Clinical trial NCT06490835: Feasibility Study on Implementing Consultation-based High-quality Palliative Care Services in Intensive Care Units
Official title: A Feasibility Study Protocol for Implementing Consultation-based Palliative Care Services to Provide High-quality Palliative Care to Families of Critically Ill Patients in Intensive Care Units: A Single-arm Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Critical Illness
Keywords: Intensive Care Units, Palliative Care, Decision Making
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of Applying Consultation-Based High-Quality Palliative Care
timeFrame: 1 day (at discharge)
Secondary outcomes:
measure: Change in Surrogates' Decisional Conflict before and after the Intervention
timeFrame: Pre-post comparison (baseline vs. within one week after consultation)
measure: Change in Surrogates' Decisional Self-Efficacy before and after the Intervention
timeFrame: Pre-post comparison (baseline vs. within one week after consultation)
measure: Change in Surrogates' Emotional State before and after the Intervention
timeFrame: Pre-post comparison (baseline vs. within one week after consultation)
measure: Surrogates' Decision Regret after the Intervention
timeFrame: Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)
measure: Level of Patient- and Family-Centered Care Experienced by Surrogates after the Intervention
timeFrame: Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)
measure: Surrogates' Satisfaction with the Intervention Services
timeFrame: Within one week after the final consultation
measure: Length of Hospital Stay
timeFrame: 1 day (at discharge)
measure: Survival to Discharge Rate
timeFrame: 1 day (at discharge)
measure: Days of Symptom Relief Treatments received in the ICU
timeFrame: 1 day (at discharge)
measure: Proportion of Patients receiving Symptom Relief Treatments During the ICU stay
timeFrame: 1 day (at discharge)
measure: Use of Life-Sustaining Procedures within 48 Hours before Death
timeFrame: 1 day (at discharge)
measure: Use of Symptom Relief Treatments within 48 Hours before Death
timeFrame: 1 day (at discharge)
measure: Data Collection Completion Rate
timeFrame: Within three months after the final consultation
measure: Time Taken to Recruit Patients
timeFrame: Within the first year of study initiation
Other outcomes:
measure: Qualitative Evaluation of Intervention Feasibility and Satisfaction
timeFrame: Within three months after the final consultation
measure: Additional Analysis of Surrogates' Emotional State Changes before and after the Intervention
timeFrame: One month after the final consultation (within three months for deceased patients)
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: N/A (Not Applicable)
Study officials:
affiliation: Seoul National University Hospital
name: Shin Hye Yoo
role: PRINCIPAL_INVESTIGATOR
References: