| Protocol ID | NCT04257760 |
| Registration Date | 2020-02-06 |
| Status | completed |
| Sponsor | Ottawa Hospital Research Institute |
| Country | Canada |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-10-08 |
| Last Patient Out | 2022-10-30 |
| Publication | n |
| Gender % | ALL |
| Mean Age | – |
NCT04257760
Understanding Palliative Care and End of Life Needs in the ALS Population: The First Step to Improving Patient and Caregiver Quality of Life
| Field |
GLM
glm-5.1 8011ms / 11366 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5808ms / 12940 tok |
OPENAI
gpt-4o Thinking: o3 7830ms / 11184 tok |
Review |
|---|---|---|---|---|
| rct_type |
N/A
parallel RCT → N/A
shaky reasoning✓ Unanimous
Initial: parallel RCT
Requery: N/A — The study design is explicitly listed as 'Allocation: NON_RANDOMIZED' and allows participants to choose whether to receive the palliative care consultation.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — This study has non-randomized allocation where patients choose whether or not to receive palliative care consultation, making it an observational study rather than a randomized controlled trial.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The trial is non-randomized according to the study details and allocation, hence no randomization design is described.
|
OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | neurodegenerative | neurodegenerative | neurodegenerative | OK |
| setting_patient |
outpatient
outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The palliative care consultation takes place in the patient's location of choice, frequently at home or at the ALS clinic, indicating they are not hospitalized.
|
outpatient
mixed → outpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: outpatient — The palliative care consultations are delivered in the patient's location of choice (often the patient's home) or at the ALS clinic, with patients maintaining their usual living arrangements rather than being admitted to a hospital.
|
outpatient
outpatient → outpatient
shaky reasoning✓ Unanimous
Initial: outpatient
Requery: outpatient — The palliative care consultations are conducted at home or in the ALS clinic, indicating an outpatient setting.
|
OK |
| setting_place |
home care
home care → other
shaky reasoning✗ No consensus
Initial: home care
Requery: other — The palliative care consultations take place at an outpatient ALS clinic or the patient's home, and since the setting is mixed between the clinic and home care, the primary delivery location defaults to 'other' for multi-site/mixed outpatient settings.
|
other
other → home care → other
shaky reasoning✗ No consensus
Initial: other
Requery: home care — The intervention explicitly states palliative care consultations will occur at the patient's location of choice, often the patient's home, making this a home care delivery setting.
Thinking: other — The palliative care consultations are delivered either at the outpatient ALS clinic or at the patient's home based on patient preference, making this a mixed/flexible delivery setting.
|
other
other → home care → home care
shaky reasoning✗ No consensus
Initial: other
Requery: home care — The intervention is delivered through palliative care consultations often occurring at the patient's home.
Thinking: home care — Palliative care consultations are delivered at the patient’s chosen location, most commonly the patient’s own home rather than an inpatient unit.
|
|
| feasibility |
feasibility RCT
feasibility RCT → feasibility RCT
shaky reasoning✗ No consensus
Initial: feasibility RCT
Requery: feasibility RCT — The trial explicitly states it is 'the first to investigate the feasibility' of the intervention, tracks process outcomes like recruitment and consultation rates, and describes itself as a foundation for larger controlled studies despite having clinical outcomes and an enrollment of 66.
|
fully powered RCT
fully powered RCT → fully powered RCT → fully powered RCT
shaky reasoning✗ No consensus
Initial: fully powered RCT
Requery: fully powered RCT — This is designed as an interventional clinical effectiveness study with 66 participants comparing early palliative care to standard care, with primary outcomes focused on quality of life differences between arms rather than feasibility metrics.
Thinking: fully powered RCT — Study has n=66 enrollment with primary outcomes focused on clinical effectiveness measures (quality of life, anxiety, depression) rather than feasibility metrics.
|
fully powered RCT
fully powered RCT → N/A → N/A
shaky reasoning✗ No consensus
Initial: fully powered RCT
Requery: N/A — The study describes an interventional trial but lacks randomization and focuses on understanding palliative care needs rather than measuring recruitment, retention, or clinical effectiveness, suggesting it's not an RCT.
Thinking: N/A — The study is interventional but non-randomized, therefore it is not an RCT.
|
|
| 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 | no | no | no | 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 | OK |
| outcome_qol | yes | yes | yes | OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | no | no | no | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |