NCT07549126

Brief Summary

This study is stage 2, round 1 of a larger study which refines and optimizes the EMBED clinical decision support (CDS); see NCT03658642 to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

April 17, 2026

Last Update Submit

July 28, 2026

Conditions

Opioid Use DisorderClinical Decision Support

Keywords

Opioid Use DisorderClinical Decision Support

Outcome Measures

Primary Outcomes (1)

  • Proportion of encounters with COWS completed

    Proportion of eligible encounters with a COWS competed, by any team member and via any workflow (internal and external of EMBED). Obtained from EHR data.

    Trial round start to end up to 3 months

Secondary Outcomes (9)

  • Proportion of encounters with Buprenorphine initiation in the ED

    Trial round start to end up to 3 months

  • Proportion of eligible encounters with CDS engagement

    Trial round start to end up to 3 months

  • Teamwork on CDS Engagement

    Trial round start to end up to 3 months

  • Proportion of eligible users who used EMBED

    Trial round start to end up to 3 months

  • Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally.

    Trial round start to end up to 3 months

  • +4 more secondary outcomes

Study Arms (2)

Refined EMBED plus nurse prompt to complete COWS placed under required documentation in Epic

EXPERIMENTAL

Nurse prompt to complete COWS placed under optional documentation in Epic

Other: Nurse prompt to complete COWS under required documentationOther: Refined EMBED CDS

Refined EMBED CDS

ACTIVE COMPARATOR

EMBED CDS refined based on previous results

Other: Refined EMBED CDS

Interventions

Nurse prompt to complete COWS under required documentationOTHER

Nurse receives prompt to complete COWS under required documentation

Refined EMBED plus nurse prompt to complete COWS placed under required documentation in Epic
Refined EMBED CDSOTHER

Refined EMBED CDS

Refined EMBED CDSRefined EMBED plus nurse prompt to complete COWS placed under required documentation in Epic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency department patient
  • years of age or older
  • Moderate to severe opioid use disorder

You may not qualify if:

  • Under 18 years of age
  • Pregnant
  • Currently receiving medication for opioid use disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Yale New Haven Shoreline Medical Center

Guilford, Connecticut, 06437, United States

Location

Yale New Haven Hospital- St. Raphael

New Haven, Connecticut, 06510, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

  • Iscoe MS, Diniz Hooper C, Levy DR, Buchanan L, Dziura J, Meeker D, Taylor RA, D'Onofrio G, Oladele C, Sarpong DF, Paek H, Wilson FP, Heagerty PJ, Delgado MK, Hoppe J, Melnick ER. Adaptive decision support for addiction treatment to implement initiation of buprenorphine for opioid use disorder in the emergency department: protocol for the ADAPT Multiphase Optimization Strategy trial. BMJ Open. 2025 Feb 20;15(2):e098072. doi: 10.1136/bmjopen-2024-098072.

    PMID: 39979056BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Edward Melnick, MD, MHS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

April 23, 2026

Study Start

April 2, 2026

Primary Completion

May 7, 2026

Study Completion

May 7, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will share

De-identified data related to EHR use measurements in various levels of aggregation. e.g., time spent on the CDS or threshold outcomes such as dismissal of the CDS without action under a specific amount of time or the time spent on CDS that exceeds what was expected based on the patient's clinical opioid withdrawal (COWS) score, time in the ED, or level of acuity, patient acuity, chief complaints or diagnoses, clinician, interruptions (such as orders started but not finished), task switching, seasonality, and variation in shift timing (such as nights and weekends). Data shared will include variables relating to patient demographics, medical history, prescription information, clinician facing clinical decision support (CDS) firing and clinician action information, and clinician prescribing decisions and historical prescribing.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
De-identified data will be shared with NAHDAP as soon as possible upon completion of quality control procedures, analysis, and at the time of associated publication or end of performance period. Data will be released by NAHDAP at the time of receipt and will be available indefinitely.
Access Criteria
De-identified data sets used for analysis will be submitted to NAHDAP through the NIH HEAL Initiative and will be available for public use according to NAHDAP data sharing policies and restrictions set by our DUA with NAHDAP and our IRB. All data submissions to NAHDAP undergo confidentiality review to protect respondents' data from being re-identified. Portions of the ADAPT intervention will be built for national distribution on the Epic EHR platform. Distribution of code that is proprietary to Epic may limit distribution of certain portions of software or code. In this situation, investigators will provide dashboards and visualizations of workflow diagrams as appropriate to disclose interface and workflow concepts to the broader scientific community These portions of the data will also be subject to restricted use access outside of organizations using Epic.

Locations

US(3)