Adaptive Decision Support for Addiction Treatment Master

Recruiting now · Not applicable

Conditions studied: Opioid Use Disorder

In brief

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

Key facts

Study ID

NCT06799117

Run by

Yale University

People needed

1912

Starts

2025-03-21

Expected to finish

2028-03-31

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Emergency department patient
• 18 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

Where it is running

• Yale New Haven Shoreline Medical Center — Guilford, Connecticut, United States (enrolling)
• Yale New Haven Hospital- St. Raphael — New Haven, Connecticut, United States (enrolling)
• Yale New Haven Hospital — New Haven, Connecticut, United States (enrolling)

Full record on ClinicalTrials.gov

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