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Completed

NCT Number: NCT07549126

Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 1

This study is stage 2, round 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.

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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

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About this study

This study is stage 2, 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 study 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 first round we will test the placement of the nurse prompt to complete COWS randomizing encounters to place the prompt under either required or optional documentation. 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.

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

Nurse prompt to complete COWS under required documentation

Other

Nurse receives prompt to complete COWS under required documentation

Refined EMBED CDS

Other

Refined EMBED CDS

Primary outcomes

  1. Proportion of encounters with COWS completed

    Time frame: Trial round start to end up to 3 months

    Proportion of eligible encounters with a COWS competed, by any team member and via any workflow (internal and external of EMBED). Obtained from EHR data.

Secondary outcomes

  1. Proportion of encounters with Buprenorphine initiation in the ED

    Time frame: Trial round start to end up to 3 months

    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 eligible encounters with CDS engagement

    Time frame: Trial round start to end up to 3 months

    Proportion of eligible encounters in which any portion of the EMBED workflow was documented or completed.

  3. Teamwork on CDS Engagement

    Time frame: Trial round start to end up to 3 months

    Proportion of eligible encounters in which more than one team member (regardless of role) helped complete the EMBED workflow.

  4. Proportion of eligible users who used EMBED

    Time frame: Trial round start to end up to 3 months

    Proportion of EM staff members (Attendings, Residents and APPS) who cared for at least patient for whom the alert fired during the study period who used EMBED at least once during the study period.

  5. Proportion of encounters in which buprenorphine was ordered through EMBED vs. externally.

    Time frame: Trial round start to end up to 3 months

    Proportion of eligible encounters in which buprenorphine order is placed through EMBED (i.e., using EMBED order set)

  6. Time spent on EMBED

    Time frame: Trial round start to end up to 3 months

    Time (in seconds) spent on EMBED overall and by component.

  7. Task Completion: Proportion of encounters with OUD diagnosis was recorded

    Time frame: Trial round start to end up to 3 months

    Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded

  8. Task Completion: Proportion of Encounters with COWS Score Entered

    Time frame: Trial round start to end up to 3 months

    Proportion of encounters where EMBED was opened in which a COWS score was entered.

  9. Task completion: Buprenorphine order or prescription placed

    Time frame: Trial round start to end up to 3 months

    Proportion of encounters where EMBED was opened in which a buprenorphine order or prescription was placed.

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) Serial Randomized Testing for Usability

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2026
Registry last updated
Jul 30, 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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