CompletedNot Applicable

Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

United States1,129 participantsStarted 2025-03-21

Plain-language summary

This study is stage 1 of a larger study which 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. 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

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 has already completed recruitment — does that mean results are available, and if so, what did they find about whether the clinical decision support tool actually helped more people get buprenorphine started in the emergency department?
2Since this study focused on how emergency department providers make decisions about buprenorphine, rather than testing buprenorphine itself, does it tell us anything useful about whether starting buprenorphine in an ED setting would be a good option for my specific situation?
3The trial measured how often doctors engaged with a decision support alert — does that kind of system exist at the hospitals or EDs where you practice, and could it affect how quickly I might be offered buprenorphine if I came in through an emergency department?
4Given that this was a study about provider behavior and decision-making tools rather than a direct treatment trial, would you recommend I look at a different clinical trial that's actually testing a treatment approach for opioid use disorder, or is standard care with buprenorphine the better path for me right now?
5Since buprenorphine initiation in the ED was the key outcome being tracked, can you walk me through what starting buprenorphine in an emergency setting typically looks like compared to starting it through an outpatient or addiction medicine program, so I can understand my options?

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: Trial start to end up to 18 months

Trial details

NCT IDNCT06793696

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-14

View on ClinicalTrials.gov More Opioid Use Disorder trials