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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL145126-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Usability Score | The total usability score is measured by the Telehealth Usability Questionnaire (TUQ), a 21-item questionnaire which is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users [transport nurses and physicians] rate items on 7-point Likert-scales (1=disagree to 7=agree) in 6 separate domains (usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use). The investigators modified this questionnaire to specifically address the usability of the study telemedicine platform. The range of the total usability score is 1-7. Low scores reflect a worse outcome, while high scores are a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tehnaz Boyle, MD PhD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Boston Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Two calls did not connect so the overall number analyzed is 18. | Posted | Mean | 95% Confidence Interval | proportion agreement | During transport to the hospital via ambulance, up to 4 hours |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tehnaz Boyle, MD PhD | Boston Medical Center | 617-414-6382 | tehnaz.boyle@bmc.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2024 | Jan 8, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 9, 2024 | Sep 22, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D019114 | Remote Consultation |
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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|
| Immediately after the transport was completed, up to 48 hours |
| Video Quality | This will be measured by TUQ items #11 and #14 within the "Interaction Quality" domain. Users [transport nurses and physicians] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and standard deviation (SD) for each item will be reported. Higher scores suggest higher quality. | Immediately after the transport was completed, up to 48 hours |
| Audio Quality | This will be measured by TUQ items #12 and #13 within the "Interaction Quality" domain. Users [transport nurses and physicians] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and SD for each item will be reported. Higher scores suggest higher quality. | immediately after the transport was completed, up to 48 hours |
| Adequacy of Successful Video-call Connections | The number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequacy of successful video-call connection is defined as ≤2 attempts to achieve a video-call connection. | immediately after the transport was completed, up to 48 hours |
| Percentage of Successful Tablet Mounts | Study investigators will note any problems with tablet mounts in the ambulance cabin (e.g., location makes call activation difficult), as well as specific qualitative comments from participants regarding tablet mount strategy. If no problems are noted the tablet mount will be considered successful and the percentage of successful table mounts will be reported. | Success/failure was assessed during transport, up to 4 hours |
| Percentage of Calls With Adequate Video Quality for Assessment | This will be measured as the proportion of video-calls where clinicians are able to observe all ten items on the Respiratory Observation Checklist. This checklist tool has been previously validated for rapid, reliable assessment of children by teleconsultants in emergency settings. Medical control physicians will score 9 observable signs and a global assessment of respiratory distress dichotomously (present/absent). | during ambulance transport, up to 4 hours |
| Time to Arrival at Referring Facility | This is the time interval (minutes) from when BCH receives the patient transport request from the referring facility to the time the transport team arrives at the referring facility. This will be abstracted from transport records. | up to 240 minutes |
| Scene Time | This is the time interval (minutes) from when the BCH transport team arrives at the referring facility to when the transport team leaves the referring facility. This will be abstracted from transport records. | up to 240 minutes |
| Time to Arrival at Destination Facility | This is the time interval (minutes) from when the BCH transport team leaves the referring facility to the time of arrival at BCH/BMC (the destination facility). This will be abstracted from transport records. | up to 240 minutes |
| Total Transport Time | This time interval encompasses the time from when the transport team is dispatched to the referring facility to when they arrive at the destination (receiving facility). This will be abstracted from transport records. | up to 240 minutes |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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|
| Secondary | Total Usability Score | The total usability score is measured by the Telehealth Usability Questionnaire (TUQ), a 21-item questionnaire which is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users [transport nurses and physicians] rate items on 7-point Likert-scales (1=disagree to 7=agree) in 6 separate domains (usefulness, ease of use and learnability, interface quality, interaction quality, reliability, satisfaction and future use). The investigators modified this questionnaire to specifically address the usability of the study telemedicine platform. The range of the total usability score is 1-7. Low scores reflect a worse outcome, while high scores are a better outcome. | There were 3 transport nurses and 2 physicians and the scores represent an average of the 20 ambulance encounters. | Posted | Mean | Standard Deviation | score on a scale | Immediately after the transport was completed, up to 48 hours | encounters | encounters |
|
|
|
| Secondary | Video Quality | This will be measured by TUQ items #11 and #14 within the "Interaction Quality" domain. Users [transport nurses and physicians] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and standard deviation (SD) for each item will be reported. Higher scores suggest higher quality. | There were 3 transport nurses and 2 physicians and the scores represent an average of the 20 ambulance encounters. | Posted | Mean | Standard Deviation | units on a scale | Immediately after the transport was completed, up to 48 hours | encounters | encounters |
|
|
|
| Secondary | Audio Quality | This will be measured by TUQ items #12 and #13 within the "Interaction Quality" domain. Users [transport nurses and physicians] will rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. The mean score and SD for each item will be reported. Higher scores suggest higher quality. | There were 3 transport nurses and 2 physicians and the scores represent an average of the 20 ambulance encounters. | Posted | Mean | Standard Deviation | units on a scale | immediately after the transport was completed, up to 48 hours | encounters | encounters |
|
|
|
| Secondary | Adequacy of Successful Video-call Connections | The number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequacy of successful video-call connection is defined as ≤2 attempts to achieve a video-call connection. | Posted | Number | encounters | immediately after the transport was completed, up to 48 hours | encounters | encounters |
|
|
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| Secondary | Percentage of Successful Tablet Mounts | Study investigators will note any problems with tablet mounts in the ambulance cabin (e.g., location makes call activation difficult), as well as specific qualitative comments from participants regarding tablet mount strategy. If no problems are noted the tablet mount will be considered successful and the percentage of successful table mounts will be reported. | Posted | Number | percentage of mounts | Success/failure was assessed during transport, up to 4 hours | encounters | encounters |
|
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| Secondary | Percentage of Calls With Adequate Video Quality for Assessment | This will be measured as the proportion of video-calls where clinicians are able to observe all ten items on the Respiratory Observation Checklist. This checklist tool has been previously validated for rapid, reliable assessment of children by teleconsultants in emergency settings. Medical control physicians will score 9 observable signs and a global assessment of respiratory distress dichotomously (present/absent). | Posted | Number | percentage of video quality | during ambulance transport, up to 4 hours | encounters | encounters |
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| Secondary | Time to Arrival at Referring Facility | This is the time interval (minutes) from when BCH receives the patient transport request from the referring facility to the time the transport team arrives at the referring facility. This will be abstracted from transport records. | Posted | Median | Inter-Quartile Range | minutes | up to 240 minutes | encounters | encounters |
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| Secondary | Scene Time | This is the time interval (minutes) from when the BCH transport team arrives at the referring facility to when the transport team leaves the referring facility. This will be abstracted from transport records. | Posted | Median | Inter-Quartile Range | minutes | up to 240 minutes | encounters | encounters |
|
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| Secondary | Time to Arrival at Destination Facility | This is the time interval (minutes) from when the BCH transport team leaves the referring facility to the time of arrival at BCH/BMC (the destination facility). This will be abstracted from transport records. | Posted | Median | Inter-Quartile Range | minutes | up to 240 minutes | encounters | encounters |
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| Secondary | Total Transport Time | This time interval encompasses the time from when the transport team is dispatched to the referring facility to when they arrive at the destination (receiving facility). This will be abstracted from transport records. | Posted | Median | Inter-Quartile Range | minutes | up to 240 minutes | encounters | encounters |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
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| Physicians- "Using the telemedicine system, I can see the patient/clinician as if we met in person." |
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| Physicians- "I felt I was able to express myself effectively." |
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