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NCT Number: NCT07113938

Assessing the Efficacy and Impact of Ambient AI Scribes in Healthcare

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ambient AI Scribe

Device

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

Primary outcomes

  1. Physician Workload as Measured Using the NASA Task Load Index

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

    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.

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

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

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

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

    Time frame: Throughout study completion at 10 working days.

    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.

Secondary outcomes

  1. Documentation Quality as Measured by the PDQI-9

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

    Documentation is scored by two blinded reviewers on a scale from 1-5 (with 5 indicating a higher quality) across 9 domains: up-to-date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, and internally consistent.

  2. Time Spent Within the EMR for Each Clinical Note

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

    The amount of time spent within the EMR for each clinical note and the amount of time spent editing the note on the ambient AI platform will be tracked using EMR logs and time-tracking tools.

  3. Time Spent in the EMR After Hours

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

    The amount of time spent using the EMR after regular working hours will be measured using EMR logs and time-tracking tools.

Study contacts

Contact information is provided by the study sponsor or research team.

Scott Adams, MD, PhD, MEd, FRCPC

CONTACT

[email protected]

306-655-2402

Sundus Zia

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

Assessing the Efficacy and Impact of Ambient AI Scribes in Healthcare: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 11, 2025
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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