Trial document





This trial has been registered retrospectively.
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  DRKS00014303

Trial Description

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Title

Analysis of palliative treated children in emergency situations - focus on patient´s provisions

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Trial Acronym

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URL of the Trial

http://www.palliativpro.de/forschung

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Brief Summary in Lay Language

Palliative treated children have a potential risk of acute impairment. In these frightening situations parents could call EMS (emergency medical service) because the SPHC (specialized Palliative Home Care Team) need more time to reach the families due to far distances. So, in these emergencies, EMT (emergency medical technicans) and EMD (emergency medical doctors) are potentially unprepared and confronted with complex palliative situations.
This study "Eva in Not" investigate, if a standard operating procedure (SOP) can help to optimize care.

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Brief Summary in Scientific Language

12 month after foundation of SPHC (specialized palliative home care) team Gießen for children, a first retrospective data analysis was conducted. Surprisingly, 40% of the parents asks for CPR (cardiopulmonary resuscitation) in emergencies.
This study should help families to be prepared for these unpleasant situations.
All possibilities are explained to the families to enable an individual decision, which advice is given to the EMS (emergency medical service). Medical decision is individually open with a suggestion of the SPHC- team. Results are documented in the patient´s file.
With this study, a published standard form is established (Rellensmann, G. & Hasan, C. Monatsschr Kinderheilkd 153: 552 - 556).
So, after beginning of this study two different groups of families were treated.
Group A: Families are treated by SHPC after start of the study (prospective arm).
Group B: Historical control group with a retrospective setting.
After ending of palliative care both team members and parents are asked to complete a questionnaire. This form focusses on the process in making decisions in the emergency care planing.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014303
  •   2018/04/19
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  •   yes
  •   Approved
  •   146/16, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

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Health Condition or Problem studied

  •   C91.00 -  [generalization C91.0: Acute lymphoblastic leukaemia [ALL]]
  •   E75.4 -  Neuronal ceroid lipofuscinosis
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Interventions/Observational Groups

  •   arm 1: prospective group. In this group patients provisions for cardiopulmonary resuscitation is reevaluated regularly. Changes in the wishes of patients is documented. After completion of care parents and team members are asked to answer a self-developed questionnaire to evaluate quality of care.
  •   arm 2: retrospective group
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Supportive care
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Feasibility study, number of included and documented families/ patients > 50% of all treated individuals.

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Secondary Outcome

Level of satisfaction with the process of care planing due to results of questionnaire.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/07/01
  •   50
  •   Monocenter 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

All families and patients treated by the SPHC team with informed consent.

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Exclusion Criteria

All families and patients treated by the SPHC team without informed consent or patients dead within the first 24 hours of care.

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Addresses

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    • UKGM - Universitätsklinikum Giessen und Marburg GmbH
    • Klinikstraße 33
    • 35392  Gießen
    • Germany
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    • UKGM, Kinderpalliativteam
    • Mr.  Dr. med.  Holger  Hauch 
    • Kllinikstraße 33
    • 35394  Gießen
    • Germany
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    • UKGM, Kinderpalliativteam
    • Mr.  Dr. med.  Holger  Hauch 
    • Kllinikstraße 33
    • 35394  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • UKGM - Universitätsklinikum Giessen und Marburg GmbH
    • Klinikstraße 33
    • 35392  Gießen
    • Germany
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Status

  •   Recruiting ongoing
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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.