Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Clinical Decision Support

• Registration Number: NCT06793696
• Lead Sponsor: Yale University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-06
• Study First Submitted QC: 2025-01-23
• Study First Posted: 2025-01-27
• Study Start: 2025-03-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1088

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Proportion of encounters with Buprenorphine initiation in the ED	Upon discharge from the ED, 1 day	Proportion of eligible encounters with buprenorphine administered in the Emergency Department (ED) and/or prescribed buprenorphine on discharge from the ED. Obtained from EHR data.
Proportion of alerted encounters with CDS engagement	Trial start to end up to 18 months	Proportion of eligible encounters in the Emergency Department with an alert fired (silent or active) with CDS engagement. CDS engagement is defined as: OUD diagnosis entered via CDS, withdrawal assessment, readiness assessment, buprenorphine order/prescription placed, referral placed, or any flowsheet item completed.

Secondary Outcome Measures

Name	Time	Method
Proportion of attending physicians initiating BUP in the ED for at least one eligible patient	Trial start to end up to 18 months	Proportion of attending physicians administered or prescribed Buprenorphine in the Emergency Department (ED) for at least one encounter. Obtained from EHR data.
Proportion of encounters with patient referral to ongoing MOUD treatment	Upon discharge from the ED, 1 day	Proportion of eligible encounters with referral for ongoing MOUD treatment received on discharge from the Emergency Department (ED). Obtained from EHR data.
Proportion of encounters with Naloxone prescription upon ED discharge	Upon discharge from the ED, 1 day	Proportion of eligible encounters with naloxone prescribed on discharge from the Emergency Department (ED). Obtained from EHR data.
Proportion of encounters with patient receipt of appropriate opioid related discharge instructions	Upon discharge from the ED, 1 day	Proportion of encounters with appropriate opioid related discharge instructions. Obtained from EHR data.
Proportion of attending physician referral to ongoing MOUD treatment	Trial start to end up to 18 months	Proportion of attending physicians referring a patient to ongoing MOUD treatment on discharge from the Emergency Department (ED) for at least one encounter. Obtained from EHR data.
Proportion of attending physician prescribing naloxone upon ED discharge	Trial start to end up to18 months	Proportion of attending physicians prescribing naloxone in the Emergency Department (ED) for at least one encounter. Obtained from EHR data.
Proportion of attending physicians giving appropriate opioid related discharge instructions	Trial start to end up to 18 months	Proportion of attending physicians giving appropriate opioid related discharge instructions for at least one encounter. Obtained from EHR data.

Trial Locations

Locations (3)

Yale New Haven Shoreline Medical Center; 🇺🇸 Guilford, Connecticut, United States

Yale New Haven Hospital- St. Raphael; 🇺🇸 New Haven, Connecticut, United States

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States