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

25. august 2026 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

379

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Raffinert EMBED CDS
EMBED CDS raffinert basert på tidligere resultater
Annen: Refined EMBED CDS
Raffinert EMBED CDS
Eksperimentell: 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
Annen: Refined EMBED CDS
Raffinert EMBED CDS
Annen: Provider alert to order consultation with addiction counselor
Provider alert to order consult with addiction counselor

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Proportion of encounters with COWS completed
Tidsramme: Prøverundens start og slutt opptil 3 måneder
Andel av kvalifiserte konsultasjoner der COWS er fullført, av ethvert teammedlem og via enhver arbeidsflyt (internt og eksternt i forhold til EMBED). Hentet fra EHR-data.
Prøverundens start og slutt opptil 3 måneder
Andel møter med Buprenorfin-start i akuttmottaket
Tidsramme: Prøverunde start til slutt opptil 3 måneder
Andel kvalifiserte konsultasjoner der buprenorfin ble administrert i akuttmottaket og/eller foreskrevet ved utskrivelse fra akuttmottaket.
Hentet fra EHR-data.
Prøverunde start til slutt opptil 3 måneder
Andel kvalifiserte konsultasjoner med CDS-engasjement
Tidsramme: Trial round start to end up to 3 months
Andel av kvalifiserte møter der noen del av EMBED-arbeidsflyten ble dokumentert eller fullført.
Trial round start to end up to 3 months
Andel konsultasjoner der buprenorfin ble forskrevet gjennom EMBED kontra eksternt.
Tidsramme: Prøverunde starter til slutt opptil 3 måneder
Andel kvalifiserte konsultasjoner der buprenorfinordren legges inn via EMBED (dvs. ved bruk av EMBED-ordresett)
Prøverunde starter til slutt opptil 3 måneder
Tid brukt på EMBED
Tidsramme: Forsøkets oppstart til slutt varer opptil 3 måneder
Tid (i sekunder) brukt på EMBED totalt og per komponent.
Forsøkets oppstart til slutt varer opptil 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
Task Completion: Proportion of Encounters with COWS Score Entered
Tidsramme: Trial round start to end up to 3 months
Proportion of encounters where EMBED was opened in which a COWS score was entered.
Trial round start to end up to 3 months
Task completion: Buprenorphine order or prescription placed
Tidsramme: 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.
Trial round start to end up to 3 months
Task Completion: Proportion of encounters with OUD diagnosis was recorded
Tidsramme: Trial round start to end up to 3 months
Proportion of encounters where EMBED was opened in which the OUD diagnosis was recorded.
Trial round start to end up to 3 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Yale University

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Etterforskere

  • Hovedetterforsker: Edward Edward, MD, MHS, Yale University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. mai 2026

Primær fullføring (Faktiske)

13. juli 2026

Studiet fullført (Faktiske)

13. juli 2026

Datoer for studieregistrering

Først innsendt

15. mai 2026

Først innsendt som oppfylte QC-kriteriene

15. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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.

Tilgangskriterier for IPD-deling

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 Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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