Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 2
2 other identifiers
interventional
300
1 country
3
Brief Summary
This study is stage 2, round 2 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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2026
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2026
CompletedStudy Start
First participant enrolled
May 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
May 22, 2026
May 1, 2026
2 months
May 15, 2026
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of encounters with an order for an addiction counselor consult
Proportion of encounters with documentation of a clinician order for an addiction counselor consult specifically to assess for eligibility and initiation of MOUD.
Trial round start to end up to 3 months
Secondary Outcomes (4)
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
Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally.
Trial round start to end up to 3 months
Teamwork on ED initiation of buprenorphine
Trial round start to end up to 3 months
Study Arms (2)
Active Comparator: Refined EMBED CDS
ACTIVE COMPARATOREMBED CDS refined based on previous results
Refined EMBED plus provider alert in Epic to order a consult with an addiction counselor
EXPERIMENTALProvider alert in Epic to order a consult with an addiction counselor to assess for eligibility and initiation of MOUD
Interventions
Refined EMBED CDS
Provider alert to order consult with addiction counselor
Eligibility Criteria
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
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (3)
Yale New Haven Shoreline Medical Center
Guilford, Connecticut, 06437, United States
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, 06510, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Edward, MD, MHS
Yale University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2026
First Posted
May 22, 2026
Study Start
May 21, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- 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.
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.