Clinical Decision Support to Implement ED-initiated Buprenorphine for OUD

NCT03658642 | Completed Results

• 2 other identifiers: HIC 2000023783UG3DA047003
• Study Type: interventional
• Target: 5,047
• Locations: 1 country
• Sites: 22

Brief Summary

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.

Conditions

Clinical Decision Support; Buprenorphine; Opioid-use Disorder

Keywords

Opioid Use Disorder; Buprenorphine; Opioid-use Disorder; Health IT

Outcome Measures

Primary Outcomes (1)

• Count of Initiating BUP in the ED With Referral for Ongoing MOUD With User-centered CDS Compared With Usual Care

  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)

  Upon discharge (Up to 1 day)

Secondary Outcomes (5)

• Count of Those With Referral to Follow-up for Ongoing MOUD Treatment (Patient Level)

  Upon discharge (Up to 1 day)

• Rates Receiving a MAT Appointment Who go to the Appointment

  18 months

• Number of Clinicians Providing ED-initiated BUP

  18 months

• Number of Clinicians Providing Referral of Any Ongoing MOUD Treatment

  18 months

• Number of Clinicians Who Have Received Drug Addiction Treatment Act (DATA) of 2000 Training

  18 months

Study Arms (2)

Clinical Decision Support for BUP

EXPERIMENTAL

The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.

Behavioral: Clinical Decision Support (CDS)

Usual Care

NO INTERVENTION

The CDS will not be activated and patients will receive care as usual.

Interventions

Clinical Decision Support (CDS) BEHAVIORAL

This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)

Clinical Decision Support for BUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinicians
• All clinicians working in Emergency Departments in the selected sites
• Patients
• years or older
• Will meet an EHR-derived phenotype suggesting possible OUD will be included in the analysis
• Will be discharged from the ED
• Not pregnant
• Not currently taking any medication for Opioid Use Disorder

You may not qualify if:

• Patients
• Have a medical or psychiatric condition that requires hospitalization during the ED visit
• Have prior enrollment in the current study
• Currently in addiction treatment
• Be a prisoner or in police custody at the time of ED visit
• Note: The CDS will also be available for physicians to use when patients do not meet the EHR phenotype. These patients will be excluded from the primary analyses

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of North Carolina: collaborator
• University of Alabama at Birmingham: collaborator
• Mayo Clinic: collaborator
• The Cooper Health System: collaborator
• University of California, Davis: collaborator

Study Sites (22)

UAB Medicine Highlands - Highlands ED, (HED)

Birmingham, Alabama, 35205, United States

Location

UAB - University Hospital ED (UED)

Birmingham, Alabama, 35233, United States

Location

UAB Freestanding Emergency Department of Gardendale (GED)

Gardendale, Alabama, 35071, United States

Location

UCHealth Anschutz Medical Campus (AMC)

Aurora, Colorado, 80045, United States

Location

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

Location

UCHealth Memorial Hospital North (MHN)

Colorado Springs, Colorado, 80920, United States

Location

UCHealth Poudre Valley Hospital (PVH)

Fort Collins, Colorado, 80524, United States

Location

UCHealth Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Bridgeport Hospital ED (BPT), YNHHS

Bridgeport, Connecticut, 06610, United States

Location

Greenwich Hospital ED (GH), YNHHS

Greenwich, Connecticut, 06830, United States

Location

St Raphael's Campus (SRC), YNHHS

New Haven, Connecticut, 06410, United States

Location

Lawrence + Memorial Hospital ED (L&M), YNHHS

New London, Connecticut, 06320, United States

Location

Baystate Franklin

Greenfield, Massachusetts, 01301, United States

Location

Baystate Wing Hospital ED

Palmer, Massachusetts, 01069, United States

Location

Baystate Springfield Hospital ED

Springfield, Massachusetts, 01199, United States

Location

Baystate Mary Lane Hospital ED

Ware, Massachusetts, 01082, United States

Location

Baystate Noble

Westfield, Massachusetts, 01085, United States

Location

UNC Hospitals Emergency Department, UNCHS

Chapel Hill, North Carolina, 27514, United States

Location

REX Healthcare Emergency Department, UNCHS

Raleigh, North Carolina, 27607, United States

Location

Emergency Care Center at Nash General Hospital, UNCHS

Rocky Mount, North Carolina, 27804, United States

Location

Chatham Hospital ED, UNCHS

Siler City, North Carolina, 27344, United States

Location

Johnston Health ED, UNCHS

Smithfield, North Carolina, 27577, United States

Location

Related Publications (5)

• Cowan E, D'Onofrio G, Perrone J, Anderson E, Dziura J, Hawk K, Herring A, McCormack R, Phadke M, Samuels EA, Fiellin DA. Drug Use After Emergency Department-Initiated Injectable Buprenorphine: A Secondary Analysis of the ED-INNOVATION Ancillary Safety and Feasibility Trial. Acad Emerg Med. 2025 Nov 24. doi: 10.1111/acem.70191. Online ahead of print.

  PMID: 41287157 DERIVED

• Gao E, Melnick ER, Paek H, Nath B, Taylor RA, Loza AJ. Adoption of Emergency Department-Initiated Buprenorphine for Patients With Opioid Use Disorder: Secondary Analysis of a Cluster Randomized Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2342786. doi: 10.1001/jamanetworkopen.2023.42786.

  PMID: 37948075 DERIVED

• Melnick ER, Nath B, Dziura JD, Casey MF, Jeffery MM, Paek H, Soares WE 3rd, Hoppe JA, Rajeevan H, Li F, Skains RM, Walter LA, Patel MD, Chari SV, Platts-Mills TF, Hess EP, D'Onofrio G. User centered clinical decision support to implement initiation of buprenorphine for opioid use disorder in the emergency department: EMBED pragmatic cluster randomized controlled trial. BMJ. 2022 Jun 27;377:e069271. doi: 10.1136/bmj-2021-069271.

  PMID: 35760423 DERIVED

• Melnick ER, Nath B, Ahmed OM, Brandt C, Chartash D, Dziura JD, Hess EP, Holland WC, Hoppe JA, Jeffery MM, Katsovich L, Li F, Lu CC, Maciejewski K, Maleska M, Mao JA, Martel S, Michael S, Paek H, Patel MD, Platts-Mills TF, Rajeevan H, Ray JM, Skains RM, Soares WE 3rd, Deutsch A, Solad Y, D'Onofrio G. Progress Report on EMBED: A Pragmatic Trial of User-Centered Clinical Decision Support to Implement EMergency Department-Initiated BuprenorphinE for Opioid Use Disorder. J Psychiatr Brain Sci. 2020;5:e200003. doi: 10.20900/jpbs.20200003. Epub 2020 Feb 21.

  PMID: 32309637 DERIVED

• Melnick ER, Jeffery MM, Dziura JD, Mao JA, Hess EP, Platts-Mills TF, Solad Y, Paek H, Martel S, Patel MD, Bankowski L, Lu C, Brandt C, D'Onofrio G. 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 May 30;9(5):e028488. doi: 10.1136/bmjopen-2018-028488.

  PMID: 31152039 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Ted Melnick, MD, MHS Associate Professor of Emergency Medicine and of Biostatistics (Health Informat
• Organization: Yale School of Medicine

edward.melnick@yale.edu

(203) 785-5174

Study Officials

• Edward Melnick, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel cluster randomized

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 5, 2018
• Study Start: November 15, 2019
• Primary Completion: May 14, 2021
• Study Completion: September 15, 2021
• Last Updated: June 28, 2022
• Results First Posted: June 28, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)