- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06824675
Point-of-care Ultrasound Teledidactic Teaching for Prehospital Emergency Personnel (POCUS TT)
The goal of this clinical trial is to compare two methods of teaching emergency medical service (EMS) providers how to use point-of-care ultrasound (POCUS) to quickly assess critical conditions like internal bleedings. The main questions it aims to answer are:
Is teledidactic training as effective as face-to-face training in teaching POCUS skills? What are the participants' experiences, cognitive load, and feedback regarding these training methods? Researchers will compare remote, online hands-on training (teledidactic training) to traditional, face-to-face hands-on training (in-person training) to see if remote training is equally effective.
Participants will:
Be EMS providers from Austria and Hungary, aged 18 years or older, with no extensive prior experience in POCUS.
Be randomly assigned to either the tele-didactic or in-person training group (50 participants per group).
Undergo training sessions designed to teach POCUS skills and provide feedback on their learning experience.
This study is part of the European Union-funded Digi4Care project, which aims to promote digitalization in healthcare. It is significant because, if remote training proves effective, it could provide high-quality education to EMS providers in rural or underserved areas, ensuring they have the necessary skills to assess and respond to critical conditions.
Study Overview
Status
Intervention / Treatment
Detailed Description
POCUS is a valuable tool that helps EMS providers quickly assess critical conditions like internal bleeding or heart problems, which can be crucial in emergency situations. However, many rural and remote areas with limited infrastructure face challenges, such as restricted access to hands-on training and specialized instructors. This study aims to compare two educational approaches - teledidactic versus traditional in-person hands-on training - for teaching EMS providers the skills necessary to perform POCUS based on the eFAST protocol.
In this study participants will be devided into the intervention group (teledidactic training) and the control group (in-person training)
- Teledidactic Training: This involves remote, online hands-on training.
- In-Person Training: This is the traditional face-to-face hands-on training. Participants in this study are EMS providers from Austria and Hungary who are at least 18 years old and do not have extensive prior experience with POCUS. A total of 100 participants will be randomly assigned to either the teledidactic or in-person training group.
The primary objective of the study is to compare the effectiveness of teledidactic versus in-person training in teaching POCUS skills. Secondary objectives include evaluating participants' experiences with these teaching methods, their cognitive load during the learning process, and their feedback on the training methods.
This study is important because it seeks to determine if remote training can be as effective as in-person training. If successful, this could help provide high-quality education to EMS providers in rural or underserved areas, ensuring they have the necessary skills to quickly assess and respond to critical conditions. The study is part of the European Union-funded Digi4Care project, which aims to promote digitalization in healthcare.
All collected data will be securely stored and anonymized to protect participants' privacy. The study follows ethical guidelines to ensure participants' rights and safety. Participation is voluntary, and participants can withdraw at any time.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Vienna, Austria, 1070
- Medical University of Vienna
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- EMT-Intermediate/Advanced in the Austrian or Hungarian EMS
- ≥18 years
Exclusion Criteria:
- Experienced POCUS examiners, defined as >20 real-life or simulated POCUS examinations following the eFAST protocol
- inadequate knowledge of English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Teledidactic Training
Remote, online hands-on training
|
Participants will take part in a tele-didactic training session, matching the duration of the control group's training.
This workshop will cover the same content as the control group's session, but instead of in-person instruction, teaching experts will deliver the training remotely using telemedicine software.
|
|
Other: In-Person Hands-on Training
Traditional face-to-face hands on-training
|
Participants will attend a face-to-face, hands-on workshop led by experts to learn the eFAST protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in the performance of an eFAST POCUS examination between randomized groups
Time Frame: evaluation within 3 weeks after study completion
|
The primary outcome measure is the difference in the total Objective Structured Assessment of Ultrasound Skill (OSAUS) score between the participants' of the two groups.
Possible assessment scores range from 7 to 37 points, with higher scores indicating better performance.
|
evaluation within 3 weeks after study completion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in OSAUS score for each objective between randomized groups
Time Frame: evaluation within 3 weeks after study completion
|
The evaluation of different objectives within the two intervention groups using the respective OSAUS score for each individual objective.
Objectives: indication for the examination; applied knowledge of ultrasound equipment; image optimization; systematic examination, interpretation of images, documentation of examination, medical decision making.
|
evaluation within 3 weeks after study completion
|
|
Difference in time taken to demonstrate all views as required by the assessment checklist
Time Frame: evaluation within 3 weeks after study completion
|
Evaluation of the time taken to demonstrate all required views listed on the checklist.
Views: Right Upper Quadrant (Subphrenic space, right costodiaphragmatic recess, hepatorenal space, liver, right kidney); Left Upper Quadrant (Subphrenic space, left costodiaphragmatic recess, splenorenal recess, spleen, left kidney); Pelvic view (rectouterine such in females or rectovesical such in males); Cardiac View subcostal (4-chamber view); Lungs (left and right) (pleural sliding including M-Mode image, Presence or absence of B-Lines)
|
evaluation within 3 weeks after study completion
|
|
Difference in cognitive load between randomized groups
Time Frame: evaluation within 3 weeks after study completion
|
Assessment of the cognitive load using the NASA Task load index for overall cognitive load and for each individual objective (mental demand, physical demand, temporal demand, performance, effort, frustration)
|
evaluation within 3 weeks after study completion
|
|
Difference in learning outcomes and training design using TEI between randomized groups
Time Frame: evaluation within 3 weeks after study completion
|
Compare learning outcomes and training design between randomized groups using the Training Evaluation Inventory (TEI).
Learning outcomes include subjective fun, perceived usefulness, difficulty, knowledge growth, and attitudes toward the training.
Training design elements such as problem-based learning, activation of prior knowledge, demonstration, application, and integration will also be assessed.
These aspects will be measured with a 45-item inventory using a 5-point Likert scale, ranging from "I do not agree" to "I agree very much," providing insights into the effectiveness of the training methods.
|
evaluation within 3 weeks after study completion
|
|
Technical issues/usability
Time Frame: evaluation within 3 weeks after study completion
|
Assessment whether participants in the intervention group encountered issues with the software or hardware used for the teledidactic training. Participants will indicate "yes" or "no" and, if they experienced issues, provide free-text explanations. |
evaluation within 3 weeks after study completion
|
|
Evaluation of participants' feedback on specific questions
Time Frame: evaluation within 3 weeks after study completion
|
Evaluation of participants' feedback on their learning experience using specific questions.
Participants will rate, on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), whether the e-learning course provided adequate knowledge for the subsequent hands-on training.
Additionally, they will assess their confidence in performing and interpreting the eFAST protocol.
For the intervention group only, participants will also indicate whether they would have preferred in-person training instead of the teledidactic and whether they found the software/hardware easy to use.
|
evaluation within 3 weeks after study completion
|
Collaborators and Investigators
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2107/2024
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
product manufactured in and exported from the U.S.
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