Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

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

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder; Clinical Decision Support
• Intervention / Treatment: Other: EMBED; Other: Nurse prompt; Other: Provider prompt; Other: Patient facing materials

• Study Type: Interventional
• Enrollment (Actual): 1129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Guilford, Connecticut, United States, 06437
      • Yale New Haven Shoreline Medical Center
    • New Haven, Connecticut, United States, 06510
      • 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: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EMBED CDS; Provider receives EMBED CDS	Other: EMBED; Original EMBED CDS
Experimental: EMBED CDS and nurse prompt; EMBED CDS and nurse receives prompt to complete COWS	Other: EMBED; Original EMBED CDS; Other: Nurse prompt; Nurse prompt to complete COWS
Experimental: EMBED CDS and provider prompt; EMBED CDS and provider prompt for EMBED CDS	Other: EMBED; Original EMBED CDS; Other: Provider prompt; Provider prompt to use EMBED CDS
Experimental: EMBED CDS and patient facing materials; EMBED CDS and patient materials at patient discharge from ED	Other: EMBED; Original EMBED CDS; Other: Patient facing materials; Patient materials provided at discharge from ED
Experimental: EMBED CDS and nurse prompt and provider prompt; EMBED CDS and nurse prompt to complete COWS and provider prompt for CDS	Other: EMBED; Original EMBED CDS; Other: Nurse prompt; Nurse prompt to complete COWS; Other: Provider prompt; Provider prompt to use EMBED CDS
Experimental: EMBED CDS and nurse prompt and patient facing materials; EMBED CDS and nurse prompt to complete COWS and patient materials at discharge from ED	Other: EMBED; Original EMBED CDS; Other: Nurse prompt; Nurse prompt to complete COWS; Other: Patient facing materials; Patient materials provided at discharge from ED
Experimental: EMBED CDS and provider prompt and patient facing materials; EMBED CDS and provider prompt for EMBED and patient materials at discharge from ED	Other: EMBED; Original EMBED CDS; Other: Provider prompt; Provider prompt to use EMBED CDS; Other: Patient facing materials; Patient materials provided at discharge from ED
Experimental: EMBED CDS and nurse prompt and provider prompt and patient facing materials; EMBED CDS and nurse prompt to complete COWS and provider prompt to complete CDS and patient materials at discharge from ED	Other: EMBED; Original EMBED CDS; Other: Nurse prompt; Nurse prompt to complete COWS; Other: Provider prompt; Provider prompt to use EMBED CDS; Other: Patient facing materials; Patient materials provided at discharge from ED

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.	Upon discharge from the ED, 1 day
Proportion of alerted encounters with CDS engagement	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.	Trial start to end up to 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Actual): October 14, 2025
• Study Completion (Actual): October 14, 2025

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Opioid use disorder; clinical decision support
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 2000038624-A; 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
• product manufactured in and exported from the U.S.: No