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

NCT07489469 | Completed

• 1 other identifier: Bio-5718
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. Outcomes include surgeon documentation time, administrative processing time, time from consultation to note delivery to the family physician, patient satisfaction, and documentation accuracy.

Conditions

Clinical Documentation; Artifical Intelligence

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Within 7 days after completion of the consultation note.

• Patient Satisfaction

  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).

Study Arms (2)

AI Scribe Documentation

OTHER

Orthopaedic consultation documentation generated using an AI medical scribe that records and transcribes the clinical encounter in real time

Other: AI Medical Scribe

Standard Dictation Template Documentation

OTHER

Orthopedic consultation documentation generated using routine surgeon dictation templates with administrative transcription and processing

Other: Routine Dictation Template

Interventions

AI Medical Scribe OTHER

Use of an artificial intelligence-based medical scribe for automated clinical documentation

AI Scribe Documentation

Routine Dictation Template OTHER

Standard clinical documentation using surgeon dictation templates and administrative transcription

Standard Dictation Template Documentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults attending an orthopaedic consultation for total hip arthroplasty or total knee arthroplasty, and are able to provide informed consent

You may not qualify if:

• Trauma cases or patients undergoing revision surgery

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Orthopaedic Associates

Saskatoon, Saskatchewan, S7J3C1, Canada

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 24, 2026
• Study Start: June 18, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)