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Adaptive Decision Support for Addiction Treatment (ADAPT) Serial Randomized Testing for Usability, Round 2

15. maj 2026 opdateret af: Yale University
This study is stage 2, round 2 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.

Studieoversigt

Detaljeret beskrivelse

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 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 second round we will randomize an alert to providers to order a consult with addiction counselors. 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Connecticut
      • Guilford, Connecticut, Forenede Stater, 06437
        • Yale New Haven Shoreline Medical Center
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale New Haven Hospital
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale New Haven Hospital- St. Raphael

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active Comparator: Refined EMBED CDS
EMBED CDS refined based on previous results
Raffineret EMBED CDS
Eksperimentel: Refined EMBED plus provider alert in Epic to order a consult with an addiction counselor
Provider alert in Epic to order a consult with an addiction counselor to assess for eligibility and initiation of MOUD
Raffineret EMBED CDS
Provider alert to order consult with addiction counselor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of encounters with an order for an addiction counselor consult
Tidsramme: Trial round start to end up to 3 months
Proportion of encounters with documentation of a clinician order for an addiction counselor consult specifically to assess for eligibility and initiation of MOUD.
Trial round start to end up to 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Andel af møder med buprenorphin-initiering på skadestuen
Tidsramme: Forsøgsrunde start til slut op til 3 måneder
Andel af kvalificerede konsultationer, hvor buprenorphin administreres på skadestuen (ED) og/eller ordineres buprenorphin ved udskrivning fra skadestuen.
Indhentet fra EHR-data.
Forsøgsrunde start til slut op til 3 måneder
Andel af berettigede konsultationer med CDS-engagement
Tidsramme: Forsøgsrundestart til slutning op til 3 måneder
Andel af berettigede møder, hvor en del af EMBED-arbejdsgangen blev dokumenteret eller afsluttet.
Forsøgsrundestart til slutning op til 3 måneder
Andel af møder, hvor buprenorphin blev ordineret via EMBED vs. eksternt.
Tidsramme: Forsøgets runde starter til slutter op til 3 måneder
Andel af berettigede møder, hvor buprenorphin ordren placeres via EMBED (dvs. ved brug af EMBED ordresæt)
Forsøgets runde starter til slutter op til 3 måneder
Teamwork on ED initiation of buprenorphine
Tidsramme: Trial round start to end up to 3 months
Proportion of encounters with multi-team-member use of EMBED for buprenorphine initiation, out of encounters with any team member use of EMBED for buprenorphine initiation
Trial round start to end up to 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Edward Edward, MD, MHS, Yale University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

21. maj 2026

Primær færdiggørelse (Anslået)

1. august 2026

Studieafslutning (Anslået)

1. august 2026

Datoer for studieregistrering

Først indsendt

15. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

22. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2000038624-B2
  • 5R33DA059884-02 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified data related to EHR use measurements in various levels of aggregation. e.g., time spent on the CDS or threshold outcomes such as dismissal of the CDS without action under a specific amount of time or the time spent on CDS that exceeds what was expected based on the patient's clinical opioid withdrawal (COWS) score, time in the ED, or level of acuity, patient acuity, chief complaints or diagnoses, clinician, interruptions (such as orders started but not finished), task switching, seasonality, and variation in shift timing (such as nights and weekends). Data shared will include variables relating to patient demographics, medical history, prescription information, clinician facing clinical decision support (CDS) firing and clinician action information, and clinician prescribing decisions and historical prescribing.

IPD-delingstidsramme

De-identified data will be shared with NAHDAP as soon as possible upon completion of quality control procedures, analysis, and at the time of associated publication or end of performance period. Data will be released by NAHDAP at the time of receipt and will be available indefinitely.

IPD-delingsadgangskriterier

De-identified data sets used for analysis will be submitted to NAHDAP through the NIH HEAL Initiative and will be available for public use according to NAHDAP data sharing policies and restrictions set by our DUA with NAHDAP and our IRB. All data submissions to NAHDAP undergo confidentiality review to protect respondents' data from being re-identified.

Portions of the ADAPT intervention will be built for national distribution on the Epic EHR platform. Distribution of code that is proprietary to Epic may limit distribution of certain portions of software or code. In this situation, investigators will provide dashboards and visualizations of workflow diagrams as appropriate to disclose interface and workflow concepts to the broader scientific community These portions of the data will also be subject to restricted use access outside of organizations using Epic.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Opioidbrugsforstyrrelse

Kliniske forsøg med Refined EMBED CDS

Abonner