Telemedical Support for Emergency Care

(R01 Trial)

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

Trial Summary

What is the purpose of this trial?

In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. 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 expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Telemedical Support for Emergency Care?

Research shows that telemedicine, which includes real-time video consultations, can improve emergency care by providing timely access to specialists, especially in rural or pre-hospital settings. It has been particularly effective in managing conditions like stroke and heart attacks, enhancing diagnosis and treatment delivery. ^{1 2 3 4 5}

Is telemedical support generally safe for use in emergency care?

Research shows that using telemedical support in emergency situations is generally safe and does not lead to more adverse events (unwanted side effects or complications) compared to traditional in-person care. ^{1 6 7 8 9}

How does the treatment Telemedical Support differ from other treatments for emergency care?

Telemedical Support is unique because it uses technology to provide remote medical assistance, allowing for real-time video consultations and the transmission of vital signs and ECGs (heart activity recordings) from the emergency site to specialists. This approach can significantly reduce treatment times and improve coordination in emergency situations, especially in rural areas where immediate access to a physician may be limited. ^{2 5 10 11 12}

Research Team

Tehnaz Boyle, MD PhD

Principal Investigator

Bosotn Medical Center, Pediatrics Department

Eligibility Criteria

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

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

Resident physicians-in-training

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of critical care telemedicine consultations on children in rural emergency departments. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Real-time video telemedicine applications in the emergency department: a scoping review of literature. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Impact of an ultrabroadband emergency department telemedicine system on the care of acutely ill patients and clinicians' work. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Telemedicine in pre-hospital care: a review of telemedicine applications in the pre-hospital environment. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

Decision Support Capabilities of Telemedicine in Emergency Prehospital Care: Systematic Review. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Measuring adverse events in helicopter emergency medical services: establishing content validity. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Appropriateness of disposition following telemedicine consultations in rural emergency departments. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Telemedical support for prehospital emergency medical service in severe emergencies: an open-label randomised non-inferiority clinical trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The Abrupt Expansion of Ambulatory Telemedicine: Implications for Patient Safety. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

[ANMCO/SIT Consensus document: Telemedicine and the emergency/urgency care network]. [2016]

11. England pubmed.ncbi.nlm.nih.gov

ANMCO/SIT Consensus Document: telemedicine for cardiovascular emergency networks. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

The Telemedical Rescue Assistance System "TemRas"--development, first results, and impact. [2014]