NCT05900440

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jun 2021Dec 2027

Study Start

First participant enrolled

June 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2025

Enrollment Period

5.6 years

First QC Date

May 31, 2023

Last Update Submit

April 23, 2026

Conditions

Education, MedicalUltrasound Imaging

Keywords

Medical EducationPoint-of-Care Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Time to acquire cardiac ultrasound images

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

    During procedure (300 seconds)

Secondary Outcomes (1)

  • Assessment of the quality of captured images

    During procedure (300 seconds)

Study Arms (2)

Artificial Intelligence Group

EXPERIMENTAL
Other: Ultrasound with Artificial Inteligence Engabled

Non Artificial Intelligence Group

ACTIVE COMPARATOR
Other: Ultrasound without Artificial Intelligence Enabled

Interventions

Ultrasound with Artificial Inteligence EngabledOTHER

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.

Artificial Intelligence Group
Ultrasound without Artificial Intelligence EnabledOTHER

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.

Non Artificial Intelligence Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 95403, United States

Location

Related Publications (1)

  • 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.

    PMID: 32118565BACKGROUND

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Andre D Kumar, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 12, 2023

Study Start

June 1, 2021

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

April 29, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)