Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations

March 17, 2026 updated by: Jans van der Merwe, University of Saskatchewan

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.

Study Overview

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

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7J3C1
        • Orthopaedic Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2025

Primary Completion (Actual)

January 30, 2026

Study Completion (Actual)

January 30, 2026

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 17, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Clinical Documentation

Clinical Trials on AI Medical Scribe

Subscribe