- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04083924
Preclinical Medical Student Echocardiography Training American Society of Echocardiography Curriculum
Preclinical Medical Student Handheld Echocardiography Training American Society of Echocardiography Curriculum
Study Overview
Status
Intervention / Treatment
Detailed Description
Background There is expanding need for cardiac ultrasound training for medical students, although most of medical schools do not integrate cardiac ultrasound training into their curricula. Most of residency programs already have some standardized cardiac ultrasound training for residents, but there is no standardized cardiac ultrasound training for medical students. Last year, the American Society of Echocardiography (ASE), which takes a leading role in establishing training for echocardiography, presented the recommended training methods of cardiac ultrasound for medical students with flipped classroom methods which consist of pre-training e-learning, hands-on training, and competency assessment after the hands-on training. But no researchers evaluated the effectiveness of the ASE recommended training methods at this moment. In addition, hand-held ultrasound (HHU) probe which enable us to perform echocardiography just connecting to cell phone, have become commercially available this year. The investigators believe most medical students will have their own HHU probe as well as physicians in ten years. Thus, the purpose of this study is to evaluate the ASE cardiac ultrasound training methods with applying the training methods to the pre-clinical medical students in University of Hawaii at Manoa using HHU probe.
Methods The investigators will perform a prospective, experimental educational study investigating the learning effects of ASE recommended echocardiography training in pre-clinical medical students on cognitive and psychomotor skill using HHU device, when performing a basic echocardiography on a healthy volunteer.
The investigators will use e-mail, presentations and public posting on bulletin board in University of Hawaii for recruiting participants of 1st or 2nd year medical students. Target sample size is 130 at maximum. After recruitment of participants, first, participants will take a pre-training knowledge assessment and questionnaire on basic cardiac ultrasound (30 minutes) one week before the day of hands-on training. Second, after the pre-training assessment, participants will independently review the 40 minute American Society of Echocardiography (ASE) recommended e-learning module (https://aseuniversity.org/ase/lessons/47) on basic cardiac ultrasound prior to the hands-on training day. Third, on the day of hands-on training, participants will take a pre-training skill assessment and receive hands-on training for basic cardiac ultrasound with a healthy volunteer (HV) (60 minutes). Immediately after the hands-on training, participants will complete a post-training knowledge and skill assessment on basic cardiac ultrasound with a HV and questionnaire about participants' experience (30 minutes). Finally participants will take another post-training knowledge & skill assessment on basic cardiac ultrasound and questionnaire about participants' experience eight weeks after the hands-on training day to assess retention of their knowledge and skills on basic cardiac ultrasound with a HV (30 minutes).
In this study, investigators plan to use HHU probe, named Butterfly iQ hand-held ultrasound, Butterfly Network, Inc.
The knowledge assessment contains 40 MCQs on 5 basic views. In the skill assessment, participants will be asked to obtain 5 basic views on a HV in 2 minutes per view and the images are to be video-recorded. After de-identification of obtained images, the image quality of 5 basic views will be assessed by three independent blinded assessors using image quality scoring system investigators devised. One of investigators will take a role of a HV for echocardiography throughout this study consistently.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- SimTiki Simulation Center, John A. Burns school of medicine, University of Hawaii at Manoa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Basic cardiac ultrasound training
Single group education intervention study.
No control group.
Pre-post educational outcomes only.
|
Pre-training online module of the American society of Echocardiography and hands-on training of basic cardiac ultrasound with Butterfly iQ handheld ultrasound.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image quality score change from pre-training to eight weeks after training.
Time Frame: Eight weeks after hands-on 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Image quality score change from pre-training to immediately after training.
Time Frame: Immediately after hands-on 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.
|
Immediately after hands-on training.
|
Knowledge test score change from pre-training to eight weeks after training.
Time Frame: Eight weeks after hands-on training.
|
40 multiple choice questions about anatomical knowledge of five basic cardiac ultrasound views using Google Form.
Total score ranges from 0 to 40 points.
|
Eight weeks after hands-on training.
|
Knowledge test score change from pre-training to immediately after training.
Time Frame: Immediately after hands-on training.
|
40 multiple choice questions about anatomical knowledge of five basic cardiac ultrasound views using Google Form.
Total score ranges from 0 to 40 points.
|
Immediately after hands-on training.
|
Overall 5-point Likert scale participants training satisfaction
Time Frame: Immediately after hands-on training.
|
Overall participants training satisfaction assessed with 5-point Likert scale.
This scale ranges from 1 to 5. Higher Likert scale represents higher participant training satisfaction.
|
Immediately after hands-on training.
|
Overall 5-point Likert scale participants training satisfaction
Time Frame: Eight weeks after hands-on training.
|
Overall participants training satisfaction assessed with 5-point Likert scale.
This scale ranges from 1 to 5. Higher Likert scale represents higher participant training satisfaction.
|
Eight weeks after hands-on training.
|
Participant confidence in basic cardiac ultrasound.
Time Frame: Immediately before hands-on training.
|
Participant confidence in basic cardiac ultrasound assessed with 5-point Likert scale.
This scale ranges from 1 to 5. Higher Likert scale represents higher participants confidence in basic cardiac ultrasound.
|
Immediately before hands-on training.
|
Participant confidence in basic cardiac ultrasound.
Time Frame: Immediately after hands-on training.
|
Participant confidence in basic cardiac ultrasound assessed with 5-point Likert scale.
This scale ranges from 1 to 5. Higher Likert scale represents higher participants confidence in basic cardiac ultrasound.
|
Immediately after hands-on training.
|
Participant confidence in basic cardiac ultrasound.
Time Frame: Eight weeks after hands-on training.
|
Participant confidence in basic cardiac ultrasound assessed with 5-point Likert scale.
This scale ranges from 1 to 5. Higher Likert scale represents higher participants confidence in basic cardiac ultrasound.
|
Eight weeks after hands-on training.
|
Findings of post-training predefined survey
Time Frame: Immediately after hands-on training.
|
Findings of post-training predefined survey regarding usefulness of training.
|
Immediately after hands-on training.
|
Findings of post-training predefined survey
Time Frame: Eight weeks after hands-on training.
|
Findings of post-training predefined survey regarding usefulness of training.
|
Eight weeks after hands-on training.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Benjamin W Berg, MD, SimTiki Simulation Center, John A. Burns School of Medicine.
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019-00265
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Education
-
Sakarya UniversityRecruiting
-
Istanbul University - Cerrahpasa (IUC)Istinye UniversityActive, not recruitingEducation | Newborn; Vitality | Breastfeeding EducationTurkey
-
H. Lee Moffitt Cancer Center and Research InstituteNational Cancer Institute (NCI)RecruitingCancer Education | Spanish Language Cancer EducationUnited States, Puerto Rico
-
Istanbul University - Cerrahpasa (IUC)CompletedBariatric Surgery Candidate | Education | Patient EducationTurkey
-
Liverpool John Moores UniversityUniversity of Central Lancashire; Queen's University, Belfast; Newcastle University and other collaboratorsCompletedMedical Education | Health Education | Educational AssessmentUnited Kingdom
-
Mansoura UniversityCompletedBlood Pressure Determination | Continuing Nursing Education | Education, DistanceEgypt
-
Rigshospitalet, DenmarkWithdrawnEducation, Professional | Ultrasound Simulation | Simulation-based Medical Education
-
Children's Hospital Medical Center, CincinnatiAmbulatory Pediatric AssociationCompletedCommunication | Education, Medical | Education, Competency-Based | Feedback | HumanismUnited States
-
Francisco Javier Navarro MoyaAndaluz Health ServiceUnknownHealth Education | Blood Coagulation Tests | Patient Education as TopicSpain
-
Rigshospitalet, DenmarkDanish Child Cancer FoundationTerminatedEducation | Interprofessional Education | Continuing Professional Development | Case-based LearningDenmark
Clinical Trials on Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound
-
Yale UniversityCompletedUltrasonographyUnited States
-
University of ManitobaButterfly NetworkRecruitingTemporomandibular Joint Disorders | Magnetic Resonance Image | Handheld UltrasoundCanada
-
Mayo ClinicCompletedVascular Access ComplicationUnited States
-
University of Colorado, DenverCompletedEducation | Ultrasound | VirtualUnited States
-
Arkansas Children's Hospital Research InstituteNot yet recruiting
-
Baylor College of MedicineCompletedCervix; PregnancyUnited States
-
Yale UniversityButterfly Network, IncCompletedVoiding Disorders | Voiding DysfunctionUnited States
-
Brigham and Women's HospitalKlinikum Nürnberg; Institut fuer Notfallmedizin Kempten e.V., GermanyCompleted
-
University Hospital, MontpellierRecruitingChildhood Cancer | CardiotoxicityFrance
-
Keller Fire RescueUnknownKidney Calculi | Pregnancy | Multiple Trauma | Ultrasonography | Aortic Aneurysm, Abdominal | Catheterization, VenousUnited States