Artificial Intelligence for Learning Point-of-Care Ultrasound

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05900440
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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 artificial intelligence systems 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 with artificial intelligence vs devices with no artificial intelligence. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and performance on quizzes.

Condition or Disease	Intervention/Treatment	Phase
Education, Medical; Ultrasound Imaging	Other: Ultrasound with Artificial Inteligence Engabled; Other: Ultrasound without Artificial Intelligence Enabled	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Use of Artificial Intelligence for Acquisition of Limited Echocardiograms
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: May 30, 2023
• Actual Study Completion Date: May 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artificial Intelligence Group	Other: Ultrasound with Artificial Inteligence Engabled; Participants shall be randomized 1:1 to receive personal access to a handheld ultrasound device with artificial intelligence vs a device with no artificial intelligence. The groups shall not cross over in which intervention they received.
Active Comparator: Non Artificial Intelligence Group	Other: Ultrasound without Artificial Intelligence Enabled; Participants shall be randomized 1:1 to receive personal access to a handheld ultrasound device with artificial intelligence vs a device with no artificial intelligence. The groups shall not cross over in which intervention they received.

Outcome Measures

Primary Outcome Measures

1. Time to acquire cardiac ultrasound images [During procedure (300 seconds)]

   This will be measured as the time to acquire a cardiac ultrasound image on a standardized patient, measured in seconds.

Secondary Outcome Measures

1. Assessment of the quality of captured images [During procedure (300 seconds)]

   Participants will acquire cardiac ultrasound images on a standardized patient. Two reviewers will review the images and provide a numerical assessment of image quality based on the Rapid Assessment for Competency in Echocardiography (RACE) Scale. This is a 0-20 point scale, with higher scores denoting higher image quality (e.g. a better quality image).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Internal medicine residents rotating on the general inpatient wards service.

Exclusion Criteria:

• Residents who had taken an ultrasound elective offered by our residency program

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	95403

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Andre D Kumar, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kumar A, Weng Y, Wang L, Bentley J, Almli M, Hom J, Witteles R, Ahuja N, Kugler J. Portable Ultrasound Device Usage and Learning Outcomes Among Internal Medicine Trainees: A Parallel-Group Randomized Trial. J Hosp Med. 2020 Feb 11;15(2):e1-e6. doi: 10.12788/jhm.3351. Online ahead of print.

• Responsible Party: Andre Kumar, Clinical Associate Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT05900440
• Other Study ID Numbers: IRB-42094
• First Posted: Jun 12, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andre Kumar, Clinical Associate Professor, Stanford University: Medical Education; Point-of-Care Ultrasound

Study Results

No Results Posted as of Jun 12, 2023