Improving electronic prompts to help emergency clinicians start buprenorphine for opioid use disorder
Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability
NA · Yale University · NCT07549126
This study will test whether placing the nursing COWS prompt as required versus optional in the emergency department helps clinicians use the EMBED decision tool and start buprenorphine for adults with moderate to severe opioid use disorder.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 3 sites (Guilford, Connecticut and 2 other locations) |
| Trial ID | NCT07549126 on ClinicalTrials.gov |
What this trial studies
Using a Multiphase Optimization Strategy (MOST) framework, investigators are conducting rapid, serial A-B randomized tests in the optimization phase to refine the EMBED clinical decision support (CDS) interface and workflow. In round 1, ED encounters will be randomized to show the nurse COWS prompt as either required or optional and usability outcomes will be measured to identify errors, workflow disruption, and abandonment. The more successful condition in each round will advance to be compared against a new test condition across up to five rounds of iterative refinement. The final evaluation phase will be a randomized trial comparing the optimized multicomponent CDS package to the original EMBED tool for ED initiation of buprenorphine.
Who should consider this trial
Good fit: Adults (18+) presenting to participating emergency departments with moderate to severe opioid use disorder who are not currently receiving medication for opioid use disorder and are not pregnant are the intended participants.
Not a fit: People under 18, those who are pregnant, those already receiving medication for opioid use disorder, or patients seen outside the participating Yale New Haven Health EDs are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the optimized prompts and workflow could increase the number of eligible patients started on buprenorphine in the ED, improving access to treatment and reducing overdose risk.
How similar studies have performed: This work builds on the prior EMBED effort (see NCT03658642) that aimed to increase ED initiation of buprenorphine, and the current project focuses on novel, iterative usability testing to refine that CDS.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Guilford, Connecticut and 2 other locations
- Yale New Haven Shoreline Medical Center — Guilford, Connecticut, United States (RECRUITING)
- Yale New Haven Hospital- St. Raphael — New Haven, Connecticut, United States (RECRUITING)
- Yale New Haven Hospital — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Edward Melnick, MD, MHS — Yale University
- Study coordinator: Edward Melnick, MD, MHS
- Email: edward.melnick@yale.edu
- Phone: 203-785-4363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use Disorder, Clinical Decision Support