- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07689084
Training Program to Improve EEG Competence (EPI-Train)
Implementation of a Training Program to Improve EEG Competence in Neurocritical Care Nursing and Non-Physician Treatment Teams for the Recognition of Epileptiform and Ictal Patterns (EPI-TRAIN: EEG Training for the Detection of Pathological Ictal Patterns in Neurocritical Care)
The goal of this clinical trial is to investigate the extent to which a practice-oriented training program for intensive care nursing staff and non-physician treatment teams can contribute to the earlier detection of epileptic seizures, with particular emphasis on SE.
Further objectives include enhancing competence in EEG interpretation and minimizing existing communication and procedural barriers within the interdisciplinary treatment team.
Participants will participate in a half-day training session, which will include:
- attending a specialist lecture,
- completing two knowledge assessments and one evaluation questionnaire,
- completing an additional brief evaluation questionnaire after one month, and
- completing a further brief evaluation questionnaire after three months to assess the sustainability of the learning outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hesse
-
Marburg, Hesse, Germany, 35043
- University Hospital Marburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- neurocritical care nursing staff and non-physician treatment teams at the Neurocritical Care Units of Marburg University Hospital
Exclusion Criteria:
- under 18 years old
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training Group
|
1x Training Program for the neurocritical care nursing staff and non-physician treatment teams at the Neurocritical Care Units
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of correct responses on the study-specific 16-item EEG Knowledge Questionnaire
Time Frame: Baseline (before the training session) and immediately after completion of the training session (Day 0).
|
Number of correctly answered items (range 0-16) on a study-specific 16-item multiple-choice questionnaire assessing EEG knowledge and seizure recognition.
|
Baseline (before the training session) and immediately after completion of the training session (Day 0).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Responses to items of a study-specific EEG training evaluation questionnaire (6-point Likert scale)
Time Frame: Immediately after completion of the training session (Day 0), approximately 1 month (30 ± 7 days), and approximately 3 months (90 ± 14 days) after completion of the training session.
|
Responses to individual questionnaire items evaluating participants' perceptions of the training program and EEG use in clinical practice.
Individual item scores (1 = strongly agree to 6 = strongly disagree) will be reported separately.
|
Immediately after completion of the training session (Day 0), approximately 1 month (30 ± 7 days), and approximately 3 months (90 ± 14 days) after completion of the training session.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Thijs RD, Surges R, O'Brien TJ, Sander JW. Epilepsy in adults. Lancet. 2019 Feb 16;393(10172):689-701. doi: 10.1016/S0140-6736(18)32596-0. Epub 2019 Jan 24.
- Leitinger M, Trinka E, Giovannini G, Zimmermann G, Florea C, Rohracher A, Kalss G, Neuray C, Kreidenhuber R, Hofler J, Kuchukhidze G, Granbichler C, Dobesberger J, Novak HF, Pilz G, Meletti S, Siebert U. Epidemiology of status epilepticus in adults: A population-based study on incidence, causes, and outcomes. Epilepsia. 2019 Jan;60(1):53-62. doi: 10.1111/epi.14607. Epub 2018 Nov 26.
- Kaleem S, Kang JH, Sahgal A, Hernandez CE, Sinha SR, Swisher CB. Electrographic Seizure Detection by Neuroscience Intensive Care Unit Nurses via Bedside Real-Time Quantitative EEG. Neurol Clin Pract. 2021 Oct;11(5):420-428. doi: 10.1212/CPJ.0000000000001107.
- Goswami I, Bello-Espinosa L, Buchhalter J, Amin H, Howlett A, Esser M, Thomas S, Metcalfe C, Lind J, Oliver N, Kozlik S, Mohammad K. Introduction of Continuous Video EEG Monitoring into 2 Different NICU Models by Training Neonatal Nurses. Adv Neonatal Care. 2018 Aug;18(4):250-259. doi: 10.1097/ANC.0000000000000523.
- Falco-Walter J. Epilepsy-Definition, Classification, Pathophysiology, and Epidemiology. Semin Neurol. 2020 Dec;40(6):617-623. doi: 10.1055/s-0040-1718719. Epub 2020 Nov 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-170 BO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
- Two knowledge assessments and one evaluation questionnaire directly after the training program
- Additional brief evaluation questionnaire after one month and after three months
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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