Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial
2 other identifiers
interventional
1,129
1 country
3
Brief Summary
This study is stage 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. This study does not have open enrollment. Investigators will use a Multiphase Optimization STrategy (MOST) framework study with preparation, optimization, and confirmatory phases. In the current project, optimization phase, stage1 investigators will conduct a 2x2x2 factorial trial in which they expand EMBED to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompt to use the CDS along with patient resources to promote equity and motivate readiness to start treatment. Later study phases will include optimization phase, stage 2: rapid-cycle randomized testing, and evaluation phase: a randomized trial of the optimized package compared to the original EMBED and the evaluation phase in which investigators will compare the efficacy of the optimized, multicomponent CDS package to the original EMBED CDS on ED-initiation of buprenorphine rates in patients with OUD in a randomized trial. \*EMBED is a user centered, clinician facing clinical decision support system integrated into the electronic health record workflow to facilitate initiating buprenorphine in the emergency department by: diagnosing opioid use disorder with a checklist based on the diagnostic criteria of the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, fifth edition), assessing the severity of withdrawal with the Clinical Opioid Withdrawal Scale (COWS), motivating patients to accept treatment with a scripted brief negotiation interview, and automating the electronic health record workflow, including clinical and after visit documentation, order entry, prescribing, and referral for ongoing treatment in the community
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
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
January 6, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedStudy Start
First participant enrolled
March 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2025
CompletedJanuary 27, 2026
January 1, 2026
7 months
January 6, 2025
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of encounters with Buprenorphine initiation in the ED
Proportion of eligible encounters with buprenorphine administered in the Emergency Department (ED) and/or prescribed buprenorphine on discharge from the ED. Obtained from EHR data.
Upon discharge from the ED, 1 day
Proportion of alerted encounters with CDS engagement
Proportion of eligible encounters in the Emergency Department with an alert fired (silent or active) with CDS engagement. CDS engagement is defined as: OUD diagnosis entered via CDS, withdrawal assessment, readiness assessment, buprenorphine order/prescription placed, referral placed, or any flowsheet item completed.
Trial start to end up to 18 months
Secondary Outcomes (7)
Proportion of encounters with Naloxone prescription upon ED discharge
Upon discharge from the ED, 1 day
Proportion of encounters with patient referral to ongoing MOUD treatment
Upon discharge from the ED, 1 day
Proportion of encounters with patient receipt of appropriate opioid related discharge instructions
Upon discharge from the ED, 1 day
Proportion of attending physicians initiating BUP in the ED for at least one eligible patient
Trial start to end up to 18 months
Proportion of attending physician prescribing naloxone upon ED discharge
Trial start to end up to18 months
- +2 more secondary outcomes
Study Arms (8)
EMBED CDS
ACTIVE COMPARATORProvider receives EMBED CDS
EMBED CDS and nurse prompt
EXPERIMENTALEMBED CDS and nurse receives prompt to complete COWS
EMBED CDS and provider prompt
EXPERIMENTALEMBED CDS and provider prompt for EMBED CDS
EMBED CDS and patient facing materials
EXPERIMENTALEMBED CDS and patient materials at patient discharge from ED
EMBED CDS and nurse prompt and provider prompt
EXPERIMENTALEMBED CDS and nurse prompt to complete COWS and provider prompt for CDS
EMBED CDS and nurse prompt and patient facing materials
EXPERIMENTALEMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED
EMBED CDS and provider prompt and patient facing materials
EXPERIMENTALEMBED CDS and provider prompt for EMBED and patient materials at discharge from ED
EMBED CDS and nurse prompt and provider prompt and patient facing materials
EXPERIMENTALEMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED
Interventions
Nurse prompt to complete COWS
Provider prompt to use EMBED CDS
Patient materials provided at discharge from ED
Original EMBED CDS
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Melnick, MD, MHS
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2025
First Posted
January 27, 2025
Study Start
March 21, 2025
Primary Completion
October 14, 2025
Study Completion
October 14, 2025
Last Updated
January 27, 2026
Record last verified: 2026-01
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