Telemedical Support for Emergency Care

(R01 Trial)

Recruiting at 3 trial locations

Overseen By Divya Gumudavelly, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Interfacility transport, Resident physicians, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

420 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if video calls with pediatric emergency experts can enhance paramedics' care for children in life-threatening emergencies, such as severe breathing problems. Paramedics typically rely on audio calls with doctors, which may be insufficient without visual access to the patient. The trial will compare video call support (telemedical support) to audio call support to assess which method reduces paramedic errors. Certified emergency responders or doctors who provide emergency care guidance over the phone or radio are suitable participants for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative emergency care solutions that could improve outcomes for children in critical situations.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What prior data suggests that telemedical support is safe for pediatric emergency care?

Research has shown that telemedical support is generally safe for use in emergency care. Studies have found that video during emergency calls can improve care quality. For instance, one study discovered that video use reduced the need for the most urgent dispatches by 5%. This finding suggests that telemedical support might help paramedics make better decisions in emergencies.

Other research has examined the long-term safety and effectiveness of telemedical systems. The findings indicate that these systems improve emergency care by enhancing communication between paramedics and doctors. They enable real-time video and audio exchange, allowing doctors to see and assess patients more accurately than with audio alone.

Overall, the evidence suggests that telemedical support is well-accepted, with no major safety concerns reported. This makes it a promising tool for emergency medical services, especially in life-threatening situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for telemedical support in emergency care because it explores innovative ways to enhance real-time medical assistance. Unlike traditional emergency responses that rely solely on in-person evaluations, this trial investigates the use of video teleconsultations with Pediatric Emergency Medicine (PEM) physicians and audio support from Emergency Medicine (EM) physicians. This approach could provide EMS providers with rapid access to specialized expertise, potentially improving patient outcomes by offering more precise and timely interventions. The trial aims to determine how these telemedical methods can optimize emergency care delivery, particularly in pediatric settings.

What evidence suggests that telemedical support is effective for improving emergency care for children?

Research has shown that telemedicine, which allows paramedics to connect with doctors via video and audio, can enhance emergency care. In this trial, EMS providers will be randomized into different groups to receive either video teleconsultation with Pediatric Emergency Medicine (PEM) physicians or audio support from usual care Emergency Medicine (EM) physicians. One study found that paramedics using telemedicine made fewer mistakes in emergencies compared to those using only radio communication. Another study discovered that video connections enabled doctors to give better advice because they could see the patient. Using telemedicine in emergency services has been linked to better treatment options and higher quality care. Overall, telemedicine helps paramedics provide more accurate and effective care during emergencies. ^{1 3 4 6 7}

Who Is on the Research Team?

Tehnaz Boyle, MD PhD

Principal Investigator

Bosotn Medical Center, Pediatrics Department

Are You a Good Fit for This Trial?

This trial is for paramedics and emergency medical technicians who respond to emergencies, as well as board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians who provide remote support. It's not suitable for those outside of these professional roles.

Inclusion Criteria

Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible

Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response

I am a physician in the control group providing care via phone or radio.

Exclusion Criteria

Non-physician providers

Resident physicians-in-training

I work in EMS and provide transport between facilities or specialize in pediatric transport.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulation-based Treatment

Paramedics receive real-time telemedical support by a pediatric expert during simulated cases of pediatric medical emergencies

4 hours per session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 hours

What Are the Treatments Tested in This Trial?

Interventions

• Telemedical Support

Trial Overview The study tests if using video calls between paramedics at the scene and pediatric experts improves care in simulated child emergency cases, compared to standard audio-only support.

How Is the Trial Designed?

Group I: Teleconsultation video arm with PEM physicians Experimental Treatment 1 Intervention

Emergency Medical Services (EMS) providers randomized into this arm will receive video teleconsultation with Pediatric Emergency Medicine (PEM) physicians.

Group II: Audio support arm with EM physicians Active Control 1 Intervention

EMS providers randomized into this arm will receive audio support by usual care Emergency Medicine (EM) physicians.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

In a study of 138 acutely ill and injured children in rural emergency departments, those receiving telemedicine consultations had a significantly lower hospital admission rate (59.5%) compared to those receiving telephone consultations (87.5%), suggesting that telemedicine may lead to more appropriate care.

Despite the lower admission rate with telemedicine, the observed-to-expected admission ratios were not statistically different between the two groups, indicating that both consultation methods provided similar levels of care quality, which supports the use of telemedicine in pediatric emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Appropriateness of disposition following telemedicine consultations in rural emergency departments. Yang, NH., Dharmar, M., Kuppermann, N., et al.[2022]

In a study of 320 critically ill children in rural emergency departments, telemedicine consultations provided the highest quality of care compared to telephone consultations and no consultations, as rated by pediatric emergency medicine physicians.

Parents reported significantly higher satisfaction and perceived quality of care when telemedicine was used, and telemedicine led to more frequent changes in diagnosis and treatment by referring physicians compared to telephone consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of critical care telemedicine consultations on children in rural emergency departments. Dharmar, M., Romano, PS., Kuppermann, N., et al.[2022]

In a study involving 3531 patients, the tele-emergency medical service was found to be non-inferior to conventional physician-based emergency services, with only one adverse event occurring in the tele-emergency group, indicating its safety in severe emergencies.

The tele-emergency service was utilized in a significantly higher percentage of cases (57.8%) compared to the conventional service (6.4%), suggesting it can effectively manage many emergencies without the need for a physical physician on-site.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedical support for prehospital emergency medical service in severe emergencies: an open-label randomised non-inferiority clinical trial. Kowark, A., Felzen, M., Ziemann, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10311733/

Telemedical support for prehospital emergency medical ... In brief, the tele-EMS transfers all vital, audio, and video data from the emergency scene to a teleconsultation centre equipped with an EMS ...

2. nature.com nature.com/articles/s41598-023-50924-5

Long-term effects of a prehospital telemedicine system on ... The aim of this study was to investigate the long-term effects of implementing a tele-EMS system on the structural and procedural quality indicators.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06441760?term=cardiology&locStr=United+States&country=United+States&aggFilters=status:

Simulation Trial of Telemedical Support for Paramedics The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK597357/

EMS Telemedicine in the Prehospital Setting - StatPearls - NCBI The future of telemedicine in EMS is promising, but more data are needed on its cost-effectiveness and impact on patient outcomes.[64] ...

5. bmcemergmed.biomedcentral.com bmcemergmed.biomedcentral.com/articles/10.1186/s12873-024-01034-6

Improving the introduction of telemedicine in pre-hospital ... Most participants approved that telemedicine positively impacts EM and improved treatment options with an overall Usabilty Score of 68,68.

6. jmir.org jmir.org/2019/10/e14907/

Utilization, Safety, and Technical Performance of a ... Objective: We sought to assess the utilization, safety, and technical performance of this telemedical emergency service. Methods: We conducted a ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2835842

Video Streaming or Telephone Communication During ... This cluster randomized clinical trial of 18 745 emergency calls demonstrated that video streaming reduced the percentage of highest-urgency dispatches by 5.0%.