Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-01 @ 7:56 AM
Study NCT ID:
NCT04021693
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Learning Outcomes With Point-of-Care Ultrasound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intern physicians were randomized 1:1 to receive personal access to a handheld ultrasound device vs. no device. The groups did not cross over in which intervention they received.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-15', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-07-15', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Percent Correct On Image Assessments at 1 year', 'timeFrame': '1 year', 'description': 'Image assessments will include videos and photographs of ultrasound images that will require the intern to interpret the image.'}], 'secondaryOutcomes': [{'measure': 'Mean Reported Device Usage Rates at 1 year', 'timeFrame': '1 year', 'description': 'Self-reported usage rates of the ultrasound devices per week by the interns'}, {'measure': 'Mean Lecture Attendance at 1 year', 'timeFrame': '1 year', 'description': 'Mean Lecture Attendance per Study Arm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical Education'], 'conditions': ['Ultrasound']}, 'referencesModule': {'references': [{'pmid': '30924088', 'type': 'BACKGROUND', 'citation': 'Kumar A, Kugler J, Jensen T. Evaluation of Trainee Competency with Point-of-Care Ultrasonography (POCUS): a Conceptual Framework and Review of Existing Assessments. J Gen Intern Med. 2019 Jun;34(6):1025-1031. doi: 10.1007/s11606-019-04945-4.'}, {'pmid': '21345104', 'type': 'BACKGROUND', 'citation': 'Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether handheld ultrasound devices, along with a year-long lecture series, improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning vs. no personal access. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and lecture attendance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Internal Medicine Intern Physicians at Stanford University\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04021693', 'briefTitle': 'Learning Outcomes With Point-of-Care Ultrasound', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Does Improved Access to a Portable Ultrasound Device Improve Trainee Learning With Point-of-care Ultrasonography: A Randomized Trial', 'orgStudyIdInfo': {'id': '42094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Handheld Ultrasound Devices', 'interventionNames': ['Other: Handheld Ultrasound Devices']}, {'type': 'NO_INTERVENTION', 'label': 'No Handheld Ultrasound Devices'}], 'interventions': [{'name': 'Handheld Ultrasound Devices', 'type': 'OTHER', 'description': 'Interns in the handheld ultrasound device arm shall carry a personal handheld ultrasound device to be used for self-directed learning', 'armGroupLabels': ['Handheld Ultrasound Devices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95401', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Andre D Kumar, MD, MEd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Assistant Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Andre Kumar', 'investigatorAffiliation': 'Stanford University'}}}}