Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 3

This study is stage 2, round 3 of a larger study which refines and optimizes the EMBED clinical decision support (CDS) to increase number of ED physicians following standard of care for the administration of buprenorphine to appropriate patients with opioid use disorder. See NCT03658642

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical Decision Support; Opioid Abuse (Disorder)
• Intervention / Treatment: Other: Refined EMBED CDS; Other: Provider alert that nurse completed COWS

Detailed Description

This study is stage 3, rapid response testing (RRT), of the optimization phase 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. Investigators will use a Multiphase Optimization Strategy (MOST) framework with preparation, optimization, and confirmatory phases.

In stage 2, optimization phase, investigators will conduct serial rapid-cycle 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 with the goal of improving CDS usability.

Five rounds of A-B testing are expected. The more successful condition will be tested in the subsequent round against a novel test condition. In this second round investigators will randomize an alert to providers to order a consult with addiction counselors. Future rounds will be planned, with arms and interventions added, as the project progresses in order to build on insights gained in each round.

Phase 3, the evaluation phase will consist of 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

This study does not have open enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edward Melnick, MD, MHS; Phone Number: 203-785-4363; Email: edward.melnick@yale.edu
• Study Contact Backup: Name: Laurel Buchanan, MA; Phone Number: 203-785-4363; Email: laurel.buchanan@yale.edu

Study Locations

• United States
  • Connecticut
    • Guilford, Connecticut, United States, 06437
      • Yale New Haven Shoreline Medical Center
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital- St. Raphael

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Refined EMBED CDS; EMBED CDS refined based on previous results	Other: Refined EMBED CDS; Refined EMBED CDS; Other: Provider alert that nurse completed COWS; Provider alert that nurse completed COWS
Experimental: Refined EMBED plus provider alert the nurse completed COWS; Alert to provider in Epic that the nurse completed COWS	Other: Provider alert that nurse completed COWS; Provider alert that nurse completed COWS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of encounters with Buprenorphine initiation in the ED	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.	Trial round start to end up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible encounters with CDS engagement	Proportion of eligible encounters in which any portion of the EMBED workflow was documented or completed.	Trial round start to end up to 3 months
Time spent on EMBED	Time (in seconds) spent on EMBED overall and by component.	Trial round start to end up to 3 months
Task completion: Buprenorphine order or prescription placed	Proportion of encounters where EMBED was opened in which a buprenorphine order or prescription was placed.	Trial round start to end up to 3 months
Task Completion: Proportion of encounters with OUD diagnosis was recorded	Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded.	Trial round start to end up to 3 months
Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally	Proportion of eligible encounters in which buprenorphine order is placed through EMBED (i.e., using EMBED order set).	Trial round start to end up to 3 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Edward Mel, MD, MHS, Yale University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 25, 2026
• First Submitted That Met QC Criteria: August 25, 2026
• First Posted (Actual): August 28, 2026

Study Record Updates

• Last Update Posted (Actual): August 28, 2026
• Last Update Submitted That Met QC Criteria: August 25, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000038624-B3; 5R33DA059884-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data related to EHR use measurements in various levels of aggregation. e.g., time spent on the CDS or threshold outcomes such as dismissal of the CDS without action under a specific amount of time or the time spent on CDS that exceeds what was expected based on the patient's clinical opioid withdrawal (COWS) score, time in the ED, or level of acuity, patient acuity, chief complaints or diagnoses, clinician, interruptions (such as orders started but not finished), task switching, seasonality, and variation in shift timing (such as nights and weekends). Data shared will include variables relating to patient demographics, medical history, prescription information, clinician facing clinical decision support (CDS) firing and clinician action information, and clinician prescribing decisions and historical prescribing.
• IPD Sharing Time Frame: De-identified data will be shared with NAHDAP as soon as possible upon completion of quality control procedures, analysis, and at the time of associated publication or end of performance period. Data will be released by NAHDAP at the time of receipt and will be available indefinitely.

IPD Sharing Access Criteria

De-identified data sets used for analysis will be submitted to NAHDAP through the NIH HEAL Initiative and will be available for public use according to NAHDAP data sharing policies and restrictions set by our DUA with NAHDAP and our IRB. All data submissions to NAHDAP undergo confidentiality review to protect respondents' data from being re-identified.

Portions of the ADAPT intervention will be built for national distribution on the Epic EHR platform. Distribution of code that is proprietary to Epic may limit distribution of certain portions of software or code. In this situation, investigators will provide dashboards and visualizations of workflow diagrams as appropriate to disclose interface and workflow concepts to the broader scientific community These portions of the data will also be subject to restricted use access outside of organizations using Epic.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No