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The goal of this clinical trial is to evaluate whether Large Language Models (LLMs) combined with an optimized care program can effectively manage Post-Intensive Care Syndrome (PICS) in adult ICU survivors (aged ≥18 years) discharged from a tertiary hospital in China. The main questions it aims to answer are:
Researchers will compare three groups:
Participants will:
Install and use the Kimi Smart Assistant LLM (Group C only) for health queries under nurse supervision.
Complete standardized questionnaires at discharge (baseline), 7 days, 1 month, 3 months, and 6 months post-discharge:
Attend semi-structured interviews (Group C only) at 3 and 6 months to share experiences with LLM use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Care Group | Other | Participants receive standard post-ICU follow-up care according to hospital protocols . This includes routine health assessments and general rehabilitation guidance at designated intervals (discharge, 7 days, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided. |
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| Optimized Program Group | Other | Participants receive an evidence-based, optimized PICS management program developed using the Health Promotion Model (HPM). This includes personalized rehabilitation plans, psychological support, and education tailored to PICS symptoms. Interventions are delivered by clinical staff at discharge, 7 days, and 1/3/6 months post-discharge. No AI/LLM technology is used. |
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| Optimized Program + LLMs Group | Other | Participants receive the same optimized PICS program as Group B, enhanced with Large Language Models (LLMs). Key components: Personalized AI-generated plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create monthly rehabilitation plans, reviewed by a multidisciplinary expert team. LLM access: Installation of "Kimi Smart Assistant" for daily health queries. Safety protocols: Patients must validate LLM advice with nurses via WeChat before use . Phased intervention: Pre-discharge: LLM training + baseline plan generation. 1 month: Plan updates based on new data. 3/6 months: Plan updates + semi-structured interviews about LLM experience. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine Care | Behavioral | Participants receive standard post-ICU follow-up care according to hospital protocols . This includes routine health assessments and general rehabilitation guidance at designated intervals (discharge, 1/3/6 months post-discharge). No structured PICS management program or AI technology is provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Post-Intensive Care Syndrome (PICS) Symptom Severity | - Total score of the Chinese Version of the Post-Intensive Care Syndrome Questionnaire (PICSQ). Domains: Physical function (6 items), cognitive impairment (6 items), psychological symptoms (6 items). Scoring: 18 items × 0-3 points = 0-54 total; higher scores = worse symptoms.
| Measured at baseline (pre-discharge), 1 month, 3 months, and 6 months post-discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Management Ability | - Total score of the Adults Health Self-Management Ability Rating Scale (AHSMSRS). Scoring: 38 items × 1-3 points = 38-114 total; higher scores = poorer self-management. | 1m, 3m, 6m post-discharge. |
| Patient Experience with LLMs |
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Inclusion Criteria:
Exclusion Criteria:
Hearing impairment Dysarthria Other conditions preventing follow-up assessments.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550004 | China |
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| Health Promotion Model-Based Optimized Program | Behavioral | An evidence-based, multidisciplinary rehabilitation protocol for Post-Intensive Care Syndrome (PICS) management, developed using the Health Promotion Model (HPM). It includes: Personalized rehabilitation plans addressing physical, cognitive, and psychological recovery. Structured follow-up at discharge, 1/3/6 months post-discharge. Components: Physical function training, cognitive exercises, anxiety/depression coping strategies, and sleep hygiene education. Delivery: Clinician-guided (no AI/technology involved). Developed via literature review and validated by ICU physicians and nursing experts . |
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| LLM-Enhanced Optimized Program | Behavioral | Combines the HPM-Based Optimized Program with Large Language Model (LLM) technology for dynamic personalization: AI-generated rehabilitation plans: ChatGPT-4 synthesizes patient data (baseline + follow-ups) to create/update monthly plans, reviewed by a multidisciplinary expert team. Patient-facing LLM tool: "Kimi Smart Assistant" installed for daily health queries under strict safety protocols (all outputs validated by nurses via WeChat). Phased implementation: Pre-discharge: LLM training + baseline plan generation. 1/3/6 months: Plan updates + outcome tracking. 3/6 months: Semi-structured interviews on LLM experience. Includes LLM usage guidelines and expert validation safeguards . |
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Qualitative insights from semi-structured interviews based on the Technology Acceptance Model (TAM). |
| 3 months and 6 months post-discharge (Group C only). |
| ID | Term |
|---|---|
| C000657744 | postintensive care syndrome |
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