Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial
NCT ID: NCT06793696
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1129 participants
INTERVENTIONAL
2025-03-21
2025-10-14
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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EMBED CDS
Provider receives EMBED CDS
EMBED
Original EMBED CDS
EMBED CDS and nurse prompt
EMBED CDS and nurse receives prompt to complete COWS
Nurse prompt
Nurse prompt to complete COWS
EMBED
Original EMBED CDS
EMBED CDS and provider prompt
EMBED CDS and provider prompt for EMBED CDS
Provider prompt
Provider prompt to use EMBED CDS
EMBED
Original EMBED CDS
EMBED CDS and patient facing materials
EMBED CDS and patient materials at patient discharge from ED
Patient facing materials
Patient materials provided at discharge from ED
EMBED
Original EMBED CDS
EMBED CDS and nurse prompt and provider prompt
EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS
Nurse prompt
Nurse prompt to complete COWS
Provider prompt
Provider prompt to use EMBED CDS
EMBED
Original EMBED CDS
EMBED CDS and nurse prompt and patient facing materials
EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED
Nurse prompt
Nurse prompt to complete COWS
Patient facing materials
Patient materials provided at discharge from ED
EMBED
Original EMBED CDS
EMBED CDS and provider prompt and patient facing materials
EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED
Provider prompt
Provider prompt to use EMBED CDS
Patient facing materials
Patient materials provided at discharge from ED
EMBED
Original EMBED CDS
EMBED CDS and nurse prompt and provider prompt and patient facing materials
EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED
Nurse prompt
Nurse prompt to complete COWS
Provider prompt
Provider prompt to use EMBED CDS
Patient facing materials
Patient materials provided at discharge from ED
EMBED
Original EMBED CDS
Interventions
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Nurse prompt
Nurse prompt to complete COWS
Provider prompt
Provider prompt to use EMBED CDS
Patient facing materials
Patient materials provided at discharge from ED
EMBED
Original EMBED CDS
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Moderate to severe opioid use disorder
Exclusion Criteria
* Pregnant
* Currently receiving medication for opioid use disorder
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Edward Melnick, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Shoreline Medical Center
Guilford, Connecticut, United States
Yale New Haven Hospital- St. Raphael
New Haven, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Countries
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Other Identifiers
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2000038624-A
Identifier Type: -
Identifier Source: org_study_id
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