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

Extracted Fields (from Registry)
Protocol IDNCT06490835
Registration Date2024-07-08
Statusrecruiting
SponsorSeoul National University Hospital
CountrySouth Korea
Industrynot industry
Blindingunblinded
Center Typesingel-center RCT
Scopenational RCT
First Patient In2024-06-19
Last Patient Out2025-12-31
Publicationn
Gender %ALL
Mean Age19 Years -
LLM Classifications (Side-by-Side)
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
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