Ambient AI for Provider Well-Being

NCT06517082 | Completed DMC

• 3 other identifiers: 2024-1028A534285Protocol Version 7/7/2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether using Ambient Artificial Intelligence for provider documentation will enhance provider well-being and improve documentation quality. Participants will complete their documentation using the Ambient AI software.

Conditions

Healthcare Provider Well-being

Keywords

Artificial Intelligence; Physician well-being; Healthcare provider

Outcome Measures

Primary Outcomes (2)

• Change in provider fulfillment index

  Using the Professional Well-Being Academic Consortium Survey Measures, the fulfillment index is a 6-item questionnaire. Each question is scored on a 0-4 Likert scale, with total possible scores of 0-24. Higher scores indicate greater fulfillment

  Baseline to weeks 6, 12, 18, and 24

• Change in provider burnout

  Using the Professional Well-Being Academic Consortium Survey Measures, the burnout index includes two subcomponents of work exhaustion and interpersonal disengagement. It is a 10-item questionnaire, scored together as a composite. Each question is scored on a 0-4 Likert scale, with a total possible range of 0-40. Higher scores indicate greater burnout, indicating lower well-being

  Baseline to weeks 6, 12, 18, and 24

Secondary Outcomes (4)

• Change in time spent on documentation outside work hours

  Baseline to 24 weeks

• Change in task load

  Baseline to 24 weeks

• Change in meaningfulness of work

  Baseline to 24 weeks

• Change in meaningful relationships

  Baseline to 24 weeks

Study Arms (3)

Ambient Listening Group 1

EXPERIMENTAL

Participants randomized to this arm will start using Ambient AI at week 7.

Other: Artificial Intelligence

Ambient Listening Group 2

EXPERIMENTAL

Participants randomized to this arm will start using Ambient AI at week 13.

Other: Artificial Intelligence

Ambient Listening Group 3

EXPERIMENTAL

Participants randomized to this arm will start using Ambient AI at week 19.

Other: Artificial Intelligence

Interventions

Artificial Intelligence OTHER

Ambient AI software intervention is implemented into the providers workflow. The software incorporates Automated Speech Recognition technology with Large Language Models to generate clinical documentation in real-time.

Ambient Listening Group 1; Ambient Listening Group 2; Ambient Listening Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthcare Provider in the UW Health Outpatient Clinic Setting
• Willingness to engage and use ambient technology
• Owns an Apple mobile device, as the software is accessible only on this platform
• Adult (greater than 18 years)
• English or Spanish speaking
• Completed the training and in-servicing required to use the tool
• Providing outpatient care to no less than 20 encounters on a weekly average

You may not qualify if:

• Planned leave in 6 weeks following randomization
• Not registered onto Epic's mobile Haiku system for access
• Enrolled in a virtual scribe program and not willing to leave the program

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (3)

• 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: 41625485 DERIVED

• Afshar M, Resnik F, Baumann MR, Hintzke J, Lemmon K, Sullivan AG, Shah T, Stordalen A, Oberst M, Dambach J, Mrotek LA, Quinn M, Abramson K, Kleinschmidt P, Brazelton T, Twedt H, Kunstman D, Wills G, Long J, Patterson BW, Liao FJ, Rasmussen S, Burnside E, Goswami C, Gordon JE. A Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice. NEJM AI. 2025 Sep;2(9):10.1056/aidbp2401267. doi: 10.1056/aidbp2401267. Epub 2025 Aug 28.

  PMID: 40959192 DERIVED

• Afshar M, Resnik F, Baumann MR, Hintzke J, Lemmon K, Sullivan AG, Shah T, Stordalen A, Oberst M, Dambach J, Mrotek LA, Quinn M, Abramson K, Kleinschmidt P, Brazelton T, Twedt H, Kunstman D, Wills G, Long J, Patterson BW, Liao FJ, Rasmussen S, Burnside E, Goswami C, Gordon JE. A Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice. medRxiv [Preprint]. 2025 Aug 14:2024.12.27.24319685. doi: 10.1101/2024.12.27.24319685.

  PMID: 39763559 DERIVED

MeSH Terms

Interventions

Artificial Intelligence

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Study Officials

• Majid Afshar, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Joel Gordon, MD

  University of Wisconsin, Madison

  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: SPONSOR

Model Details: The stepped wedge design involves staggered implementation of an intervention across different providers over multiple time periods, allowing all providers to eventually receive the intervention.

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: August 15, 2024
• Primary Completion: March 27, 2025
• Study Completion: March 27, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Duration of storage will be at least 10 years.
• Access Criteria: Access to data and recordings and security measures will require IRB approval and request through CRDS.

Locations

US (1)