RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial

IF 1.5 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-12-01 Epub Date: 2025-10-08 DOI:10.1016/j.conctc.2025.101558

Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise

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引用次数: 0

Abstract

Background

Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).

Objective

This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.

Study design

This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.

Main outcome measures

Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.^1,2

Conclusion

We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.

Trial Registration Number

NCT06768099 (ClinicalTrials.gov).

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RESCUER移动应用程序支持儿科复苏：随机对照试验的研究方案

儿童院外心脏骤停是儿童死亡的主要原因。本文描述了随机对照试验的研究方案，该试验旨在测试线性认知辅助应用程序（RESCUER），该应用程序旨在支持紧急医疗服务（EMS）临床医生应对新生儿和儿科院外心脏骤停（POHCA）。目的：本随机对照试验（RCT）将研究RESCUER应用程序与现有EMS实践和工具在模拟pohca中的效果。研究设计本随机对照试验将在美国（US）农村和城市EMS机构的急救人员中进行。EMS团队将随机使用(1)RESCUER应用程序或(2)他们当前的护理标准和工具来应对模拟的新生儿和pohca。除了随机分配干预和控制，我们也将随机化模拟场景的顺序。主要结局指标主要结局包括完成美国心脏协会（AHA）推荐的NRP和PALS步骤的时间。次要结果包括参与者自评的认知负荷、测量的团队合作以及以用户为中心的工具可行性、可用性和有用性评估。结论：与EMS团队目前的护理标准和工具相比，我们假设该应用程序将减少完成AHA推荐的NRP和PALS步骤的时间。本研究将检验EMS团队在应对模拟新生儿和儿科ohca时使用的应用程序是否会改善复苏表现并降低认知负荷。试验注册号：06768099 （ClinicalTrials.gov）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.