NCT06812234

Brief Summary

This randomized quality improvement pilot project aims to assess whether the implementation of generative AI software for documentation, Microsoft Nuance's Digital Ambient eXperience (DAX) Copilot, enhances physician documentation efficiency and reduces burnout.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 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

May 1, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

May 28, 2024

Last Update Submit

January 31, 2025

Conditions

Keywords

Documentation burdenClinician EfficiencyGenerative AIDigital Ambient eXperience (DAX)Pediatric subspecialty care

Outcome Measures

Primary Outcomes (2)

  • Pajama Time

    Per Epic Signal: Average number of minutes per scheduled day spent in charting activities outside 7 AM to 5:30 PM on weekdays, time outside scheduled hours on weekends, and time on unscheduled holidays. Numerator: Minutes spent in charting activities outside 7 AM to 5:30 PM on weekdays and outside scheduled hours on weekends. Denominator: Scheduled days where time was spent in the system within the reporting period.

    12 months prior to study through end of study period.

  • Time in Notes per Appointment

    Per Epic Signal: Time spent writing notes per appointment. Numerator: Minutes providers spent in a notes activity or navigator section within the reporting period. Denominator: Appointments within the reporting period. Excludes data from days where the User Action Log data was not submitted.

    12 months prior to study through end of study period.

Secondary Outcomes (7)

  • Progress Note Length (characters)

    12 months prior to study through end of study period.

  • Note Contribution

    12 months prior to study through end of study period.

  • Time to Appointment Closure

    12 months prior to study through end of study period.

  • Proportion of notes completed using DAX copilot generative AI software

    12 months prior to study through end of study period.

  • Patient Volume

    12 months prior to study through end of study period.

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

* No change in documentation practice * Complete modified KLAS net EHR experience surveys

Intervention

EXPERIMENTAL

\- Enrolled in DAX Copilot with appropriate training and asked to use for every eligible visit where the family does not decline use for 3 months.

Other: DAX Copilot

Interventions

* Enrolled in DAX Copilot program. * Epic Haiku verified and adapted to record visits for DAX. * Virtual training to add Patient List column to schedule for DAX Note Status, add appropriate smartlinks to note templates (AI-generated history of present illness, physical exam, and assessment and plan). * In person at-the-elbow support from Children's Epic Support on Site team at initiation and up to 2 additional sessions.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Providers:
  • Practices at Children's in a specialty supported by DAX Copilot product and with available documentation efficiency metrics from Epic's Signal product.
  • \>0.5 clinical full time equivalent (cFTE)
  • or more half days per week on average seeing outpatients as the primary provider (not overseeing trainees or APPs).
  • Agrees to use the Children's EHR mobile application (Haiku) on their personal device.
  • Agrees to offer use of the DAX Copilot generative AI software for all eligible patient visit encounters for the duration of the project period
  • Sufficient and stable EHR data on documentation efficiency from Epic's Signal product, defined as:
  • Having populated data available for at least 40 of the last 52 weeks.
  • Having stable metrics for pajama time and time in notes in the last 6 months as determined by two physician informaticists based on visual inspection.
  • \>75% of ambulatory documentation completed by the provider themselves (as opposed to taking over a note of a trainee or advanced practice provider).
  • Visits: In person office visits in which interactions occur in English. For example, a visit with an interpreter present who translates verbally into English during the visit would be eligible. A visit in which all interactions occur in another language (i.e. the provider speaks the language the family uses as well) would not be eligible as the AI has not been developed yet for other languages.

You may not qualify if:

  • Poor WiFi and cellular coverage in the clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Stella Shin, MD

    Children's Healthcare of Atlanta

    PRINCIPAL INVESTIGATOR
  • Evan Orenstein, MD

    Children's Healthcare of Atlanta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2024

First Posted

February 6, 2025

Study Start

May 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

February 6, 2025

Record last verified: 2025-01

Locations