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

NCT ID: NCT06490835

Last Updated: 2024-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-19

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Critically ill patients requiring ICU admission and their surrogates

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shin Hye Yoo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shin Hye Yoo

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National University Hospital

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

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shin Hye Yoo

Role: CONTACT

+82-2-2072-1589

Ye Sul Jeung

Role: CONTACT

+82-2-2072-3066

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shin Hye Yoo

Role: primary

+82-2-2072-1589

Ye Sul Jeung

Role: backup

+82-2-2072-3066

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40441768 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2404-111-1532

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.