| Protocol ID | NCT02955563 |
| Registration Date | 2016-11-04 |
| Status | completed |
| Sponsor | University of Pittsburgh |
| Country | United States |
| Industry | not industry |
| Blinding | blinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2017-05-01 |
| Last Patient Out | 2019-05-16 |
| Publication | n |
| Gender % | ALL |
| Mean Age | 18 Years - |
NCT02955563
CSDM: A Trial to Improve Communication and Shared Decision Making Using a Web-Based Tool
| Field |
GLM
glm-5.1 7534ms / 9394 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 4956ms / 10655 tok |
OPENAI
gpt-4o Thinking: o3 2775ms / 9228 tok |
Review |
|---|---|---|---|---|
| rct_type | parallel RCT | parallel RCT | parallel RCT | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec |
N/A
N/A
shaky reasoning✓ Unanimous
Initial: N/A
|
N/A
early palliative care → N/A → N/A
shaky reasoning✓ Unanimous
Initial: early palliative care
Requery: N/A — This study focuses on ICU patients with mixed critical illnesses rather than a specific non-cancer condition, and the population is too general to classify into a specific category.
Thinking: N/A — The study targets general ICU patients at high risk of death without specifying particular non-cancer diseases, making the population too mixed/heterogeneous.
|
N/A
N/A → early palliative care → N/A
shaky reasoning✓ Unanimous
Initial: N/A
Requery: early palliative care — The study focuses on improving surrogate decision making in ICU settings for incapacitated patients at high risk of death, a scenario that demands early integration of palliative care without being disease-specific.
Thinking: N/A — The study involves a broad mixed population of critically ill ICU patients without focusing on a specific non-cancer disease category or early palliative care integration.
|
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 | no | OK |
| intervention_complex | no | no | no | OK |
| intervention_acp |
no
no → no
shaky reasoning✗ No consensus
Initial: no
Requery: no — The trial focuses on a web-based decision support tool to improve communication and shared decision making for surrogates, without specifying structured Advance Care Planning components such as advance directives, POLST, or specific ACP methodologies as a core part of the intervention.
|
yes
yes → yes → no
shaky reasoning✗ No consensus
Initial: yes
Requery: yes — The web-based tool specifically helps surrogates learn how to make values-based decisions for their incapacitated loved ones and prepares them for family meetings about goals of care, which are core components of advance care planning focused on honoring patient preferences and values.
Thinking: no — The intervention is a decision support tool for surrogates during ICU care, not formal advance care planning with structured goals-of-care conversations or advance directives.
|
no
no → no → yes
shaky reasoning✗ No consensus
Initial: no
Requery: no — The trial focuses on improving communication and decision-making for surrogates using a web-based tool without specific emphasis on advance care planning as a core component.
Thinking: yes — Web-based tool explicitly prepares surrogates for ICU goals-of-care discussions and making values-based treatment decisions, i.e., structured advance care planning.
|
|
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
no
shaky reasoning✓ Unanimous
Initial: no
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a web-based communication and decision-making tool for ICU surrogates, not palliative care consultation or service delivery itself.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The intervention focuses on a web-based tool to improve communication and decision-making in ICU settings, not palliative care itself.
|
OK |
| intervention_education | yes | yes | yes | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other | no | no | no | OK |
| outcome_symptom | yes | yes | yes | OK |
| outcome_qol |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The trial measures anxiety, depression, PTSD, grief, communication quality, and satisfaction using scales such as HADS and IES, which are symptom-specific or psychosocial measures rather than validated quality of life instruments like the SF-36 or EQ-5D.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study measures anxiety, depression, and PTSD symptoms using HADS and IES scales, but does not include any validated quality of life instruments like EORTC QLQ-C30, FACT-G, EQ-5D, SF-36, or WHOQOL.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The trial does not use any validated Quality of Life instruments; it focuses on communication, decision-making, and psychological outcomes.
|
OK |
| outcome_dignity | no | no | no | OK |
| outcome_cost | yes | yes | yes | OK |
| outcome_other | yes | yes | yes | OK |
| pharmacologic_sub | N/A | N/A | N/A | OK |