Enhancing Palliative Care in ICU

NCT06605079 | Recruiting

• 1 other identifier: EPIC
• Study Type: interventional
• Target: 2,040
• Locations: 5 countries
• Sites: 31

Brief Summary

The aim of this study is to reduce the suffering in intensive care through palliative care consultations.

Conditions

Palliative Care

Outcome Measures

Primary Outcomes (1)

• Length of intensive care stay

  The primary endpoint is the number of days the patient spent in each Intensive Care Unit (ICU) of the index hospital during the first hospitalization. For example, if the patient was transferred from the first ICU participating in the EPIC study to another, second ICU within the same hospital, or if the patient was transferred back from a ward to the first ICU, the duration of the secondary ICU is included in the calculation of the primary endpoint.

  During intensive care unit stay, an average of 5 days

Secondary Outcomes (67)

• Costs

  During intensive care unit stay, an average of 5 days

• Cost effectiveness

  During intensive care unit stay, an average of 5 days

• Readmissions to intensive care unit

  During hospital stay, an expected average of 8 days

• Maximum Sepsis-related organ failure assessment score (SOFA Score) in the intensive care unit

  During intensive care unit stay, an average of 5 days

• Palliative Care assessment

  During intensive care unit stay, an average of 5 days

Other Outcomes (3)

• Demographic data of the patients

  During intensive care unit stay, an average of 5 days

• Demographic data of the relatives

  Up to three months

• Employee demographics

  Up to 34 months

Study Arms (2)

Intervention

EXPERIMENTAL

Intensive care unit patients in the intervention phase.

Behavioral: Complex intervention

Control

ACTIVE COMPARATOR

Intensive care unit patients with routine treatment in the control phase.

Other: Routine treatment

Interventions

Complex intervention BEHAVIORAL

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.

Intervention

Routine treatment OTHER

No complex intervention is established, just routine procedures.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in ICU who can give consent and those who can not (via their authorized representative or legal guardian, also possible with delayed consent)
• 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.

You may not qualify if:

• \- Patient is moribund and is expected to die within the next 24h
• Study cohort relatives:
• \- At least one relative(s) of a patient. This may or may not be the legal representative, depending on national legislation.
• Refusal by the relative
• Refusal of the patient to participate in the intervention study
• \<18 years of age
• Cohort of employees:
• Employed on the ITS as a doctor/nurse
• Employed in the clinical center as a member of the palliative care consultation service

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• European Commission: collaborator

Study Sites (31)

ICU General Resuscitation (RES UP), General University hospital

Prague, Czechia

RECRUITING

ICU General Resuscitation (RES2)

Prague, Czechia

RECRUITING

ICU Metabolic, General University hospital

Prague, Czechia

RECRUITING

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin

Mitte, State of Berlin, Germany

RECRUITING

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin

Wedding, State of Berlin, Germany

RECRUITING

CARITAS Klinik Maria Heimsuchung

Berlin, Germany

RECRUITING

Charité - Department of Anesthesiology and Intensive Care Medicine CBF

Berlin, Germany

RECRUITING

Department of Cardiology, Angiology and Intensive Care Medicine | CVK, Charité - University Berlin

Berlin, Germany

RECRUITING

Evangelisches Krankenhaus Hubertus

Berlin, Germany

RECRUITING

Unfallkrankenhaus Berlin

Berlin, Germany

WITHDRAWN

Medical and Neurological Intensive Care Unit, University Hospital of Düsseldorf

Düsseldorf, Germany

RECRUITING

Neurosurgical and Traumatological ICU ZI13, University Hospital of Düsseldorf

Düsseldorf, Germany

RECRUITING

Surgical Intensive Care Unit CIA1/CIB1, University Hospital of Düsseldorf

Düsseldorf, Germany

RECRUITING

Universitätsklinikum Halle (Saale): Klinik für Innere Medizin III

Halle, Germany

RECRUITING

Johanna-Etienne Hospital Neuss, Interdisciplinary ICU

Neuss, Germany

RECRUITING

Ev. Krankenhaus Paul-Gerhardt-Stift Wittenberg:Angiologie und Kardiologie

Wittenberg, Germany

WITHDRAWN

Department of Intensive Care Medicine, University Hospital of Heraklion

Heraklion, Crete, Greece

RECRUITING

Department of Intensive Care Medicine, University Hospital of Patras

Pátrai, Rio, Greece

RECRUITING

Department of Intensive Care Medicine, University Hospital of Alexandroupolis

Alexandroupoli, Greece

RECRUITING

Cardiothoracic Intensive Care Unit of the Onassis Cardiac Surgery Center

Athens, Greece

RECRUITING

Department of Intensive Care Medicine, Alexandra General Hospital

Athens, Greece

RECRUITING

Department of Intensive Care Medicine, Evaggelismos General Hospital

Athens, Greece

RECRUITING

Department of Intensive Care Medicine, University Hospital of Ioannina

Ioannina, Greece

RECRUITING

University Hospital of Larissa, Critical Care Department

Larissa, Greece

RECRUITING

General Intensive Care Unit, Hadassah Medical Organisation

Jerusalem, Israel

RECRUITING

The Coronary Care Intensive Care Unit, Hadassah Hospital, Ein Kerem

Jerusalem, Israel

RECRUITING

The Neurosurgical Intensive Care Unit, Hadassah Hospital, Ein Kerem

Jerusalem, Israel

RECRUITING

S.C. Anestesia e Rianimazione 1 - Terapia Intensiva Cardiochirurgica, Azienda Ospedaliera Universitaria S. Maria della Misericordia

Perugia, Italy

WITHDRAWN

S.C. Anestesia e Rianimazione 2 - Terapia Intensiva, Azienda Ospedaliera Universitaria S. Maria della Misericordia

Perugia, Italy

RECRUITING

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

RECRUITING

S.C. Anestesia - Rianimazione Azienda Ospedaliera Santa Maria - Terni

Terni, Italy

WITHDRAWN

Study Officials

• Claudia Spies, MD, Prof.

  Charité-University Medicine (Berlin, Germany)

  STUDY DIRECTOR

• Martin Neukirchen, MD

  Heinrich-Heine-University Düsseldorf, Germany

  STUDY DIRECTOR

• Jochen Dutzmann, MD

  University Medicine Halle, Germany

  STUDY DIRECTOR

• Spyros Mentzelopoulos, MD, Prof.

  National and Kapodistrian University of Athens, Greece

  STUDY DIRECTOR

• Katerina Rusinova, MD

  Charles University in Prague, Italy

  STUDY DIRECTOR

• Akiva Nachshon, MD

  Hebrew University of Jerusalem, Israel

  STUDY DIRECTOR

• Edoardo de Robertis, MD, Prof.

  University Of Perugia

  STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

+4930450551102; claudia.spies@charite.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine,Charité- University Berlin

Model Details: Controlled, cluster-randomized, non-blinded, study in a stepped-wedge design with cross-over month.

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 20, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (13); IL (3); CZ (3); IT (4); GR (8)