Clinical trial NCT06605079: Enhancing Palliative Care in ICU
Official title: Enhancing Palliative Care in ICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Palliative Care
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2024-09-20
Enrollment: 2040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Controlled, cluster-randomized, non-blinded, cross-over study in a stepped-wedge design.
Primary purpose: PREVENTION

Brief summary: 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).

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

Primary outcomes:
measure: Length of intensive care stay
timeFrame: During intensive care unit stay, an average of 5 days
Secondary outcomes:
measure: Costs
timeFrame: During intensive care unit stay, an average of 5 days
measure: Cost effectiveness
timeFrame: During intensive care unit stay, an average of 5 days
measure: Readmissions to intensive care unit
timeFrame: During hospital stay, an expected average of 8 days
measure: Maximum Sepsis-related organ failure assessment score (SOFA Score) in the intensive care unit
timeFrame: During intensive care unit stay, an average of 5 days
measure: Palliative Care assessment
timeFrame: During intensive care unit stay, an average of 5 days
measure: Presence of refractory symptoms I
timeFrame: During hospital stay, an expected average of 8 days
measure: Presence of refractory symptoms II
timeFrame: During intensive care unit stay, an average of 5 days
measure: Presence of refractory symptoms III
timeFrame: During intensive care unit stay, an average of 5 days
measure: Presence of refractory symptoms IV
timeFrame: During intensive care unit stay, an average of 5 days
measure: Incidence of delirium
timeFrame: During intensive care unit stay, an average of 5 days
measure: Presence and nature of treatment limitations
timeFrame: During intensive care unit stay, an average of 5 days
measure: Length of hospital stay
timeFrame: During hospital stay, an average of 8 days
measure: Informations on discharge
timeFrame: During hospital stay, an average of 8 days
measure: Informations on discharge
timeFrame: During intensive care unit stay, an average of 5 days
measure: Specialized palliative care expert
timeFrame: During hospital stay, an average of 8 days
measure: Mortality
timeFrame: Up to three months
measure: Social Status of the patient
timeFrame: Up to three months
measure: Place of stay after hospitalization
timeFrame: Up to three months
measure: Home care after hospitalization
timeFrame: Up to three months
measure: Stress thermometer
timeFrame: Up to three months
measure: Facilitators and barriers to high quality palliative care I
timeFrame: Up to three months
measure: Facilitators and barriers to high quality palliative care II
timeFrame: Up to three months
measure: Symptom management by intensive care staff I
timeFrame: Up to three months
measure: Symptom management by intensive care staff II
timeFrame: Up to three months
measure: Treatment evaluation I
timeFrame: Up to three months
measure: Treatment evaluation II
timeFrame: Up to three months
measure: Evaluation of the provider's question about goals for treatment I
timeFrame: Up to three months
measure: Evaluation of the provider's question about goals for treatment II
timeFrame: Up to three months
measure: Satisfaction with regard to communication I
timeFrame: Up to three months
measure: Satisfaction with regard to communication II
timeFrame: Up to three months
measure: Evaluation of the quality of information regarding the treatment I
timeFrame: Up to three months
measure: Evaluation of the quality of information regarding the treatment II
timeFrame: Up to three months
measure: Suitability of care from the patient's perspective
timeFrame: Up to three months
measure: Outpatient resource utilization
timeFrame: Up to three months
measure: Utilization of medical resources I
timeFrame: Up to three months
measure: Utilization of medical resources II
timeFrame: Up to three months
measure: Utilization of medical resources III
timeFrame: Up to three months
measure: Utilization of medical resources IV
timeFrame: Up to three months
measure: Medical utilization after discharge from hospital I
timeFrame: During intensive care unit stay, an average of 5 days
measure: Medical utilization after discharge from hospital II
timeFrame: Up to three months
measure: Medical utilization after discharge from hospital III
timeFrame: Up to three months
measure: Medical utilization after discharge from hospital IV
timeFrame: Up to three months
measure: Medical utilization after discharge from hospital V
timeFrame: Up to three months
measure: Patient Health Questionnaire-4 I
timeFrame: Up to three months
measure: Patient Health Questionnaire-4 II
timeFrame: Up to three months
measure: Health related quality of life I
timeFrame: Up to three months
measure: Question about the opinion of relatives on the unnecessary prolongation of life
timeFrame: Up to three months
measure: Question about opinion of relatives on discomfort during the final hours before death
timeFrame: Up to three months
measure: Question about opinion of relatives on loneliness during dying process.
timeFrame: Up to three months
measure: Patient and family friendliness of intensive care unit care I
timeFrame: Up to three months
measure: Patient and family friendliness of intensive care unit care II
timeFrame: Up to three months
measure: Informal care by relatives I
timeFrame: Up to three months
measure: Informal care by relatives II
timeFrame: Up to three months
measure: Informal care by relatives III
timeFrame: Up to three months
measure: Informal care by relatives IV
timeFrame: Up to three months
measure: Burnout Assessment Tool (BAT-12)
timeFrame: Up to 34 months.
measure: Inappropriate therapy
timeFrame: Up to 34 months
measure: Moral distress
timeFrame: Up to 34 months
measure: Implementation of the end-of-life practice
timeFrame: Up to 34 months
measure: Ethical decision-making climate in the intensive care unit
timeFrame: Up to 34 months
measure: Questions on the existence of Standard Operating Procedures
timeFrame: Up to 34 months
measure: Questions about using the ABCDEF bundle
timeFrame: Up to 34 months
measure: Questions about supporting measures
timeFrame: Up to 34 months
measure: Perception of palliative care and law
timeFrame: Up to 34 months
measure: Question about hurdles to palliative care
timeFrame: Up to 34 months
measure: Question about supporting factors
timeFrame: Up to 34 months
measure: Comments after beginning of the intervention phase
timeFrame: Up to 34 months
Other outcomes:
measure: Demographic data of the patients
timeFrame: During intensive care unit stay, an average of 5 days
measure: Demographic data of the relatives
timeFrame: Up to three months
measure: Employee demographics
timeFrame: Up to 34 months
Locations:
city: Prague
country: Czechia
facility: ICU General University hospital
city: Berlin-Mitte
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin
city: Berlin
country: Germany
facility: CARITAS Klinik Maria Heimsuchung
city: Berlin
country: Germany
facility: Department of Cardiology, Angiology and Intensive Care Medicine | CVK, Charité - University Berlin
city: Berlin
country: Germany
facility: Evangelisches Krankenhaus Hubertus
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Düsseldorf
country: Germany
facility: Medical and Neurological Intensive Care Unit, University Hospital of Düsseldorf
city: Düsseldorf
country: Germany
facility: Neurosurgical and Traumatological ICU ZI13, University Hospital of Düsseldorf
city: Düsseldorf
country: Germany
facility: Surgical Intensive Care Unit CIA1/CIB1, University Hospital of Düsseldorf
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale): Klinik für Innere Medizin III
city: Neuss
country: Germany
facility: Johanna-Etienne Hospital Neuss, Interdisciplinary ICU
city: Wittenberg
country: Germany
facility: Ev. Krankenhaus Paul-Gerhardt-Stift Wittenberg:Angiologie und Kardiologie
city: Heraklion
country: Greece
facility: Department of Intensive Care Medicine, University Hospital of Heraklion
state: Crete
city: Patras
country: Greece
facility: Department of Intensive Care Medicine, University Hospital of Patras
state: Rio
city: Alexandroupolis
country: Greece
facility: Department of Intensive Care Medicine, University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Cardiothoracic Intensive Care Unit of the Onassis Cardiac Surgery Center
city: Athens
country: Greece
facility: Department of Intensive Care Medicine, Alexandra General Hospital
city: Athens
country: Greece
facility: Department of Intensive Care Medicine, Evaggelismos General Hospital
city: Ioánnina
country: Greece
facility: Department of Intensive Care Medicine, University Hospital of Ioannina
city: Larissa
country: Greece
facility: University Hospital of Larissa, Critical Care Department
city: Jerusalem
country: Israel
facility: General Intensive Care Unit, Hadassah Medical Organisation
city: Jerusalem
country: Israel
facility: The Coronary Care Intensive Care Unit, Hadassah Hospital, Ein Kerem
city: Jerusalem
country: Israel
facility: The Neurosurgical Intensive Care Unit, Hadassah Hospital, Ein Kerem
city: Perugia
country: Italy
facility: S.C. Anestesia e Rianimazione 1 - Terapia Intensiva Cardiochirurgica, Azienda Ospedaliera Universitaria S. Maria della Misericordia
city: Perugia
country: Italy
facility: S.C. Anestesia e Rianimazione 2 - Terapia Intensiva, Azienda Ospedaliera Universitaria S. Maria della Misericordia
city: Salerno
country: Italy
facility: UOC di Anestesia e Rianimazione Cardio Toraco Vascolare dell'AOU San Giovanni di Dio e Ruggi d'Aragona "Scuola Medica Salernitana", Salerno University Hospital
city: Terni
country: Italy
facility: S.C. Anestesia - Rianimazione Azienda Ospedaliera Santa Maria - Terni
Study officials:
affiliation: Charité-University Medicine (Berlin, Germany)
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Heinrich-Heine-University Düsseldorf, Germany
name: Martin Neukirchen, MD
role: STUDY_DIRECTOR
affiliation: University Medicine Halle, Germany
name: Jochen Dutzmann, MD
role: STUDY_DIRECTOR
affiliation: National and Kapodistrian University of Athens, Greece
name: Spyros Mentzelopoulos, MD, Prof.
role: STUDY_DIRECTOR
affiliation: Charles University in Prague, Italy
name: Katerina Rusinova, MD
role: STUDY_DIRECTOR
affiliation: Hadassah Medical Organisation, Jerusalem, Israel
name: Vernon Van Heerden, MD
role: STUDY_DIRECTOR
affiliation: University Of Perugia
name: Edoardo de Robertis, MD, Prof.
role: STUDY_DIRECTOR
References: