Use of Ambient AI ScribesNCT07113938
Assessing the Efficacy and Impact of Ambient AI Scribes in Healthcare
A study testing Ambient AI Scribe in people with Use of Ambient AI Scribes and Patient-Phyisican Interaction, run by University of Saskatchewan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Use of Ambient AI Scribes, Patient-Phyisican Interaction, Physician Workload
- What is being tested?
- Ambient AI Scribe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Physicians from family medicine or any specialty
- Physicians who regularly see patients in a clinic setting at least 2 days per week
Who cannot join
- Physicians who are planning to leave their practice during the study period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sundus Zia contact
About this study
Official title: Assessing the Efficacy and Impact of Ambient AI Scribes in Healthcare: A Randomized Controlled Trial
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:
Read more
- 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
- Being tested
- Ambient AI Scribe
- Keywords
- artificial intelligence, physician workload, physician burnout, documentation quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambient AI ScribeDevice
Software that records audio of a clinical interaction and generates a clinical note.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Throughout study completion at 10 working days.
Secondary outcomes (3)
Documentation Quality as Measured by the PDQI-9
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.
Measured: From enrollment to the completion of the study at 10 working days.
Time Spent Within the EMR for Each Clinical Note
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.
Measured: From enrollment to the completion of the study at 10 working days.
Time Spent in the EMR After Hours
The amount of time spent using the EMR after regular working hours will be measured using EMR logs and time-tracking tools.
Measured: From enrollment to the completion of the study at 10 working days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Use of Ambient AI ScribesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Adams, University of Saskatchewan
- Investigators
- Scott Adams, MD, PhD, MEd, FRCPC, Principal investigator, University of Saskatchewan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113938
- Sponsor's protocol ID
- 5336
- Status last verified
- Aug 2025
- First submitted
- 21 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
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.
PubMed 31363513Saag 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.
PubMed 31073856Tierney 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
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.
PubMed 27814840
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Impact of Ambient AI Scribes in Healthcare: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07113938
- Acronym / sponsor ID
- 5336
- Conditions
- Use of Ambient AI Scribes, Patient-Phyisican Interaction, Physician Workload, Physician Burnout
- Keywords
- artificial intelligence, physician workload, physician burnout, documentation quality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambient AI Scribe Users | Experimental | Device: Ambient AI ScribeThis 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Physicians from family medicine or any specialty
- Physicians who regularly see patients in a clinic setting at least 2 days per week
Key exclusion criteria (1 listed)
- Physicians who are planning to leave their practice during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambient AI ScribeSoftware that records audio of a clinical interaction and generates a clinical note. | Device | Ambient AI Scribe Users |
Primary outcome
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.
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).
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.
3 secondary outcomes
Documentation Quality as Measured by the PDQI-9
Time frame: From enrollment to the completion of the study at 10 working days.
Time Spent Within the EMR for Each Clinical Note
Time frame: From enrollment to the completion of the study at 10 working days.
Time Spent in the EMR After Hours
Time frame: From enrollment to the completion of the study at 10 working days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- BackgroundLi 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: PubMed 31363513Davenport 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.
- Background: PubMed 31073856Saag 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.
- BackgroundTierney 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: PubMed 27814840Shanafelt 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sundus Zia contact
Scott Adams, MD, PhD, MEd, FRCPC principal investigator
University of Saskatchewan College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Ambient AI Scribe in people with Use of Ambient AI Scribes and Patient-Phyisican Interaction, run by University of Saskatchewan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Adams, MD, PhD, MEd, FRCPC (306-655-2402, scott.adams@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07113938, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.