly Report, March 9, 2018).
  • With medication-assisted treatment, patients are 2 times more likely to be engaged in addiction treatment at 30 days.
  • EMBED’s user-centered design aims to streamline workflows, address barriers to adoption, embed ED-initiated buprenorphine into routine ED care, and optimize adoption, dissemination, implementation, and scalability.

Discussion Themes

Poor usability of health information technology (HIT) is major source of frustration for clinicians. Electronic health record usability is a fundamental barrier to implementation of evidence-based medicine.

The science of usability in healthcare is still in the early stages. The EMBED study wants to improve the HIT experience.

How much does the study rely on EHR data for outcomes, and how detailed are the pilot outcomes data requested from each system? How do you plan to verify the accuracy of those data?

For more information on treatment of opioid use disorder in the emergency department, visit the National Institute on Drug Abuse (NIDA) website’s Initiating Buprenorphine Treatment in the Emergency Department.

Tags

@Ted_Melnick, @DonofrioGail, @yaleem2, @YaleMed, @Collaboratory1, #pctGR, #EmergencyMedicine