NCT07603843

Brief Summary

This study aims to evaluate whether cognitive aids improve the management performance of sixth-year Emergency Medicine interns during simulated status epilepticus scenarios. It will also examine whether the format of the cognitive aid (paper-based or digital) influences technical and non-technical performance during crisis management. The main questions it aims to answer are: Do cognitive aids improve adherence to evidence-based status epilepticus management during simulation? Do cognitive aids reduce time to initiation of critical treatments? Is there a difference between paper-based and digital cognitive aids in terms of performance, cognitive workload, and stress levels? Researchers will compare paper-based cognitive aids, digital cognitive aids, and standard management without cognitive aids in standardized simulation scenarios. Participants will: Attend a standardized didactic session on status epilepticus management Participate in a high-fidelity simulation scenario approximately one month after the educational session Use either a paper-based cognitive aid, a digital cognitive aid, or no cognitive aid during the simulation scenario Complete post-simulation assessments evaluating stress levels, cognitive workload, and participant satisfaction Participate in structured debriefing sessions following the simulation exercise Study Groups Intervention Group A A cognitive aid (status epilepticus management checklist/algorithm in paper format) will be provided during the simulated scenario. Intervention Group B A cognitive aid (status epilepticus management checklist/algorithm in digital format) will be provided during the simulated scenario. Control Group No cognitive aid will be provided. Participants will manage the patient using only their existing knowledge and clinical reasoning skills. Study Procedure

  1. 1.Pre-Simulation Preparation All participants will receive a standardized didactic lecture on status epilepticus management delivered by a faculty member from the Department of Emergency Medicine.
  2. 2.Simulation Scenarios Participants will manage standardized status epilepticus scenarios requiring timely and appropriate interventions, including: benzodiazepine administration, escalation to second-line therapy, glucose assessment and correction, airway management when indicated.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 25, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 4, 2026

Last Update Submit

May 17, 2026

Conditions

Keywords

cognitive aidsstatus epilepticussimulation

Outcome Measures

Primary Outcomes (2)

  • Technical performance of participants in status epilepticus management

    1\. Technical Performance Score in Status Epilepticus Management The checklist will evaluate completion and accuracy of critical management steps, including first-line treatment administration, escalation to second-line therapy, glucose assessment, and airway management. Unit of Measure:Checklist score (points) Score Range:0-100 Interpretation:Higher scores indicate better technical performance.

    from the beginning of the simulation session to the end

  • Non-Technical Skill Performance Assessed by the Ottawa Global Rating Scale

    Non-Technical Skill Performance Assessed by the Ottawa Global Rating Scale Unit of Measure: Ottawa Global Rating Scale score Score Range: 1-7 for each domain Interpretation: Higher scores indicate better non-technical performance.

    from the beginning of the simulation session to the end

Study Arms (3)

Paper Cognitive aids

EXPERIMENTAL

Intervention Group A: A cognitive aid (status epilepticus management checklist/algorithm in paper format) will be provided during the simulated scenario.

Behavioral: Management of status epilepticus with paper cognitive aids

Digital cognitive aid

EXPERIMENTAL

Intervention Group B: A cognitive aid (status epilepticus management checklist/algorithm in digital format) will be provided during the simulated scenario.

Behavioral: Management of status epilepticus with digital cognitive aids

Control Group

EXPERIMENTAL

No cognitive aid will be provided. Participants will manage the patient using only their existing knowledge and clinical reasoning skills

Behavioral: Management of status epilepticus with no cognitive aid

Interventions

Students assigned in the paper cognitive aids group will manage status epilepticus using paper cognitive aids

Also known as: Paper CA
Paper Cognitive aids

Students assigned in the digital cognitive aids group will manage status epilepticus using digital cognitive aids

Also known as: Digital CA
Digital cognitive aid

Students assigned in the No cognitive aids group will manage status epilepticus using their existing knowledge

Also known as: No CA
Control Group

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Model Details: Study Groups 1. Intervention Group-A: A cognitive aid (status epilepticus management checklist or algorithm in paper format) will be provided during the simulated scenario. 2. Intervention Group-B: A cognitive aid (status epilepticus management checklist or algorithm in digital format) will be provided during the simulated scenario. 3. Control Group: No cognitive aid was provided. Participants manage the patient using only their own knowledge.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 22, 2026

Study Start (Estimated)

May 25, 2026

Primary Completion (Estimated)

June 25, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

May 22, 2026

Record last verified: 2026-05