NCT05013476

Brief Summary

This study is intended to perform a comparative analysis of novice ultrasound users when taught in person versus virtually. This study aims to show that students will not demonstrate a statistical difference in scores learning in in a virtual environment, guided by professionals, when compared to students learning ultrasound in a traditional, in-person format. Utilizing a Butterfly ultrasound machine, a hand held personal ultrasound device, students wil be guided through a FAST (Focused assessment with sonography in trauma) examination and imaging of the carpal tunnel using modules and instructor aid. The FAST (Focused assessment with sonography in trauma) exam images the heart and abdomen for free flowing blood. The carpal tunnel is a region in the wrist that houses the tendons for finger movement. Participants will be assessed on the ability to identify key regions, anatomical landmarks and confidence in utilize the ultrasound machine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

August 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2023

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

August 16, 2021

Last Update Submit

January 29, 2024

Conditions

Keywords

tele-educationultrasoundFASTCarpal Tunnel

Outcome Measures

Primary Outcomes (1)

  • Comparison of participant assesment scores when asked to identify key features of the FAST and Carpal Tunnel between in person learners and virtual learners.

    Scores are measured on a pass (1) or fail (0) grading system with a total number of 17 points per participant. An Anderson-Darling test will determine if the data is normally distributed. If the data demonstrates normal distribution, either a parametric analysis via a two-way ANOVA or non-parametric equivalent analysis via pairwise Mann-Whitney U will be performed to compare responses from the different groups. Further a Bran-Altman Test will be considered.

    10 minutes

Secondary Outcomes (2)

  • Student comparative confidence levels in ultrasound between virtual learners and in-person learners.

    1.5 hours

  • Student comparative satisfaction levels in ultrasound between virtual learners and in-person learners.

    1.5 hours

Study Arms (2)

In-Person ultrasound participants

ACTIVE COMPARATOR

In-Person ultrasound participant's will receive ultrasound training that is guided by online modules (identical to virtual) with trained faculty in the same room with a ration of 4 students to 1 instructor.

Combination Product: Butterfly handheld ultrasound machine

Virtual ultrasound participants

ACTIVE COMPARATOR

Virtual ultrasound participants will receive ultrasound training that is guided by online modules (identical to in-person) with trained faculty present in a private zoom classroom. Faculty will be rotating between breakout rooms and will share the same ratio of participants to staff.

Combination Product: Butterfly handheld ultrasound machine

Interventions

Both arms of study will utilize the Butterfly ultrasound machine. Only the virtual learners will utilize zoom for their virtual education

Also known as: Zoom
In-Person ultrasound participantsVirtual ultrasound participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First year medical students enrolled at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.
  • First year graduate students enrolled in the Modern Human Anatomy program (MHA) at the University of Colorado, Anschutz Medical Campus with minimal previous ultrasound experience.

You may not qualify if:

  • individuals younger than the age of 18.
  • individuals not enrolled in the medical school or Modern Human Anatomy program (MHA) programs at Anschutz Medical Campus
  • Individuals with greater than minimal ultrasound experience.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

logan T scott

Englewood, Colorado, 80110, United States

Location

Related Publications (3)

  • Drake AE, Hy J, MacDougall GA, Holmes B, Icken L, Schrock JW, Jones RA. Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners. Ultrasound J. 2021 Feb 14;13(1):6. doi: 10.1186/s13089-021-00210-0.

    PMID: 33586112BACKGROUND
  • Royer DF, Kessler R, Stowell JR. Evaluation of an innovative hands-on anatomy-centered ultrasound curriculum to supplement graduate gross anatomy education. Anat Sci Educ. 2017 Jul;10(4):348-362. doi: 10.1002/ase.1670. Epub 2016 Nov 21.

    PMID: 27870531BACKGROUND
  • Dietrich CF, Hoffmann B, Abramowicz J, Badea R, Braden B, Cantisani V, Chammas MC, Cui XW, Dong Y, Gilja OH, Hari R, Nisenbaum H, Nicholls D, Nolsoe CP, Nurnberg D, Prosch H, Radzina M, Recker F, Sachs A, Saftoiu A, Serra A, Sweet L, Vinayak S, Westerway S, Chou YH, Blaivas M. Medical Student Ultrasound Education: A WFUMB Position Paper, Part I. Ultrasound Med Biol. 2019 Feb;45(2):271-281. doi: 10.1016/j.ultrasmedbio.2018.09.017. Epub 2018 Nov 27.

    PMID: 30497768BACKGROUND

MeSH Terms

Conditions

Median Neuropathy

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • logan T scott, B.S.

    Graduate Student, Masters in Modern Human Anatomy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Participants and staff will be aware of each of the study conditions.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be divided into 2 groups which will experience different experimental conditions.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 19, 2021

Study Start

September 30, 2021

Primary Completion

October 4, 2023

Study Completion

October 4, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Participant data will not be shared with other researchers. Statistical analysis and results will be shared.

Locations