Clinical trial NCT06799117: Adaptive Decision Support for Addiction Treatment Master
Official title: Adaptive Decision Support for Addiction Treatment (ADAPT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Opioid use disorder
Clinical Decision Support
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-01-29
Enrollment: 1912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients are randomized to a study arm during Emergency Department encounters at study sites. There is no open enrollment.
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Proportion of encounters with Buprenorphine initiation in the ED
timeFrame: Upon discharge from the ED, 1 day
measure: Proportion of alerted encounters with CDS engagement
timeFrame: From ED visit through end of trial stage/cycle, up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guilford
country: United States
facility: Yale New Haven Shoreline Medical Center
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital- St. Raphael
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Edward Melnick, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: