Clinical trial NCT06793696: Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial
Official title: Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Clinical Decision Support
Keywords: Opioid use disorder
clinical decision support
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-01-27
Enrollment: 1088
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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 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


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: Trial start to end up to 18 months
Secondary outcomes:
measure: Proportion of encounters with Naloxone prescription upon ED discharge
timeFrame: Upon discharge from the ED, 1 day
measure: Proportion of encounters with patient referral to ongoing MOUD treatment
timeFrame: Upon discharge from the ED, 1 day
measure: Proportion of encounters with patient receipt of appropriate opioid related discharge instructions
timeFrame: Upon discharge from the ED, 1 day
measure: Proportion of attending physicians initiating BUP in the ED for at least one eligible patient
timeFrame: Trial start to end up to 18 months
measure: Proportion of attending physician prescribing naloxone upon ED discharge
timeFrame: Trial start to end up to18 months
measure: Proportion of attending physician referral to ongoing MOUD treatment
timeFrame: Trial start to end up to 18 months
measure: Proportion of attending physicians giving appropriate opioid related discharge instructions
timeFrame: Trial start to end up to 18 months
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: