NCT06777641

Brief Summary

Ultrasonography is a non-invasive, minimal-radiation tool for clinical diagnosis. Relevant clinical protocols have been developed. Recently, as the technology of ultrasonography progresses, small and portable ultrasound machines become available. The use of ultrasonography has gradually moved from the examination laboratories to the bedside. With this revolution, ultrasonography produces a tremendous paradigm shift in the diagnostic process at the bedside by clinicians. Point-of-care ultrasound (PoCUS) focuses on an acute problem that a patient has, trying to simplify the items of examination, shorten the time required for examination, but maximize the efficiency and accessibility. Unlike traditional ultrasound which has high learning threshold, PoCUS has become a feasible curriculum for undergraduate medical students and also post-graduate residents. However, the needs assessment, curriculum design, assessment tools of PoCUS education for medical students are scarcely reported. And the effectiveness of using new teaching skills, such as E-learning, standardized patient simulation, and high-fidelity simulators, in teaching PoCUS remains unanswered. There is also no established assessment tool for learning PoCUS in undergraduate medical education. The COVID-19 pandemic also challenges medical education, including the training of PoCUS. As a skill-based curriculum, a pure E-learning is not feasible. Therefore, an important issue is to find a way to lower the physical contact during the PoCUS training. To date, scarce study has focused on the contact time and contact density of a skill-based curriculum. The main purpose of this study is establishing a low-contact PoCUS curriculum, with incorporation of small group teaching, near-peer training (NPT) design, and remote supervision (RS). It is also mandatory to make sure the effectiveness of this new curriculum, through a competency-based assessment such as entrustable professional activity (EPA). In the second year of the project, students will be randomized into two groups, including NPT+ RS group and traditional groups, to compare the amount and intensity of contact during curriculum and the effectiveness of training through objective structured clinical examination (OSCE) between two groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

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

January 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

January 10, 2025

Last Update Submit

April 13, 2026

Conditions

Keywords

ultrasoundpeer teachingremote supervision

Outcome Measures

Primary Outcomes (1)

  • Performance score on OSCE

    The effectiveness of the curriculum will be evaluated approximately one month after completing the PoCUS course for both the experimental and control groups, using OSCE assessments incorporating EPA constructs. The OSCE will be evaluated independently by two reviewers, with the final score calculated as the average of their individual assessments. Students' performance will be analyzed based on their total OSCE scores as well as their scores for each construct of the EPA.

    1 month

Secondary Outcomes (2)

  • TAM survey

    1 month

  • Survey of OSCE test

    1 month

Study Arms (2)

Experimental

EXPERIMENTAL

This group will experience lectures combined with peer instructor for hands-on training (lecture + NPT hands-on with remote supervision). The PoCUS teacher will not be physically present but will supervise remotely via video conferencing to monitor and communicate in real-time.

Other: remote supervision

Control

NO INTERVENTION

This group will follow the conventional teaching model, combining lectures with on-site PoCUS teacher supervised hands-on training (lecture + on-site teacher supervised hands-on).

Interventions

teacher use remote supervision to assist peer training

Experimental

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ■Fifth- or sixth-year medical students at National Taiwan University College of Medicine, aged 20 or older.

You may not qualify if:

  • Unwillingness to participate in the study.
  • Prior exposure to the bedside ultrasound course at National Taiwan University College of Medicine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (7)

  • ten Cate O. Entrustability of professional activities and competency-based training. Med Educ. 2005 Dec;39(12):1176-7. doi: 10.1111/j.1365-2929.2005.02341.x. No abstract available.

    PMID: 16313574BACKGROUND
  • Frenk J, Chen L, Bhutta ZA, Cohen J, Crisp N, Evans T, Fineberg H, Garcia P, Ke Y, Kelley P, Kistnasamy B, Meleis A, Naylor D, Pablos-Mendez A, Reddy S, Scrimshaw S, Sepulveda J, Serwadda D, Zurayk H. Health professionals for a new century: transforming education to strengthen health systems in an interdependent world. Lancet. 2010 Dec 4;376(9756):1923-58. doi: 10.1016/S0140-6736(10)61854-5. Epub 2010 Nov 26. No abstract available.

    PMID: 21112623BACKGROUND
  • Lichtenstein D, Malbrain ML. Critical care ultrasound in cardiac arrest. Technological requirements for performing the SESAME-protocol--a holistic approach. Anaesthesiol Intensive Ther. 2015;47(5):471-81. doi: 10.5603/AIT.a2015.0072. Epub 2015 Nov 18.

    PMID: 26578398BACKGROUND
  • Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008 Jul;134(1):117-25. doi: 10.1378/chest.07-2800. Epub 2008 Apr 10.

    PMID: 18403664BACKGROUND
  • Shokoohi H, Boniface KS, Zaragoza M, Pourmand A, Earls JP. Point-of-care ultrasound leads to diagnostic shifts in patients with undifferentiated hypotension. Am J Emerg Med. 2017 Dec;35(12):1984.e3-1984.e7. doi: 10.1016/j.ajem.2017.08.054. Epub 2017 Aug 26.

    PMID: 28851498BACKGROUND
  • Kirkpatrick AW, Sirois M, Laupland KB, Liu D, Rowan K, Ball CG, Hameed SM, Brown R, Simons R, Dulchavsky SA, Hamiilton DR, Nicolaou S. Hand-held thoracic sonography for detecting post-traumatic pneumothoraces: the Extended Focused Assessment with Sonography for Trauma (EFAST). J Trauma. 2004 Aug;57(2):288-95. doi: 10.1097/01.ta.0000133565.88871.e4.

    PMID: 15345974BACKGROUND
  • Moore CL, Copel JA. Point-of-care ultrasonography. N Engl J Med. 2011 Feb 24;364(8):749-57. doi: 10.1056/NEJMra0909487. No abstract available.

    PMID: 21345104BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
NTUH-CTC

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 16, 2025

Study Start

January 15, 2025

Primary Completion

May 19, 2025

Study Completion

April 14, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) regarding the survey of TAM model and feedbak on OSCE test will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of the study
Access Criteria
Upon request to the principal investigator with relevant IRB consent

Locations