Trial document




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  DRKS00012988

Trial Description

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Title

The desire to die in palliative care: Optimalization of management

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Trial Acronym

DEDIPOM

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URL of the Trial

https://palliativzentrum.uk-koeln.de/forschung/letzte-lebenszeit/umgang-mit-todeswuenschen/

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Brief Summary in Lay Language

The aim of this study is the further development of and the consensus finding on the interview schedule drafted to routinely address death and dying distress and to proactively evaluate a desire to die. Furthermore, confidence in dealing with a desire to die in health professionals will be strengthened by the evaluated two day training programm using the consented interview schedule. This is intended to reduce health professional uncertainties and deepen health professional-patient relationship where such difficult topics can be addressed. An evaluation of conversations between health professionals and patients is planned to test the outcome of the intervention in a broad range of clinical situations. Further the study aims at increasing patients' health-related quality of life.

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Brief Summary in Scientific Language

The aim of this study is the further development of and the consensus finding on the interview schedule drafted to routinely address death and dying distress and to proactively evaluate a desire to die (DD). Furthermore, confidence in dealing with a DD in HP will be strengthened by the evaluated two day training programm using the consented interview schedule. This is intended to reduce health professionals' (HP) uncertainties and deepen HP-patient relationship where such difficult topics can be addressed. A quantitative and qualitative evaluation of conversations between HP and patients is planned to test the outcome of the intervention in a broad range of clinical situations.

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

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00012988
  •   2017/09/27
  •   2017/09/05
  •   yes
  •   Approved
  •   17-265, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   VfD_DEDIPOM_17_003889  (Versorgungsforschung Deutschland)
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Health Condition or Problem studied

  •   Development of conversation guide, Management of desire to die in palliative care
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Interventions/Observational Groups

  •  
    Step 1:
    Qualitative interviews with patients in order to further develop a conversation guide
    Delphi interview with experts in order to further develop a conversation guide
  •  
    Step 2:
    Training of health professionals in using the conversation guide
  •  
    Step 3:
    Evaluation of application of the conversation guide
    Qualitative interviews with patients, relatives and HPs (health professionals)
    Quantiativative evaluation (PDRQ-9 (Patient-Doctor-Relationship Questionnaire) – German, DADDS – G - Death and Dying Distress Scale German Version, SAHD-D – Schedule of Attitudes Towards Hastened Death Deutsche Version, etc.)
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Characteristics

  •   Interventional
  •   [---]*
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Optimalization of the HP-patient relationship

(questionnaires, pre: max. 1 week before conversations, post: max. 1 week after conversations, and follow-up: 4-6 weeks after conversations)

PDRQ-9 – German: questionnaire assessing the HP-patient-relationship

DADDS – G- Death and Dying Distress Scale German Version: assessing fears of death and dying

SAHD-D – Schedule of Attitudes Towards Hastened Death German Version: assessing desire to die

PHQ9- Patient Health Questionnaire: assessing depression

BHS - Beck Hopelessness Scale: assessing hopelessness

VAS – visual analogue scale: assessing will of life

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Secondary Outcome

Development of a conversation guide

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/09/22
  •   375
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

step 1:

patients:
*life expectancy 3 to 9 months
*good German speaker competency
*cognitively and conditionally able to give an interview
*adult
*written consent

experts:
*Occupational group (multi-professional plus ethical experts, patient representatives)
*At least 5 years of experience with DD and/or suicidality
*High scores in self-assed confidence and expertise in DD

step 2:

HPs:
*worked with palliative patients in the past year
*written consent

step 3:

patients:
*good German speaker competency
*cognitively and conditionally able to give an interview
*adult
*written consent

relatives:
*relatives of palliative patients that died in the past year in Cologne
*good German speaker competency
*adult
*written consent

HPs:
*used the conversation guide
*worked with palliative patients in the past year
*written consent

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Exclusion Criteria

Patients:
*life expectancy less than 3 months
*not cognitively or conditionally able to give an interview

All participants:
*bad German speaker competency
*no written consent
*do not wish to partake

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Addresses

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    • MSH - Zentrum für Palliativmedizin Mildred-Scheel-Haus
    • Mr.  Univ.-Prof. Dr. med.  Raymond  Voltz 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    •   0221 9440490
    •   [---]*
    •   [---]*
    •   [---]*
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    • MSH - Zentrum für Palliativmedizin Mildred-Scheel-Haus
    • Ms.  Dr.  Kerstin  Kremeike 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • MSH - Zentrum für Palliativmedizin Mildred-Scheel-Haus
    • Ms.  Dr.  Kerstin  Kremeike 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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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 complete, follow-up complete
  •   [---]*
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  •   2020/12/31
  •   87
  •   87
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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.