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临床试验/NCT03742167
NCT03742167已完成不适用

Pilot Randomized Control Trial of Telemedical Support for Paramedics in Simulated Pre-hospital Pediatric Emergencies

Boston Medical Center2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Paramedic Team Performance score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Live and video raters of paramedic performance are blinded to group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

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

结局指标

主要结局

Paramedic Team Performance score

时间窗: 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.

次要结局

  • Error in medication choice(9 months)
  • Telemedicine Platform Usability(9 months)
  • Equipment use errors(9 months)
  • EMS protocol error(9 months)
  • NASA Task load Index(9 months)
  • Error in weight-based medication dosing(9 months)
  • Equipment size error(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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