Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:04 AM
Study NCT ID:
NCT07489469
Status:
COMPLETED
Last Update Posted:
2026-03-24
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgeon Documentation Time', 'timeFrame': '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).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Administrative Processing Time', 'timeFrame': "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).", 'description': '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.'}, {'measure': 'Documentation Accuracy', 'timeFrame': 'Within 7 days after completion of the consultation note.', 'description': 'This outcome measures the accuracy of the finalized consultation note by assessing spelling, grammar, wording, and clinical correctness identified by reviewer evaluation.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '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).', 'description': 'This outcome measures patient satisfaction with the consultation process and comfort with the documentation method using a study-specific 5-point Likert scale questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Clinical Documentation', 'Artifical Intelligence']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe purpose of this randomized study is to compare the effectiveness of an AI scribe versus routine dictation templates in orthopedic consultations.\n\nPatients 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.\n\nData collected will include:\n\n* Surgeon documentation time per patient encounter\n* Administrative processing time\n* Time from consultation to delivery of the consultation note to the family physician\n* Patient satisfaction, including comfort with documentation methods and perceived usefulness of timely note availability\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults attending an orthopaedic consultation for total hip arthroplasty or total knee arthroplasty, and are able to provide informed consent\n\nExclusion Criteria:\n\n* Trauma cases or patients undergoing revision surgery'}, 'identificationModule': {'nctId': 'NCT07489469', 'briefTitle': 'Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Effectiveness of an AI Scribe Compared to Routine Templates for Clinical Documentation in Orthopedic Consultations: A Randomized Study', 'orgStudyIdInfo': {'id': 'Bio-5718'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'AI Scribe Documentation', 'description': 'Orthopaedic consultation documentation generated using an AI medical scribe that records and transcribes the clinical encounter in real time', 'interventionNames': ['Other: AI Medical Scribe']}, {'type': 'OTHER', 'label': 'Standard Dictation Template Documentation', 'description': 'Orthopedic consultation documentation generated using routine surgeon dictation templates with administrative transcription and processing', 'interventionNames': ['Other: Routine Dictation Template']}], 'interventions': [{'name': 'AI Medical Scribe', 'type': 'OTHER', 'description': 'Use of an artificial intelligence-based medical scribe for automated clinical documentation', 'armGroupLabels': ['AI Scribe Documentation']}, {'name': 'Routine Dictation Template', 'type': 'OTHER', 'description': 'Standard clinical documentation using surgeon dictation templates and administrative transcription', 'armGroupLabels': ['Standard Dictation Template Documentation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7J3C1', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Orthopaedic Associates', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jans van der Merwe', 'investigatorAffiliation': 'University of Saskatchewan'}}}}