Clinical DocumentationNCT07489469
Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations
A study testing AI Medical Scribe and Routine Dictation Template in people with Clinical Documentation and Artifical Intelligence, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This randomized study compares AI-generated clinical documentation with traditional dictation templates during orthopedic consultations. Patients are randomized to have their consultation documented using either an AI medical scribe or a routine dictation template. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Documentation, Artifical Intelligence
- What is being tested?
- AI Medical Scribe and Routine Dictation Template
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jun 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults attending an orthopaedic consultation for total hip arthroplasty or total knee arthroplasty, and are able to provide informed consent
Who cannot join
- Trauma cases or patients undergoing revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations: A Randomized Study
This randomized study compares AI-generated clinical documentation with traditional dictation templates during orthopedic consultations. Patients are randomized to have their consultation documented using either an AI medical scribe or a routine dictation template. Outcomes include surgeon documentation time, administrative processing time, time from consultation to note delivery to the family physician, patient satisfaction, and documentation accuracy.
Read the detailed description
Clinical documentation is a necessary but time-consuming component of surgical practice. Traditional documentation relies on dictation templates that require manual transcription and editing by administrative staff. Artificial intelligence (AI) medical scribes have been developed to automate documentation by recording and transcribing consultations in real time.
The purpose of this randomized study is to compare the effectiveness of an AI scribe versus routine dictation templates in orthopedic consultations.
Patients undergoing consultation for total hip arthroplasty, total knee arthroplasty, or meniscal pathology will be invited to participate. Participants will be randomized in a 1:1 ratio to either AI-generated documentation or standard dictation template documentation. Consultations will otherwise occur according to usual clinical practice.
Data collected will include:
- Surgeon documentation time per patient encounter
- Administrative processing time
- Time from consultation to delivery of the consultation note to the family physician
- Patient satisfaction, including comfort with documentation methods and perceived usefulness of timely note availability
- Documentation accuracy, including spelling, grammar, completeness, and clinical correctness assessed by a blinded reviewer A total of 200 participants will be enrolled. Outcomes will be compared between groups using appropriate statistical tests with a significance level of p < 0.05.
- Conditions
- Clinical Documentation, Artifical Intelligence
- Being tested
- AI Medical Scribe, Routine Dictation Template
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Medical ScribeOther
Use of an artificial intelligence-based medical scribe for automated clinical documentation
Routine Dictation TemplateOther
Standard clinical documentation using surgeon dictation templates and administrative transcription
| Study group | Role | What they receive |
|---|---|---|
| AI Scribe Documentation | Other | Orthopaedic consultation documentation generated using an AI medical scribe that records and transcribes the clinical encounter in real time Receives: Other: AI Medical Scribe |
| Standard Dictation Template Documentation | Other | Orthopedic consultation documentation generated using routine surgeon dictation templates with administrative transcription and processing Receives: Other: Routine Dictation Template |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon Documentation Time
Surgeon documentation time is defined as the total time spent completing clinical documentation associated with a patient encounter. It begins when the surgeon initiates documentation during or immediately after entering the consultation room and ends when the consultation note is finalized and ready for handover or processing. In the conventional group, this includes dictation or completion of templates following the patient encounter. In the AI scribe group, this includes real-time capture of the encounter, followed by surgeon review and correction of the generated note. This measure reflects the direct documentation workload and efficiency of the surgeon within the clinical workflow.
Measured: Per consultation visit, time is measured from initiation of documentation during the patient encounter to completion of the consultation note, assessed at a defined time point of Day 1 (same-day visit, perioperative timeframe).
Secondary outcomes (3)
Administrative Processing Time
Administrator documentation time is defined as the total time required for office staff to process, finalize, and distribute the consultation note after the surgeon has completed their portion. It begins when the documentation is handed over to the administrator and ends when the finalized letter is sent to the referring physician and/or patient. In the conventional group, this includes transcription of dictated notes, editing, formatting, and faxing or emailing. In the AI scribe group, this primarily involves reviewing the auto-generated note for grammar, spelling, and formatting, followed by distribution. This measure reflects administrative workload, processing efficiency, and system-related delays.
Measured: Per consultation visit, administrative time is measured from receipt of the surgeon's completed documentation to finalization and transmission of the consultation letter, assessed at a defined time point of Day 1 (same-day visit, perioperative period).
Documentation Accuracy
This outcome measures the accuracy of the finalized consultation note by assessing spelling, grammar, wording, and clinical correctness identified by reviewer evaluation.
Measured: Within 7 days after completion of the consultation note.
Patient Satisfaction
This outcome measures patient satisfaction with the consultation process and comfort with the documentation method using a study-specific 5-point Likert scale questionnaire.
Measured: Assessed at a clearly defined time point of Day 1, immediately after the consultation is completed, during the same visit and before the patient leaves the clinic (perioperative timeframe).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start18 Jun 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical DocumentationStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jans van der Merwe, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489469
- Sponsor's protocol ID
- Bio-5718
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations: A Randomized Study
- ClinicalTrials.gov ID
- NCT07489469
- Acronym / sponsor ID
- Bio-5718
- Conditions
- Clinical Documentation, Artifical Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 24 Mar 2026 (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.
This randomized study compares AI-generated clinical documentation with traditional dictation templates during orthopedic consultations. Patients are randomized to have their consultation documented using either an AI medical scribe or a routine dictation template. Outcomes include surgeon documentation time, administrative processing time, time from consultation to note delivery to the family physician, patient satisfaction, and documentation accuracy.
Detailed description
Clinical documentation is a necessary but time-consuming component of surgical practice. Traditional documentation relies on dictation templates that require manual transcription and editing by administrative staff. Artificial intelligence (AI) medical scribes have been developed to automate documentation by recording and transcribing consultations in real time.
The purpose of this randomized study is to compare the effectiveness of an AI scribe versus routine dictation templates in orthopedic consultations.
Patients undergoing consultation for total hip arthroplasty, total knee arthroplasty, or meniscal pathology will be invited to participate. Participants will be randomized in a 1:1 ratio to either AI-generated documentation or standard dictation template documentation. Consultations will otherwise occur according to usual clinical practice.
Data collected will include:
- Surgeon documentation time per patient encounter
- Administrative processing time
- Time from consultation to delivery of the consultation note to the family physician
- Patient satisfaction, including comfort with documentation methods and perceived usefulness of timely note availability
- Documentation accuracy, including spelling, grammar, completeness, and clinical correctness assessed by a blinded reviewer A total of 200 participants will be enrolled. Outcomes will be compared between groups using appropriate statistical tests with a significance level of p < 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Scribe Documentation | Other | Other: AI Medical ScribeOrthopaedic consultation documentation generated using an AI medical scribe that records and transcribes the clinical encounter in real time |
| Standard Dictation Template Documentation | Other | Other: Routine Dictation TemplateOrthopedic consultation documentation generated using routine surgeon dictation templates with administrative transcription and processing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults attending an orthopaedic consultation for total hip arthroplasty or total knee arthroplasty, and are able to provide informed consent
Key exclusion criteria (1 listed)
- Trauma cases or patients undergoing revision surgery
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 |
|---|---|---|
| AI Medical ScribeUse of an artificial intelligence-based medical scribe for automated clinical documentation | Other | AI Scribe Documentation |
| Routine Dictation TemplateStandard clinical documentation using surgeon dictation templates and administrative transcription | Other | Standard Dictation Template Documentation |
Primary outcome
Surgeon Documentation Time
Time frame: Per consultation visit, time is measured from initiation of documentation during the patient encounter to completion of the consultation note, assessed at a defined time point of Day 1 (same-day visit, perioperative timeframe).
Surgeon documentation time is defined as the total time spent completing clinical documentation associated with a patient encounter. It begins when the surgeon initiates documentation during or immediately after entering the consultation room and ends when the consultation note is finalized and ready for handover or processing. In the conventional group, this includes dictation or completion of templates following the patient encounter. In the AI scribe group, this includes real-time capture of the encounter, followed by surgeon review and correction of the generated note. This measure reflects the direct documentation workload and efficiency of the surgeon within the clinical workflow.
3 secondary outcomes
Administrative Processing Time
Time frame: Per consultation visit, administrative time is measured from receipt of the surgeon's completed documentation to finalization and transmission of the consultation letter, assessed at a defined time point of Day 1 (same-day visit, perioperative period).
Documentation Accuracy
Time frame: Within 7 days after completion of the consultation note.
Patient Satisfaction
Time frame: Assessed at a clearly defined time point of Day 1, immediately after the consultation is completed, during the same visit and before the patient leaves the clinic (perioperative timeframe).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI Medical Scribe and Routine Dictation Template in people with Clinical Documentation and Artifical Intelligence, run by University of Saskatchewan at 1 site in Canada.
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 1 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: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon Documentation Time (time frame: Per consultation visit, time is measured from initiation of documentation during the patient encounter to completion of the consultation note, assessed at a defined time point of Day 1 (same-day visit, perioperative timeframe).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.