EducationNCT07307573
A Remotely Supported Pediatric Simulation-Based Procedural Training Curriculum for EMS Clinicians
A study testing education in people with Education and Emergency Medical Services, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to study and compare the efficacy and feasibility of a remotely supported simulation-based procedural curriculum for Emergency Medical Services (EMS) clinicians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Emergency Medical Services
- What is being tested?
- education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all full-time or part-time EMS clinicians at the recruited agencies with BVM ventilation, SGD placement, and/or IO catheterization within their scope of practice
Who cannot join
- no procedures of interest within scope of practice
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: A Remotely Supported Pediatric Simulation-Based Procedural Training Curriculum for EMS Clinicians: Partnering PECCs and Pediatric Experts at a Distance
The purpose of this study is to study and compare the efficacy and feasibility of a remotely supported simulation-based procedural curriculum for Emergency Medical Services (EMS) clinicians.
Read the detailed description
This study transitioned a previously reported, traditional, simulation-based training curriculum delivered by on-site pediatric simulation experts, into a program delivered by agency Pediatric Emergency Care Coordinators (PECCs) supported by remote pediatric experts. The PECCs delivered the curriculum on site, and submitted first-person-view videos captured using a head-mounted camera of three procedures (bag-valve mask [BVM] ventilation, supraglottic device [SGD] insertion, and intraosseous [IO] catheterization) to pediatric education experts who provided scoring and feedback to the participants. The team tracked scores for all three procedures during the study period, compared scores to the previous study's, and solicited feedback from the PECCs and participants regarding these educational methods.
- Conditions
- Education, Emergency Medical Services
- Being tested
- education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
pediatric emergency care coordinator provided education on each procedure performed
| Study group | Role | What they receive |
|---|---|---|
| educational intervention | Experimental | received training and submitted video on each procedure Receives: Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraosseous (IO) catheterization procedural outcome score
The IO assessment tool was adapted from a previously validated simulation assessment tool. The score ranged from 0-12, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.
Measured: participants submitted 1-2 procedural videos based on training date during the 1-year study period
bag valve mask (BVM) ventilation procedural outcome score
The BVM assessment tool was adapted from a previously validated simulation assessment tool. The score ranged from 0-12, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.
Measured: participants submitted 1-2 procedural videos based on training date during the 1-year study period
supraglottic device (SGD) placement procedural outcome score
The SGD assessment tool was modified from a prior psychomotor examination checklist used by the National Registry of Emergency Medical Technicians. The score ranged from 0-14, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.
Measured: participants submitted 1-2 procedural videos based on training date during the 1-year study period
Secondary outcomes (1)
qualitative feedback regarding the curriculum
Feedback regarding the curriculum and educational experience was solicited via e-mail from participants at time of score reporting. Similar feedback was solicited via e-mail from educators throughout the study period during scheduling or troubleshooting correspondences. Comments were tabulated and summarized.
Measured: 1 year study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start14 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all participants received the same educational intervention
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Sang Hoon Lee, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307573
- Sponsor's protocol ID
- 2021-0172
- Other IDs
- 2UL1TR001425-05A1
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee SH, Riney LC, Merkt B, McDonough SD, Baker J, Boyd S, Zhang Y, Geis GL. Improving Pediatric Procedural Skills for EMS Clinicians: A Longitudinal Simulation-Based Curriculum with Novel, Remote, First-Person-View Video-Based Outcome Measurement. Prehosp Emerg Care. 2024;28(2):352-362. doi: 10.1080/10903127.2023.2263555. Epub 2024 Feb 1.
PubMed 37751212
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remotely Supported Pediatric Simulation-Based Procedural Training Curriculum for EMS Clinicians: Partnering PECCs and Pediatric Experts at a Distance
- ClinicalTrials.gov ID
- NCT07307573
- Acronym / sponsor ID
- 2021-0172
- Conditions
- Education, Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study and compare the efficacy and feasibility of a remotely supported simulation-based procedural curriculum for Emergency Medical Services (EMS) clinicians.
Detailed description
This study transitioned a previously reported, traditional, simulation-based training curriculum delivered by on-site pediatric simulation experts, into a program delivered by agency Pediatric Emergency Care Coordinators (PECCs) supported by remote pediatric experts. The PECCs delivered the curriculum on site, and submitted first-person-view videos captured using a head-mounted camera of three procedures (bag-valve mask [BVM] ventilation, supraglottic device [SGD] insertion, and intraosseous [IO] catheterization) to pediatric education experts who provided scoring and feedback to the participants. The team tracked scores for all three procedures during the study period, compared scores to the previous study's, and solicited feedback from the PECCs and participants regarding these educational methods.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all participants received the same educational intervention
| Arm | Type | Receives |
|---|---|---|
| educational intervention | Experimental | Behavioral: educationreceived training and submitted video on each procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all full-time or part-time EMS clinicians at the recruited agencies with BVM ventilation, SGD placement, and/or IO catheterization within their scope of practice
Key exclusion criteria (1 listed)
- no procedures of interest within scope of practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationpediatric emergency care coordinator provided education on each procedure performed | Behavioural | educational intervention |
Primary outcome
intraosseous (IO) catheterization procedural outcome score
Time frame: participants submitted 1-2 procedural videos based on training date during the 1-year study period
The IO assessment tool was adapted from a previously validated simulation assessment tool. The score ranged from 0-12, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.
bag valve mask (BVM) ventilation procedural outcome score
Time frame: participants submitted 1-2 procedural videos based on training date during the 1-year study period
The BVM assessment tool was adapted from a previously validated simulation assessment tool. The score ranged from 0-12, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.
supraglottic device (SGD) placement procedural outcome score
Time frame: participants submitted 1-2 procedural videos based on training date during the 1-year study period
The SGD assessment tool was modified from a prior psychomotor examination checklist used by the National Registry of Emergency Medical Technicians. The score ranged from 0-14, with higher score demonstrating better performance. Participants submitted videos for review, which were scored by trained video reviewers using the assessment tool based on a corresponding data dictionary. Scores were then aggregated for analysis.
1 secondary outcome
qualitative feedback regarding the curriculum
Time frame: 1 year study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Background: PubMed 37751212Lee SH, Riney LC, Merkt B, McDonough SD, Baker J, Boyd S, Zhang Y, Geis GL. Improving Pediatric Procedural Skills for EMS Clinicians: A Longitudinal Simulation-Based Curriculum with Novel, Remote, First-Person-View Video-Based Outcome Measurement. Prehosp Emerg Care. 2024;28(2):352-362. doi: 10.1080/10903127.2023.2263555. Epub 2024 Feb 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Hoon Lee principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Education and Emergency Medical Services, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraosseous (IO) catheterization procedural outcome score (time frame: participants submitted 1-2 procedural videos based on training date during the 1-year study period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07307573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.