Assessing the Efficacy and Impact of Ambient AI Scribes in Healthcare

NCT07113938 | Not Yet Recruiting

• 1 other identifier: 5336
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to assess the impacts of ambient AI scribes on the workload and burnout in physicians who see patients in a clinic setting at least twice in a week, as well as the impacts on patient-physician interaction. The main questions it aims to answer are:

• What is the impact of ambient AI scribe use on physician workload and burnout?
• What is the impact of ambient AI scribe use on quality of patient-physician interaction? Researchers will compare the group of physicians using the ambient AI scribes to the group not using ambient AI scribes to see if there are any significant differences. Participants randomly assigned to Group A will make use of the AI scribe and participants randomly assigned to Group B will not use any AI scribe for the 10 working day duration of the study. They will be asked to complete a survey assessing workload and burnout immediately prior to the commencement of the study and at the end of each week of the study or 5 full working days for part time physicians. They will also invite their patients to complete a survey assessing their experience after each clinical interaction.

Conditions

Use of Ambient AI Scribes; Patient-Phyisican Interaction; Physician Workload; Physician Burnout

Keywords

artificial intelligence; physician workload; physician burnout; documentation quality

Outcome Measures

Primary Outcomes (3)

• Physician Workload as Measured Using the NASA Task Load Index

  The NASA-TLX is separated into six 100-point scales with 5-point steps that assess mental demand, physical demand, temporal demand, performance, effort, and frustration. A higher score indicates that they feel a greater degree of each of the domains.

  From enrolment to the end of the study at 10 working days.

• Physician Burnout as Measured Using the MBI - HSS (MP)

  The MBI-HSS (MP) is created specifically for medical personnel and assesses emotional exhaustion (9 items), depersonalization (5 items), and personal accomplishment (8 items).

  From enrolment to the end of the study at 10 working days.

• Quality of Patient-Physician Interaction As Measured Using the CARE Patient Feedback Measure Domain of "Really Listening"

  The CARE measure consists of a series of 10 questions asked of patients with our focus on the domain of whether the physician was "really listening (paying close attention to what you were saying; not looking at the notes or computer as you were talking)" scored on a 5 point Likert scale.

  Throughout study completion at 10 working days.

Secondary Outcomes (3)

• Documentation Quality as Measured by the PDQI-9

  From enrollment to the completion of the study at 10 working days.

• Time Spent Within the EMR for Each Clinical Note

  From enrollment to the completion of the study at 10 working days.

• Time Spent in the EMR After Hours

  From enrollment to the completion of the study at 10 working days.

Study Arms (2)

Ambient AI Scribe Users

EXPERIMENTAL

This group will make use of the ambient AI scribe in their clinical visits to generate clinical notes for them over the duration of the study.

Device: Ambient AI Scribe

Non-Ambient AI Users

NO INTERVENTION

This group will continue to generate their own clinical notes without the use of ambient AI scribes over the duration of the study.

Interventions

Ambient AI Scribe DEVICE

Software that records audio of a clinical interaction and generates a clinical note.

Ambient AI Scribe Users

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Physicians from family medicine or any specialty
• Physicians who regularly see patients in a clinic setting at least 2 days per week

You may not qualify if:

• Physicians who are planning to leave their practice during the study period

Sponsors & Collaborators

• University of Saskatchewan: lead

Related Publications (5)

• Li B, Crampton N, Yeates T, Xia Y, Tian X, Truong KN. Automating Clinical Documentation with Digital Scribes: Understanding the Impact on Physicians. In: CHI '21: Proceedings of the 2021 CHI Conference on Human Factors in Computing Systems. Association for Computing Machinery; 2021. Accessed July 1, 2024. https://doi.org/10.1145/3411764.3445172

  BACKGROUND

• Davenport T, Kalakota R. The potential for artificial intelligence in healthcare. Future Healthc J. 2019 Jun;6(2):94-98. doi: 10.7861/futurehosp.6-2-94.

  PMID: 31363513 BACKGROUND

• Saag HS, Shah K, Jones SA, Testa PA, Horwitz LI. Pajama Time: Working After Work in the Electronic Health Record. J Gen Intern Med. 2019 Sep;34(9):1695-1696. doi: 10.1007/s11606-019-05055-x. No abstract available.

  PMID: 31073856 BACKGROUND

• Tierney AA, Gayre G, Hoberman B, et al. Ambient Artificial Intelligence Scribes to Alleviate the Burden of Clinical Documentation. NEJM Catal. 2024;5(3). doi:10.1056/cat.23.0404

  BACKGROUND

• Shanafelt TD, Dyrbye LN, West CP, Sinsky CA. Potential Impact of Burnout on the US Physician Workforce. Mayo Clin Proc. 2016 Nov;91(11):1667-1668. doi: 10.1016/j.mayocp.2016.08.016. No abstract available.

  PMID: 27814840 BACKGROUND

Study Officials

• Scott Adams, MD, PhD, MEd, FRCPC

  University of Saskatchewan College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Adams, MD, PhD, MEd, FRCPC

CONTACT

306-655-2402; scott.adams@usask.ca

Sundus Zia

CONTACT

sundus.zia@usask.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Two blinded reviewers will independently review each clinical note and assign a PDQI-9 score according to the nine attributes that measure various aspects of documentation quality.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medical Imaging, University of Saskatchewan

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 11, 2025
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share