Trial document




drksid header

  DRKS00013469

Trial Description

start of 1:1-Block title

Title

Heidelberg Milestone-Communication Approach (Heidelberger Meilenstein-Kommunikationskonzept, HeiMeKOM) - A Mixed-Method Study

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

Trial Acronym

HeiMeKOM

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

Communication with lung cancer patients with a limited prognosis is perceived to be challenging for all involved in this situation and breaking bad news can be considered one of the most difficult tasks for physicians. Communication about death and dying is often avoided by patients and physicians which results in patients not being fully informed, not receiving enough emotional support and often even receiving more aggressive therapies at end of life. Therefore, a necessity for a better physician-patient-communication exists. According to the National Cancer Plan in Germany, patients should be actively involved in decision-making concerning their treatment, and communication competencies of health care professionals should be improved.
Studies have shown that the integration of palliative care and advance care planning early in the disease trajectory can increase quality of life in patients and caregivers, and even lead to longer survival by improved symptom management and communication regarding coping and end-of-life decision making. Moreover, interprofessional approaches to end-of-life communication show more consistent results.
Therefore, a continuing and interprofessional (meaning: different health care providers work together) communication approach for lung cancer patients with a limited prognosis is planned at the Hospital for Thoracic Diseases, Heidelberg. The implementation and evaluation of the ‘Heidelberg Milestone-Communication Approach’ (HeiMeKOM) is being developed. The implementation plan comprises of different interventions. One of them is the theoretical development and implementation of the Milestone-Communication concept which will be carried out by an interprofessional tandem consisting of a nurse and a physician. At four pivotal consultation moments within the disease trajectory in lung cancer patients, structured consultations between the interprofessional tandem and lung cancer patients and their relatives will be undertaken. These four consultation moments are: 1.) Diagnosis and Prognosis, 2.) Stable phase in the course of treatment, 3.) Progression of the disease, 4.) Transition to best supportive care.
A mixed methods design with collection of qualitative and quantitative data will be used for the evaluation of HeiMeKOM. We hypothesize that HeiMeKOM will foster communication about prognosis and end-of-life decision making, improve patient Quality of Life and decrease aggressive medical care by the use of guideline-concordant palliative care. Additionally, the project aims to improve the communication competencies of health care professionals and positively influence job satisfaction and interprofessional team processes.

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

Brief Summary in Scientific Language

Communication with lung cancer patients with a limited prognosis is perceived to be challenging for all involved in this situation and breaking bad news can be considered one of the most difficult tasks for physicians. Communication about death and dying is often avoided by patients and physicians which results in patients not being fully informed, not receiving enough emotional support and often even receiving more aggressive therapies at end of life. Therefore, a necessity for a better physician-patient-communication exists. According to the National Cancer Plan in Germany, patients should be actively involved in decision-making concerning their treatment, and communication competencies of health care professionals should be improved.
Studies have shown that the integration of palliative care and advance care planning early in the disease trajectory can increase quality of life in patients and caregivers, and even lead to longer survival by improved symptom management and communication regarding coping and end-of-life decision making. Moreover, interprofessional approaches to end-of-life communication show more consistent results.
Therefore, a longitudinal and interprofessional communication approach for lung cancer patients with a limited prognosis is planned at the Hospital for Thoracic Diseases, Heidelberg. The implementation and evaluation of the ‘Heidelberg Milestone-Communication Approach’ (HeiMeKOM) is being developed.
The HeiMeKOM-project consists of three phases: development, implementation and evaluation of the HeiMeKOM-concept. In the first phase the concept was further developed by integrating perceived barriers and facilitators to implementation by physicians and nurses working at the Hospital for Thoracic Diseases, Heidelberg. These were collected using individual and group interviews.
The second phase comprises of an interprofessional communication training for physicians and nurses, who will be performing the so-called Milestone-Consultations in an interprofessional tandem with patients and their relatives in future at four pivotal consultation moments within the disease trajectory in lung cancer patients. These four consultation moments are: 1.) Diagnosis and Prognosis, 2.) Stable phase in the course of treatment, 3.) Progression of the disease, 4.) Transition to best supportive care.
In the third phase the effects of the HeiMeKOM-project will be evaluated using qualitative and quantitative methods. We hypothesize that HeiMeKOM will foster communication about prognosis and end-of-life decision making, improve patient Quality of Life and decrease aggressive medical care by the use of guideline-concordant palliative care. Additionally, the project aims to improve the communication competencies of health care professionals and positively influence job satisfaction and interprofessional team processes.
A mixed methods approach will be used to combine results from the single qualitative and quantitative investigations, as well as from a randomized controlled trial (DRKS00013649) and analysis will be performed using Framework Analysis.

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

Organizational Data

  •   DRKS00013469
  •   2017/12/22
  •   [---]*
  •   yes
  •   Approved
  •   S-561/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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

  •   C30-C39 -  Malignant neoplasms of respiratory and intrathoracic organs
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Physician-patient-communication as described in the HeiMeKOM-communication-concept:
    - Structured communication at four pivotal consultation moments in disease trajectory by an interprofessional tandem consisting of a nurse and a physician who have received a communication training in advance
    - Aim: enhance advance care planning and integration of early palliative care
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

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

Primary Outcome

There is no primary outcome for this project part. A primary outcome is defined in a further RCT (DRKS00013649) connected to this project.

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

Secondary Outcome

Secondary outcomes:

Perception of empathy: Interviews with patients/relatives

Shared decision-making: protocols of consultations, medical records, interviews with patients/relatives

Further contacts with health system: Interviews with patients/relatives

Further contacts/ consultations in Thoraxklinik Heidelberg: medical records

Evaluation of the training: group interviews with participants of training, protocols of consultations, Kirkpatrick questionnaire (level 1 und 2)
Interprofessional collaboration: UWE-IP questionnaire

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

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

Recruitment

  •   Actual
  •   2017/12/07
  •   100
  •   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

Phase 2 and 3 (process and outcome evaluation)
Group interviews with employees and questionnaires:
-Physicians and nurses participating in the communication training
-Further physicians, nurses and other team members (further health professionals)
-Capability to give consent

Phase 3 (outcome evaluation)
Study with patients:
-Patients: requirements for milestone-consultations fulfilled (newly diagnosed incurable lung cancer (stage IV)), 18 years and older, capability to give consent, good knowledge of German language, willingness to participate in study
-Relatives of patients: 18 years and older, capability to give consent, good knowledge of German language, willingness to participate in study

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

Exclusion Criteria

-Patient does not speak German
-Patient is in a medical condition (e.g. acute life-threatening condition), which does not allow consultations

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Thoraxklinik Heidelberg gGmbH
    • Mr.  Matthias  Villalobos 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • 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 other
    • Abteilung Allgemeinmedizin und Versorgungsforschung, Universitätsklinikum Heidelberg
    • Mr.  Prof. Dr.  Michel  Wensing 
    • Im Neuenheimer Feld 130.3, Marsilius-Arkaden, Turm West
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Institut für medizinische und pharmazeutische Prüfungsfragen
    • Ms.  Prof. Dr. med.  Jana  Jünger 
    • Große Langgasse 8
    • 55116  Mainz
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Thoraxklinik Heidelberg gGmbH
    • Mr.  Matthias  Villalobos 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • 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
    • Thoraxklinik Heidelberg gGmbH
    • Ms.  Dr.   Corinna  Jung 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • 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
    • Bundesverwaltungsamt, Zuwendungsmanagement Verwaltungs- und Ordnungsaufgaben, Referat ZMV 1, Grundsatzangelegenheiten ZMV 1, ESF Bescheinigungsstelle, Zuwendungen im Bereich BMG
    • Ms.  Hildegard  Bongartz 
    • Eupener Straße 125
    • 50933  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   022899 358 5233
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT)
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
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.