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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05013476
Other study ID # 21-3964
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 30, 2021
Est. completion date October 4, 2023

Study information

Verified date January 2024
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

This project intends to adapt previous research ("Innovations with tele-ultrasound in education sonography: the use of tele-ultrasound to train novice scanners") to assess the effectiveness of tele-education using the Butterfly handheld ultrasound device when compared to in person education imaging devices, learning modules and assessments will be kept constant across experimental groups. This experiment aims to adapt the current ultrasound modules used by the University of Colorado Anschutz school of Medicine and Modern Human Anatomy program to formulate in depth modules that outline the following: Carpal Tunnel (wrist), Brachial Plexus (shoulder), and FAST "Focused Assessment with Sonography in Trauma". Additionally, participants will be provided an orientation module that will be completed prior to the live session. Participants will be divided into either the in-person group or virtual group and participate in a live session where participants go through each module with a trained instructor. Participants will be asked to complete a pre/post assessment to determine prior knowledge and the level of learning that took place during the session as well as participant satisfaction and confidence levels.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date October 4, 2023
Est. primary completion date October 4, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States logan T scott Englewood Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Student comparative confidence levels in ultrasound between virtual learners and in-person learners. Likert Scale measures participant's subjective opinion on a question. Five answer choices are provided on a scale of 0 to 5 with an extreme on both ends, a neutral choice and a middle ground answer for both ends of the spectrum. A higher score represents a greater degree of confidence in the material. Lower scores indicate little to no confidence in the material. 1.5 hours
Secondary Student comparative satisfaction levels in ultrasound between virtual learners and in-person learners. Likert Scale measures participant's subjective opinion on a question. Five answer choices are provided on a scale of 0 to 5 with an extreme on both ends, a neutral choice and a middle ground answer for both ends of the spectrum. Higher scores indicate high satisfaction levels with the learning modality. Low scores indicate that participant's did not enjoy the learning modality. 1.5 hours
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