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NCT Number: 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

Hospital Emergency and Disaster Plans (Krankenhausalarm- und Einsatzplan-KAEP) are a central component of hospital preparedness in Germany. Despite national and international recommendations, considerable variability exists in structure, responsibilities, communication pathways, and training concepts across hospitals. This study aims to systematically analyze and compare KAEP documents from German hospitals using a structured qualitative and quantitative document analysis. The goal is to identify strengths, deficits, institutional influencing factors, and best-practice elements to support evidence-based improvements and harmonization of hospital emergency planning.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Stabsstelle Krisen- und Katastrophenmanagement

Heidelberg, 69120, Germany

Location status: Recruiting

Location contact

Maik von der Forst, Dr. med.

CONTACT

[email protected]

+49 6221-5632939

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Maturity of Hospital Emergency Plans

    Time frame: Baseline

    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.

  2. Derivation of Practice-Oriented Recommendations

    Time frame: through study completion, an average of 1 year

    Identification of strengths, weaknesses, and improvement potential across hospitals.

Secondary outcomes

  1. 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).

  2. Training and Exercise Practices

    Time frame: Baseline

    Frequency, documentation, and evaluation mechanisms related to KAEP exercises.

  3. Best-Practice Elements

    Time frame: through study completion, an average of 1 year

    Identification of recurring high-quality structural or procedural elements.

  4. Use of Digital or AI-Supported Components

    Time frame: Baseline

    Exploratory assessment of digital tools referenced in KAEP documents.

Study contacts

Contact information is provided by the study sponsor or research team.

Lea Kölsch

CONTACT

[email protected]

Maik von der Forst, Dr. med.

CONTACT

[email protected]

+49 6221-5632939

Sponsors and collaborators

Lead sponsor

Lea Kölsch

Other

Collaborators

  • Dr. med. Maik von der Forst - Deputy Head, Department of Crisis and Disaster Management
  • Hanne Schäfer - Head of Operational KAEP, Department of Crisis and Disaster Management
  • PD Dr. med. Fabian Weykamp - Senior Physician, Department of Radiotherapy
  • Prof. Erik Popp - Head, Department of Crisis and Disaster Management
  • Prof. Markus Ries - Head of Research, Department of Crisis and Disaster Management
  • University Hospital Heidelberg

Registry information

Official study title

KAEPacity - Eine Vergleichende Analyse Der Krankenhausalarm- Und Einsatzpläne (KAEP) Deutscher Krankenhäuser

Acronym: KAEPacity

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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