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Completed

NCT Number: NCT06793696

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

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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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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

Other

Nurse prompt to complete COWS

Provider prompt

Other

Provider prompt to use EMBED CDS

Patient facing materials

Other

Patient materials provided at discharge from ED

EMBED

Other

Original EMBED CDS

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: Trial start to end 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.

Secondary outcomes

  1. Proportion of encounters with Naloxone prescription upon ED discharge

    Time frame: Upon discharge from the ED, 1 day

    Proportion of eligible encounters with naloxone prescribed on discharge from the Emergency Department (ED). Obtained from EHR data.

  2. Proportion of encounters with patient referral to ongoing MOUD treatment

    Time frame: Upon discharge from the ED, 1 day

    Proportion of eligible encounters with referral for ongoing MOUD treatment received on discharge from the Emergency Department (ED). Obtained from EHR data.

  3. Proportion of encounters with patient receipt of appropriate opioid related discharge instructions

    Time frame: Upon discharge from the ED, 1 day

    Proportion of encounters with appropriate opioid related discharge instructions. Obtained from EHR data.

  4. Proportion of attending physicians initiating BUP in the ED for at least one eligible patient

    Time frame: Trial start to end up to 18 months

    Proportion of attending physicians administered or prescribed Buprenorphine in the Emergency Department (ED) for at least one encounter. Obtained from EHR data.

  5. Proportion of attending physician prescribing naloxone upon ED discharge

    Time frame: Trial start to end up to18 months

    Proportion of attending physicians prescribing naloxone in the Emergency Department (ED) for at least one encounter. Obtained from EHR data.

  6. Proportion of attending physician referral to ongoing MOUD treatment

    Time frame: Trial start to end up to 18 months

    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.

  7. Proportion of attending physicians giving appropriate opioid related discharge instructions

    Time frame: Trial start to end up to 18 months

    Proportion of attending physicians giving appropriate opioid related discharge instructions for at least one encounter. Obtained from EHR data.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2025
Registry last updated
Jan 27, 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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