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| Name | Class |
|---|---|
| European Commission | OTHER |
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The aim of this study is to reduce the suffering in intensive care through palliative care consultations.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intensive care unit patients in the intervention phase. |
|
| Control | Active Comparator | Intensive care unit patients with routine treatment in the control phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex intervention | Behavioral | A complex intervention is carried out in the intensive care unit. This includes:
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. |
| 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 |
| 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 |
| 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 |
Patients:
Inclusion Criteria:
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:
Cohort of employees:
Inclusion criteria
Exclusion criterion Refusal to participate
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claudia Spies, MD, Prof. | Contact | +4930450551102 | claudia.spies@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Charité-University Medicine (Berlin, Germany) | Study Director |
| Martin Neukirchen, MD | Heinrich-Heine-University Düsseldorf, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICU General Resuscitation (RES UP), General University hospital | Recruiting | Prague | Czechia | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41702660 | Derived | 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 Open. 2026 Feb 17;16(2):e108168. doi: 10.1136/bmjopen-2025-108168. |
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Controlled, cluster-randomized, non-blinded, study in a stepped-wedge design with cross-over month.
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|
| Routine treatment | Other | No complex intervention is established, just routine procedures. |
|
| 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 |
| Informations on discharge | Where the patient is discharged to. | During intensive care unit stay, an average of 5 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 |
| 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 |
| 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 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 |
| 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 |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Jochen Dutzmann, MD |
| University Medicine Halle, Germany |
| Study Director |
| Spyros Mentzelopoulos, MD, Prof. | National and Kapodistrian University of Athens | Study Director |
| Katerina Rusinova, MD | Charles University in Prague, Italy | Study Director |
| Akiva Nachshon, MD | Hebrew University of Jerusalem, Israel | Study Director |
| Edoardo de Robertis, MD, Prof. | University Of Perugia | Study Director |
| ICU General Resuscitation (RES2) |
| Recruiting |
| Prague |
| Czechia |
| ICU Metabolic, General University hospital | Recruiting | Prague | Czechia |
| Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin | Recruiting | Mitte | State of Berlin | Germany |
| Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin | Recruiting | Wedding | State of Berlin | Germany |
| CARITAS Klinik Maria Heimsuchung | Recruiting | Berlin | Germany |
| Charité - Department of Anesthesiology and Intensive Care Medicine CBF | Recruiting | Berlin | Germany |
| Department of Cardiology, Angiology and Intensive Care Medicine | CVK, Charité - University Berlin | Recruiting | Berlin | Germany |
| Evangelisches Krankenhaus Hubertus | Recruiting | Berlin | Germany |
| Unfallkrankenhaus Berlin | Withdrawn | Berlin | Germany |
| Medical and Neurological Intensive Care Unit, University Hospital of Düsseldorf | Recruiting | Düsseldorf | Germany |
| Neurosurgical and Traumatological ICU ZI13, University Hospital of Düsseldorf | Recruiting | Düsseldorf | Germany |
| Surgical Intensive Care Unit CIA1/CIB1, University Hospital of Düsseldorf | Recruiting | Düsseldorf | Germany |
| Universitätsklinikum Halle (Saale): Klinik für Innere Medizin III | Recruiting | Halle | Germany |
| Johanna-Etienne Hospital Neuss, Interdisciplinary ICU | Recruiting | Neuss | Germany |
| Ev. Krankenhaus Paul-Gerhardt-Stift Wittenberg:Angiologie und Kardiologie | Withdrawn | Wittenberg | Germany |
| Department of Intensive Care Medicine, University Hospital of Heraklion | Recruiting | Heraklion | Crete | Greece |
| Department of Intensive Care Medicine, University Hospital of Patras | Recruiting | Pátrai | Rio | Greece |
| Department of Intensive Care Medicine, University Hospital of Alexandroupolis | Recruiting | Alexandroupoli | Greece |
| Cardiothoracic Intensive Care Unit of the Onassis Cardiac Surgery Center | Recruiting | Athens | Greece |
| Department of Intensive Care Medicine, Alexandra General Hospital | Recruiting | Athens | Greece |
| Department of Intensive Care Medicine, Evaggelismos General Hospital | Recruiting | Athens | Greece |
| Department of Intensive Care Medicine, University Hospital of Ioannina | Recruiting | Ioannina | Greece |
| University Hospital of Larissa, Critical Care Department | Recruiting | Larissa | Greece |
| General Intensive Care Unit, Hadassah Medical Organisation | Recruiting | Jerusalem | Israel |
| The Coronary Care Intensive Care Unit, Hadassah Hospital, Ein Kerem | Recruiting | Jerusalem | Israel |
| The Neurosurgical Intensive Care Unit, Hadassah Hospital, Ein Kerem | Recruiting | Jerusalem | Israel |
| S.C. Anestesia e Rianimazione 1 - Terapia Intensiva Cardiochirurgica, Azienda Ospedaliera Universitaria S. Maria della Misericordia | Withdrawn | Perugia | Italy |
| S.C. Anestesia e Rianimazione 2 - Terapia Intensiva, Azienda Ospedaliera Universitaria S. Maria della Misericordia | Recruiting | Perugia | Italy |
| UOC di Anestesia e Rianimazione Cardio Toraco Vascolare dell'AOU San Giovanni di Dio e Ruggi d'Aragona "Scuola Medica Salernitana", Salerno University Hospital | Recruiting | Salerno | Italy |
| S.C. Anestesia - Rianimazione Azienda Ospedaliera Santa Maria - Terni | Withdrawn | Terni | Italy |