Status:
RECRUITING
Feasibility Study on Implementing Consultation-based High-quality Palliative Care Services in Intensive Care Units
Lead Sponsor:
Seoul National University Hospital
Conditions:
Critical Illness
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
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 existe...
Eligibility Criteria
Inclusion
- Both patients and surrogates must meet the inclusion criteria and not fall under any exclusion criteria
- \[Inclusion Criteria\]
- Patients:
- 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
- Glasgow Coma Scale score of 3-8 for at least 24 hours after the patient's admission AND
- Unable to express themselves verbally or otherwise
- OR
- 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
- APACHE II score ≥ 14 at the time of screening AND
- ICU stay of 7 days or more
- Surrogates:
- 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)
- Aged 19 or older
- Willing and able to provide consent for participation in the study
- \[Exclusion Criteria\]
- Patients:
- Under 19 years of age
- Unable to speak, understand, or read Korean
- Refusal of palliative care consultation
- Referred to palliative care prior to study enrollment
- Within 48 hours of ICU admission
- Presence of active cancer under treatment within 6 months prior to ICU admission
- Care goals set to "comfort care" at the time of study enrollment
- Death expected within 48 hours at the time of study enrollment
- Lack of capacity to participate in the study without an appropriate surrogate
- Surrogates:
- Under 19 years of age
- Unable to speak, understand, or read Korean
- Determined by a physician to be in extremely poor health, making participation in the study infeasible
- Refusal of palliative care consultation
Exclusion
Key Trial Info
Start Date :
June 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06490835
Start Date
June 19 2024
End Date
December 31 2025
Last Update
July 8 2024
Active Locations (1)
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1
Seoul National University Hospital
Seoul, N/A (Not Applicable), South Korea, 03080