Trials / Completed
CompletedNCT05967624
Prehospital Telemedicine Feasibility/Acceptability Pilot
Feasibility and Acceptability of a Low-cost, Mobile Telemedicine Platform for Remote Assessment of Children Transported by Ambulance
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Boston Medical Center · Academic / Other
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
Timeline
- Start date
- 2024-06-21
- Primary completion
- 2025-02-14
- Completion
- 2025-06-30
- First posted
- 2023-08-01
- Last updated
- 2026-02-19
- Results posted
- 2026-02-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05967624. Inclusion in this directory is not an endorsement.