- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440329
The KAEPacity Study Analyzes Hospital Emergency and Disaster Plans From Hospitals Across Germany to Evaluate How Well Hospitals Are Prepared for Crises and Disasters Organizational Structures Communication Leadership Training Are Examined Within These Plans No Medical Intervention is Performed (KAEPacity)
KAEPacity - Eine Vergleichende Analyse Der Krankenhausalarm- Und Einsatzpläne (KAEP) Deutscher Krankenhäuser
Study Overview
Status
Conditions
Detailed Description
KAEPacity is an observational, mixed-methods, descriptive-comparative document analysis of Hospital Emergency and Disaster Plans (Krankenhausalarm- und -einsatzpläne; KAEP) from hospitals in Germany. The aim is to characterize and compare how hospitals operationalize preparedness for exceptional events (e.g., mass casualty incidents, technical failures, security incidents, pandemics) through their written emergency planning documents, and to derive evidence-informed recommendations for quality improvement and harmonization.
Participating hospitals provide their current KAEP documents (and, if available, related materials such as exercise plans, training concepts, evaluation reports, and "lessons learned" documentation). All received documents are stored in a secure institutional environment and processed confidentially. Prior to analysis, documents are pseudonymized: identifying information about hospitals and individuals is removed as far as feasible, and each hospital is assigned a study code (e.g., KH01). Hospital-level characteristics relevant for comparative analyses (e.g., care level, size category, ownership/management type, region) are recorded in a separate, access-restricted key file and used only for aggregated comparisons.
The analysis is conducted using a structured criteria framework derived from national guidance (including the BBK KAEP handbook) and international recommendations (including the WHO Hospital Emergency Response Checklist), complemented by findings from current hospital preparedness and disaster medicine literature. The framework covers core preparedness domains such as: plan structure and governance, leadership and command arrangements, alerting and activation processes, triage concepts and patient flow organization, internal and external communication pathways, defined hazard scenarios and functional annexes, and training, exercises, evaluation, and plan maintenance.
Qualitative analysis follows a deductive-inductive content analytic approach: an initial codebook is developed from guidelines and established models, and then iteratively refined by adding inductive subcategories when additional recurring themes or organizational patterns emerge from the material. In addition to explicit content, the analysis considers aspects such as role logic, implied assumptions, handling of uncertainty, and indications of preparedness culture as reflected in the documents' structure and language.
To support comparability across hospitals, selected structural and process features are additionally rated on an ordinal 0-5 scale (0 = not present; 1 = insufficient; 2 = partially present; 3 = adequate; 4 = well developed; 5 = fully operationalized). This allows descriptive summaries and stratified comparisons across hospital categories without identifying individual institutions. Where feasible, interrater reliability procedures are implemented (e.g., double-coding of a subset and consensus review) to increase the robustness of coding and ratings.
The study does not involve patient recruitment, clinical interventions, or collection of personal health data. Results will be reported exclusively in aggregated form to prevent identification of individual hospitals. The primary intent is to generate an evidence base on current KAEP practice in Germany and to highlight best-practice elements and development needs that can inform future preparedness guidance, training, and quality assurance initiatives.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maik von der Forst, Dr. med.
- Phone Number: +49 6221-5632939
- Email: maik.forst@med.uni-heidelberg.de
Study Contact Backup
- Name: Lea Kölsch
- Email: l.koelsch@student.maastrichtuniversity.nl
Study Locations
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Heidelberg, Germany, 69120
- Recruiting
- Stabsstelle Krisen- und Katastrophenmanagement
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Contact:
- Maik von der Forst, Dr. med.
- Phone Number: +49 6221-5632939
- Email: maik.forst@med.uni-heidelberg.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
German hospitals with a documented KAEP Institutional consent to provide KAEP documents for analysis
Exclusion Criteria:
Hospitals declining participation Specialized facilities without emergency or acute care services (e.g., rehabilitation clinics)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Maturity of Hospital Emergency Plans
Time Frame: Baseline
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Overall maturity of hospital emergency and disaster plans assessed using a predefined composite score.
The score is calculated by aggregating four predefined domains (structure, operational processes, communication, training/exercises) each rated on a standardized 0-5 ordinal scale.
Domain scores are summed to generate a single overall maturity score per hospital.
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Baseline
|
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Derivation of Practice-Oriented Recommendations
Time Frame: through study completion, an average of 1 year
|
Identification of strengths, weaknesses, and improvement potential across hospitals.
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through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Institutional Influencing Factors
Time Frame: through study completion, an average of 1 year
|
Association between KAEP quality and hospital characteristics (care level, size, ownership, region).
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through study completion, an average of 1 year
|
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Training and Exercise Practices
Time Frame: Baseline
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Frequency, documentation, and evaluation mechanisms related to KAEP exercises.
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Baseline
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Best-Practice Elements
Time Frame: through study completion, an average of 1 year
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Identification of recurring high-quality structural or procedural elements.
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through study completion, an average of 1 year
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Use of Digital or AI-Supported Components
Time Frame: Baseline
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Exploratory assessment of digital tools referenced in KAEP documents.
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Mayring, P. (2014). Qualitative content analysis: theoretical foundation, basic procedures and software solution. Social Science Open Access Repository (GESIS - Leibniz Institute for the Social Sciences), 143. http://www.ssoar.info/ssoar/handle/document/39517
- Wurmb, T., Kurz, S., Schwarzmann, G., Trautner, H., Kinstle, U., Wagenhäuser, U., Koch, F., Münch, M., Meybohm, P., & Kippnich, M. (2024). Application of quality indicators and critical lessons learned assessment as a research approach for the evaluation of rescue missions during terrorist attacks. Scientific Reports, 14(1), 25087. https://doi.org/10.1038/s41598-024-7626
- Was sind Kritische Infrastrukturen? (n.d.). Bundesamt Für Sicherheit in Der Informationstechnik. Retrieved November 20, 2025, from https://www.bsi.bund.de/dok/kritis-allgemein
- Walcher, F., Ramshorn-Zimmer, A., Janssens, U., Hoffmann, F., Werdehausen, R., & Wurmb, T. (2025). 10 Punkte zur Verbesserung der Notfall- und Katastrophenversorgung im deutschen Gesundheitswesen. Notarzt, 41(02), 76-79. https://doi.org/10.1055/a-2549-8964
- Von Der Forst, M., Popp, E., Weigand, M. A., & Neuhaus, C. (2023). Sonderlagen und Gefahrenabwehr in deutschen Krankenhäusern - eine Umfrage zum Ist-Zustand. Die Anaesthesiologie, 72(11), 784-790. https://doi.org/10.1007/s00101-023-01349-2
- Von Der Forst, M., Germann, B. J., Schaefer, H., Salg, G. A., Weigand, M. A., Schmitt, F. C., Dietrich, M., Mohr, S., Küllenberg, J., Ries, M., & Popp, E. (2025). Impact of a full-scale mass casualty exercise on hospital staff and implications for future preparedness - A pre-post study. Progress in Disaster Science, 28, 100478. https://doi.org/10.1016/j.pdisas.2025.100478
- Von Der Forst, M., Dietrich, M., Schmitt, F. C. F., Popp, E., & Ries, M. (2025). Perennial disaster patterns in Central Europe since 2000 and implications for hospital preparedness planning - a cross-sectional analysis. Scientific Reports, 15(1), 620. https://doi.org/10.1038/s41598-024-84223-4
- Speicher, C., Wurmb, T., Schwarzmann, G., Zech, C., Jansen, H., Weismann, D., Anger, F., Paul, M., Münch, A., Ohr, M., Meybohm, P., & Kippnich, M. (2024). Evaluation der Krankenhausalarm- und -einsatzplanung anhand einer Übung eines Massenanfalls von Verletzten. Die Anaesthesiologie, 73(12), 810-818. https://doi.org/10.1007/s00101-024-01475-5
- Sorensen, B. S., Zane, R. D., Wante, B. E., Rao, M. B., Bortolin, M., Brigham and Women's Hospital, Harvard Humanitarian Initiative, Harvard Medical School, Rockenschaub, G., & WHO Regional Office for Europe. (2011). Hospital emergency response checklist. In Hospital emergency response checklist (p. 6). https://www.who.int/docs/default-source/documents/publications/hospital-emergency-response-checklist.pdf
- Schulz, M., Oestmann, J., & Schütz, T. (2023). Resilienz deutscher Kliniken in Amok- und Terrorlagen. Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz, 66(10), 1146-1152. https://doi.org/10.1007/s00103-023-03752-x
- Schorscher, N., Kippnich, M., Meybohm, P., & Wurmb, T. (2022). Lessons learned from terror attacks: thematic priorities and development since 2001-results from a systematic review. European Journal of Trauma and Emergency Surgery, 48(4), 2613-2638. https://doi.org/10.1007/s00068-021-01858-y
- Rohde, A., Schmidbauer, W., Didion, N., Ritter, D., Demare, T., & Jänig, C. (2024). Medizinische Herausforderungen in der Starkregenkatastrophe im Ahrtal 2021. Notfall + Rettungsmedizin, 28(1), 1-8. https://doi.org/10.1007/s10049-024-01428-w
- Ramshorn-Zimmer, A., Wurmb, T., Walcher, F., Werdehausen, R., Grashey, R., Drewitz, K., & Brod, T. (2025). Status quo der Krankenhausalarm- und -einsatzplanung in Deutschland. Notfall + Rettungsmedizin, 28(5), 344-351. https://doi.org/10.1007/s10049-025-01578-5
- Künstliche Intelligenz im Krankenhaus - Fraunhofer IAIS. (n.d.). Fraunhofer-Institut Für Intelligente Analyse- Und Informationssysteme IAIS. https://www.iais.fraunhofer.de/de/publikationen/studien/2020/lotte.html
- Imach, S., Lefering, R., Kölbel, B., Wolf, M., Hackenberg, L., & Bieler, D. (2024). Nutzung von Registern zur Schaffung eines evidenzbasierten Vorgehens im Katastrophen- und Zivilschutzfall. Die Unfallchirurgie, 127(12), 855-860. https://doi.org/10.1007/s00113-024-01487-1
- Franke, A., Tralls, P., Wurmb, T., & Heller, A. R. (2025). Rahmenbedingungen und Grundannahmen bei der Erstellung der Leitlinie Klinische Katastrophen Medizin Deutschland (LeiKliKatMeD). Die Unfallchirurgie, 128(9), 645-653. https://doi.org/10.1007/s00113-025-01608-4
- Coffey, A. (2014). Analysing Documents. In Types of Documents and their analysis (pp. 367-379). https://doi.org/10.4135/9781446282243.n25
- Bundesamt für Bevölkerungsschutz und Katastrophenhilfe (BBK), Kowalzik, B., Hähn, F., Helmerichs, J., Stolzenburg, K., Weber, M., Rebuck, J., Degenhardt, L., Braubach, A., Scholtes, K., Wurmb, T., Kolibay, F., Franke, A., Tralls, P., Lücking, G., Jung, H. G., Lampe, I., Scheidmantel, S., Gottschalk, A., . . . Eberl, S. (2020). Handbuch Krankenhausalarm- und -einsatzplanung (KAEP). https://www.bbk.bund.de/SharedDocs/Downloads/DE/Mediathek/Publikationen/Gesundheit/KAEP/handbuch-kaep.pdf?__blob=publicationFile&v=15
- Achatz, G., Bieler, D., Schweigkofler, U., Hoefer, C., Lehmann, W., & Franke, A. (2024). Berücksichtigung und Umsetzung der Elemente der Krankenhausalarm- und Einsatzplanung in den Kliniken der TraumaNetzwerke DGU®. Die Unfallchirurgie, 127(12), 867-877. https://doi.org/10.1007/s00113-024-01494-2
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- S-672/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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