Trial document




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  DRKS00009805

Trial Description

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Title

Improvement of health care research in emergency medicine in Germany through development of a national emergency department register

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Trial Acronym

AKTIN

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URL of the Trial

http://www.aktin.org

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Brief Summary in Lay Language

there are no nationwide data about the participation of German hospitals to emergency care. Besides sampling stick data collection in the context of individual surveys or studies no regular and cross-institutional data collection in clinical emergency medicine are available. An improvement in the medical care of the estimated more than 21 million emergency patients annually through health services research, quality assurance measures and health surveillance are therefore currently in the field of intra-hospital emergency medicine hardly possible. The joint research project "Improvement of health services research in acute medicine in Germany by setting up a National Emergency register" short "AKTIN" has the aim to set the foundations for a national emergency department registers.

The basis of the project is the emergency room protocol of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) developed by the emergency room protocol section for a standardized, structured documentation in the emergency room. In order to merge relevant data for different issues it is planned to develop a decentralized IT infrastructure. With this IT architecture, the data remain in the individual clinics and thereby the treatment context. For a scientific question, only the necessary data are gathered providing data security. Basis of the project is the work with anonymized data.

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Brief Summary in Scientific Language

there are no nationwide data about the participation of German hospitals to emergency care. Besides sampling stick data collection in the context of individual surveys or studies no regular and cross-institutional data collection in clinical emergency medicine are available. An improvement in the medical care of the estimated more than 21 million emergency patients annually through health services research, quality assurance measures and health surveillance are therefore currently in the field of intra-hospital emergency medicine hardly possible. The joint research project "Improvement of health services research in acute medicine in Germany by setting up a National Emergency register" short "AKTIN" has the aim to set the foundations for a national emergency department registers.

The basis of the project is the emergency room protocol of the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) developed by the emergency room protocol section for a standardized, structured documentation in the emergency room. In order to merge relevant data for different issues it is planned to develop a decentralized IT infrastructure. With this IT architecture, the data remain in the individual clinics and thereby the treatment context. For a scientific question, only the necessary data are gathered providing data security. Basis of the project is the work with anonymized data.

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Organizational Data

  •   DRKS00009805
  •   2016/08/04
  •   [---]*
  •   yes
  •   Approved
  •   160/15, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1177-7285 
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Health Condition or Problem studied

  •   All patients presenting in the emergency department
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Interventions/Observational Groups

  •   Purpose of the emergency department data registry is the collection and accessibility of clinical emergency department routine data for health services research.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Development of a national emergency department data registry with structured clincial data according to DIVI-emergency department protocoll

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

  •   Planned
  •   2016/10/01
  •   250000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Presentation in emergency department

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Exclusion Criteria

None

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Addresses

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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.
*** This entry means that data is not displayed due to insufficient data privacy clearing.