- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07489469
Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations
Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations: A Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7J3C1
- Orthopaedic Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults attending an orthopaedic consultation for total hip arthroplasty or total knee arthroplasty, and are able to provide informed consent
Exclusion Criteria:
- Trauma cases or patients undergoing revision surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: AI Scribe Documentation
Orthopaedic consultation documentation generated using an AI medical scribe that records and transcribes the clinical encounter in real time
|
Use of an artificial intelligence-based medical scribe for automated clinical documentation
|
|
Other: Standard Dictation Template Documentation
Orthopedic consultation documentation generated using routine surgeon dictation templates with administrative transcription and processing
|
Standard clinical documentation using surgeon dictation templates and administrative transcription
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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.
|
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.
|
This outcome measures the accuracy of the finalized consultation note by assessing spelling, grammar, wording, and clinical correctness identified by reviewer evaluation.
|
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).
|
This outcome measures patient satisfaction with the consultation process and comfort with the documentation method using a study-specific 5-point Likert scale questionnaire.
|
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).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Bio-5718
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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