Adaptive Decision Support for Addiction Treatment (ADAPT) Factorial Trial

Last updated: April 17, 2025
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Patient facing materials

EMBED

Nurse prompt

Clinical Study ID

NCT06793696
2000038624-A
5R33DA059884-02
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Emergency department patient

  • 18 years of age or older

  • Moderate to severe opioid use disorder

Exclusion

Exclusion Criteria:

  • Under 18 years of age

  • Pregnant

  • Currently receiving medication for opioid use disorder

Study Design

Total Participants: 1088
Treatment Group(s): 4
Primary Treatment: Patient facing materials
Phase:
Study Start date:
March 21, 2025
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • Yale New Haven Shoreline Medical Center

    Guilford, Connecticut 06437
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Yale New Haven Hospital- St. Raphael

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

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