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NOT YET RECRUITING
NCT07603843
NA

Use of Cognitive Aid Methods in the Management of Status Epilepticus

Sponsor: Ankara University

View on ClinicalTrials.gov

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.

Official title: İmpact of Cognitive Aid Methods on Clinical Decision-making in the Management of Status Epilepticus in the Emergency Department: A Simulation-based Study

Key Details

Gender

All

Age Range

Any - 80 Years

Study Type

INTERVENTIONAL

Enrollment

76

Start Date

2026-05-25

Completion Date

2026-07-10

Last Updated

2026-05-29

Healthy Volunteers

Yes

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