NCT07598721

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

April 27, 2026

Last Update Submit

May 13, 2026

Conditions

Keywords

Artificial intelligenceAmbient scribeClinical trialBurnoutPrimary careUrologyOncology

Outcome Measures

Primary Outcomes (3)

  • Professional Fulfillment Index (PFI)

    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)

    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 (%)

    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.

Secondary Outcomes (2)

  • Time Spent in the Electronic Health Record on Clinical Note Documentation (Minutes)

    Through study completion, up to 150 days after the start of the pilot.

  • Time spent in the electronic health record outside of working hours

    Through study completion, up to 150 days after the start of the pilot.

Study Arms (2)

Ambient AI scribe

EXPERIMENTAL
Other: Ambient AI scribe

Routine patient care

NO INTERVENTION

Interventions

The ambient AI scribe will be available for the provider to use in the outpatient setting at their discretion.

Ambient AI scribe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Burnout, PsychologicalNeoplasms

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Christopher W Lewis, MD, MS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialty Chief Clinical Information Officer for Rehabilitation Medicine

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 20, 2026

Study Start

December 19, 2024

Primary Completion

July 4, 2025

Study Completion

July 4, 2025

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available for at least 10 years.
Access Criteria
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.
More information

Locations