Actively Recruiting
Led by Yale University · Updated on 2025-06-25
1912
Participants Needed
3
Research Sites
N/A
Total Duration
Y
Yale University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
Researchers are refining and optimizing the EMBED clinical decision support system to help emergency department (ED) physicians better follow guidelines for giving buprenorphine to patients with opioid use disorder (OUD). This study uses a Multiphase Optimization Strategy (MOST) with preparation, optimization, and confirmation phases to improve how the system supports treatment initiation in emergency care. The goal is to increase the number of physicians using the standard of care for buprenorphine administration in appropriate patients. The study has multiple phases. In the first optimization stage, a 2x2x2 factorial trial tests adding sustainable strategies like nurse prompts for withdrawal assessment, targeted clinician prompts to use the decision support system, and patient resources to promote equity and readiness for treatment. The second stage involves rapid serial randomized testing to improve system usability and reduce errors by refining the interface and workflow. The evaluation phase compares the optimized system to the original in a randomized trial focused on rates of buprenorphine initiation in the ED. Participants are emergency department patients aged 18 or older with moderate to severe opioid use disorder. Researchers will monitor the proportion of patient encounters where buprenorphine is started and assess engagement with the clinical decision support system. The study tracks outcomes from the ED visit through the end of each trial phase, which may last up to 18 months. The system integrates diagnosis, withdrawal severity assessment, patient motivation techniques, and automates clinical workflow including documentation and referrals.
CONDITIONS
Adaptive Decision Support for Addiction Treatment Master
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants experience the EMBED clinical decision support system with various implementation strategies including nurse prompts, clinician prompts, and patient-facing materials to support initiation of buprenorphine treatment in the emergency department.
Visits occur during emergency department encounters as needed
Duration - Variable, within the trial period
Participants undergo iterative testing of refinements to the EMBED system interface and workflow to improve usability and reduce errors based on user feedback.
Visits occur during emergency department encounters as needed
Duration - Up to 18 months
Participants are randomized to receive either the optimized EMBED system or the original EMBED system to compare effectiveness on buprenorphine initiation rates during emergency department visits.
Visits during emergency department encounters as part of routine care
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
E
Edward Melnick, MD, MHS
L
Laurel Buchanan
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Mark S Iscoe, Carolina Diniz Hooper, Deborah R Levy...
https://pubmed.ncbi.nlm.nih.gov/39979056