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
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AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
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Frequently Asked Questions
Research Publications
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
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
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
Complete this quick 3-step screening to check your eligibility
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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
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
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...