Enhancing Palliative Care in ICU

Overview

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

Detailed description

This project investigates the effectiveness and cost-effectiveness of palliative care consultations in the Intensive care unit. Charité will implement the Working Package 2 "Europe-wide harmonized and recommended palliative care practice for ICU" of the approved HORIZON funding application EPIC, to which this ethics application refers.

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).

Interventions

• Behavioral 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
• Other Routine treatment
  No complex intervention is established, just routine procedures.

Primary outcome measures

• Length of intensive care stay [Time frame: During intensive care unit stay, an average of 5 days]

Secondary outcome measures (12)

• Costs [Time frame: During intensive care unit stay, an average of 5 days]
• Cost effectiveness [Time frame: During intensive care unit stay, an average of 5 days]
• Readmissions to intensive care unit [Time frame: During hospital stay, an expected average of 8 days]
• Maximum Sepsis-related organ failure assessment score (SOFA Score) in the intensive care unit [Time frame: During intensive care unit stay, an average of 5 days]
• Palliative Care assessment [Time frame: During intensive care unit stay, an average of 5 days]
• Presence of refractory symptoms I [Time frame: During hospital stay, an expected average of 8 days]
• Presence of refractory symptoms II [Time frame: During intensive care unit stay, an average of 5 days]
• Presence of refractory symptoms III [Time frame: During intensive care unit stay, an average of 5 days]
• Presence of refractory symptoms IV [Time frame: During intensive care unit stay, an average of 5 days]
• Incidence of delirium [Time frame: During intensive care unit stay, an average of 5 days]
• Presence and nature of treatment limitations [Time frame: During intensive care unit stay, an average of 5 days]
• Length of hospital stay [Time frame: During hospital stay, an average of 8 days]

Eligibility criteria

Patients:

Inclusion criteria

• 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.

Exclusion criteria

\- Patient is moribund and is expected to die within the next 24h

Study cohort relatives:

Inclusion criteria

\- At least one relative(s) of a patient. This may or may not be the legal representative, depending on national legislation.

Exclusion criteria

• Refusal by the relative
• Refusal of the patient to participate in the intervention study
• <18 years of age

Cohort of employees:

Inclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Prevention

Study locations

Germany · 13 centers

• Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Me — Mitte
• Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Me — Wedding
• CARITAS Klinik Maria Heimsuchung — Berlin
• Charité - Department of Anesthesiology and Intensive Care Medicine CBF — Berlin
• Department of Cardiology, Angiology and Intensive Care Medicine | CVK, Charité - Universit — Berlin
• Evangelisches Krankenhaus Hubertus — Berlin
• Unfallkrankenhaus Berlin — Berlin
• Medical and Neurological Intensive Care Unit, University Hospital of Düsseldorf — Düsseldorf
• … and 5 more centers

Greece · 8 centers

• Department of Intensive Care Medicine, University Hospital of Heraklion — Heraklion
• Department of Intensive Care Medicine, University Hospital of Patras — Pátrai
• Department of Intensive Care Medicine, University Hospital of Alexandroupolis — Alexandroupoli
• Cardiothoracic Intensive Care Unit of the Onassis Cardiac Surgery Center — Athens
• Department of Intensive Care Medicine, Alexandra General Hospital — Athens
• Department of Intensive Care Medicine, Evaggelismos General Hospital — Athens
• Department of Intensive Care Medicine, University Hospital of Ioannina — Ioannina
• University Hospital of Larissa, Critical Care Department — Larissa

Italy · 4 centers

• S.C. Anestesia e Rianimazione 1 - Terapia Intensiva Cardiochirurgica, Azienda Ospedaliera — Perugia
• S.C. Anestesia e Rianimazione 2 - Terapia Intensiva, Azienda Ospedaliera Universitaria S. — Perugia
• UOC di Anestesia e Rianimazione Cardio Toraco Vascolare dell'AOU San Giovanni di Dio e Rug — Salerno
• S.C. Anestesia - Rianimazione Azienda Ospedaliera Santa Maria - Terni — Terni

Czechia · 3 centers

• ICU General Resuscitation (RES UP), General University hospital — Prague
• ICU General Resuscitation (RES2) — Prague
• ICU Metabolic, General University hospital — Prague

Israel · 3 centers

• General Intensive Care Unit, Hadassah Medical Organisation — Jerusalem
• The Coronary Care Intensive Care Unit, Hadassah Hospital, Ein Kerem — Jerusalem
• The Neurosurgical Intensive Care Unit, Hadassah Hospital, Ein Kerem — Jerusalem

Publications

• Mentzelopoulos SD, Hartog CS, Tenge T, Schwenkglenks M, Piper SK, Barbier M, Rusinova K, Neukirchen M, Schuurhuis S, Jensen HI, van Heerden V, Dutzmann J, Drescher D, Zvara M, Metaxa V, Nachshon A, De Robertis E, Spies C, Edel A. Enhancing palliative care in intensive care units: protocol of EPIC, a controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase. BMJ Op PMID 41702660

Identifiers

NCT: NCT06605079 · EPIC

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗