| Protocol ID | NCT02281032 |
| Registration Date | 2014-11-03 |
| Status | Unknown Status |
| Sponsor | KU Leuven |
| Country | Belgium |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2013-11-01 |
| Last Patient Out | 2015-02-01 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 65 Years - |
NCT02281032
Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument: A Study Protocol Based on the Medical Research Council Framework
| Field |
GLM
glm-5.1 6537ms / 9085 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 9637ms / 10346 tok |
OPENAI
gpt-4o Thinking: o3 3215ms / 8941 tok |
Review |
|---|---|---|---|---|
| rct_type |
N/A
parallel RCT → N/A
shaky reasoning✓ Unanimous
Initial: parallel RCT
Requery: N/A — The allocation is explicitly listed as NON_RANDOMIZED and the methodology describes a quasi-experimental design.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — This study uses quasi-experimental design with non-randomized allocation, not a randomized controlled trial.
|
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study uses a quasi-experimental pretest-posttest design with non-randomized allocation, indicating no randomization design is described.
|
OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec |
N/A
N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study population consists of general nursing home residents with palliative care needs without restriction to a specific non-cancer disease category, making the population too mixed/general.
|
N/A
N/A → N/A → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: N/A — The study targets nursing home residents with general palliative care needs (mixed population) rather than focusing on a specific disease category or early palliative care integration.
Thinking: N/A — The study targets a mixed population of nursing home residents with palliative care needs regardless of specific diagnosis, making it too general to classify into a specific non-cancer category.
|
N/A
early palliative care → early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: early palliative care — The study focuses on integrating palliative care for nursing home residents in a non-specific, disease-agnostic manner, aligning with early palliative care principles.
Thinking: N/A — Population is a mixed, disease-agnostic group of nursing-home residents already identified as having palliative care needs, without focus on early integration or a specific non-cancer disease category.
|
OK |
| setting_patient |
inpatient
inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
|
inpatient
inpatient → inpatient
shaky reasoning✓ Unanimous
Initial: inpatient
Requery: inpatient — The study involves nursing home residents, who are admitted/residing in the facility and receive continuous care, making this an inpatient setting.
|
inpatient
mixed → inpatient
shaky reasoning✓ Unanimous
Initial: mixed
Requery: inpatient — The intervention is delivered to nursing home residents, which are typically considered an inpatient setting as they involve residing in the facility.
|
OK |
| setting_place | nursing home | nursing home | nursing home | OK |
| feasibility |
feasibility RCT
feasibility RCT → N/A
shaky reasoning✗ No consensus
Initial: feasibility RCT
Requery: N/A — The study employs a quasi-experimental design with quasi-random (non-randomized) allocation rather than a true randomized controlled trial (RCT).
|
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 a quasi-experimental pretest-posttest design with n=172 participants designed to evaluate the effect of an intervention on quality of palliative care as the primary outcome, representing a fully powered effectiveness study rather than a feasibility trial.
Thinking: fully powered RCT — The study has 172 participants and primary outcome focused on clinical effectiveness (quality of palliative care) rather than feasibility metrics.
|
feasibility RCT
feasibility RCT → N/A → N/A
shaky reasoning✗ No consensus
Initial: feasibility RCT
Requery: N/A — The study is quasi-experimental, not a randomized controlled trial, and it focuses on evaluating the interRAI PC in nursing homes.
Thinking: N/A — The study uses a non-randomized quasi-experimental design, so 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 | yes | yes | yes | OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | yes | yes | yes | OK |
| intervention_palliative | yes | yes | yes | OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The trial uses the Palliative care Outcome Scale (POS) as a primary outcome measure, which is a validated instrument that assesses symptoms like pain and dyspnea.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome uses the Palliative care Outcome Scale (POS), which is a validated instrument that measures multiple symptoms including pain, nausea, anxiety, depression, and other symptom-related concerns in palliative care patients.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study uses the Palliative care Outcome Scale (POS), which is a symptom burden scale to evaluate the quality of palliative care, indicating it measures symptoms directly.
|
OK |
| outcome_qol |
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study uses the Palliative care Outcome Scale (POS), which includes quality of life domains and is listed in the guidance as a valid QoL instrument.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The primary outcome uses the Palliative care Outcome Scale (POS), which is a validated quality of life instrument specifically designed for palliative care settings.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The study evaluates the quality of palliative care using the Palliative care Outcome Scale (POS), which includes quality of life domains.
|
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 |