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Simulation RCT of Telemedical Support for Paramedics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03742167
Recruitment Status : Suspended (Currently suspended due to COVID-19 policies.)
First Posted : November 15, 2018
Last Update Posted : April 8, 2020
Information provided by (Responsible Party):
Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Respiratory Failure Status Epilepticus Status Asthmaticus Cardiopulmonary Arrest Other: Telemedicine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Live and video raters of paramedic performance are blinded to group allocation.
Primary Purpose: Health Services Research
Official Title: Randomized Control Trial of Telemedical Support for Paramedics in Simulated Pre-hospital Pediatric Emergencies
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Telemedicine
The telemedicine arm will have 2-way audiovisual connection with a pediatric medical control physician.
Other: Telemedicine
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.

No Intervention: Control
The control arm will receive pediatric medical control physician consultation via telephone.

Primary Outcome Measures :
  1. Paramedic Team Performance score [ Time Frame: 9 months ]
    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 :
  1. NASA Task load Index [ Time Frame: 9 months ]
    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.

  2. Telemedicine Platform Usability [ Time Frame: 9 months ]
    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.

  3. Error in medication choice [ Time Frame: 9 months ]
    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.

  4. Error in weight-based medication dosing [ Time Frame: 9 months ]
    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.

  5. Equipment size error [ Time Frame: 9 months ]
    This includes errors in equipment size during each simulated resuscitation. This data is collected in the paramedic performance checklist.

  6. Equipment use errors [ Time Frame: 9 months ]
    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.

  7. EMS protocol error [ Time Frame: 9 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03742167

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
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Principal Investigator: Tehnaz Boyle, MD PhD Boston Medical Center
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Responsible Party: Boston Medical Center Identifier: NCT03742167    
Other Study ID Numbers: H-37817
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Medical Center:
Prehospital emergency care
Paramedic performance
Medical control physician
Infant mannequin smulation
Pediatric life threatening illness
Additional relevant MeSH terms:
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Respiratory Insufficiency
Status Asthmaticus
Status Epilepticus
Heart Arrest
Respiration Disorders
Respiratory Tract Diseases
Neurologic Manifestations
Nervous System Diseases
Bronchial Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Heart Diseases
Cardiovascular Diseases