Pediatric Emergency MedicineNCT06768099
A Clinical Trial to Study the Feasibility and Acceptability of an App to Support Pediatric Resuscitation
A study testing Linear Cognitive Aid in people with Pediatric Emergency Medicine and Resuscitation, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Emergency Medicine, Resuscitation, Pediatrics
- What is being tested?
- Linear Cognitive Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Feb 2025to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active public, private, volunteer, hospital-based, or third-party EMS providers
- Speaks and understands English
- Age 18 and over
Who cannot join
- Not clinically active
Trial locations and contacts
2 sites in 1 country.
United States2 sites
20 Overland 4th floor
Boston, Massachusetts, 02215
BIDMC
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read more
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.
- Conditions
- Pediatric Emergency Medicine, Resuscitation, Pediatrics, Emergency Medical Services, Arrest Cardio Respiratory
- Being tested
- Linear Cognitive Aid
- 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
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linear Cognitive AidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Current Standard with Existing Cognitive Aids | No intervention | 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. |
| Linear Cognitive Aid | Experimental | We will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using a linear cognitive aid Receives: Other: Linear Cognitive Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Achieve AHA Technical Milestones
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.
Measured: 10 minute simulation
Secondary outcomes (2)
Teamwork
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."
Measured: Cumulative evaluation over each 10 minute simulation
Cognitive load
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.
Measured: Cumulative evaluation over each 10 minute simulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start18 Feb 2025
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Emergency MedicineStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeanne-Marie Guise, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768099
- Sponsor's protocol ID
- 2023P000386
- Other IDs
- R01HL141429
- Status last verified
- Jun 2026
- First submitted
- 30 Dec 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Lee SA, Trujillo D, Meckler GD, Eriksson C, Huynh T, Bahr N, Sanjeevi J, Hansen M, Guise JM. RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2025 Oct 8;48:101558. doi: 10.1016/j.conctc.2025.101558. eCollection 2025 Dec.
PubMed 41142041
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06768099
- Acronym / sponsor ID
- 2023P000386
- Conditions
- Pediatric Emergency Medicine, Resuscitation, Pediatrics, Emergency Medical Services, Arrest Cardio Respiratory
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Current Standard with Existing Cognitive Aids | No intervention | –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. |
| Linear Cognitive Aid | Experimental | Other: Linear Cognitive AidWe will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using a linear cognitive aid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active public, private, volunteer, hospital-based, or third-party EMS providers
- Speaks and understands English
- Age 18 and over
Key exclusion criteria (1 listed)
- Not clinically active
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linear Cognitive AidKey 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. | Other | Linear Cognitive Aid |
Primary outcome
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.
2 secondary outcomes
Teamwork
Time frame: Cumulative evaluation over each 10 minute simulation
Cognitive load
Time frame: Cumulative evaluation over each 10 minute simulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Derived from this study: PubMed 41142041Lee SA, Trujillo D, Meckler GD, Eriksson C, Huynh T, Bahr N, Sanjeevi J, Hansen M, Guise JM. RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial. Contemp Clin Trials Commun. 2025 Oct 8;48:101558. doi: 10.1016/j.conctc.2025.101558. eCollection 2025 Dec.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linear Cognitive Aid in people with Pediatric Emergency Medicine and Resuscitation, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Achieve AHA Technical Milestones (time frame: 10 minute simulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06768099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.