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Last Year Medical StudentNCT07603843

Use of Cognitive Aid Methods in the Management of Status Epilepticus

A study testing Management of status epilepticus with paper cognitive aids, Management of status epilepticus with digital cognitive aids and Management of status epilepticus with no cognitive aid in people with Last Year Medical Student, run by Ankara University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 80 yearsHealthy volunteers can take part
Conditions the study is for
Last Year Medical Student
What is being tested?
Management of status epilepticus with paper cognitive aids, Management of status epilepticus with digital cognitive aids and Management of status epilepticus with no cognitive aid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
No sites listed yet
Study dates
25 May 2026to 10 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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:

Read more

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.

Being tested
Management of status epilepticus with paper cognitive aids, Management of status epilepticus with digital cognitive aids, Management of status epilepticus with no cognitive aid
Keywords
cognitive aids, status epilepticus, simulation
Medical subject headings
Status Epilepticus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Management of status epilepticus with paper cognitive aidsBehavioural

    Also called Paper CA

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

  • Management of status epilepticus with digital cognitive aidsBehavioural

    Also called Digital CA

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

  • Management of status epilepticus with no cognitive aidBehavioural

    Also called No CA

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

Study groups in NCT07603843
Study groupRoleWhat they receive
Paper Cognitive aidsExperimentalIntervention Group A: A cognitive aid (status epilepticus management checklist/algorithm in paper format) will be provided during the simulated scenario.
Receives: Behavioral: Management of status epilepticus with paper cognitive aids
Digital cognitive aidExperimentalIntervention Group B: A cognitive aid (status epilepticus management checklist/algorithm in digital format) will be provided during the simulated scenario.
Receives: Behavioral: Management of status epilepticus with digital cognitive aids
Control GroupExperimentalNo cognitive aid will be provided. Participants will manage the patient using only their existing knowledge and clinical reasoning skills
Receives: Behavioral: Management of status epilepticus with no cognitive aid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: from the beginning of the simulation session to the end

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start25 May 2026 (estimated)
  3. Primary completion25 Jun 2026 (estimated)
  4. Study completion10 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Factorial
Model description
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.
Masking
None (open label)
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603843
Sponsor's protocol ID
AnkaraUU
Status last verified
May 2026
First submitted
4 May 2026
Last updated
29 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Management of status epilepticus with paper cognitive aids, Management of status epilepticus with digital cognitive aids and Management of status epilepticus with no cognitive aid in people with Last Year Medical Student, run by Ankara University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical performance of participants in status epilepticus management (time frame: from the beginning of the simulation session to the end). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.

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