Linear Cognitive Aid for Pediatric Emergencies

Recruiting at 1 trial location

Overseen By Jeanne-Marie Guise, MD, MPH, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Not clinically active

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new tool, called a linear cognitive aid, can improve emergency medical services (EMS) teams' responses during pediatric emergencies. Researchers seek to assess the tool's ease of use and effectiveness compared to current EMS methods. Teams will be randomly assigned to use either the new tool or their usual methods in managing simulated pediatric emergency situations. EMS providers who are actively working and understand English may qualify for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance emergency response for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this linear cognitive aid is safe for pediatric emergencies?

Research has shown that cognitive aids can enhance the performance and safety of emergency medical teams during high-pressure situations, such as emergencies involving children. Despite their potential benefits, many emergency teams do not widely use these aids.

The cognitive aid under study is a new tool designed to assist teams during children's resuscitations. As a tool, it does not carry safety risks like side effects or adverse reactions. The primary concern is whether it aids or confuses the medical teams using it.

This study focuses on the tool's ease of use and helpfulness for emergency teams, rather than testing its safety in the traditional sense. So far, no reports indicate the tool is unsafe. The main goal is to determine if it can make emergency responses more effective and less stressful for the teams involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Linear Cognitive Aid for pediatric emergencies because it offers a streamlined approach to handling critical situations involving children. Unlike the current standard, which often relies on various cognitive aids, this new method uses a linear, step-by-step guide to assist medical teams during high-pressure resuscitations. This structured approach could potentially improve decision-making speed and accuracy, ultimately leading to better outcomes for young patients in emergency settings.

What evidence suggests that this linear cognitive aid is effective for pediatric emergencies?

Research has shown that cognitive aids can enhance medical team performance during emergencies. These tools help teams adhere to guidelines more accurately and reduce errors. In this trial, one group will use a Linear Cognitive Aid, which presents information in a simple, step-by-step order, during high-fidelity simulations of pediatric emergencies. Another group will use the current standard of care with existing cognitive aids. One study found that using a cognitive aid helped teams adhere to resuscitation guidelines. This suggests that a straightforward cognitive aid could improve team performance in pediatric emergencies. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for Emergency Medical Services (EMS) teams who respond to pediatric emergencies involving cardiac arrest and other critical situations. It's designed to see if a new app, which provides step-by-step guidance during resuscitation, helps these teams.

Inclusion Criteria

Speaks and understands English

Active public, private, volunteer, hospital-based, or third-party EMS providers

Exclusion Criteria

My condition is currently stable and not worsening.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulation

Participants perform in situ high-fidelity simulation of two critical children's resuscitation scenarios

10 minutes per simulation

2 simulation sessions

Evaluation

Technical performance, teamwork, and cognitive load are evaluated

Cumulative over each 10 minute simulation

Follow-up

Participants are monitored for feedback on feasibility and acceptability of the cognitive aid

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Linear Cognitive Aid

Trial Overview The study tests an app called 'Linear Cognitive Aid' that supports EMS teams in pediatric resuscitations. Teams will be randomly chosen to use either their usual aids or the new app during simulated emergency scenarios to compare effectiveness.

How Is the Trial Designed?

Group I: Linear Cognitive Aid Experimental Treatment 1 Intervention

We will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using a linear cognitive aid

Group II: Current Standard with Existing Cognitive Aids Active Control 1 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.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Cognitive interventions for children with neurological and neurodevelopmental disorders showed significant positive effects in areas like attention, working memory, and memory tasks, based on a review of 13 randomized controlled trials.

Despite these positive findings, the overall quality of evidence was rated very low, indicating uncertainty about the effectiveness of these interventions across different outcome domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of cognitive interventions for children with central nervous system disorders and neurodevelopmental disorders. Robinson, KE., Kaizar, E., Catroppa, C., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9420676/

The impact of cognitive aids on resuscitation performance in in ... Our study shows that cognitive aids improved overall performance and adherence to guidelines, especially in terms of fewer omission of actions, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425001322

RESCUER mobile app to support pediatric resuscitation Studies suggest linear cognitive aids may be more effective than those using branching logic. 11, 12 A study using a branching logic mobile ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2807929

Effectiveness of a Novel Tablet Application in Reducing ... This randomized clinical trial found that the use of the cognitive aid tablet application improved adherence to resuscitation guidelines.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11170275/

Cognitive aids used in simulated resuscitation To compare the effectiveness of cognitive aid use during resuscitation with no use of cognitive aids on cardiopulmonary resuscitation ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/11/7/e047208

PediAppRREST: effectiveness of an interactive cognitive ... The aim of the study is to evaluate the effectiveness of the PediAppRREST app in reducing deviations from guideline recommendations in PCA management.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12549407/

RESCUER mobile app to support pediatric resuscitation This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06768099

NCT06768099 | A Clinical Trial to Study the Feasibility and ... Linear Cognitive Aid. We will perform in situ high-fidelity simulation of two critical children's emergency resuscitation scenarios using a linear cognitive aid.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666520424001267

Review Cognitive aids used in simulated resuscitation Enhancing pediatric safety: assessing and improving resident competency in life-threatening events with a computer-based interactive resuscitation tool.

9. reporter.nih.gov reporter.nih.gov/project-details/10885936

Reducing Disparities for Children in Rural Emergency ... Summary Mortality for infants is almost 2 times higher and for children 2.6 times higher in rural communities compared with urban settings; little is known ...

10. internationaljournalofparamedicine.com internationaljournalofparamedicine.com/index.php/ijop/article/view/2683

Examining Cognitive Aid Use in Emergency Medical Services Overall, cognitive aid use in EMS is limited, with a median score of 1.67. The length-based tape was the most used aid.