RecruitingNot Applicable

Adaptive Decision Support for Addiction Treatment Master

United States1,912 participantsStarted 2025-03-21

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Emergency department patient * 18 years of age or older * Moderate to severe opioid use disorder Exclusion Criteria: * Under 18 years of age * Pregnant * Currently receiving medication for opioid use disorder

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing a computer-based decision support tool to help emergency department doctors start buprenorphine treatment for opioid use disorder — how does getting buprenorphine initiated in the ED compare to starting it through a scheduled clinic appointment for someone in my situation?
2The study is measuring how often the decision support alert actually leads doctors to engage with it, not just whether patients do better on buprenorphine — does that mean my direct health outcomes aren't the main thing being tracked, and what would that mean for my care?
3Since this trial involves a decision support tool aimed at the emergency department setting, would I need to come through the ED to be part of it, and is that a realistic or appropriate path given where I am right now?
4Buprenorphine has an established track record as a treatment for opioid use disorder outside of this study — would starting buprenorphine through standard care right now make more sense for me than waiting to be seen in an ED setting that's part of this trial?
5Are there any risks to me as a patient if the decision support tool isn't used or followed by the ED provider, and what happens to my treatment plan after the ED visit in the context of this study?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of encounters with Buprenorphine initiation in the ED

Timeframe: Upon discharge from the ED, 1 day

Proportion of alerted encounters with CDS engagement

Timeframe: From ED visit through end of trial stage/cycle, up to 18 months

Trial details

NCT IDNCT06799117

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Edward Melnick, MD, MHS

203-785-4363 edward.melnick@yale.edu

View on ClinicalTrials.gov More Opioid Use Disorder trials