| Protocol ID | NCT03958552 |
| Registration Date | 2019-05-22 |
| Status | completed |
| Sponsor | University of Maryland, Baltimore |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2019-10-01 |
| Last Patient Out | 2022-12-31 |
| Publication | y |
| Gender % | ALL |
| Mean Age | 60 Years - |
NCT03958552
Palliative Care Consultations for Persons in the Medicare Skilled Nursing Facility (SNF) Setting
| Field |
GLM
glm-5.1 11531ms / 9029 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4723ms / 10266 tok |
OPENAI
gpt-4o Thinking: o3 4905ms / 8857 tok |
Review |
|---|---|---|---|---|
| rct_type |
N/A
parallel RCT → N/A
shaky reasoning✓ Unanimous
Initial: parallel RCT
Requery: N/A — The study design is explicitly non-randomized, as indicated by 'Allocation: NON_RANDOMIZED', meaning it is not an RCT.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study uses non-randomized allocation, with participants being assigned to groups rather than randomly allocated to interventions.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The trial specifies an allocation as 'NON_RANDOMIZED', therefore it does not fit into any randomized control trial category.
|
OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec |
N/A
early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: N/A — The study population includes older adults with general advanced serious illnesses in a skilled nursing facility, making it too mixed to classify into a specific organ system or non-cancer disease category.
|
N/A
N/A → N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study targets older adults in skilled nursing facilities with mixed advanced serious illnesses and general palliative care needs, making the population too general and mixed to classify into a specific non-cancer category.
Thinking: N/A — The study targets Medicare SNF patients with advanced serious illness without specifying particular diseases, making the non-cancer population too general/mixed.
|
N/A
N/A → early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: early palliative care — The study focuses on integrating palliative care early in the SNF setting for patients with serious, life-limiting illnesses, without specifying a single disease category.
Thinking: N/A — The trial involves a mixed population of SNF residents with assorted serious illnesses, not one specific non-cancer disease or an explicitly early, disease-agnostic palliative-care model.
|
OK |
| setting_patient | inpatient | inpatient | inpatient | OK |
| setting_place | nursing home | nursing home | nursing home | 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 | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp | yes | yes | yes | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention is palliative care consultation focused on clinical care (discussing illness trajectories, establishing goals, treating symptoms, addressing psycho-spiritual needs) rather than primarily educational or training activities.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The primary intervention is palliative care consultation focused on improving care through communication and symptom management, not primarily educational or training.
|
OK |
| intervention_digital | no | no | no | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
yes
yes
shaky reasoning✓ Unanimous
Initial: yes
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome uses the Patient Outcome Survey (POS) which measures quality of life in multiple dimensions including physical symptoms, and the study specifically mentions identifying and treating illness-related symptoms as part of the intervention.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The primary outcome includes the Patient Outcome Survey (POS) which measures physical symptoms among other dimensions.
|
OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity |
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome measure Patient Outcome Survey (POS) specifically includes spiritual needs as one of its five dimensions, which directly relates to dignity and existential well-being.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The primary outcomes measure includes spiritual needs assessment, which addresses existential and spiritual themes, thus aligning with the dignity outcome criteria.
|
OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |