Learning Outcomes With Point-of-Care Ultrasound

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04021693
• Collaborator: (none)
• Enrollment: 47
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.4
• Patients Per Site Per Month: 4.5

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 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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasound	Other: Handheld Ultrasound Devices	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Does Improved Access to a Portable Ultrasound Device Improve Trainee Learning With Point-of-care Ultrasonography: A Randomized Trial
• Actual Study Start Date: Aug 16, 2017
• Actual Primary Completion Date: Jun 30, 2018
• Actual Study Completion Date: Jun 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Handheld Ultrasound Devices	Other: 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

Outcome Measures

Primary Outcome Measures

1. Mean Percent Correct On Image Assessments at 1 year [1 year]

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

Secondary Outcome Measures

1. Mean Reported Device Usage Rates at 1 year [1 year]

   Self-reported usage rates of the ultrasound devices per week by the interns

2. Mean Lecture Attendance at 1 year [1 year]

   Mean Lecture Attendance per Study Arm

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Internal Medicine Intern Physicians at Stanford University

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	95401

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Andre D Kumar, MD, MEd, Clinical Assistant Professor

Study Documents (Full-Text)

None provided.

More Information

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. Review.
• Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. Review.

• Responsible Party: Andre Kumar, Clinical Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT04021693
• Other Study ID Numbers: 42094
• First Posted: Jul 16, 2019
• Last Update Posted: Jul 16, 2019
• Last Verified: Jul 1, 2019

• 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 Assistant Professor, Stanford University: Medical Education

Study Results

No Results Posted as of Jul 16, 2019