| Protocol ID | NCT06490835 |
| Registration Date | 2024-07-08 |
| Status | recruiting |
| Sponsor | Seoul National University Hospital |
| Country | South Korea |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2024-06-19 |
| Last Patient Out | 2025-12-31 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 19 Years - |
NCT06490835
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
| Field |
CLAUDE
claude-sonnet-4-20250514 5575ms / 11673 tok |
GLM
glm-5.1 11873ms / 10227 tok |
OPENAI
gpt-4o Thinking: o3 2671ms / 10070 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | inpatient | inpatient | inpatient | OK |
| setting_place | hospital | hospital | hospital | OK |
| feasibility | feasibility RCT | feasibility RCT | feasibility RCT | OK |
| intervention_pharmacologic | no | no | no | OK |
| intervention_chemo_immuno_radio | no | no | no | OK |
| intervention_complementary | no | no | no | OK |
| intervention_device | no | no | no | OK |
| intervention_psychological | no |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention consists of general supportive counseling, family meetings, and consultations for palliative care, which do not meet the criteria for a structured or named psychological therapy.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial focuses on multidisciplinary palliative care support, including family counseling and support meeting facilitation but does not specify a named or structured psychological therapeutic approach like CBT or psychotherapy.
|
OK |
| intervention_complex | yes |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention integrates multiple interacting components across different categories, including psychological support (family counseling), educational/organizational facilitation (family meetings), and medical consultation (symptom management, goal of care) delivered by a multidisciplinary palliative care team.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention combines palliative care consultations (behavioral/psychological) with family counseling (educational/supportive), indicating multiple interacting components from different categories.
|
OK |
| intervention_acp | yes |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention includes 'goal of care setting' and family meeting support to reduce communication conflicts and respect patient values, which constitutes advance care planning.
|
yes
no → no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention focuses on consultation-based palliative care services without specific mention of Advance Care Planning as a core component.
Thinking: yes — The consultation-based palliative care service centrally provides family meetings and counseling focused on goals-of-care and decisional support, making structured advance care planning a core part of the intervention.
|
OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education | no | no | no | OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The secondary and other outcomes include the Hospital Anxiety and Depression Scale (HADS), which is a validated instrument for measuring anxiety and depression symptoms.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study measures surrogates' emotional state using the Hospital Anxiety and Depression Scale (HADS), which is a validated tool for assessing symptoms of anxiety and depression.
|
OK |
| outcome_qol | no | no | no | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes |
yes
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The study measures length of stay as a clinical outcome without framing it in terms of cost analysis, healthcare utilization, or resource use.
|
yes
no → yes → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial measures length of hospital stay, which can be a proxy for cost analysis.
Thinking: yes — It measures ICU and hospital length of stay, a recognized proxy for healthcare resource use.
|
OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |