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Prehospital Telemedicine Feasibility/Acceptability Pilot

Primary Purpose

Respiratory Distress Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teleconsultation
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Respiratory Distress Syndrome focused on measuring Teleconsultation

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital
  • Boston Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Teleconsultation group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total Usability Score
The total usability score is measured by the Telehealth Usability Questionnaire (TUQ). This 21-item questionnaire is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users 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 total usability score is the total mean score for all 21 questions (maximum possible score=7).
Video quality
This will be measured by TUQ items #11 and #14 within the "Interaction Quality" domain. Users 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.
Audio quality
This will be measured by TUQ items #12 and #13 within the "Interaction Quality" domain. Users 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.
Success of video-call connection
The number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequate success of video-call connection is defined as ≤2 attempts to achieve a video-call connection.
Proportion 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 proportion of successful table mounts will be reported.
Proportion 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).
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.
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.
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.
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.

Full Information

First Posted
July 21, 2023
Last Updated
October 16, 2023
Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05967624
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
Teleconsultation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Teleconsultation group
Arm Type
Experimental
Arm Description
Eligible children managed by urban paramedic teams responding to 911 calls in the prehospital setting to support a future trial of clinical efficacy.
Intervention Type
Other
Intervention Name(s)
Teleconsultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Agreement in assessment of respiratory distress
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Total Usability Score
Description
The total usability score is measured by the Telehealth Usability Questionnaire (TUQ). This 21-item questionnaire is a validated measure of all the key usability characteristics of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). Users 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 total usability score is the total mean score for all 21 questions (maximum possible score=7).
Time Frame
6 months
Title
Video quality
Description
This will be measured by TUQ items #11 and #14 within the "Interaction Quality" domain. Users 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.
Time Frame
6 months
Title
Audio quality
Description
This will be measured by TUQ items #12 and #13 within the "Interaction Quality" domain. Users 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.
Time Frame
6 months
Title
Success of video-call connection
Description
The number of attempts transport team providers make to successfully connect with the medical control physician via video-call will be recorded. Adequate success of video-call connection is defined as ≤2 attempts to achieve a video-call connection.
Time Frame
6 months
Title
Proportion of successful tablet mounts
Description
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 proportion of successful table mounts will be reported.
Time Frame
6 months
Title
Proportion of calls with adequate video quality for assessment
Description
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).
Time Frame
6 months
Title
Time to arrival at referring facility
Description
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.
Time Frame
6 months
Title
Scene time
Description
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.
Time Frame
6 months
Title
Time to arrival at destination facility
Description
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.
Time Frame
6 months
Title
Total transport time
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tehnaz Boyle, MD PhD
Phone
617-414-6382
Email
tehnaz.boyle@bmc.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tehnaz Boyle, MD PhD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Kleinman, MD
Phone
617-355-7327
Email
monica.kleinman@childrens.harvard.edu
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tehnaz Boyle, MD PhD
Phone
617-414-6382
Email
tehnaz.boyle@bmc.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Prehospital Telemedicine Feasibility/Acceptability Pilot

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