Prehospital Telemedicine Feasibility/Acceptability Pilot
NCT ID: NCT05967624
Last Updated: 2026-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-06-21
2025-06-30
Brief Summary
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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.
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Clinically stable for transportation \[e.g., need supplemental oxygen, medications, or are stable on mechanical ventilation\]
Exclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Boston Medical Center
OTHER
Responsible Party
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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
Boston Medical Center
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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H-38282
Identifier Type: -
Identifier Source: org_study_id
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