Prehospital Telemedicine Feasibility/Acceptability Pilot

NCT ID: NCT05967624

Last Updated: 2026-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-21

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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An open-label, nonrandomized, pilot feasibility trial will be conducted of children with respiratory distress transported by the Boston Children's Hospital (BCH) critical care transport team that also serves Boston Medical Center (BMC). Transport providers will initiate a video-call from the ambulance to medical control physician on call who will be at a geographically distant location. The physician will view streamed video of the child and complete a brief respiratory assessment checklist tool to determine video quality, a feasibility measure.

The investigators will measure acceptability (primary outcome) and feasibility (secondary outcomes) on a validated questionnaire administered to users after each call. In this pilot study, efficacy will not be tested; all decision making will occur according to usual care protocols.

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Teleconsultation group

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

Group Type EXPERIMENTAL

Teleconsultation

Intervention Type 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.

Interventions

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Teleconsultation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tehnaz Boyle, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5K23HL145126-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-38282

Identifier Type: -

Identifier Source: org_study_id

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