Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06605079

Enhancing Palliative Care in the Intensive Care Unit A Cluster-Randomized Controlled Trial Evaluating Telemedical Consultation, Staff Training, and Checklists

Led by Charite University, Berlin, Germany · Updated on 2025-09-30

2040

Participants Needed

31

Research Sites

13 weeks

Total Duration

On this page

Sponsors

C

Charite University, Berlin, Germany

Lead Sponsor

E

European Commission

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to reduce suffering in intensive care units by studying palliative care consultations. It evaluates how effective and cost-efficient these consultations are for ICU patients, implementing a Europe-wide recommended palliative care practice. The study also includes anonymous surveys of doctors and nurses during both intervention and control phases across multiple centers. Participants in the intervention group will receive a complex approach including telemedical consultations by specialized palliative care experts, training for ICU staff in basic palliative care, and use of checklists to identify patients needing palliative care early. The control group will receive routine ICU treatment without these additional interventions. The study uses a cluster-randomized controlled design to assess the impact of these practices. During their ICU stay, patients will be monitored for length of stay, costs, symptom presence, organ failure scores, readmissions, and use of medical resources. Follow-ups extend up to three months to assess outcomes such as mortality, quality of life, communication satisfaction, and resource use. Staff and relatives will also be surveyed about care quality and experiences. The total observation period for some measures extends up to 34 months to evaluate long-term effects and ethical aspects of care.

CONDITIONS

Brief Title

Enhancing Palliative Care in ICU

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients in ICU who can give consent or have an authorized representative to provide consent
  • Age 18 years or older
  • Critical illness not primarily caused by cancer
  • New admission to participating ICU for more than 72 hours
  • Assessment by ICU physician indicating need for palliative care consultation due to treatment disagreements, therapy limitations, or expected benefit
  • At least one relative of a patient, regardless of legal representation status
  • Employed as a doctor or nurse on the ICU or part of the hospital's palliative care consultation service
Not Eligible

You will not qualify if you...

  • Patient expected to die within 24 hours (moribund)
  • Relatives who refuse to participate
  • Patients who refuse participation in the intervention study
  • Relatives under 18 years of age
  • ICU staff who refuse to participate in the employee survey

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Outpatient Treatment

Duration - During intensive care unit stay, an average of 5 days

Participants in the intensive care unit receive either the complex intervention including telemedical consultations, staff training, and checklists or routine treatment as part of their ICU care.

Daily ICU care visits during the ICU stay

Follow-up

Duration - Up to three months

Participants are followed for up to three months after hospital discharge to assess health status, resource utilization, quality of life, and experiences of patients and relatives.

Follow-up assessments at intervals up to three months post-discharge

Trial Site Locations

Total: 31 locations

1

ICU General Resuscitation (RES UP), General University hospital

Prague, Czechia

Actively Recruiting

2

ICU General Resuscitation (RES2)

Prague, Czechia

Actively Recruiting

3

ICU Metabolic, General University hospital

Prague, Czechia

Actively Recruiting

4

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

Mitte, State of Berlin, Germany

Actively Recruiting

5

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

Wedding, State of Berlin, Germany

Actively Recruiting

6

CARITAS Klinik Maria Heimsuchung

Berlin, Germany

Actively Recruiting

7

Charité - Department of Anesthesiology and Intensive Care Medicine CBF

Berlin, Germany

Actively Recruiting

8

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

Berlin, Germany

Actively Recruiting

9

Evangelisches Krankenhaus Hubertus

Berlin, Germany

Actively Recruiting

10

Unfallkrankenhaus Berlin

Berlin, Germany

Withdrawn

11

Medical and Neurological Intensive Care Unit, University Hospital of Düsseldorf

Düsseldorf, Germany

Actively Recruiting

12

Neurosurgical and Traumatological ICU ZI13, University Hospital of Düsseldorf

Düsseldorf, Germany

Actively Recruiting

13

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

Düsseldorf, Germany

Actively Recruiting

14

Universitätsklinikum Halle (Saale): Klinik für Innere Medizin III

Halle, Germany

Actively Recruiting

15

Johanna-Etienne Hospital Neuss, Interdisciplinary ICU

Neuss, Germany

Actively Recruiting

16

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

Wittenberg, Germany

Withdrawn

17

Department of Intensive Care Medicine, University Hospital of Heraklion

Heraklion, Crete, Greece

Actively Recruiting

18

Department of Intensive Care Medicine, University Hospital of Patras

Pátrai, Rio, Greece

Actively Recruiting

19

Department of Intensive Care Medicine, University Hospital of Alexandroupolis

Alexandroupoli, Greece

Actively Recruiting

20

Cardiothoracic Intensive Care Unit of the Onassis Cardiac Surgery Center

Athens, Greece

Actively Recruiting

21

Department of Intensive Care Medicine, Alexandra General Hospital

Athens, Greece

Actively Recruiting

22

Department of Intensive Care Medicine, Evaggelismos General Hospital

Athens, Greece

Actively Recruiting

23

Department of Intensive Care Medicine, University Hospital of Ioannina

Ioannina, Greece

Actively Recruiting

24

University Hospital of Larissa, Critical Care Department

Larissa, Greece

Actively Recruiting

25

General Intensive Care Unit, Hadassah Medical Organisation

Jerusalem, Israel

Actively Recruiting

26

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

Jerusalem, Israel

Actively Recruiting

27

The Neurosurgical Intensive Care Unit, Hadassah Hospital, Ein Kerem

Jerusalem, Israel

Actively Recruiting

28

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

Perugia, Italy

Withdrawn

29

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

Perugia, Italy

Actively Recruiting

30

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

Actively Recruiting

31

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

Terni, Italy

Withdrawn

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Research Team

C

Claudia Spies, MD, Prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Enhancing palliative care in intensive care units: protocol of EPIC, a controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase.

Spyros D Mentzelopoulos, Christiane S Hartog, Theresa Tenge...

https://pubmed.ncbi.nlm.nih.gov/41702660