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Not yet recruitingNCT07603843Updated May 29, 2026

Use of Cognitive Aid Methods in the Management of Status Epilepticus

An interventional study of Management of status epilepticus with paper cognitive aids and Management of status epilepticus with digital cognitive aids in Last Year Medical Student, sponsored by Ankara University. Not yet recruiting. Open to participants aged Up to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-29.

Sponsored by Ankara University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
Up to 80 Years
Sex
All
01

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.

Read the detailed description

Status epilepticus (SE) is a neurological emergency requiring rapid recognition, timely escalation of therapy, and coordinated team-based management. Delays in treatment initiation and deviations from evidence-based algorithms are associated with increased morbidity and mortality. In high-stress emergency settings, healthcare trainees may experience cognitive overload, impaired situational awareness, and reduced adherence to treatment protocols. Cognitive aids have been increasingly incorporated into crisis resource management strategies to support clinical decision-making and reduce omission of critical steps during time-sensitive emergencies.

The present study is designed as a simulation-based educational intervention investigating the impact of cognitive aids on the management of status epilepticus among sixth-year Emergency Medicine interns. The study specifically examines whether the availability and format of cognitive aids influence crisis management performance in a standardized simulated environment.

  • Inclusion Criteria Being a sixth-year Emergency Medicine intern, Willingness to participate in the study
  • Exclusion Criteria Previous participation in simulation studies involving cognitive aids, Prior involvement in the development of the cognitive aids used in this study

The cognitive aids used in the study will be developed according to contemporary evidence-based recommendations for status epilepticus management. Their content and clinical appropriateness will be reviewed by an expert panel consisting of emergency medicine specialists, neurologists and intensive care specialists. Both paper-based and digital-format cognitive aids will contain identical clinical content and treatment algorithms.

All participants will receive standardized baseline instruction on status epilepticus management before participation in simulation activities. Simulation sessions will be conducted approximately one month after the didactic training in order to evaluate retention and practical application of knowledge rather than immediate post-lecture recall.

Simulation scenarios will be conducted in a high-fidelity simulation environment using predefined case scripts, standardized patient progression, and uniform learning objectives. Scenarios will involve dynamic clinical deterioration requiring participants to recognize ongoing seizure activity, initiate first-line therapy, escalate treatment appropriately, assess reversible causes, and manage airway and hemodynamic complications. Simulation conditions will be standardized across all groups to minimize variability in scenario delivery.

The study will be conducted as a prospective, simulation-based, controlled educational intervention study involving sixth-year Emergency Medicine interns. Participants will be allocated into three study groups:

Intervention Group A: Participants will be provided with a paper-based cognitive aid consisting of a status epilepticus management checklist/algorithm during the simulation scenario.

Intervention Group B: Participants will be provided with a digital-format cognitive aid consisting of a status epilepticus management checklist/algorithm during the simulation scenario.

Control Group: Participants will manage the simulated patient without the use of any cognitive aid and will rely solely on their existing knowledge and clinical reasoning skills.

Participants assigned to cognitive aid groups will receive a brief orientation regarding the practical use of the aid before the simulation session. This orientation will focus solely on usability and navigation of the tool and will not include additional clinical instruction.

Performance assessment will include both technical and non-technical domains. Technical performance will be evaluated using structured scenario-specific checklists derived from guideline-based management steps. Non-technical performance will be assessed using validated crisis resource management assessment principles, including leadership, communication, situational awareness, task prioritization, and decision-making behaviors.

Simulation encounters will be video recorded for assessment purposes. Evaluators responsible for scoring participant performance will use standardized assessment tools and predefined scoring criteria to improve scoring consistency. Structured debriefing sessions will be conducted after completion of the scenarios to facilitate reflective learning and reinforce evidence-based management principles.

The study is expected to provide evidence regarding the educational effectiveness of cognitive aids in emergency medicine simulation training and may contribute to the development of future crisis resource management strategies in time-critical neurological emergencies. In addition, findings from this study may help clarify whether digital or paper-based cognitive support tools provide advantages in clinical performance, workflow integration, and cognitive workload management during acute emergency scenarios.

02

Conditions studied

  • Last Year Medical Student

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Keywords

  • cognitive aids
  • status epilepticus
  • simulation
03

In context

Status Epilepticus

126 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.

This study's planned enrollment of 76 is close to the median of 70 across 74 interventional studies indexed under Status Epilepticus.

Browse Status Epilepticus studies →

Lead sponsor

Ankara University is the lead sponsor of 312 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Being a sixth-year Emergency Medicine intern
  • Willingness to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Previous participation in simulation studies involving cognitive aids,
  • Prior involvement in the development of the cognitive aids used in this study
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Paper Cognitive aids

    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

  • Experimental
    Digital cognitive aid

    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

  • Experimental
    Control Group

    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

  • BehavioralManagement of status epilepticus with paper cognitive aids

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

    Also known as: Paper CA

  • BehavioralManagement of status epilepticus with digital cognitive aids

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

    Also known as: Digital CA

  • BehavioralManagement of status epilepticus with no cognitive aid

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

    Also known as: No CA

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: from the beginning of the simulation session to the end

  2. 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.

    Time frame: from the beginning of the simulation session to the end

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07603843
Lead sponsor
Ankara University
Responsible party
Ayca Koca (Associate Professor, Ankara University) — Principal investigator
First posted
May 22, 2026
Start date
May 25, 2026 (estimated)
Primary completion
Jun 25, 2026 (estimated)
Completion
Jul 10, 2026 (estimated)
Last update
May 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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