Critical IllnessNCT06490835
Feasibility Study on Implementing Consultation-based High-quality Palliative Care Services in Intensive Care Units
A study testing High-quality palliative care through consultation-based palliative care services in the ICU in people with Critical Illness, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- High-quality palliative care through consultation-based palliative care services in the ICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, N/A (Not Applicable), 03080
Shin Hye Yoo, +82-2-2072-1589, ifi1024@snu.ac.kr
Ye Sul Jeung, +82-2-2072-3066, roseyesul@naver.com
About this study
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
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
- Being tested
- High-quality palliative care through consultation-based palliative care services in the ICU
- Keywords
- Intensive Care Units, Palliative Care, Decision Making
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-quality palliative care through consultation-based palliative care services in the ICUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High-quality palliative care through consultation-based palliative care services in the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day (at discharge)
Secondary outcomes (14)
Change in Surrogates' Decisional Conflict before and after the Intervention
The Decisional Conflict Scale (DCS) is a validated tool designed to evaluate personal uncertainty when making healthcare decisions, including modifiable factors that contribute to such uncertainty and the overall quality of the decision. It consists of 16 questions, each rated on a 5-point scale from "strongly agree" (1) to "strongly disagree" (5). Scores range from 16 to 80, with higher scores reflecting greater uncertainty and less favorable outcomes.
Measured: Pre-post comparison (baseline vs. within one week after consultation)
Change in Surrogates' Decisional Self-Efficacy before and after the Intervention
The Decisional Self-Efficacy Scale (DSES) evaluates an individual's self-confidence or belief in their decision-making abilities, including the ability to participate in shared decision making. The scale consists of 11 items, each rated on a five-point Likert scale from "0" (no confidence) to "4" (very confident). To determine the total score, the sum of the item scores is divided by 11 and then multiplied by 25. Scores range between 0 and 100, with higher scores indicating higher levels of decision-making self-efficacy.
Measured: Pre-post comparison (baseline vs. within one week after consultation)
Change in Surrogates' Emotional State before and after the Intervention
The Hospital Anxiety and Depression Scale (HADS) is a questionnaire consisting of fourteen items. Seven items focus on anxiety, while the other seven address depression. Scores for each subscale range from 0 to 21, with higher scores reflecting higher levels of anxiety or depression.
Measured: Pre-post comparison (baseline vs. within one week after consultation)
Surrogates' Decision Regret after the Intervention
The Decision Regret Scale (DRS) is a 5-item, 5-point Likert-type self-report measure used to assess distress or remorse following a healthcare decision. Items are rated from 1 ("strongly agree") to 5 ("strongly disagree"), with two items (2 and 4) phrased negatively. To calculate the total score, the negatively phrased items are first reversed, then the mean of all five items is computed. This mean is rescaled from 0 to 100 by subtracting 1 and multiplying by 25. A score of 0 represents no regret, while 100 indicates a high level of regret.
Measured: 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
The Modified Patient Perception of Patient-Centeredness (PPPC) scale, utilized by surrogates, consists of 12 items. The scores range from 0 to 100, with higher scores indicating a higher level of patient-centered care.
Measured: Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)
Surrogates' Satisfaction with the Intervention Services
Overall satisfaction with ICU palliative care, family counseling satisfaction, consultation satisfaction, and family meeting satisfaction, assessed on a 5-point scale (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)
Measured: Within one week after the final consultation
Length of Hospital Stay
Length of ICU stay and overall hospital stay
Measured: 1 day (at discharge)
Survival to Discharge Rate
Vital status at discharge
Measured: 1 day (at discharge)
Days of Symptom Relief Treatments received in the ICU
Number of days receiving comfort-focused care (opioids and/or antipsychotics) during the ICU stay, based on a retrospective review of medical records
Measured: 1 day (at discharge)
Proportion of Patients receiving Symptom Relief Treatments During the ICU stay
The percentage of the total study population who received comfort-focused care (opioids and/or antipsychotics) during the ICU stay, based on a retrospective review of medical records
Measured: 1 day (at discharge)
Use of Life-Sustaining Procedures within 48 Hours before Death
We assessed the life-sustaining procedures administered during the end-of-life (EOL) stage using seven indicators: cardiopulmonary resuscitation (CPR), mechanical ventilation, continuous renal replacement therapy, surgery, vasopressors, extracorporeal membrane oxygenation (ECMO), and high-flow oxygen (HFO2). The percentage of the total study population that received each procedure within the last 48 hours of life was measured.
Measured: 1 day (at discharge)
Use of Symptom Relief Treatments within 48 Hours before Death
Administration of opioid analgesics and/or antipsychotic medications within the final 48 hours of life was regarded as receiving end-of-life comfort care. We analyzed the percentage of the total study population that received opioid analgesics and/or antipsychotic medications during the last 48 hours of life.
Measured: 1 day (at discharge)
Data Collection Completion Rate
Proportion of data collected at each time point exceeding 90%
Measured: Within three months after the final consultation
Time Taken to Recruit Patients
Time interval between enrollment of the first and tenth patients
Measured: Within the first year of study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start19 Jun 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shin Hye Yoo, Seoul National University Hospital
- Investigators
- Shin Hye Yoo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490835
- Sponsor's protocol ID
- 2404-111-1532
- Status last verified
- Jul 2024
- First submitted
- 24 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40441768
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06490835
- Acronym / sponsor ID
- 2404-111-1532
- Conditions
- Critical Illness
- Keywords
- Intensive Care Units, Palliative Care, Decision Making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients requiring ICU admission and their surrogates | Experimental | Behavioral: High-quality palliative care through consultation-based palliative care services in the ICUParticipants receive high-quality palliative care through consultation-based palliative care services in addition to standard critical care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-quality palliative care through consultation-based palliative care services in the ICUFamily 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. | Behavioural | Critically ill patients requiring ICU admission and their surrogates |
Primary outcome
Feasibility of Applying Consultation-Based High-Quality Palliative Care
Time frame: 1 day (at discharge)
Proportion of eligible contacts who consented and participated in the study, palliative care family counseling rate, and study completion rate.
14 secondary outcomes
Change in Surrogates' Decisional Conflict before and after the Intervention
Time frame: Pre-post comparison (baseline vs. within one week after consultation)
Change in Surrogates' Decisional Self-Efficacy before and after the Intervention
Time frame: Pre-post comparison (baseline vs. within one week after consultation)
Change in Surrogates' Emotional State before and after the Intervention
Time frame: Pre-post comparison (baseline vs. within one week after consultation)
Surrogates' Decision Regret after the Intervention
Time frame: 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
Time frame: Follow-up (within one week after consultation and one month after consultation; up to three months after the final consultation for deceased patients)
Surrogates' Satisfaction with the Intervention Services
Time frame: Within one week after the final consultation
Length of Hospital Stay
Time frame: 1 day (at discharge)
Survival to Discharge Rate
Time frame: 1 day (at discharge)
Days of Symptom Relief Treatments received in the ICU
Time frame: 1 day (at discharge)
Proportion of Patients receiving Symptom Relief Treatments During the ICU stay
Time frame: 1 day (at discharge)
Use of Life-Sustaining Procedures within 48 Hours before Death
Time frame: 1 day (at discharge)
Use of Symptom Relief Treatments within 48 Hours before Death
Time frame: 1 day (at discharge)
Data Collection Completion Rate
Time frame: Within three months after the final consultation
Time Taken to Recruit Patients
Time frame: Within the first year of study initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Derived from this study: PubMed 40441768Jeung 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.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
Not yet recruitingObservational study
Targeted Antimicrobial Comparison for Treatment Individualization in Critically Ill Patients With CRAB Infection
Carbapenem-Resistant Acinetobacter Baumannii Infection
Not yet recruitingObservational study
Effect of Filter Lifespan in CRRT on New Infections in Critically Ill Patients With AKI
Acute Kidney Injury
Recruiting
Effectiveness of Virtual Reality in Improving Upper Limb Function in Critically Ill Patients
Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), Critical Illness
RecruitingObservational study
Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients
Severe Pneumonia
Active, not recruitingObservational study
Adverse Events During Physical Therapy in Neurocritical ICU Patients
Critical Illness, Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shin Hye Yoo principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-quality palliative care through consultation-based palliative care services in the ICU in people with Critical Illness, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shin Hye Yoo (+82-2-2072-1589, ifi1024@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Applying Consultation-Based High-Quality Palliative Care (time frame: 1 day (at discharge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.