NCT07742761

Brief Summary

The primary objective of the study is to investigate the impact of an ambient AI scribe on clinicians' wellness and well-being outcomes; additionally, we also investigate how the use of the ambient AI scribe will lead to changes in documentation burden, clinical note characteristics and financial productivity.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Apr 2026Jul 2027

Study Start

First participant enrolled

April 29, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 3, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 21, 2026

Last Update Submit

July 28, 2026

Conditions

Keywords

Ambient AI ScribesWellness, well-being outcomesBurnout

Outcome Measures

Primary Outcomes (1)

  • Impact of an ambient AI scribe on clinician well-being and professional fulfillment

    We will fit a linear model to describe the effect of Ambient tool introduction on our co-primary outcomes under the intention-to-treat (ITT) framework with a random effects structure to describe within provider variability. While we anticipate high or complete survey completion rates, in the event that not all surveys are completed and returned, we will perform a primary analysis on completed surveys only, and perform sensitivity analyses accounting for potentially systematic survey non-response bias using a response weighting strategy, using provider, scheduling, and patient encounter characteristics to create survey response weights (within each survey time period), then reweighting observations to account for non-response patterns. In analyses for both co-primary outcomes, we will perform Wald type hypothesis tests for inferences on the overall Ambient treatment effect and compare p-values to 0.05 / 2 to conservatively account for multiple comparisons using Bonferroni's method.

    From enrollment to the end of maintenance phase at 24 weeks

Secondary Outcomes (1)

  • Assessment of the longitudinal changes in documentation burden

    From enrollment to the end of maintenance phase at 42 weeks

Study Arms (3)

Ambient AI Scribe Intervention, Wave 1 (Step-wedge design)

EXPERIMENTAL

Clinicians use an ambient AI scribe during patient encounters to assist with clinical documentation. Wave 1 participants receive the intervention for 18 weeks. Outcomes are compared before and after implementation.

Other: Ambient AI Scribe

Ambient AI Scribe Intervention, Wave 2 (Step-wedge design)

EXPERIMENTAL

Clinicians use an ambient AI scribe during patient encounters to assist with clinical documentation. Wave 2 participants receive the intervention for 12 weeks. Outcomes are compared before and after implementation.

Other: Ambient AI Scribe

Ambient AI Scribe Intervention Wave 3 (Step-wedge design)

EXPERIMENTAL

Clinicians use an ambient AI scribe during patient encounters to assist with clinical documentation. Wave 1 participants receive the intervention for 6 weeks. Outcomes are compared before and after implementation.

Other: Ambient AI Scribe

Interventions

Clinicians will use an ambient AI scribe as part of routine clinical care. The AI scribe captures the patient-clinician conversation, generates a draft clinical note, and supports documentation in the electronic health record. Clinicians receive training before beginning use of the AI scribe. The intervention is introduced in three sequential waves using a stepped-wedge design, with all participants eventually receiving the intervention.

Ambient AI Scribe Intervention Wave 3 (Step-wedge design)Ambient AI Scribe Intervention, Wave 1 (Step-wedge design)Ambient AI Scribe Intervention, Wave 2 (Step-wedge design)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be a Clinician (attendings and advanced practice practitioners) who is part of the Emergency Medicine Department
  • Must be willing to use Ambient AI as apart of their clinical practice work

You may not qualify if:

  • Residents who are apart of the Emergency Medicine Department

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (30)

  • Tierney, Aaron A., et al. "Ambient artificial intelligence scribes to alleviate the burden of clinical documentation." NEJM Catalyst Innovations in Care Delivery

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  • Ma SP, Liang AS, Shah SJ, Smith M, Jeong Y, Devon-Sand A, Crowell T, Delahaie C, Hsia C, Lin S, Shanafelt T, Pfeffer MA, Sharp C, Garcia P. Ambient artificial intelligence scribes: utilization and impact on documentation time. J Am Med Inform Assoc. 2025 Feb 1;32(2):381-385. doi: 10.1093/jamia/ocae304.

    PMID: 39688515BACKGROUND
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    PMID: 41100159BACKGROUND
  • Lukac PJ, Turner W, Vangala S, Chin AT, Khalili J, Shih YT, Sarkisian C, Cheng EM, Mafi JN. A Randomized-Clinical Trial of Two Ambient Artificial Intelligence Scribes: Measuring Documentation Efficiency and Physician Burnout. medRxiv [Preprint]. 2025 Jul 11:2025.07.10.25331333. doi: 10.1101/2025.07.10.25331333.

    PMID: 40672471BACKGROUND
  • Afshar M, Baumann MR, Resnik F, Hintzke J, Sullivan AG, Wills G, Lemmon K, Dambach J, Ann Mrotek L, Quinn M, Abramson K, Kleinschmidt P, Brazelton TB, Leaf MA, Twedt H, Kunstman D, Patterson B, Liao F, Rasmussen S, Burnside ES, Goswami C, Gordon J. A Pragmatic Randomized Controlled Trial of Ambient Artificial Intelligence to Improve Health Practitioner Well-Being. NEJM AI. 2025 Dec;2(12):10.1056/aioa2500945. doi: 10.1056/aioa2500945. Epub 2025 Nov 26.

    PMID: 41625485BACKGROUND
  • Stults CD, Deng S, Martinez MC, Wilcox J, Szwerinski N, Chen KH, Driscoll S, Washburn J, Jones VG. Evaluation of an Ambient Artificial Intelligence Documentation Platform for Clinicians. JAMA Netw Open. 2025 May 1;8(5):e258614. doi: 10.1001/jamanetworkopen.2025.8614.

    PMID: 40314951BACKGROUND
  • Kanaparthy NS, Villuendas-Rey Y, Bakare T, Diao Z, Iscoe M, Loza A, Wright D, Safranek C, Faustino IV, Brackett A, Melnick ER, Taylor RA. Real-World Evidence Synthesis of Digital Scribes Using Ambient Listening and Generative Artificial Intelligence for Clinician Documentation Workflows: Rapid Review. JMIR AI. 2025 Oct 10;4:e76743. doi: 10.2196/76743.

    PMID: 41071988BACKGROUND
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    PMID: 27595430BACKGROUND
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    PMID: 35344006BACKGROUND
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    PMID: 36342001BACKGROUND
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    PMID: 33434273BACKGROUND
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    PMID: 29410388BACKGROUND
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    PMID: 31984357BACKGROUND
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    PMID: 35710654BACKGROUND
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MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Thomas Kannampallil, PhD

    Washington University in Saint Louis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Institute for Informatics, Data Science, and Biostatistics (I2DB), WashU Medicine Vice Chancellor for Biomedical Informatics and Data Science, WashU Medicine Chief Health AI Officer, BJC Health and WashU Medicine

Study Record Dates

First Submitted

July 21, 2026

First Posted

August 3, 2026

Study Start

April 29, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

August 3, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations