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A Clinical Trial to Study the Feasibility and Acceptability of an App to Support Pediatric Resuscitation

Reducing Disparities for Children in Rural Emergency Resuscitation (RESCU-ER): Developing and Testing the Acceptability and Feasibility of an Integrated Linear Cognitive Aid for Pediatric Resuscitation in a Pilot RCT

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06768099
Enrollment
222
Registered
2025-01-10
Start date
2025-02-18
Completion date
2026-06-05
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrest Cardio Respiratory, Emergency Medical Services, Pediatric Emergency Medicine, Pediatrics, Resuscitation

Keywords

Pediatric emergency medical services, Rural-urban health disparities, Child mortality, Adverse safety events (ASEs), Prehospital pediatric care, Cognitive aid, Randomized controlled trial (RCT), Emergency resuscitation, Out of hospital Cardiac arrest

Brief summary

The goal of this clinicial trial is to test the acceptability and feasibility of linear cognitive aid intervention to support EMS teams in responding to pediatric emergencies. We are testing the hypothesis that cognitive aids with linear logic will be feasible to use and acceptable to EMS teams in urban and rural areas. Researchers will compare technical performance, teamwork, and self-assessed cognitive load of participants to see the difference between performing resuscitations using their current standard with existing cognitive aids and using our linear cognitive aid. Participants' teams will: * perform in situ high-fidelity simulation of two critical children's resuscitation scenarios * be randomized to 1) perform both resuscitations with their current standard with existing cognitive aids or 2) perform both resuscitations using our linear cognitive aid.

Interventions

OTHERLinear Cognitive Aid

Key features of this tool include: * Minimal input: Teams input the patient's age and clinical scenario (e.g. arrest, childbirth, or trauma). * Linear logic: Based on initial simple input, the tool provides straightforward guidance without requiring multiple Y/N input or advanced decision-making. * Guidance based on individual characteristics: The tool tailors AHA guidance for the specific emergency scenario to the individual patient's size (estimated by age), emphasizing key interventions for the individual scenario and giving appropriate size-based guidance regarding choice of equipment, medication dosage, and resuscitation technique (e.g., chest compression depth). * Time-based and on-demand guidance: Based on the time elapsed from the start of the resuscitation, the app will provide audio guidance regarding the next key steps.

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

We propose to conduct a pilot feasibility randomized control trial of a mobile app that provides AHA cardiac resuscitation guidance. We will perform high-fidelity simulation of two children's resuscitation scenarios. Teams will be randomized to: 1) perform both resuscitations with their current standard with existing cognitive aids or 2) perform both resuscitations using our mobile app. The order of the scenarios will be randomized for each team.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Active public, private, volunteer, hospital-based, or third-party EMS providers * Speaks and understands English * Age 18 and over

Exclusion criteria

\- Not clinically active

Design outcomes

Primary

MeasureTime frameDescription
Time to Achieve AHA Technical Milestones10 minute simulationTime stamps for achieving completion of clinically recommended steps according to AHA guidance in minutes and seconds over a total 10 min simulation session. Less time taken is better performance.

Secondary

MeasureTime frameDescription
TeamworkCumulative evaluation over each 10 minute simulationTeamwork will be evaluated in real time using the validated Clinical Teamwork Scale (CTS™) over each 10 minute simulation. The scale ranges from 0 to 10, with 0 being "unacceptable" and 10 being "perfect."
Cognitive loadCumulative evaluation over each 10 minute simulationCognitive load will be self-assessed after each 10 minute simulation, using the NASA-TLX, a previously validated and widely used tool that measures mental, physical, and temporal demand, overall performance, effort, and frustration level to create an overall task load index for each team member. The scale has a range of 0 to 100 with a higher score indicating higher cognitive load.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026