Palliative CareNCT06605079
Enhancing Palliative Care in ICU
A study testing Complex intervention and Routine treatment in people with Palliative Care, run by Charite University, Berlin, Germany at 31 sites in 5 countries.
Trial summary
The aim of this study is to reduce the suffering in intensive care through palliative care consultations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- What is being tested?
- Complex intervention and Routine treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,040 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 10 Oct 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- At least one relative(s) of a patient. This may or may not be the legal representative, depending on national legislation.
- Employed on the ITS as a doctor/nurse
- Employed in the clinical center as a member of the palliative care consultation service
Who cannot join
- Patient is moribund and is expected to die within the next 24h
- Study cohort relatives:
- Refusal by the relative
- Refusal of the patient to participate in the intervention study
- <18 years of age
- Cohort of employees:
Trial locations and contacts
31 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 5 countries
Germany13 sites, 11 recruiting
- Recruiting
CARITAS Klinik Maria Heimsuchung
Berlin
- Recruiting
Charité - Department of Anesthesiology and Intensive Care Medicine CBF
Berlin
- Recruiting
Department of Cardiology, Angiology and Intensive Care Medicine | CVK, Charité - University Berlin
Berlin
- Recruiting
Evangelisches Krankenhaus Hubertus
Berlin
- Withdrawn
Unfallkrankenhaus Berlin
Berlin
- Recruiting
Medical and Neurological Intensive Care Unit, University Hospital of Düsseldorf
Düsseldorf
- Recruiting
Neurosurgical and Traumatological ICU ZI13, University Hospital of Düsseldorf
Düsseldorf
- Recruiting
Surgical Intensive Care Unit CIA1/CIB1, University Hospital of Düsseldorf
Düsseldorf
- Recruiting
Universitätsklinikum Halle (Saale): Klinik für Innere Medizin III
Halle
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin
Mitte, State of Berlin
- Recruiting
Johanna-Etienne Hospital Neuss, Interdisciplinary ICU
Neuss
- Recruiting
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK),Charité - University Medicine Berlin
Wedding, State of Berlin
- Withdrawn
Ev. Krankenhaus Paul-Gerhardt-Stift Wittenberg:Angiologie und Kardiologie
Wittenberg
Greece8 sites, 8 recruiting
- Recruiting
Department of Intensive Care Medicine, University Hospital of Alexandroupolis
Alexandroupoli
- Recruiting
Cardiothoracic Intensive Care Unit of the Onassis Cardiac Surgery Center
Athens
- Recruiting
Department of Intensive Care Medicine, Alexandra General Hospital
Athens
- Recruiting
Department of Intensive Care Medicine, Evaggelismos General Hospital
Athens
- Recruiting
Department of Intensive Care Medicine, University Hospital of Heraklion
Heraklion, Crete
- Recruiting
Department of Intensive Care Medicine, University Hospital of Ioannina
Ioannina
- Recruiting
University Hospital of Larissa, Critical Care Department
Larissa
- Recruiting
Department of Intensive Care Medicine, University Hospital of Patras
Pátrai, Rio
Italy4 sites, 2 recruiting
- Withdrawn
S.C. Anestesia e Rianimazione 1 - Terapia Intensiva Cardiochirurgica, Azienda Ospedaliera Universitaria S. Maria della Misericordia
Perugia
- Recruiting
S.C. Anestesia e Rianimazione 2 - Terapia Intensiva, Azienda Ospedaliera Universitaria S. Maria della Misericordia
Perugia
- 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
Salerno
- Withdrawn
S.C. Anestesia - Rianimazione Azienda Ospedaliera Santa Maria - Terni
Terni
Czechia3 sites, 3 recruiting
- Recruiting
ICU General Resuscitation (RES UP), General University hospital
Prague
- Recruiting
ICU General Resuscitation (RES2)
Prague
- Recruiting
ICU Metabolic, General University hospital
Prague
Israel3 sites, 3 recruiting
- Recruiting
General Intensive Care Unit, Hadassah Medical Organisation
Jerusalem
- Recruiting
The Coronary Care Intensive Care Unit, Hadassah Hospital, Ein Kerem
Jerusalem
- Recruiting
The Neurosurgical Intensive Care Unit, Hadassah Hospital, Ein Kerem
Jerusalem
About this study
The aim of this study is to reduce the suffering in intensive care through palliative care consultations.
Read the 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).
- Conditions
- Palliative Care
- Being tested
- Complex intervention, Routine treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex interventionBehavioural
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.
Routine treatmentOther
No complex intervention is established, just routine procedures.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intensive care unit patients in the intervention phase. Receives: Behavioral: Complex intervention |
| Control | Active comparator | Intensive care unit patients with routine treatment in the control phase. Receives: Other: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During intensive care unit stay, an average of 5 days
Secondary outcomes (67)
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.
Measured: During intensive care unit stay, an average of 5 days
Cost effectiveness
Hospital data on salaries per occupational group
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During intensive care unit stay, an average of 5 days
Incidence of delirium
Delirium is measured with validated delirium scores.
Measured: 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.
Measured: 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.
Measured: During hospital stay, an average of 8 days
Informations on discharge
Where the patient is discharged to.
Measured: During hospital stay, an average of 8 days
Informations on discharge
Where the patient is discharged to.
Measured: 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
Measured: During hospital stay, an average of 8 days
Mortality
Intensive care unit, inhouse, until 30 days and until 3 months
Measured: 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."
Measured: Up to three months
Place of stay after hospitalization
Place of stay after hospitalization is measured in questionnaire.
Measured: Up to three months
Home care after hospitalization
Home care after hospitalization is measured in days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Up to three months
Outpatient resource utilization
Outpatient resource utilization is measured by the number of outpatient visits.
Measured: Up to three months
Utilization of medical resources I
Utilization of medical resources I is measured in days of mechanical ventilation.
Measured: Up to three months
Utilization of medical resources II
Utilization of medical resources II is measured by Extracorporeal membrane oxygenation Yes/No.
Measured: Up to three months
Utilization of medical resources III
Utilization of medical resources III is measured by dialysis Yes/No.
Measured: Up to three months
Utilization of medical resources IV
Utilization of medical resources IV is measured by other organ replacement therapies. Yes/No.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Up to three months
Informal care by relatives I
Informal care by relatives I is measured by time spent with the patient.
Measured: Up to three months
Informal care by relatives II
Informal care by relatives II is measured by impact on relative's income.
Measured: Up to three months
Informal care by relatives III
Informal care by relatives III is measured by giving up relative´s professional activity.
Measured: Up to three months
Informal care by relatives IV
Informal care by relatives IV is measured by reducing relative's professional activity.
Measured: 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.
Measured: 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.
Measured: Up to 34 months
Moral distress
Moral distress per employee is measured with numeric rating scale once per intervention and once per control period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 34 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start10 Oct 2024
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Controlled, cluster-randomized, non-blinded, study in a stepped-wedge design with cross-over month.
- Masking
- None (open label)
- Enrolment
- 2,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charité-University Medicine (Berlin, Germany)Martin Neukirchen, MD, Study director, Heinrich-Heine-University Düsseldorf, GermanyJochen Dutzmann, MD, Study director, University Medicine Halle, GermanySpyros Mentzelopoulos, MD, Prof., Study director, National and Kapodistrian University of AthensKaterina Rusinova, MD, Study director, Charles University in Prague, ItalyAkiva Nachshon, MD, Study director, Hebrew University of Jerusalem, IsraelEdoardo de Robertis, MD, Prof., Study director, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605079
- Sponsor's protocol ID
- EPIC
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Open. 2026 Feb 17;16(2):e108168. doi: 10.1136/bmjopen-2025-108168.
PubMed 41702660
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Palliative Care in ICU
- ClinicalTrials.gov ID
- NCT06605079
- Acronym / sponsor ID
- EPIC
- Conditions
- Palliative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,040 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Controlled, cluster-randomized, non-blinded, study in a stepped-wedge design with cross-over month.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Complex interventionIntensive care unit patients in the intervention phase. |
| Control | Active comparator | Other: Routine treatmentIntensive care unit patients with routine treatment in the control phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- Patient is moribund and is expected to die within the next 24h
- Refusal by the relative
- Refusal of the patient to participate in the intervention study
- <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex interventionA 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. | Behavioural | Intervention |
| Routine treatmentNo complex intervention is established, just routine procedures. | Other | Control |
Primary outcome
Length of intensive care stay
Time frame: During intensive care unit stay, an average of 5 days
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.
67 secondary outcomes
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
Informations on discharge
Time frame: During hospital stay, an average of 8 days
Informations on discharge
Time frame: During intensive care unit stay, an average of 5 days
Specialized palliative care expert
Time frame: During hospital stay, an average of 8 days
Mortality
Time frame: Up to three months
Social Status of the patient
Time frame: Up to three months
Place of stay after hospitalization
Time frame: Up to three months
Home care after hospitalization
Time frame: Up to three months
Stress thermometer
Time frame: Up to three months
Facilitators and barriers to high quality palliative care I
Time frame: Up to three months
Facilitators and barriers to high quality palliative care II
Time frame: Up to three months
Symptom management by intensive care staff I
Time frame: Up to three months
Symptom management by intensive care staff II
Time frame: Up to three months
Treatment evaluation I
Time frame: Up to three months
Treatment evaluation II
Time frame: Up to three months
Evaluation of the provider's question about goals for treatment I
Time frame: Up to three months
Evaluation of the provider's question about goals for treatment II
Time frame: Up to three months
Satisfaction with regard to communication I
Time frame: Up to three months
Satisfaction with regard to communication II
Time frame: Up to three months
Evaluation of the quality of information regarding the treatment I
Time frame: Up to three months
Evaluation of the quality of information regarding the treatment II
Time frame: Up to three months
Suitability of care from the patient's perspective
Time frame: Up to three months
Outpatient resource utilization
Time frame: Up to three months
Utilization of medical resources I
Time frame: Up to three months
Utilization of medical resources II
Time frame: Up to three months
Utilization of medical resources III
Time frame: Up to three months
Utilization of medical resources IV
Time frame: Up to three months
Medical utilization after discharge from hospital I
Time frame: During intensive care unit stay, an average of 5 days
Medical utilization after discharge from hospital II
Time frame: Up to three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Derived from this study: PubMed 41702660Mentzelopoulos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia Spies, MD, Prof. study director
Charité-University Medicine (Berlin, Germany)
Martin Neukirchen, MD study director
Heinrich-Heine-University Düsseldorf, Germany
Jochen Dutzmann, MD study director
University Medicine Halle, Germany
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex intervention and Routine treatment in people with Palliative Care, run by Charite University, Berlin, Germany at 31 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, Greece, Italy, Czechia, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia Spies, MD, Prof. (+4930450551102, claudia.spies@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of intensive care stay (time frame: During intensive care unit stay, an average of 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06605079, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.