Clinical trial NCT05967624: Prehospital Telemedicine Feasibility/Acceptability Pilot
Official title: Feasibility and Acceptability of a Low-cost, Mobile Telemedicine Platform for Remote Assessment of Children Transported by Ambulance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome
Keywords: Teleconsultation
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-08-01
Enrollment: 20
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Agreement in assessment of respiratory distress
timeFrame: 6 months
Secondary outcomes:
measure: Total Usability Score
timeFrame: 6 months
measure: Video quality
timeFrame: 6 months
measure: Audio quality
timeFrame: 6 months
measure: Success of video-call connection
timeFrame: 6 months
measure: Proportion of successful tablet mounts
timeFrame: 6 months
measure: Proportion of calls with adequate video quality for assessment
timeFrame: 6 months
measure: Time to arrival at referring facility
timeFrame: 6 months
measure: Scene time
timeFrame: 6 months
measure: Time to arrival at destination facility
timeFrame: 6 months
measure: Total transport time
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Tehnaz Boyle, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: