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

April 7, 2026 updated by: Jeanne-Marie Guise, Beth Israel Deaconess Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • BIDMC
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • 20 Overland 4th floor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Current Standard with Existing Cognitive Aids
We will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using the current standard of care with existing cognitive aids.
Experimental: Linear Cognitive Aid
We will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using a linear cognitive aid
Other: Linear 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Achieve AHA Technical Milestones
Time Frame: 10 minute simulation
Time 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.
10 minute simulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Teamwork
Time Frame: Cumulative evaluation over each 10 minute simulation
Teamwork 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."
Cumulative evaluation over each 10 minute simulation
Cognitive load
Time Frame: Cumulative evaluation over each 10 minute simulation
Cognitive 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.
Cumulative evaluation over each 10 minute simulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 30, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023P000386
  • R01HL141429 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study does not involve patients. It involves prooviders responding to simulated emergencies and is part of quality and safety and is protected under this.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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