- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021693
Learning Outcomes With Point-of-Care Ultrasound
July 15, 2019 updated by: Andre Kumar, Stanford University
Does Improved Access to a Portable Ultrasound Device Improve Trainee Learning With Point-of-care Ultrasonography: A Randomized Trial
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 95401
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Internal Medicine Intern Physicians at Stanford University
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Handheld Ultrasound Devices
|
Interns in the handheld ultrasound device arm shall carry a personal handheld ultrasound device to be used for self-directed learning
|
|
No Intervention: No Handheld Ultrasound Devices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Percent Correct On Image Assessments at 1 year
Time Frame: 1 year
|
Image assessments will include videos and photographs of ultrasound images that will require the intern to interpret the image.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Reported Device Usage Rates at 1 year
Time Frame: 1 year
|
Self-reported usage rates of the ultrasound devices per week by the interns
|
1 year
|
|
Mean Lecture Attendance at 1 year
Time Frame: 1 year
|
Mean Lecture Attendance per Study Arm
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andre D Kumar, MD, MEd, Clinical Assistant Professor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 16, 2017
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
July 12, 2019
First Submitted That Met QC Criteria
July 15, 2019
First Posted (Actual)
July 16, 2019
Study Record Updates
Last Update Posted (Actual)
July 16, 2019
Last Update Submitted That Met QC Criteria
July 15, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 42094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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