NCT04021693

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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 16, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

July 12, 2019

Last Update Submit

July 15, 2019

Conditions

Keywords

Medical Education

Outcome Measures

Primary Outcomes (1)

  • Mean Percent Correct On Image Assessments at 1 year

    Image assessments will include videos and photographs of ultrasound images that will require the intern to interpret the image.

    1 year

Secondary Outcomes (2)

  • Mean Reported Device Usage Rates at 1 year

    1 year

  • Mean Lecture Attendance at 1 year

    1 year

Study Arms (2)

Handheld Ultrasound Devices

EXPERIMENTAL
Other: Handheld Ultrasound Devices

No Handheld Ultrasound Devices

NO INTERVENTION

Interventions

Interns in the handheld ultrasound device arm shall carry a personal handheld ultrasound device to be used for self-directed learning

Handheld Ultrasound Devices

Eligibility Criteria

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

You may qualify if:

  • Internal Medicine Intern Physicians at Stanford University

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 95401, United States

Location

Related Publications (2)

  • 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: 30924088BACKGROUND
  • 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.

    PMID: 21345104BACKGROUND

Study Officials

  • Andre D Kumar, MD, MEd

    Clinical Assistant Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 16, 2019

Study Start

August 16, 2017

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

July 16, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations