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Ambient AI Clinical Trial

22. Mai 2026 aktualisiert von: Chris Lewis, University of Washington

Evaluation of Abridge Ambient AI Technology Regarding Provider Burnout and Patient Satisfaction With the Clinical Encounter

This is a single-site pragmatic randomized control trial studying the effect of ambient artificial intelligence (AI) scribes on the delivery of medical care to patients in the ambulatory setting. The study will last 150 days and include up to 65 providers in the intervention group. Providers will be recruited from three medical specialties, including primary care, oncology, and urology. The study will enroll providers and randomize them to an intervention group (access to the ambient AI scribe product) or a control group (routine patient care). Providers will be evaluated for burnout and task load measures through digital surveys at the beginning, middle, and end of the study. Provider electronic health record (EHR) usage data will also be evaluated for time spent documenting, time spent after hours on days with scheduled clinical care, and time between the start of the clinical encounter and signing it.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

139

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Washington
      • Seattle, Washington, Vereinigte Staaten, 98195
        • University of Washington Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Provider is an employee of the University of Washington Medicine.
  • Clinical specialty of primary care, oncology, or urology.
  • Clinical full-time equivalent (FTE) of 0.2 or greater (provider must have an outpatient clinic of at least 20% of an FTE).
  • Provider is a physician or an advanced practice provider.

Exclusion Criteria:

  • Trainees (e.g., medical students, residents, or fellows)
  • Provider does not have access to a mobile device that is compatible with the ambient AI scribe service (e.g., Android mobile phone).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Ambient AI scribe users
Participants in this arm will utilize the ambient AI scribe tools from Abridge. They will otherwise continue their usual clinical activities, including providing care with trainees (e.g., medical students, residents) and multiple family members in the room. The tool will be used exclusively in the outpatient clinical setting and only when the participant is present. The ambient AI scribe tool integrates into the electronic health record (EHR), and the EHR's mobile app is used to collect the recording on a mobile device. The ambient AI scribe tool is transcriptional and does not provide clinical decision support.
Sonstiges: Use of Ambient AI scribe tool on participant's mobile device

Ambient artificial intelligence (AI) scribes are a clinical documentation tool that uses automated speech recognition and large-scale language models to capture and transcribe synchronous patient-provider encounters in real time. Clinicians then review, edit, and authorize the AI-generated text before finalizing the chart, ensuring necessary human oversight and medical accuracy. In this study, participants used Ambient AI scribes on mobile devices for the recordings.

The ambient AI scribe will be available for the provider to use in the outpatient setting. They were not required to use the Ambient AI scribe, but could choose whether to use it and with which patients. Consent to use the device was documented for all patient encounters.

Andere Namen:
  • Kürzen
Kein Eingriff: Routine patient care (no AI scribe)
These participants were not provided with the ambient AI scribe application on their mobile device. They still had access to documentation with dictation or existing scribe services (non-AI).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Professional Fulfillment Index (PFI)
Zeitfenster: Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
Change in professional fulfillment and burnout, measured using the Professional Fulfillment Index (PFI), a validated 16-item self-report questionnaire. The instrument comprises three subscales: Professional Fulfillment (6 items), Work Exhaustion (4 items), and Interpersonal Disengagement (6 items). Items are rated on a 5-point Likert scale (0 = "Not at all true" / "Not at all" to 4 = "Completely true" / "Extremely"). Subscale scores are calculated as the mean of constituent items. Unit of measure: mean subscale score (range 0-4) and overall burnout score (mean of Work Exhaustion and Interpersonal Disengagement subscales, range 0-4).
Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
Mean Score on NASA Task Load Index (NASA-TLX)
Zeitfenster: Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
Change in perceived workload, measured using the NASA Task Load Index (NASA-TLX), a validated multidimensional self-report questionnaire. The instrument comprises six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is rated on a 0-100 scale in 5-point increments. Unit of measure: subscale score (range 0-100) and overall workload score, calculated as the unweighted mean of the six subscales (range 0-100). Higher scores indicate greater perceived task workload associated with clinical documentation.
Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
Ambient AI scribe utilization rate (%)
Zeitfenster: Through study completion, up to 150 days after the start of the pilot.
Percentage of clinical encounters in which the provider used the Abridge ambient AI scribe, measured using Abridge platform usage logs cross-referenced with electronic health record (EHR) encounter data. Unit of measure: utilization rate, calculated as (number of encounters in which Abridge was used divided by the total number of clinical encounters during the same period). This fraction is then represented as a percentage (range 0-100%) and aggregated monthly by provider.
Through study completion, up to 150 days after the start of the pilot.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time Spent in the Electronic Health Record on Clinical Note Documentation (Minutes)
Zeitfenster: Through study completion, up to 150 days after the start of the pilot.
Time spent by the provider in the electronic health record on clinical note documentation activities, measured using EHR audit log data (e.g., Epic Signal Provider Efficiency Profile). Unit of measure: minutes per scheduled clinic day on note documentation, normalized to clinical workload (clinical Full-Time Equivalent), and aggregated in 4-week windows per provider. No patient information will be collected for this outcome measure.
Through study completion, up to 150 days after the start of the pilot.
Time spent in the electronic health record outside of working hours
Zeitfenster: Through study completion, up to 150 days after the start of the pilot.
Time spent by the provider in the electronic health record outside of scheduled clinic/working hours (commonly referred to as "work outside of work" or "pajama time"), measured using EHR audit log data (e.g., Epic Signal Provider Efficiency Profile). Unit of measure: minutes per scheduled clinic day spent in the EHR outside of working hours, normalized to clinical workload and aggregated in 4-week windows per provider. No patient information will be collected for this outcome measure.
Through study completion, up to 150 days after the start of the pilot.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Washington

Ermittler

  • Hauptermittler: Christopher W Lewis, MD, MS, University of Washington

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Dezember 2024

Primärer Abschluss (Tatsächlich)

4. Juli 2025

Studienabschluss (Tatsächlich)

4. Juli 2025

Studienanmeldedaten

Zuerst eingereicht

27. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00022081

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

All participant data will be deidentified (limited dataset), aggregated, or normalized. Data will be managed and stored on Dryad (https://datadryad.org/), a nonprofit membership organization that is committed to making data available for research and educational reuse.

IPD-Sharing-Zeitrahmen

Data will be available for at least 10 years.

IPD-Sharing-Zugriffskriterien

Data will be shared with qualified researchers whose proposed use has been approved by an institutional review board. Request for deidentified data will be available through Dryad. Requests for additional data can be made to the study's PI.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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