Trial document




drksid header

  DRKS00008878

Trial Description

start of 1:1-Block title

Title

Subjective Experience and Effects of Consultative Conversations on Advance Directives among Palliative Patients

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Palliative Care provides professional and personalized support at the end of life for patients suffering from incurable, life-limiting illnesses and their families. Respect for patient autonomy plays a central role in the care of palliative patients. Advanced directives are an important instrument for documenting the will of the patient for situations in which the patient is no longer able to make informed, conscious medical decisions. Despite the importance of advance directives in the palliative setting, most patients who are admitted to the palliative care ward have not yet completed an advanced directive. For this reason, it is often necessary that the treating physician conducts a consultative conversation on advance directives with the patient. On the one hand, these conversations are meant to encourage patients to complete an advance directive. On the other hand, it is most important that these conversations also allow patients to seriously consider and discuss what kind of medical treatment that desire at the end of life and that patients are then able to communicate their desires to family members. A positive physician-patient relationship as well as open communication is essential for such discussions. In this study, we aim to investigate how palliative patients experience consultative conversations about advance directives, particularly in regard to physician-patient communication in the conversation, expectations and fears before the conversation, content of the conversation and the personal meaning and effects of the conversation for the individual patients.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

One of the main goals of palliative care is to provide profession, patient-centered support at the end of life, in which patient autonomy is respected. Advance directives are an important instrument for documenting the will of the patient at the end of life, in order to ensure that he receives the treatment he prefers, in the case that the patient is no longer capable of making an active, informed and conscious decision. From research, it is known that patients, particularly those with an advanced, incurable, life-limiting illness, value their autonomy highly.
By completing an advance directive, patients have the opportunity to decide for themselves which medical procedures should be carried out or not at the end of life. Despite the importance of advance directives even in early stages of incurable, life-limiting illnesses, studies conducted in Germany have shown that only a small portion of patients in a palliative situation decide to complete an advance directive early in the course of their disease.
Upon admission to the palliative care ward, most patients have not yet considered completing an advance directive. Therefore, it is often necessary to offer a consultative conversation on this subject. In the context of palliative care, consultations about advance directives are meant to encourage patients not only to complete an advance directive but also to support open communication about end-of-life decisions between the physician, patient and patient’s family. Results of a recent German study show that patients view advance directives as an important method of communication between the physician and patient. The relationship between the physician and patient and his/her family plays an important role, even once an advance directive has been completed. Clear, open communication and discussion and documentation of the patient’s will can help to better respect the patient’s wishes at the end of life. In this way, quality of life can also be improved for patients, another important goal of palliative care.
Previous research has shown that palliative patients would like more information about advance directives and would prefer to receive this information in a meeting with their treating physician. Until now, it has not been investigated how patients experience consultative conversations about advance directives in the palliative context and what sort of positive or negative effects these conversations have for them. The goal of this study is to gain insight into the subjective experience of palliative patients, particularly in regard to expections/fears, content and process, physician-patient communication, personal meaning and short-term effects of a consultative conversation about advance directives.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00008878
  •   2015/07/06
  •   [---]*
  •   yes
  •   Approved
  •   270/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Palliative patients
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Investigation of the subjective experience of a consultative conversation on advance directives among palliative patients using interviews.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Investigation of the subjective experience of a consultative conversation about advance directives among palliative patients, particularly in regard to: expectations/fears, content and process, physician-patient communication, meaning and short-term effects (both thoughts and actions). The interviews are our main data source and will be content analyzed to identify common themes.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

n/a

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/08/11
  •   20
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Patient is being treated on the palliative care ward or by the palliative care consultation team of the University Medical Center Freiburg
- A consultative conversation about advance directives is conducted with the patient as part of standard care
- The patient has not yet completed an advance directive
- The patient is physically, mentally and emotionally capable of participating in an interview lasting between 30-60 minutes

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

-Patient has already completed an advance directive
-Patient does not possess a sufficient knowledge of the German language
-Patient’s general state of health is too poor to participate in an interview
-Speech disorder that complicates transcription

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Ms.  Prof.   Gerhild  Becker 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Ms.  Katharina  Seibel 
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Universitätsklinikum Freiburg, Klinik für Palliativmedizin
    • Robert-Koch-Str. 3
    • 79106  Freiburg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.