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临床试验/NCT07440329
NCT07440329招募中不适用

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

Lea Kölsch1 个研究点 分布在 1 个国家目标入组 319 人开始时间: 2026年3月9日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
319
试验地点
1
主要终点
Maturity of Hospital Emergency Plans

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • German hospitals with a documented KAEP Institutional consent to provide KAEP documents for analysis

排除标准

  • Hospitals declining participation Specialized facilities without emergency or acute care services (e.g., rehabilitation clinics)

结局指标

主要结局

Maturity of Hospital Emergency Plans

时间窗: 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.

Derivation of Practice-Oriented Recommendations

时间窗: through study completion, an average of 1 year

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

次要结局

  • Training and Exercise Practices(Baseline)
  • Best-Practice Elements(through study completion, an average of 1 year)
  • Institutional Influencing Factors(through study completion, an average of 1 year)
  • Use of Digital or AI-Supported Components(Baseline)

研究者

发起方
Lea Kölsch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lea Kölsch

Doctoral Researcher

Heidelberg University

研究点 (1)

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