NCT04083924

Brief Summary

The investigators would like to evaluate how well pre-clinical medical students are able to perform a basic transthoracic echocardiography examination on a healthy volunteer using a hand-held ultrasound (HHU) after completing a flipped classroom echocardiography training methods which consist of pre-training e-learning, hands-on training, and competency assessment after the hands-on training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

September 3, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

September 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

September 3, 2019

Last Update Submit

November 6, 2020

Conditions

Keywords

Preclinical medical studentsHandheld ultrasoundButterfly iQBasic cardiac ultrasoundFocused cardiac ultrasoundPoint of careTrainingEducationFlipped classroom

Outcome Measures

Primary Outcomes (1)

  • Image quality score change from pre-training to eight weeks after training.

    Image quality score of five basic cardiac ultrasound views assessed by predefined test scoring system. In the scoring system, each view is assessed excellent (2 points), acceptable (1 points), or poor (0 point) for clinical use. Summed, total score, thus, ranges from 0 to 10 points.

    Eight weeks after hands-on training.

Secondary Outcomes (10)

  • Image quality score change from pre-training to immediately after training.

    Immediately after hands-on training.

  • Knowledge test score change from pre-training to eight weeks after training.

    Eight weeks after hands-on training.

  • Knowledge test score change from pre-training to immediately after training.

    Immediately after hands-on training.

  • Overall 5-point Likert scale participants training satisfaction

    Immediately after hands-on training.

  • Overall 5-point Likert scale participants training satisfaction

    Eight weeks after hands-on training.

  • +5 more secondary outcomes

Study Arms (1)

Basic cardiac ultrasound training

EXPERIMENTAL

Single group education intervention study. No control group. Pre-post educational outcomes only.

Other: Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound

Interventions

Pre-training online module of the American society of Echocardiography and hands-on training of basic cardiac ultrasound with Butterfly iQ handheld ultrasound.

Basic cardiac ultrasound training

Eligibility Criteria

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

You may qualify if:

  • Participants must be preclinical medical students (1st year or 2nd year) at John A. Burns School of Medicine, University of Hawaii.
  • Participants are eligible after completion of 1st year medical student core cardiology curriculum at John A. Burns School of Medicine, University of Hawaii.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SimTiki Simulation Center, John A. Burns school of medicine, University of Hawaii at Manoa

Honolulu, Hawaii, 96813, United States

Location

Related Publications (2)

  • Johri AM, Durbin J, Newbigging J, Tanzola R, Chow R, De S, Tam J. Cardiac Point-of-Care Ultrasound: State-of-the-Art in Medical School Education. J Am Soc Echocardiogr. 2018 Jul;31(7):749-760. doi: 10.1016/j.echo.2018.01.014. Epub 2018 Mar 15.

    PMID: 29550326BACKGROUND
  • Jujo S, Lee-Jayaram JJ, Sakka BI, Nakahira A, Kataoka A, Izumo M, Kusunose K, Athinartrattanapong N, Oikawa S, Berg BW. Pre-clinical medical student cardiac point-of-care ultrasound curriculum based on the American Society of Echocardiography recommendations: a pilot and feasibility study. Pilot Feasibility Stud. 2021 Sep 14;7(1):175. doi: 10.1186/s40814-021-00910-3.

Related Links

Study Officials

  • Benjamin W Berg, MD

    SimTiki Simulation Center, John A. Burns School of Medicine.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Pre-post education intervention study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scholar

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 10, 2019

Study Start

September 9, 2019

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

November 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations