Pilot Simulation RCT of Telemedical Support for Paramedics

NCT03742167 | Completed

• 2 other identifiers: H-37817K23HL145126-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (7)

• NASA Task load Index

  9 months

• Telemedicine Platform Usability

  9 months

• Error in medication choice

  9 months

• Error in weight-based medication dosing

  9 months

• Equipment size error

  9 months

Study Arms (2)

Telemedicine

EXPERIMENTAL

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

Other: Telemedicine

Control

NO INTERVENTION

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

Interventions

Telemedicine OTHER

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.

Telemedicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Boston Children's Hospital: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

• 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.

  PMID: 19499472 BACKGROUND

• 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.

  PMID: 29957150 BACKGROUND

• 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.

  PMID: 27563386 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Status Epilepticus; Status Asthmaticus; Heart Arrest

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Asthma; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Tehnaz Boyle, MD PhD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Live and video raters of paramedic performance are blinded to group allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: December 18, 2018
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)