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NCT Number: NCT06799117

Adaptive Decision Support for Addiction Treatment Master

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Shoreline Medical Center, Guilford, Connecticut, United States

Loading trial locations.

About this study

Computerized clinical decision support (CDS) is a scalable strategy to standardize evidence-

based practices and respond efficiently to the evolving operational demands of the opioid crisis.

Effective practice change requires CDS tools that are usable (easy to learn, efficient to navigate, support task completion with minimal errors, and provide a satisfactory user experience), well-

integrated into clinical workflows and supported by coordinated implementation strategies. We

will refine and evaluate the uptake, usability, and reach of a nationally disseminated multicomponent CDS intervention to improve treatment initiation during emergency care for individuals with opioid use disorder.

This study refines and optimizes the EMBED* clinical decision support (CDS; see NCT03658642) to increase the 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 Phases: This phase has two stages. In stage 1, investigators will conduct a 2x2x2 factorial trial to expand EMBED to include sustainable implementation strategies: nurse prompts 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. We will be randomizing these 3 strategies at the encounter level, resulting in these 8 arms:

Original EMBED

EMBED + nurse prompt

EMBED + clinician prompt

EMBED + patient facing materials

EMBED + nurse prompt + clinician prompt

EMBED + nurse prompt + patient facing materials

EMBED + clinician prompt + patient facing materials

EMBED + nurse prompt + clinician prompt + patient facing materials

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. This will be done by identifying specific targets for improvement and applying novel CDS outcome measures in serial randomized tests.

Evaluation phase: In this confirmatory phase, investigators will conduct a randomized trial to compare the efficacy and effectiveness of the optimized package compared to the original on ED-initiation of buprenorphine rates in patients with OUD. During this phase, the optimized treatment package will be tested in a fully powered 2-arm randomized trial comparing the efficacy of the optimized, multicomponent intervention package to the original EMBED CDS on rates of ED initiation of buprenorphine in patients with OUD. Based on the results of the optimization phase factorial trial in conjunction with findings from the rapid, serial randomized testing, the optimized treatment package will include individual components found to increase CDS uptake and all usability and workflow improvements found to decrease errors and increase efficiency in serial randomized testing.

*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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMBED CDS

Other

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

Other

Nurse prompt to complete COWS

Provider prompt

Other

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

Other

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

Optimized EMBED

Other

CDS following Optimization Phase, Stage 2: Rapid serialized testing

Name of Intervention

Other

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 outcomes

  1. Proportion of encounters with Buprenorphine initiation in the ED

    Time frame: 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.

  2. Proportion of alerted encounters with CDS engagement

    Time frame: From ED visit through end of trial stage/cycle, 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edward Melnick, MD, MHS

CONTACT

[email protected]

203-785-4363

Laurel Buchanan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Adaptive Decision Support for Addiction Treatment (ADAPT)

Acronym: ADAPT

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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