Enhancing Palliative Care in ICU

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

Study Overview

• Status: Recruiting
• Conditions: Palliative Care
• Intervention / Treatment: Behavioral: Complex intervention; Other: Routine treatment

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).

• Study Type: Interventional
• Enrollment (Estimated): 2040
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudia Spies, MD, Prof.; Phone Number: +4930450551102; Email: claudia.spies@charite.de

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • ICU General Resuscitation (RES UP), General University hospital
  • Prague, Czechia
    • Recruiting
    • ICU General Resuscitation (RES2)
  • Prague, Czechia
    • Recruiting
    • ICU Metabolic, General University hospital
• Germany
  • Berlin, Germany
    • Recruiting
    • CARITAS Klinik Maria Heimsuchung
  • Berlin, Germany
    • Recruiting
    • Evangelisches Krankenhaus Hubertus
  • Berlin, Germany
    • Recruiting
    • Department of Cardiology, Angiology and Intensive Care Medicine | CVK, Charité - University Berlin
  • Berlin, Germany
    • Recruiting
    • Charité - Department of Anesthesiology and Intensive Care Medicine CBF
  • Berlin, Germany
    • Withdrawn
    • Unfallkrankenhaus Berlin
  • Düsseldorf, Germany
    • Recruiting
    • 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
  • Halle, Germany
    • Recruiting
    • Universitätsklinikum Halle (Saale): Klinik für Innere Medizin III
  • Neuss, Germany
    • Recruiting
    • Johanna-Etienne Hospital Neuss, Interdisciplinary ICU
  • Wittenberg, Germany
    • Withdrawn
    • Ev. Krankenhaus Paul-Gerhardt-Stift Wittenberg:Angiologie und Kardiologie
  • State of 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
      • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin
• Greece
  • Alexandroupoli, Greece
    • Recruiting
    • Department of Intensive Care Medicine, University Hospital of Alexandroupolis
  • Athens, 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
  • Ioannina, Greece
    • Recruiting
    • Department of Intensive Care Medicine, University Hospital of Ioannina
  • Larissa, Greece
    • Recruiting
    • University Hospital of Larissa, Critical Care Department
  • Crete
    • Heraklion, Crete, Greece
      • Recruiting
      • Department of Intensive Care Medicine, University Hospital of Heraklion
  • Rio
    • Pátrai, Rio, Greece
      • Recruiting
      • Department of Intensive Care Medicine, University Hospital of Patras
• Israel
  • Jerusalem, Israel
    • 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
• Italy
  • Perugia, Italy
    • Recruiting
    • S.C. Anestesia e Rianimazione 2 - Terapia Intensiva, Azienda Ospedaliera Universitaria S. Maria della Misericordia
  • Perugia, Italy
    • Withdrawn
    • S.C. Anestesia e Rianimazione 1 - Terapia Intensiva Cardiochirurgica, Azienda Ospedaliera Universitaria S. Maria della Misericordia
  • Salerno, 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
  • Terni, Italy
    • Withdrawn
    • S.C. Anestesia - Rianimazione Azienda Ospedaliera Santa Maria - Terni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Intensive care unit patients in the intervention phase.	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 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.
Active Comparator: Control; Intensive care unit patients with routine treatment in the control phase.	Other: Routine treatment; No complex intervention is established, just routine procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Costs	Hospital cost and billing data, data on medical resource consumption combined with data on costs per unit of consumption at hospital level and from external sources, data on intervention costs including staff time for palliative care and related activities, hospital data or national data on salaries of individual professional groups.	During intensive care unit stay, an average of 5 days
Cost effectiveness	Hospital data on salaries per occupational group	During intensive care unit stay, an average of 5 days
Readmissions to intensive care unit	The readmission rate of patients transferred out of the 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	To evaluate the performance of total maximum sequential organ failure assessment (SOFA) score and a derived measure, delta SOFA (total maximum SOFA score minus admission total SOFA) as a descriptor of multiple organ dysfunction/failure in intensive care.	During intensive care unit stay, an average of 5 days
Palliative Care assessment	Presence of palliative care assessment performed during study period. The answer to the question: Has the palliative care assessment taken place? Yes/No	During intensive care unit stay, an average of 5 days
Presence of refractory symptoms I	Presence of refractory symptoms I is measured by physical symptoms.	During hospital stay, an expected average of 8 days
Presence of refractory symptoms II	Presence of refractory symptoms II is measured by distress of the patient.	During intensive care unit stay, an average of 5 days
Presence of refractory symptoms III	Presence of refractory symptoms III is measured by distress of the family.	During intensive care unit stay, an average of 5 days
Presence of refractory symptoms IV	Presence of refractory symptoms IV is measured by social problems of the patient.	During intensive care unit stay, an average of 5 days
Incidence of delirium	Delirium is measured with validated delirium scores.	During intensive care unit stay, an average of 5 days
Presence and nature of treatment limitations	Treatment limitation includes limits on the frequency of treatment, number of visits, days of coverage, or other similar limits on the scope or duration of treatment.	During intensive care unit stay, an average of 5 days
Length of hospital stay	Length of hospital stay is measured from ICU admission to discharge from hospital in days.	During hospital stay, an average of 8 days
Informations on discharge	Where the patient is discharged to.	During hospital stay, an average of 8 days
Specialized palliative care expert	Presence of specialized palliative care expert consultation. Answer to the question: Was a specialized palliative care expert consulted? Yes/No Duration of measurement: Until hospital discharge	During hospital stay, an average of 8 days
Mortality	Intensive care unit, inhouse, until 30 days and until 3 months	Up to three months
Social Status of the patient	The MacArthur Scale of Subjective Social Status (MacArthur SSS Scale) is a single-item measure that assesses a person's perceived rank relative to others in their group: To score this measure, researchers simply note the number of the rung (1-10) on which the respondent placed their "X."	Up to three months
Place of stay after hospitalization	Place of stay after hospitalization is measured in questionnaire.	Up to three months
Home care after hospitalization	Home care after hospitalization is measured in days.	Up to three months
Facilitators and barriers to high quality palliative care I	Facilitators and barriers to high quality palliative care from the perspective of patients.	Up to three months
Facilitators and barriers to high quality palliative care II	Facilitators and barriers to high quality palliative care from the perspective of relatives.	Up to three months
Symptom management by intensive care staff I	Symptom management I by intensive care staff from the patient's perspective is measured with a questionnaire.	Up to three months
Symptom management by intensive care staff II	Symptom management II by intensive care staff from the relative's perspective is measured with a questionnaire.	Up to three months
Treatment evaluation II	Treatment evaluation II is measured from the relatives' (proxy's) perspective with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Evaluation of the provider's question about goals for treatment I	Evaluation of the provider's question about goals for treatment I from the patients' perspective is measured with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Evaluation of the provider's question about goals for treatment II	Evaluation of the provider's question about goals for treatment II from the relatives' perspective is measured with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Satisfaction with regard to communication I	Satisfaction with regard to communication I from the patients' perspective is measured with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Satisfaction with regard to communication II	Satisfaction with regard to communication II from the relatives' perspective is measured with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Evaluation of the quality of information regarding the treatment I	Evaluation of the quality of information regarding the treatment from the patients' perspective is measured with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Evaluation of the quality of information regarding the treatment II	Rating of the quality of information regarding the treatment II from the relatives' perspective is measured with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Suitability of care from the patient's perspective	Suitability of care from the patient's perspective is measured with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Outpatient resource utilization	Outpatient resource utilization is measured by the number of outpatient visits.	Up to three months
Utilization of medical resources I	Utilization of medical resources I is measured in days of mechanical ventilation.	Up to three months
Utilization of medical resources II	Utilization of medical resources II is measured by Extracorporeal membrane oxygenation Yes/No.	Up to three months
Utilization of medical resources III	Utilization of medical resources III is measured by dialysis Yes/No.	Up to three months
Utilization of medical resources IV	Utilization of medical resources IV is measured by other organ replacement therapies. Yes/No.	Up to three months
Medical utilization after discharge from hospital I	Medical utilization after discharge from hospital I is measured by number and days of re-hospitalizations in days.	During intensive care unit stay, an average of 5 days
Medical utilization after discharge from hospital II	Medical utilization after discharge from hospital II is measured by days in care institutions in days.	Up to three months
Medical utilization after discharge from hospital III	Medical utilization after discharge from hospital III is measured by outpatient healthcare encounters in days.	Up to three months
Medical utilization after discharge from hospital IV	Medical utilization after discharge from hospital IV is measured by use of outpatient nursing services in days.	Up to three months
Medical utilization after discharge from hospital V	Medical utilization after discharge from hospital V is measured by specialized outpatient palliative care (SAPV) in days.	Up to three months
Patient Health Questionnaire-4 I	The Patient Health Questionnaire-4 (PHQ-4) I measures anxiety and depression in patients. The PHQ-4 is a four questionnaire answered on a four point Likert-type scale. A score of 3 or more on the depression/anxiety subscale is positive.	Up to three months
Patient Health Questionnaire-4 II	The Patient Health Questionnaire-4 (PHQ-4) II measures anxiety and depression in relatives. The PHQ-4 is a four questionnaire answered on a four point Likert-type scale. A score of 3 or more on the depression/anxiety subscale is positive.	Up to three months
Health related quality of life I	Health related quality of life I of the patient is measured with the 5-level EQ-5D version (EQ-5D-5L) from the EuroQol Group.	Up to three months
Question about the opinion of relatives on the unnecessary prolongation of life	Question about the opinion of relatives on the unnecessary prolongation of life is measured by bipolar Likert scale.	Up to three months
Question about opinion of relatives on discomfort during the final hours before death	Question about opinion of relatives on discomfort during the final hours before death is measured by bipolar Likert scale.	Up to three months
Question about opinion of relatives on loneliness during dying process.	Question about opinion of relatives on loneliness during dying process is measured by bipolar Likert scale.	Up to three months
Patient and family friendliness of intensive care unit care I	Patient and family friendliness of intensive care unit care I assessed by patients, measured with Likert scale/NRS 0-10).	Up to three months
Patient and family friendliness of intensive care unit care II	Patient and family friendliness of intensive care unit care II assessed by relatives, measured by by Likert scale (too little, just right, too much)/NRS (0-10).	Up to three months
Informal care by relatives I	Informal care by relatives I is measured by time spent with the patient.	Up to three months
Informal care by relatives II	Informal care by relatives II is measured by impact on relative's income.	Up to three months
Informal care by relatives III	Informal care by relatives III is measured by giving up relative´s professional activity.	Up to three months
Informal care by relatives IV	Informal care by relatives IV is measured by reducing relative's professional activity.	Up to three months
Inappropriate therapy	Perception of inappropriate therapy per employee based on 5 questions to employees is measured with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Ethical decision-making climate in the intensive care unit	Ethical decision-making climate in the intensive care unit per employee is measured with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Stress thermometer	To measure psychological distress the German version of the National Comprehensive Cancer Network Distress Thermometer is used. The scale ranges from 0 (no distress) to 10 (extreme distress) with a cutoff score of 5, indicating a clinically significant level of distress.	Up to three months
Treatment evaluation I	Treatment evaluation I is measured from patients' perspective with a 5-point Likert scale (The choices range from Strongly Agree to Strongly Disagree).	Up to three months
Informations on discharge	Where the patient is discharged to.	During intensive care unit stay, an average of 5 days
Burnout Assessment Tool (BAT-12)	Twelve questions from the BAT-12 per employee based on 5 questions is measured with an electronic questionnaire once per intervention and once per control period.	Up to 34 months.
Moral distress	Moral distress per employee is measured with numeric rating scale once per intervention and once per control period.	Up to 34 months
Implementation of the end-of-life practice	Questions on the current implementation of the end-of-life practice based on 12 questions that are still being developed is measured with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Questions on the existence of Standard Operating Procedures	Existence of Standard Operating Procedures per employee is measured with 4 questions with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Questions about using the ABCDEF bundle	Questions about using the ABCDEF bundle is measured with 11 questions with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Questions about supporting measures	Questions about supporting measures is measured with 4 questions with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Perception of palliative care and law	Perception of palliative care and law is measured with 4 questions with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Question about hurdles to palliative care	Question about hurdles to palliative care in the intensive care medicine is measured with 1 question with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Question about supporting factors	Question about supporting factors to palliative care in the intensive care medicine is measured with 1 question with an electronic questionnaire once per intervention and once per control period.	Up to 34 months
Comments after beginning of the intervention phase	Comments can be made via free text in an electronic questionnaire once per intervention and once per control period.	Up to 34 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic data of the patients	Demographic data of the patient (age, gender, main diagnosis and reasons for intensive care, insurance status, religion yes/no, highest level of education, employment status, existence of living will, patient power of attorney, chronic conditions) are measured with a questionnaire.	During intensive care unit stay, an average of 5 days
Demographic data of the relatives	Demographic data of the relative (age, gender, relationship to the patient, representative/guardian, religion yes/no) are measured with a questionnaire.	Up to three months
Employee demographics	Employee demographics (age group, gender, profession, years of professional experience, years and experience in palliative care and/or ethical training, type of intensive care unit) are measured with an electronic questionnaire once per intervention and once per control period.	Up to 34 months

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: European Commission
• Investigators: Study Director: 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: Edoardo de Robertis, MD, Prof., University Of Perugia; Study Director: Akiva Nachshon, MD, Hebrew University of Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 18, 2024
• First Posted (Actual): September 20, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: EPIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No