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

NCT06490835 | Recruiting DMC

• 1 other identifier: 2404-111-1532
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Critical Illness

Keywords

Intensive Care Units, Palliative Care, Decision Making

Outcome Measures

Primary Outcomes (1)

• Feasibility of Applying Consultation-Based High-Quality Palliative Care

  Proportion of eligible contacts who consented and participated in the study, palliative care family counseling rate, and study completion rate.

  1 day (at discharge)

Secondary Outcomes (14)

• Change in Surrogates' Decisional Conflict before and after the Intervention

  Pre-post comparison (baseline vs. within one week after consultation)

• Change in Surrogates' Decisional Self-Efficacy before and after the Intervention

  Pre-post comparison (baseline vs. within one week after consultation)

• Change in Surrogates' Emotional State before and after the Intervention

  Pre-post comparison (baseline vs. within one week after consultation)

• Surrogates' Decision Regret after the Intervention

  Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)

• Level of Patient- and Family-Centered Care Experienced by Surrogates after the Intervention

  Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)

Other Outcomes (2)

• Qualitative Evaluation of Intervention Feasibility and Satisfaction

  Within three months after the final consultation

• Additional Analysis of Surrogates' Emotional State Changes before and after the Intervention

  One month after the final consultation (within three months for deceased patients)

Study Arms (1)

Critically ill patients requiring ICU admission and their surrogates

EXPERIMENTAL

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

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

Interventions

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

Family Counseling: Social workers implement a supportive process for families, assessing the individualized psychosocial and decisional support needs of patients and families to provide foundational data for palliative care consultations. Family Meeting Support: In cases of high medical complexity, uncertainty, value conflicts, or communication issues, the palliative care consultation team supports the facilitation of family meetings. Consultation: The palliative care team provides consultations to the attending physician based on the palliative care needs assessed during family counseling. Topics include symptom management, understanding treatment options, decisional conflict, emotional and practical support, goal of care setting, resources, and bereavement support. Palliative Care by attending Physician: The attending physician incorporates the consultations received from the palliative care consultation team to provide high-quality palliative care to patients and their families.

Critically ill patients requiring ICU admission and their surrogates

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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:
• Aged 19 or older
• Willing and able to provide consent for participation in the study

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, N/A (Not Applicable), 03080, South Korea

RECRUITING

Related Publications (1)

• Jeung YS, Kim Y, Kim S, Jung YS, Kim TJ, Yoo SH. Feasibility study protocol: implementing consultation-based high-quality palliative care services in intensive care units. BMJ Open. 2025 May 28;15(5):e093558. doi: 10.1136/bmjopen-2024-093558.

  PMID: 40441768 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shin Hye Yoo

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin Hye Yoo

CONTACT

+82-2-2072-1589; ifi1024@snu.ac.kr

Ye Sul Jeung

CONTACT

+82-2-2072-3066; roseyesul@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 8, 2024
• Study Start: June 19, 2024
• Primary Completion: July 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)