Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06799117

Adaptive Decision Support for Addiction Treatment Master

Led by Yale University · Updated on 2025-06-25

1912

Participants Needed

3

Research Sites

158 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute on Drug Abuse (NIDA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study 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. Optimization Phase: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED is expanded to include sustainable implementation strategies: nurse prompt for withdrawal assessment, and targeted clinician prompts to use the CDS along with individualized patient resources to promote equity and motivate readiness to start treatment. In Stage 2, investigators will improve CDS usability via serial randomized testing to inform iterative refinement of the CDS interface and workflow to minimize user errors, task disruption, and abandonment through identification of specific targets for improvement via application of novel CDS outcome measures in serial randomized tests. Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD. \*EMBED is a user user-centered, clinician 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

CONDITIONS

Official Title

Adaptive Decision Support for Addiction Treatment Master

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Emergency department patient
  • 18 years of age or older
  • Moderate to severe opioid use disorder
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Yale New Haven Shoreline Medical Center

Guilford, Connecticut, United States, 06437

Actively Recruiting

2

Yale New Haven Hospital- St. Raphael

New Haven, Connecticut, United States, 06510

Actively Recruiting

3

Yale New Haven Hospital

New Haven, Connecticut, United States, 06510

Actively Recruiting

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Research Team

E

Edward Melnick, MD, MHS

CONTACT

L

Laurel Buchanan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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