Prehospital Telemedicine Feasibility/Acceptability Pilot

NCT05967624 | Completed Results DMC

• 2 other identifiers: H-382825K23HL145126-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Teleconsultation, or the use of video telecommunications technology to deliver expert recommendations for care remotely, has been used to improve the safety and quality of emergency care for children in hospital-based acute care settings by providing real-time access to remote pediatric physician experts. Whether extending teleconsultation as a patient safety intervention to emergency medical systems (EMS) outside hospitals can similarly benefit sick and injured children in the community is unknown. Advances in mobile technology have made teleconsultation more accessible and affordable for EMS systems. However, this intervention has been underutilized by EMS partially due to the lack of prehospital research supporting its efficacy for pediatric applications. In prior simulation studies, the investigators found high intervention acceptance among key stakeholder groups (pediatric emergency physicians and paramedics), and demonstrated that it was feasible to integrate video communication into prehospital clinical workflows involving critical care delivery in high-risk pediatric scenarios. These initial simulation studies were conducted in a controlled prehospital setting in static ambulances using infant simulator manikins to minimize risk to children and providers. Demonstrating feasibility and acceptability with real children in moving ambulances is the next step to build the necessary evidence base to support future planned prehospital efficacy trials with children. The investigators hypothesize that remote respiratory assessment of children by medical control physicians (expert physicians) using a mobile teleconsultation platform is acceptable to users (physicians and transport providers), and technically feasible in real transports.

Conditions

Respiratory Distress Syndrome

Keywords

Teleconsultation

Outcome Measures

Primary Outcomes (1)

• Agreement in Assessment of Respiratory Distress

  Each subject will be remotely assessed by a Medical Control Physician using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device. The remote medical control physician and the transport team member at the patient bedside in the ambulance will score the Respiratory Observation Checklist simultaneously. The range for agreement is 0 to 1.0, where 0=no agreement and 1 is perfect agreement. The following scale: 0.01-0.20=none to slight, 0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, 0.81-1.0=almost perfect agreement will be used.

  During transport to the hospital via ambulance, up to 4 hours

Secondary Outcomes (10)

• Total Usability Score

  Immediately after the transport was completed, up to 48 hours

• Video Quality

  Immediately after the transport was completed, up to 48 hours

• Audio Quality

  immediately after the transport was completed, up to 48 hours

• Adequacy of Successful Video-call Connections

  immediately after the transport was completed, up to 48 hours

• Percentage of Successful Tablet Mounts

  Success/failure was assessed during transport, up to 4 hours

Study Arms (1)

Teleconsultation group

EXPERIMENTAL

Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.

Other: Teleconsultation

Interventions

Teleconsultation OTHER

Each subject will be remotely assessed by a Medical Control Physician (MCP) using Zoom Pro (HIPAA-compliant video-conferencing software) on tablet devices as a low-cost mobile telemedicine platform and the Respiratory Observation Checklist, validated for telemedicine use in emergency settings. All prehospital clinical decision making will be made at the discretion of evaluating paramedics as per standard state-approved protocols and procedures, independent of checklist results.

Teleconsultation group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children in New England transported by the Boston Children Hospital for respiratory illness from any cause
• Clinically stable for transportation \[e.g., need supplemental oxygen, medications, or are stable on mechanical ventilation\]

You may not qualify if:

• Children with non-respiratory complaints
• Children whose illness is anticipated by providers to be acutely life-threatening during transportation \[e.g., requiring emergency resuscitation procedures in the ambulance\]
• Non-English speaking parents/guardians

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Boston Medical Center: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Remote Consultation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Results Point of Contact

• Title: Tehnaz Boyle, MD PhD
• Organization: Boston Medical Center

tehnaz.boyle@bmc.gov

617-414-6382

Study Officials

• Tehnaz Boyle, MD PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 1, 2023
• Study Start: June 21, 2024
• Primary Completion: February 14, 2025
• Study Completion: June 30, 2025
• Last Updated: February 19, 2026
• Results First Posted: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)