Enhancing Palliative Care in ICU

Обзор

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

Подробное описание

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).

Вмешательства

• Поведенческое 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
• Другое Routine treatment
  No complex intervention is established, just routine procedures.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Patients:

Критерии включения

• 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.

Критерии исключения

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

Study cohort relatives:

Критерии включения

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

Критерии исключения

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

Cohort of employees:

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Германия · 13 центров

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

Греция · 8 центров

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

Италия · 4 центра

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

Чехия · 3 центра

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

Израиль · 3 центра

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

Публикации

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

Идентификаторы

NCT: NCT06605079 · EPIC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗