- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07603843
Use of Cognitive Aid Methods in the Management of Status Epilepticus
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:
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
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.
- 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Paper Cognitive aids
Intervention Group A: A cognitive aid (status epilepticus management checklist/algorithm in paper format) will be provided during the simulated scenario. |
Students assigned in the paper cognitive aids group will manage status epilepticus using paper cognitive aids
다른 이름들:
|
|
실험적: Digital cognitive aid
Intervention Group B: A cognitive aid (status epilepticus management checklist/algorithm in digital format) will be provided during the simulated scenario. |
Students assigned in the digital cognitive aids group will manage status epilepticus using digital cognitive aids
다른 이름들:
|
|
실험적: Control Group
No cognitive aid will be provided.
Participants will manage the patient using only their existing knowledge and clinical reasoning skills
|
Students assigned in the No cognitive aids group will manage status epilepticus using their existing knowledge
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Technical performance of participants in status epilepticus management
기간: from the beginning of the simulation session to the end
|
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
기간: from the beginning of the simulation session to the end
|
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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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기타 연구 ID 번호
- AnkaraUU
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