- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598721
Ambient AI Clinical Trial
Evaluation of Abridge Ambient AI Technology Regarding Provider Burnout and Patient Satisfaction With the Clinical Encounter
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Washington
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Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
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No Intervention: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Professional Fulfillment Index (PFI)
Time Frame: 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).
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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)
Time Frame: 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 (%)
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Spent in the Electronic Health Record on Clinical Note Documentation (Minutes)
Time Frame: 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
Time Frame: 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.
|
Through study completion, up to 150 days after the start of the pilot.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher W Lewis, MD, MS, University of Washington
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00022081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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