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Pilot Simulation RCT of Telemedical Support for Paramedics

Primary Purpose

Respiratory Failure, Status Epilepticus, Status Asthmaticus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telemedicine
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 Failure focused on measuring Prehospital emergency care, Paramedic performance, Telemedicine, Medical control physician, Infant mannequin smulation, Pediatric life threatening illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Certified paramedics from three EMS systems in the Boston metropolitan area (Boston EMS, South Shore EMS, and Lahey Medical Center EMS)
  • Attending physicians and clinical fellows with expertise in pediatric emergency medicine and pediatric resuscitation from 2 pediatric referral centers (Boston Medical Center and Boston Children's Hospital)

Exclusion Criteria:

-Prehospital providers without paramedic level certification (e.g. BLS certification only)

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedicine

Control

Arm Description

The telemedicine arm will have 2-way audiovisual connection with a pediatric medical control physician.

The control arm will receive pediatric medical control physician consultation via telephone.

Outcomes

Primary Outcome Measures

Paramedic Team Performance score
The paramedic team performance score is generated from a 64-item checklist of observable actions for pediatric assessment and resuscitation that are scored dichotomously (observed/not observed). The composite performance score is calculated as the number of observed actions divided by the total number of expected actions per case, and reported as a percentage of completed observed actions. This checklist is validated for simulation-based assessment of paramedic performance using three simulated cases of pediatric pre-hospital emergencies. Paramedic team performance will be rated by 1 live and 2 video raters. The final performance score for each team will be reported as an average score for all three raters.

Secondary Outcome Measures

NASA Task load Index
This is an extensively validated measure of perceived workload of individuals. It is a multidimensional scale where individuals estimate workload during or after completing a task. It contains 7 domains (mental demand, physical demand, temporal demand, performance, effort, frustration, and anxiety) which are evaluated on a 20-point Likert scale. Study participants will complete this questionnaire immediately after completing the simulation modules.
Telemedicine Platform Usability
This 14-item questionnaire is a validated measure of all the usability of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). The investigators modified this questionnaire to specifically address the usability of a prehospital telemedicine platform. Study participants will complete this questionnaire immediately after completing the simulation modules.
Error in medication choice
This will be any incorrect type of medication utilized by a team during each simulation resuscitation. This includes unanticipated medication choices which the study raters feel was not indicated or potentially harmful by consensus opinion. This data is collected in the paramedic performance checklist.
Error in weight-based medication dosing
This will include any errors in pediatric weight-based dose calculation, including errors in volume of drug administered during each simulated case. This data is collected in the paramedic performance checklist.
Equipment size error
This includes errors in equipment size during each simulated resuscitation. This data is collected in the paramedic performance checklist.
Equipment use errors
This includes errors in equipment usage (e.g. depth of endotracheal tube insertion, rate of bag-valve-mask ventilation, location of intraosseous needle insertion) during each simulated resuscitation. This data is collected in the paramedic performance checklist.
EMS protocol error
This will be defined as any error in offline and online EMS treatment protocols that is observed during each simulated resuscitation. This data is collected in the paramedic performance checklist.

Full Information

First Posted
November 13, 2018
Last Updated
July 26, 2022
Sponsor
Boston Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03742167
Brief Title
Pilot Simulation RCT of Telemedical Support for Paramedics
Official Title
Pilot Randomized Control Trial of Telemedical Support for Paramedics in Simulated Pre-hospital Pediatric Emergencies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This study evaluates the impact of video communication via telemedicine on the quality of emergency care provided to children by paramedic teams supported by a remote physician in a simulated out-of-hospital setting. Half of the paramedic teams will use a video telemedicine platform for communication with a physician, while the other half will use an audio-only platform.
Detailed Description
In the United States, the current standard of pre-hospital (out-of-hospital) emergency care for children with life-threatening illnesses in the community includes remote physician medical direction for paramedics providing life-saving therapies while transporting the child to the hospital. Most pre-hospital emergency medical service (EMS) agencies use radios systems for audio communication between paramedics and physicians. This communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot study is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life-threatening illnesses. Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high-stakes events and involve a vulnerable population (children), this pilot randomized control trial will provide early data on the efficacy of this intervention in simulated cases of pediatric medical emergencies. The primary outcome is "paramedic resuscitation performance" measured by a checklist of observable critical actions by independent reviewers during live observation and video review. The results of this study will provide important pilot data to estimate the clinical effect of this intervention and the sample size needed for a future definitive trial with children, a vulnerable population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Status Epilepticus, Status Asthmaticus, Cardiopulmonary Arrest
Keywords
Prehospital emergency care, Paramedic performance, Telemedicine, Medical control physician, Infant mannequin smulation, Pediatric life threatening illness

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Live and video raters of paramedic performance are blinded to group allocation.
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
The telemedicine arm will have 2-way audiovisual connection with a pediatric medical control physician.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control arm will receive pediatric medical control physician consultation via telephone.
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
The mobile, HIPAA-compliant, video-conferencing platform, Zoom Pro, will be used on tablet computers as a low-cost telemedicine platform for the intervention group. This platform uses Wi-Fi or cellular data connection for video streaming. The investigators will use the telephone communication on this platform for control scenarios, to mimic the current standard for audio-only consultation. A web-based software platform (WireCast®) will capture video recordings over a secure wireless network.
Primary Outcome Measure Information:
Title
Paramedic Team Performance score
Description
The paramedic team performance score is generated from a 64-item checklist of observable actions for pediatric assessment and resuscitation that are scored dichotomously (observed/not observed). The composite performance score is calculated as the number of observed actions divided by the total number of expected actions per case, and reported as a percentage of completed observed actions. This checklist is validated for simulation-based assessment of paramedic performance using three simulated cases of pediatric pre-hospital emergencies. Paramedic team performance will be rated by 1 live and 2 video raters. The final performance score for each team will be reported as an average score for all three raters.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
NASA Task load Index
Description
This is an extensively validated measure of perceived workload of individuals. It is a multidimensional scale where individuals estimate workload during or after completing a task. It contains 7 domains (mental demand, physical demand, temporal demand, performance, effort, frustration, and anxiety) which are evaluated on a 20-point Likert scale. Study participants will complete this questionnaire immediately after completing the simulation modules.
Time Frame
9 months
Title
Telemedicine Platform Usability
Description
This 14-item questionnaire is a validated measure of all the usability of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). The investigators modified this questionnaire to specifically address the usability of a prehospital telemedicine platform. Study participants will complete this questionnaire immediately after completing the simulation modules.
Time Frame
9 months
Title
Error in medication choice
Description
This will be any incorrect type of medication utilized by a team during each simulation resuscitation. This includes unanticipated medication choices which the study raters feel was not indicated or potentially harmful by consensus opinion. This data is collected in the paramedic performance checklist.
Time Frame
9 months
Title
Error in weight-based medication dosing
Description
This will include any errors in pediatric weight-based dose calculation, including errors in volume of drug administered during each simulated case. This data is collected in the paramedic performance checklist.
Time Frame
9 months
Title
Equipment size error
Description
This includes errors in equipment size during each simulated resuscitation. This data is collected in the paramedic performance checklist.
Time Frame
9 months
Title
Equipment use errors
Description
This includes errors in equipment usage (e.g. depth of endotracheal tube insertion, rate of bag-valve-mask ventilation, location of intraosseous needle insertion) during each simulated resuscitation. This data is collected in the paramedic performance checklist.
Time Frame
9 months
Title
EMS protocol error
Description
This will be defined as any error in offline and online EMS treatment protocols that is observed during each simulated resuscitation. This data is collected in the paramedic performance checklist.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Certified paramedics from three EMS systems in the Boston metropolitan area (Boston EMS, South Shore EMS, and Lahey Medical Center EMS) Attending physicians and clinical fellows with expertise in pediatric emergency medicine and pediatric resuscitation from 2 pediatric referral centers (Boston Medical Center and Boston Children's Hospital) Exclusion Criteria: -Prehospital providers without paramedic level certification (e.g. BLS certification only)
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 Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19499472
Citation
Lammers RL, Byrwa MJ, Fales WD, Hale RA. Simulation-based assessment of paramedic pediatric resuscitation skills. Prehosp Emerg Care. 2009 Jul-Sep;13(3):345-56. doi: 10.1080/10903120802706161.
Results Reference
background
PubMed Identifier
29957150
Citation
Butler L, Whitfill T, Wong AH, Gawel M, Crispino L, Auerbach M. The Impact of Telemedicine on Teamwork and Workload in Pediatric Resuscitation: A Simulation-Based, Randomized Controlled Study. Telemed J E Health. 2019 Mar;25(3):205-212. doi: 10.1089/tmj.2018.0017. Epub 2018 Jun 29.
Results Reference
background
PubMed Identifier
27563386
Citation
Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
Results Reference
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Pilot Simulation RCT of Telemedical Support for Paramedics

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