UH3 Project: Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED)

UH3 Project: Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED)

     

 

Principal Investigators: Edward Melnick, MD, MHS, Gail D’Onofrio, MD, MS

Sponsoring Institution: Yale University

Collaborators:

  • University of North Carolina-Chapel Hill
  • University of Alabama-Birmingham
  • University of Massachusetts-Baystate
  • University of Colorado, Aurora

NIH Institute Providing Oversight: National Institute on Drug Abuse (NIDA)

Program Official: Sarah Duffy (NIDA)

Project Scientist: Shelley Su (NIDA)

ClinicalTrials.gov Identifier: NCT03658642

Trial Status: Not yet recruiting

Opioid use disorder (OUD) 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 of ED patients with OUD. However, the practice of initiating BUP in the ED has not been implemented into ED care. One major challenge to implementation is poor usability of health information technology (IT). To improve the health IT user experience and uptake of evidence-based medicine, health IT interventions should be developed by means of user-centered design.

The EMBED Demonstration Project proposes a pragmatic, multicenter, parallel, group-randomized trial to evaluate the effect of user-centered computerized clinical decision support on rates of ED-initiated BUP and referral for ongoing medication-assisted treatment for patients with OUD. In the UG3 planning phase, the EMBED study team has developed user-centered clinical decision support that facilitates management of potentially eligible patients. Aspects of EMBED include evaluation of intervention effects under usual conditions; passive collection of structured data from the electronic health record (EHR); and decreased need for specific expertise or training of clinicians. It is proposed that with user-centered clinical decision support, the rates of ED-initiated BUP will be higher.

NIH Project Information

 

Presentation


5/1/2019: Presentation to NIH Collaboratory Steering Committee (slides)

 

Interview


Interview with co-principal investigator Dr. Edward Melnick (video)

Publications

Computerized clinical decision support system for emergency department–initiated buprenorphine for opioid use disorder: user-centered design. JMIR Hum Factors. 2019;6(1):e13121.

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. JAMIA Open, ooz053.

Identifying opioid use disorder in the emergency department: multi-system electronic health record–based computable phenotype derivation and validation study. JMIR Med Inform. 2019;7(4):e15794.

User-centred clinical decision support to implement emergency department-initiated buprenorphine for opioid use disorder: protocol for the pragmatic group randomised EMBED trial. BMJ Open. 2019;9(5):e028488.

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. J Subst Abuse Treat. 2019;102(7):47-52.

Presentations

5/1/2019: Presentation to NIH Collaboratory Steering Committee (slides)

11/2/2018: PCT Grand Rounds (videoslides)

5/14/2018: Presentation to NIH Collaboratory Steering Committee (slides)

 

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Citation:

Demonstration Projects: UH3 Project: Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder (EMBED). In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/demonstration-projects/ug3-project-pragmatic-trial-of-user-centered-clinical-decision-support-to-implement-emergency-department-initiated-buprenorphine-for-opioid-use-disorder-embed/. Updated January 17, 2020.