Use of Cognitive Aid Methods in the Management of Status Epilepticus

NCT07603843 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-05-22

No results posted yet for this study

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. 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.

A validated cognitive aid for status epilepticus management (checklist/algorithm/flowchart) will be developed in accordance with current evidence-based guidelines.

One month after the didactic session, all participants will participate in a simulation scenario focused on status epilepticus management.
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.

Scenario-specific performance assessment checklists will be developed to evaluate technical skills.

Non-technical skills will be assessed using the Ottawa Global Rating Scale.

Outcomes Primary Outcomes Technical performance in status epilepticus management Non-technical performance during crisis management Time to initiation of first-line treatment (e.g., benzodiazepine administration) Time to initiation of second-line treatment Secondary Outcomes Adherence to evidence-based guidelines (appropriate medication selection, dosage, and timing) Completion of essential management steps (e.g., glucose control, airway management) Team communication and coordination (assessed using the Ottawa Global Rating Scale) Participant stress levels measured using the State-Trait Anxiety Inventory (STAI)

Post-Simulation Assessment Structured debriefing sessions will be conducted following the simulation scenarios.

Participants will complete assessments evaluating: cognitive workload (using the NASA Task Load Index), satisfaction with the cognitive aid (intervention groups only).

Ethical Considerations Written informed consent will be obtained from all participants. The anonymity and confidentiality of simulation recordings will be ensured. Participants will be informed that study participation will not affect their Emergency Medicine internship evaluation in any way.

Conditions

  • Being a Sixth-year Emergency Medicine Intern
  • Willingness to Participate in the Study

Interventions

BEHAVIORAL

Management of status epilepticus with paper cognitive aids

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

BEHAVIORAL

Management of status epilepticus with digital cognitive aids

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

BEHAVIORAL

Management of status epilepticus with no cognitive aid

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

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-25
Primary Completion
2026-06-25
Completion
2026-07-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603843 on ClinicalTrials.gov