Recruiting

Addiction Treatment

Sponsor:

Yale University

Code:

NCT06799117

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EMBED CDS

Nurse prompt to complete COWS

Provider Prompt

Patient facing materials

Optimized EMBED

Study Details

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

Conditions

Opioid Use Disorder

Study ID

NCT06799117

Start date

Mar 21, 2025

Status verified date

Jun, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1912 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Optimization Phase, Stage1: Factorial Trial

Successful completion of Optimization Phase, Stage 1 Successful completion of the 2x2x2 factorial trial in which investigators 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.

experimental: Optimization Phase, Stage 2: Rapid serialized testing

Successful completion of Optimization Phase, Stage 2: 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.

experimental: Evaluation Phase

Successful completion of the Evaluation phase: Investigators will conduct a randomized trial to compare the efficacy of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD.

Interventions

EMBED CDS

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.

Intervention to be informed by CDS measurement and user feedback during the factorial trial phase (Optimization Phase, Stage 1)

Nurse prompt to complete COWS

Nurse prompt to complete COWS

Provider Prompt

Provider Prompt to use EMBED: 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. Intervention to be informed by CDS measurement and user feedback during the factorial trial phase (Optimization Phase, Stage 1)

Patient facing materials

Provider prompt to give patient customized discharge instructions directing patient to resources matched to their needs.

Optimized EMBED

CDS following Optimization Phase, Stage 2: Rapid serialized testing

Name of Intervention

Intervention to be informed by results during Evaluation Phase, Stage 1 and will involve refinement of user interface and workflows for the EMBED CDS: 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.

Primary outcome measure

  • Proportion of encounters with Buprenorphine initiation in the ED [ Time Frame: Upon discharge from the ED, 1 day ]
  • Proportion of alerted encounters with CDS engagement [ Time Frame: From ED visit through end of trial stage/cycle, up to 18 months ]

Central Contacts and Locations

Central contacts

Locations

Yale New Haven Shoreline Medical Center

Recruiting

Guilford, Connecticut, United States, 06437

Yale New Haven Hospital- St. Raphael

Recruiting

New Haven, Connecticut, United States, 06510

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

More Information

Sponsor

Yale University

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Opioid use disorder
  • Clinical Decision Support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-11.