Ambient AI Clinical Trial
22 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
139
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
Otros nombres:
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Sin intervención: 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).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Professional Fulfillment Index (PFI)
Periodo de tiempo: Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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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).
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Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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Mean Score on NASA Task Load Index (NASA-TLX)
Periodo de tiempo: Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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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.
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Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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Ambient AI scribe utilization rate (%)
Periodo de tiempo: Through study completion, up to 150 days after the start of the pilot.
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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.
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Through study completion, up to 150 days after the start of the pilot.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Time Spent in the Electronic Health Record on Clinical Note Documentation (Minutes)
Periodo de tiempo: Through study completion, up to 150 days after the start of the pilot.
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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.
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Through study completion, up to 150 days after the start of the pilot.
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Time spent in the electronic health record outside of working hours
Periodo de tiempo: Through study completion, up to 150 days after the start of the pilot.
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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.
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Through study completion, up to 150 days after the start of the pilot.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Christopher W Lewis, MD, MS, University of Washington
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de diciembre de 2024
Finalización primaria (Actual)
4 de julio de 2025
Finalización del estudio (Actual)
4 de julio de 2025
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
22 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00022081
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
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.
Marco de tiempo para compartir IPD
Data will be available for at least 10 years.
Criterios de acceso compartido de IPD
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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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