Feasibility Study on Implementing Consultation-based High-quality Palliative Care Services in Intensive Care Units

Seoul National University

Status: Enrolling

Conditions: Critical Illness

Treatments: Behavioral: High-quality palliative care through consultation-based palliative care services in the ICU

Study type: Interventional

Funder types: Other

Identifiers

NCT06490835

2404-111-1532

Details and patient eligibility

About

Critically ill patients in intensive care units (ICUs) receive life-sustaining treatments aimed at restoring or maintaining organ function. ICU admission often involves substantial physical and existential pressures that can burden patients, their families, and surrogates. Multidisciplinary palliative care support can help alleviate potential causes of suffering. Twenty patients admitted to the ICUs at Seoul National University Hospital, diagnosed with sudden and severe acute brain injury or progressive organ failure, along with their surrogates, will be enrolled in the study. This study aims to assess the feasibility of applying consultation-based palliative care services to provide higher quality palliative care for critically ill patients with acute illnesses and their families facing poor prognoses upon ICU admission. Additionally, the study seeks to determine whether providing such palliative care services can help better respect the patient's values and goals, reduce communication conflicts, alleviate family caregivers' anxiety and depression, and enhance satisfaction with critical care.

Enrollment: 20 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Both patients and surrogates must meet the inclusion criteria and not fall under any exclusion criteria

[Inclusion Criteria]

Patients:

1. Diagnosis of sudden and severe acute brain injury due to at least one of the following etiologies: vascular, traumatic, metabolic, toxic, infectious, or anoxic AND
2. Glasgow Coma Scale score of 3-8 for at least 24 hours after the patient's admission AND
3. Unable to express themselves verbally or otherwise

OR

1. Diagnosis of advanced stage organ failure (any of the following)

   • Chronic lung disease requiring long-term oxygen therapy or mechanical ventilation
   • Decompensated liver cirrhosis
   • Chronic heart failure with NYHA class III or IV
   • Progressive neurological disease with a modified Rankin score of 3-5 (e.g., dementia, Parkinson's disease, and amyotrophic lateral sclerosis)
   • Three or more chronic comorbidities causing limitations in activities of daily living (ADL) AND

2. APACHE II score ≥ 14 at the time of screening AND

3. ICU stay of 7 days or more

Surrogates:

1. Family caregiver of a patient who meets the inclusion criteria (Family: defined as the patient's spouse, lineal ascendants and descendants within two degrees of kinship and their spouses, siblings and their spouses, and relatives within eight degrees of kinship and their spouses)
2. Aged 19 or older
3. Willing and able to provide consent for participation in the study

[Exclusion Criteria]

Patients:

1. Under 19 years of age
2. Unable to speak, understand, or read Korean
3. Refusal of palliative care consultation
4. Referred to palliative care prior to study enrollment
5. Within 48 hours of ICU admission
6. Presence of active cancer under treatment within 6 months prior to ICU admission
7. Care goals set to "comfort care" at the time of study enrollment
8. Death expected within 48 hours at the time of study enrollment
9. Lack of capacity to participate in the study without an appropriate surrogate

Surrogates:

1. Under 19 years of age
2. Unable to speak, understand, or read Korean
3. Determined by a physician to be in extremely poor health, making participation in the study infeasible
4. Refusal of palliative care consultation

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Critically ill patients requiring ICU admission and their surrogates

Experimental group

Description:

Participants receive high-quality palliative care through consultation-based palliative care services in addition to standard critical care.

Treatment:

Behavioral: High-quality palliative care through consultation-based palliative care services in the ICU