NCT07366021

✓ Unanimous Initial: parallel RCT Requery: N/A — The Allocation field explicitly states 'NON_RANDOMIZED', meaning there is no randomization design described.

✓ Unanimous Initial: N/A Requery: N/A — The study has Allocation='NON_RANDOMIZED' and uses parallel assignment, indicating this is a non-randomized controlled trial rather than a randomized controlled trial.

✓ Unanimous Initial: N/A Requery: N/A — The study describes a non-randomized allocation, thus no randomization design is described.

✓ Unanimous Initial: no

✓ Unanimous Initial: yes Requery: no — This is a behavioral intervention testing a comfort care bundle delivered by ICU nurses to improve patient comfort, not a palliative care consultation or service delivery intervention.

✓ Unanimous Initial: no Requery: no — The intervention tested is a Comfort Care Package specifically designed to improve ICU patient comfort, not a palliative care service or consultation.

✓ Unanimous Initial: yes Requery: no — The 'Comfort Care Bundle' intervention includes psychological (psychospiritual) support, environmental modifications, and organizational nursing care plans, fitting into the psychological and complex categories.

✓ Unanimous Initial: no Requery: yes — The comfort care bundle intervention involves organizational changes to nursing care delivery and environmental modifications that do not fit into the specified intervention categories of pharmacologic, device, psychological, complementary, digital, education, screening, palliative, ACP, music, chemo/immuno/radio, or complex interventions. Thinking: no — This is a complex multicomponent intervention bundle combining physical, psychospiritual, environmental, and sociocultural comfort measures.

✓ Unanimous Initial: no Requery: yes — The intervention involves a comfort care bundle that includes physical, psychosocial, environmental, and sociocultural comfort interventions, which do not fit any specified categories such as pharmacologic, device, or digital. Thinking: no — The comfort care bundle is a multi-component nursing care package, fitting the defined “complex” intervention category rather than an uncategorized residual type.

✓ Unanimous Initial: no

✓ Unanimous Initial: yes Requery: yes — The primary outcome measures comfort using the Comfort Behaviors Checklist, which assesses behavioral indicators of comfort/discomfort and includes pain assessment as specified in the intervention description. Thinking: yes — The Comfort Behaviors Checklist includes digital scoring of pain as part of the comfort assessment.

✓ Unanimous Initial: no Requery: no — The study focuses on patient comfort and physiological parameters, not on specific symptom measures like pain, nausea, or psychological symptoms using validated instruments. Thinking: yes — The primary outcome uses the Comfort Behaviors Checklist to directly measure patients’ comfort level, which constitutes assessment of a symptom experience.

✓ Unanimous Initial: yes

✓ Unanimous Initial: no

✓ Unanimous Initial: yes Requery: no — All outcomes focus on improving patient comfort and symptom management in the ICU, which fall under symptom/QoL/cost categories.