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临床试验/NCT07489469
NCT07489469已完成不适用

Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations: A Randomized Study

University of Saskatchewan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Surgeon Documentation Time

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Trauma cases or patients undergoing revision surgery

结局指标

主要结局

Surgeon Documentation Time

时间窗: 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.

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jans van der Merwe

Principal Investigator

University of Saskatchewan

研究点 (1)

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