| Protocol ID | NCT04490278 |
| Registration Date | 2020-07-29 |
| Status | completed |
| Sponsor | Washington University School of Medicine |
| Country | United States |
| Industry | not industry |
| Blinding | unblinded |
| Center Type | singel-center RCT |
| Scope | national RCT |
| First Patient In | 2020-09-29 |
| Last Patient Out | 2021-06-30 |
| Publication | y |
| Gender % | ALL |
| Mean Age | 18 Years - 100 Years |
NCT04490278
COVID-19 Virtual Post Intensive Care Syndrome (CoV-PICS) Clinic: Modern, Convenient and Practical Recovery Care
| Field |
OPENAI
gpt-4o Thinking: o3 3918ms / 9240 tok |
GLM
glm-5.1 8806ms / 9409 tok |
CLAUDE
claude-sonnet-4-20250514 Thinking: claude-opus-4-20250514 5205ms / 10763 tok |
Review |
|---|---|---|---|---|
| rct_type | N/A | N/A | N/A | OK |
| cancer_status | non-cancer | non-cancer | non-cancer | OK |
| non_cancer_spec | N/A | N/A | N/A | OK |
| setting_patient | outpatient | outpatient | outpatient | OK |
| setting_place |
home care
home care → other → home care
shaky reasoning✓ Unanimous
Initial: home care
Requery: other — The intervention is delivered through a telehealth-only virtual clinic, not requiring patients to be in a specific location like a hospital or hospice, fitting the 'other' category.
Thinking: home care — Intervention consists of telehealth virtual clinic visits and online questionnaires completed by patients at home after hospital discharge.
|
home care
other
shaky reasoning✓ Unanimous
Initial: other
|
home care
home care → home care → home care
shaky reasoning✓ Unanimous
Initial: home care
Requery: home care — This is a virtual telehealth clinic delivered to patients in their homes via internet connection or smartphone.
Thinking: home care — The intervention is delivered entirely via telehealth to patients at home through virtual visits and online questionnaires, requiring home internet/smartphone access.
|
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 → yes → no
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The intervention combines telehealth consultations, medical record reviews, and multiprofessional evaluations to create a comprehensive treatment plan, representing a multi-component approach involving both medical and organizational elements.
Thinking: no — Telehealth PICS clinic is a single supportive/organizational intervention (virtual assessment plus care plan) rather than two distinct modality types.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a single-modality supportive care model that evaluates a virtual clinic using medical record reviews and online questionnaires as part of a standard telehealth visit.
|
no
yes → no → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — This is a single-modality telehealth intervention that evaluates virtual clinic visits and questionnaires, without combining distinct intervention types from different categories.
Thinking: no — This is a single-modality virtual clinic service where record review and questionnaires are assessment tools within the clinical consultation process, not separate interacting interventions.
|
OK |
| intervention_acp | no | no | no | OK |
| intervention_music | no | no | no | OK |
| intervention_screening | no | no | no | OK |
| intervention_palliative |
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The intervention is a virtual clinic for COVID-19 recovery, not a palliative care consultation or service.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This study evaluates a virtual post-ICU recovery clinic for COVID-19 survivors, which is a supportive aftercare model rather than a specific palliative care consultation or service intervention.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — This study evaluates a virtual post-ICU care clinic delivery model, not palliative care consultation or services as the intervention.
|
OK |
| intervention_education | no | no | no | OK |
| intervention_digital | yes | yes | yes | OK |
| intervention_other |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The intervention involves a virtual post-ICU syndrome clinic focusing on medical record review and online questionnaires, fitting as an organizational change and telehealth service, not listed in the specified categories.
|
yes
no
shaky reasoning✓ Unanimous
Initial: no
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — This intervention involves organizational/care delivery changes through implementation of a virtual telehealth clinic model for post-ICU care, which does not fit the pharmacologic, device, psychological, education, or other specified categories.
|
OK |
| outcome_symptom |
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial includes symptom measures related to Post Intensive Care Syndrome (PICS), specifically assessing symptoms like cognitive function, nutrition risk which includes symptoms, and memory using validated instruments such as the Montreal Cognitive Assessment (MoCA) and PG-SGA.
|
yes
yes → yes
shaky reasoning✓ Unanimous
Initial: yes
Requery: yes — The trial assesses symptoms using the ICU Memory Tool (intrusive memories, panic) and the Patient-Generated Subjective Global Assessment (PG-SGA), which includes an evaluation of nutritional-impact symptoms such as nausea and appetite.
|
yes
no → yes
shaky reasoning✓ Unanimous
Initial: no
Requery: yes — The study includes secondary outcomes measuring Post Intensive Care Syndrome (PICS) symptoms including nutrition-related symptoms via the Scored Patient-Generated Subjective Global Assessment (PG-SGA) which assesses symptoms and their impact, and memory/psychological symptoms via the ICU Memory Tool measuring delusional memories, panic feelings, and intrusive memories.
|
OK |
| outcome_qol |
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The clinical trial does not use any validated quality of life instrument like EORTC QLQ-C30, FACT-G, or EQ-5D; the outcomes focus on symptom assessments and daily living activities, which are not classified as quality of life measures.
|
no
yes → no
shaky reasoning✓ Unanimous
Initial: yes
Requery: no — The outcomes focus on acceptability/feasibility measures (AIM, IAM, FIM), functional independence (Katz ADL), cognitive screening (MoCA), nutritional status (PG-SGA), and ICU memory, none of which are validated quality of life instruments.
|
no
no → no
shaky reasoning✓ Unanimous
Initial: no
Requery: no — The study measures acceptability, feasibility, symptoms, cognitive function, activities of daily living, nutrition, and memory but does not use any validated quality of life instruments like EORTC QLQ-C30, FACT-G, SF-36, or EQ-5D.
|
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 |