Enhancing Palliative Care in ICU

Charité University Medicine Berlin

Status: Enrolling

Conditions: Palliative Care

Treatments: Other: Routine treatment; Behavioral: Complex intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06605079

EPIC

Details and patient eligibility

About

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

Full 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).

Enrollment: 2,040 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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2,040 participants in 2 patient groups

Intervention

Experimental group

Description:

Intensive care unit patients in the intervention phase.

Treatment:

Behavioral: Complex intervention

Control

Active Comparator group

Description:

Intensive care unit patients with routine treatment in the control phase.

Treatment:

Other: Routine treatment