Consultation-based palliative care for critically ill patients in ICUs

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

This study is trying out a new palliative care program in ICUs to see if it can help critically ill patients and their families feel better and make important decisions during tough times.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Locations: 1 site (Seoul, N/A (Not Applicable))
• Trial ID: NCT06490835 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of implementing high-quality palliative care services in intensive care units for critically ill patients diagnosed with severe acute brain injuries or advanced organ failure. It involves providing multidisciplinary palliative care consultations to patients and their families to alleviate suffering and improve decision-making during challenging times. The study will enroll twenty patients at Seoul National University Hospital, focusing on respecting patient values and goals while addressing the emotional and physical burdens faced by families. The aim is to assess whether these services can enhance the quality of care provided in ICUs.

Who should consider this trial

Good fit: Ideal candidates include patients with severe acute brain injuries or advanced organ failure who are unable to communicate and have a poor prognosis.

Not a fit: Patients who are stable and able to communicate their wishes or those with less severe conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the quality of life and decision-making for critically ill patients and their families in intensive care settings.

How similar studies have performed: Other studies have shown promising results in implementing palliative care in ICU settings, indicating that this approach is both relevant and potentially beneficial.

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

Where this trial is running

Seoul, N/A (Not Applicable)

• Seoul National University Hospital — Seoul, N/A (Not Applicable), South Korea (Recruiting)

Study contacts

• Principal investigator: Shin Hye Yoo — Seoul National University Hospital
• Study coordinator: Shin Hye Yoo

Conditions Critical Illness; Intensive Care Units, Palliative Care, Decision Making