Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2040 participants
INTERVENTIONAL
2024-10-10
2027-08-31
Brief Summary
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Detailed Description
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An accompanying anonymous employee survey (doctors/nurses) is conducted once in the intervention phase and once in the control phase in all study centers (see secondary endpoints 57-68 and 71).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Intervention
Intensive care unit patients in the intervention phase.
Complex intervention
A complex intervention is carried out in the intensive care unit. This includes:
* telemedical consultations by specialized palliative care experts from external institutions for the respective hospital staff
* the training of hospital staff in the intensive care unit in basic palliative care and
* the use of checklists for the early identification of eligible patients and the structured recording of palliative care needs.
The efficacy and cost-effectiveness of the complex intervention will be investigated using a controlled clinical trial in a cluster-randomized controlled design. In addition, as part of the multicenter clinical study in WP 2 staff, patients and relatives will also be surveyed.
Control
Intensive care unit patients with routine treatment in the control phase.
Routine treatment
No complex intervention is established, just routine procedures.
Interventions
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Complex intervention
A complex intervention is carried out in the intensive care unit. This includes:
* telemedical consultations by specialized palliative care experts from external institutions for the respective hospital staff
* the training of hospital staff in the intensive care unit in basic palliative care and
* the use of checklists for the early identification of eligible patients and the structured recording of palliative care needs.
The efficacy and cost-effectiveness of the complex intervention will be investigated using a controlled clinical trial in a cluster-randomized controlled design. In addition, as part of the multicenter clinical study in WP 2 staff, patients and relatives will also be surveyed.
Routine treatment
No complex intervention is established, just routine procedures.
Eligibility Criteria
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Inclusion Criteria
* From 18 years
* The leading cause of critical illness is not cancer
* New admission on the participating ICU \> 72h
* Assessment of the need for palliative care by the in-charge physi-cian of the ICU, because (1) there is a significant disagreement about ICU treatment or (2) because the physician considers ther-apy limitations for the patient or (3) the physician considers a benefit from specialized PC consultation for ICU physician, nurse, or patient or family.
\- At least one relative(s) of a patient. This may or may not be the legal representative, depending on national legislation.
* Employed on the ITS as a doctor/nurse
* Employed in the clinical center as a member of the palliative care consultation service
Exclusion criterion Refusal to participate
Exclusion Criteria
Study cohort relatives:
* Refusal by the relative
* Refusal of the patient to participate in the intervention study
* \<18 years of age
Cohort of employees:
18 Years
ALL
Yes
Sponsors
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European Commission
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine,Charité- University Berlin
Principal Investigators
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Claudia Spies, MD, Prof.
Role: STUDY_DIRECTOR
Charité-University Medicine (Berlin, Germany)
Martin Neukirchen, MD
Role: STUDY_DIRECTOR
Heinrich-Heine-University Düsseldorf, Germany
Jochen Dutzmann, MD
Role: STUDY_DIRECTOR
University Medicine Halle, Germany
Spyros Mentzelopoulos, MD, Prof.
Role: STUDY_DIRECTOR
National and Kapodistrian University of Athens, Greece
Katerina Rusinova, MD
Role: STUDY_DIRECTOR
Charles University in Prague, Italy
Akiva Nachshon, MD
Role: STUDY_DIRECTOR
Hebrew University of Jerusalem, Israel
Edoardo de Robertis, MD, Prof.
Role: STUDY_DIRECTOR
University Of Perugia
Locations
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ICU General Resuscitation (RES UP), General University hospital
Prague, , Czechia
ICU General Resuscitation (RES2)
Prague, , Czechia
ICU Metabolic, General University hospital
Prague, , Czechia
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin
Mitte, State of Berlin, Germany
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin
Wedding, State of Berlin, Germany
CARITAS Klinik Maria Heimsuchung
Berlin, , Germany
Charité - Department of Anesthesiology and Intensive Care Medicine CBF
Berlin, , Germany
Department of Cardiology, Angiology and Intensive Care Medicine | CVK, Charité - University Berlin
Berlin, , Germany
Evangelisches Krankenhaus Hubertus
Berlin, , Germany
Unfallkrankenhaus Berlin
Berlin, , Germany
Medical and Neurological Intensive Care Unit, University Hospital of Düsseldorf
Düsseldorf, , Germany
Neurosurgical and Traumatological ICU ZI13, University Hospital of Düsseldorf
Düsseldorf, , Germany
Surgical Intensive Care Unit CIA1/CIB1, University Hospital of Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Halle (Saale): Klinik für Innere Medizin III
Halle, , Germany
Johanna-Etienne Hospital Neuss, Interdisciplinary ICU
Neuss, , Germany
Ev. Krankenhaus Paul-Gerhardt-Stift Wittenberg:Angiologie und Kardiologie
Wittenberg, , Germany
Department of Intensive Care Medicine, University Hospital of Heraklion
Heraklion, Crete, Greece
Department of Intensive Care Medicine, University Hospital of Patras
Pátrai, Rio, Greece
Department of Intensive Care Medicine, University Hospital of Alexandroupolis
Alexandroupoli, , Greece
Cardiothoracic Intensive Care Unit of the Onassis Cardiac Surgery Center
Athens, , Greece
Department of Intensive Care Medicine, Alexandra General Hospital
Athens, , Greece
Department of Intensive Care Medicine, Evaggelismos General Hospital
Athens, , Greece
Department of Intensive Care Medicine, University Hospital of Ioannina
Ioannina, , Greece
University Hospital of Larissa, Critical Care Department
Larissa, , Greece
General Intensive Care Unit, Hadassah Medical Organisation
Jerusalem, , Israel
The Coronary Care Intensive Care Unit, Hadassah Hospital, Ein Kerem
Jerusalem, , Israel
The Neurosurgical Intensive Care Unit, Hadassah Hospital, Ein Kerem
Jerusalem, , Israel
S.C. Anestesia e Rianimazione 1 - Terapia Intensiva Cardiochirurgica, Azienda Ospedaliera Universitaria S. Maria della Misericordia
Perugia, , Italy
S.C. Anestesia e Rianimazione 2 - Terapia Intensiva, Azienda Ospedaliera Universitaria S. Maria della Misericordia
Perugia, , Italy
UOC di Anestesia e Rianimazione Cardio Toraco Vascolare dell'AOU San Giovanni di Dio e Ruggi d'Aragona "Scuola Medica Salernitana", Salerno University Hospital
Salerno, , Italy
S.C. Anestesia - Rianimazione Azienda Ospedaliera Santa Maria - Terni
Terni, , Italy
Countries
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Central Contacts
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Other Identifiers
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EPIC
Identifier Type: -
Identifier Source: org_study_id
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