NCT06792890

Brief Summary

This is a three-arm pragmatic RCT of 238 outpatient physicians at a large academic health system, randomized 1:1:1 to one of two AI scribe tools or a usual-care control group. The two-month study will observe and compare the effects of each tool prior to system-wide roll out of selected tool (anticipated Spring 2025). We will use covariate-constrained randomization to balance the arms in terms of physician baseline time in notes, survey-measured level of burnout, and clinic days per week. The primary purpose of the initiative is to improve quality, efficiency, and business operations at University of California, Los Angeles (UCLA) Health, and this initiative is not being done for research purposes. The results of this operational initiative will inform the widespread roll out of AI scribe tools across all providers within the UCLA Health System. Nevertheless, the UCLA study team plans to rigorously examine and publish the impact of this intervention across the health system, which is why the study team pre-registered the initiative.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

April 24, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

December 9, 2024

Results QC Date

February 12, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

Artificial Intelligence ScribeRandomized Controlled TrialDocumentation EfficiencyPhysician Burnout

Outcome Measures

Primary Outcomes (1)

  • Change in the Time in Notes Per Note

    The primary outcome measure is the change in provider mean time in notes per note in the second month of the trial from the providers baseline mean time in notes per note for the six months prior to enrollment. This change will be computed on the natural log scale. No patient level information will be collected for this outcome measure.

    Study month 2

Secondary Outcomes (8)

  • Provider Burnout Score

    Study month 2

  • Provider Task Load Score

    Study month 2

  • Provider Professional Fulfillment

    Study month 2

  • Number of Physicians Who Are Considered Detractors, Passive, or Promoters

    Study month 2

  • Change in Provider RVU

    Study month 2

  • +3 more secondary outcomes

Study Arms (3)

Nabla, Vendor of virtual AI scribe technology

OTHER

Participants in this arm will utilize AI scribe tools from Nabla and will continue their usual clinical documentation processes, supported by the scribe software, which integrates with the EHR and automatically adds the generated text to the note. The Nabla AI scribe tool is transcriptional and does not provide clinical decision support.

Other: Use Nabla AI Scribe tool provided

Vendor B of virtual AI scribe technology

OTHER

Participants in this arm will utilize AI scribe tools from Vendor B and will continue their usual clinical documentation processes, supported by the scribe software, which integrates with the EHR and automatically adds the generated text to the note. The AI scribe tool is transcriptional and does not provide clinical decision support.

Other: Use AI Scribe tool provided by Vendor B

No Scribe

NO INTERVENTION

Participants in this arm will not have access to AI scribe tools and will continue their usual clinical documentation processes

Interventions

AI Scribe technologies capture physician-patient conversations to create a transcript, then summarize the transcript in the form of a clinical notes. These tools are integrated into the EHR and automatically adds the generated text to the provider note. All physicians must inform patients about the recording and obtain their verbal consent, and instances of patients declining to consent are tracked. Nabla leverages its proprietary speech-to-text to transform the conversation into a written context, combined with HIPAA compliant Large Language Models (LLM) like Azure OpenAI's GPT-4. Nabla does not store any audio.

Nabla, Vendor of virtual AI scribe technology

AI Scribe technologies capture physician-patient conversations to create a transcript, then summarize the transcript in the form of a clinical notes. These tools are integrated into the EHR and automatically adds the generated text to the provider note. All physicians must inform patients about the recording and obtain their verbal consent, and instances of patients declining to consent are tracked.

Vendor B of virtual AI scribe technology

Eligibility Criteria

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

You may qualify if:

  • Ambulatory care physicians within the UCLA Health system who held at least one half-day of clinic per week

You may not qualify if:

  • Trainee providers (e.g., residents, medical students) and allied healthcare professionals (e.g., RNs, PAs)
  • Attendings who work exclusively with trainees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Health System

Los Angeles, California, 90024, United States

Location

Related Publications (25)

  • Sittig DF, Singh H. Recommendations to Ensure Safety of AI in Real-World Clinical Care. JAMA. 2025 Feb 11;333(6):457-458. doi: 10.1001/jama.2024.24598.

    PMID: 39602298BACKGROUND
  • Gianfrancesco MA, Tamang S, Yazdany J, Schmajuk G. Potential Biases in Machine Learning Algorithms Using Electronic Health Record Data. JAMA Intern Med. 2018 Nov 1;178(11):1544-1547. doi: 10.1001/jamainternmed.2018.3763.

    PMID: 30128552BACKGROUND
  • Linzer M, McLoughlin C, Poplau S, Goelz E, Brown R, Sinsky C; AMA-Hennepin Health System (HHS) burnout reduction writing team. The Mini Z Worklife and Burnout Reduction Instrument: Psychometrics and Clinical Implications. J Gen Intern Med. 2022 Aug;37(11):2876-2878. doi: 10.1007/s11606-021-07278-3. Epub 2022 Jan 19. No abstract available.

    PMID: 35048290BACKGROUND
  • Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.

    PMID: 29196982BACKGROUND
  • Garcia P, Ma SP, Shah S, Smith M, Jeong Y, Devon-Sand A, Tai-Seale M, Takazawa K, Clutter D, Vogt K, Lugtu C, Rojo M, Lin S, Shanafelt T, Pfeffer MA, Sharp C. Artificial Intelligence-Generated Draft Replies to Patient Inbox Messages. JAMA Netw Open. 2024 Mar 4;7(3):e243201. doi: 10.1001/jamanetworkopen.2024.3201.

    PMID: 38506805BACKGROUND
  • Cruz Rivera S, Liu X, Chan AW, Denniston AK, Calvert MJ; SPIRIT-AI and CONSORT-AI Working Group; SPIRIT-AI and CONSORT-AI Steering Group; SPIRIT-AI and CONSORT-AI Consensus Group. Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension. Nat Med. 2020 Sep;26(9):1351-1363. doi: 10.1038/s41591-020-1037-7. Epub 2020 Sep 9.

    PMID: 32908284BACKGROUND
  • McCoy LG, Manrai AK, Rodman A. Large Language Models and the Degradation of the Medical Record. N Engl J Med. 2024 Oct 31;391(17):1561-1564. doi: 10.1056/NEJMp2405999. Epub 2024 Oct 26. No abstract available.

    PMID: 39465898BACKGROUND
  • Hendrix N, Veenstra DL, Cheng M, Anderson NC, Verguet S. Assessing the Economic Value of Clinical Artificial Intelligence: Challenges and Opportunities. Value Health. 2022 Mar;25(3):331-339. doi: 10.1016/j.jval.2021.08.015. Epub 2021 Oct 9.

    PMID: 35227443BACKGROUND
  • Rotenstein L, Melnick ER, Iannaccone C, Zhang J, Mugal A, Lipsitz SR, Healey MJ, Holland C, Snyder R, Sinsky CA, Ting D, Bates DW. Virtual Scribes and Physician Time Spent on Electronic Health Records. JAMA Netw Open. 2024 May 1;7(5):e2413140. doi: 10.1001/jamanetworkopen.2024.13140.

    PMID: 38787556BACKGROUND
  • Cao DY, Silkey JR, Decker MC, Wanat KA. Artificial intelligence-driven digital scribes in clinical documentation: Pilot study assessing the impact on dermatologist workflow and patient encounters. JAAD Int. 2024 Feb 20;15:149-151. doi: 10.1016/j.jdin.2024.02.009. eCollection 2024 Jun. No abstract available.

    PMID: 38571698BACKGROUND
  • Owens LM, Wilda JJ, Grifka R, Westendorp J, Fletcher JJ. Effect of Ambient Voice Technology, Natural Language Processing, and Artificial Intelligence on the Patient-Physician Relationship. Appl Clin Inform. 2024 Aug;15(4):660-667. doi: 10.1055/a-2337-4739. Epub 2024 Jun 4.

    PMID: 38834180BACKGROUND
  • Haberle T, Cleveland C, Snow GL, Barber C, Stookey N, Thornock C, Younger L, Mullahkhel B, Ize-Ludlow D. The impact of nuance DAX ambient listening AI documentation: a cohort study. J Am Med Inform Assoc. 2024 Apr 3;31(4):975-979. doi: 10.1093/jamia/ocae022.

    PMID: 38345343BACKGROUND
  • Liu TL, Hetherington TC, Stephens C, McWilliams A, Dharod A, Carroll T, Cleveland JA. AI-Powered Clinical Documentation and Clinicians' Electronic Health Record Experience: A Nonrandomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2432460. doi: 10.1001/jamanetworkopen.2024.32460.

    PMID: 39240568BACKGROUND
  • Blackley SV, Huynh J, Wang L, Korach Z, Zhou L. Speech recognition for clinical documentation from 1990 to 2018: a systematic review. J Am Med Inform Assoc. 2019 Apr 1;26(4):324-338. doi: 10.1093/jamia/ocy179.

    PMID: 30753666BACKGROUND
  • Heckman J, Mukamal KJ, Christensen A, Reynolds EE. Medical Scribes, Provider and Patient Experience, and Patient Throughput: a Trial in an Academic General Internal Medicine Practice. J Gen Intern Med. 2020 Mar;35(3):770-774. doi: 10.1007/s11606-019-05352-5. Epub 2019 Dec 5.

    PMID: 31808131BACKGROUND
  • Bates DW, Landman AB. Use of Medical Scribes to Reduce Documentation Burden: Are They Where We Need to Go With Clinical Documentation? JAMA Intern Med. 2018 Nov 1;178(11):1472-1473. doi: 10.1001/jamainternmed.2018.3945. No abstract available.

    PMID: 30242315BACKGROUND
  • Mishra P, Kiang JC, Grant RW. Association of Medical Scribes in Primary Care With Physician Workflow and Patient Experience. JAMA Intern Med. 2018 Nov 1;178(11):1467-1472. doi: 10.1001/jamainternmed.2018.3956.

    PMID: 30242380BACKGROUND
  • Steinkamp J, Kantrowitz JJ, Airan-Javia S. Prevalence and Sources of Duplicate Information in the Electronic Medical Record. JAMA Netw Open. 2022 Sep 1;5(9):e2233348. doi: 10.1001/jamanetworkopen.2022.33348.

    PMID: 36156143BACKGROUND
  • Sinsky C, Colligan L, Li L, Prgomet M, Reynolds S, Goeders L, Westbrook J, Tutty M, Blike G. Allocation of Physician Time in Ambulatory Practice: A Time and Motion Study in 4 Specialties. Ann Intern Med. 2016 Dec 6;165(11):753-760. doi: 10.7326/M16-0961. Epub 2016 Sep 6.

    PMID: 27595430BACKGROUND
  • Guille C, Sen S. Burnout, Depression, and Diminished Well-Being among Physicians. N Engl J Med. 2024 Oct 24;391(16):1519-1527. doi: 10.1056/NEJMra2302878. No abstract available.

    PMID: 39442042BACKGROUND
  • Lou SS, Lew D, Harford DR, Lu C, Evanoff BA, Duncan JG, Kannampallil T. Temporal Associations Between EHR-Derived Workload, Burnout, and Errors: a Prospective Cohort Study. J Gen Intern Med. 2022 Jul;37(9):2165-2172. doi: 10.1007/s11606-022-07620-3. Epub 2022 Jun 16.

    PMID: 35710654BACKGROUND
  • Moy AJ, Schwartz JM, Chen R, Sadri S, Lucas E, Cato KD, Rossetti SC. Measurement of clinical documentation burden among physicians and nurses using electronic health records: a scoping review. J Am Med Inform Assoc. 2021 Apr 23;28(5):998-1008. doi: 10.1093/jamia/ocaa325.

    PMID: 33434273BACKGROUND
  • Peccoralo LA, Kaplan CA, Pietrzak RH, Charney DS, Ripp JA. The impact of time spent on the electronic health record after work and of clerical work on burnout among clinical faculty. J Am Med Inform Assoc. 2021 Apr 23;28(5):938-947. doi: 10.1093/jamia/ocaa349.

    PMID: 33550392BACKGROUND
  • Lukac PJ, Turner W, Vangala S, Chin AT, Khalili J, Shih YT, Sarkisian C, Cheng EM, Mafi JN. Ambient AI Scribes in Clinical Practice: A Randomized Trial. NEJM AI. 2025 Dec;2(12):10.1056/aioa2501000. doi: 10.1056/aioa2501000. Epub 2025 Nov 26.

  • 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.

Results Point of Contact

Title
Dr. John N. Mafi, MD, MPH
Organization
University of California, Los Angeles

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The outpatient physicians are not told which tool that they are assigned to.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

December 9, 2024

First Posted

January 27, 2025

Study Start

November 4, 2024

Primary Completion

January 3, 2025

Study Completion

January 15, 2025

Last Updated

April 24, 2026

Results First Posted

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations