Post-Intensive Care Syndrome
Conditions
Brief summary
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: * Does the intervention (optimized program + LLMs) improve physical, psychological, cognitive, and social function recovery compared to standard care or the optimized program alone? * How do patients experience and perceive the utility of LLMs in PICS self-management during recovery? Researchers will compare three groups: 1. Group A (routine care) 2. Group B (optimized program without LLMs) 3. Group C (optimized program + LLMs) to see if adding LLMs significantly enhances PICS symptom management, patient self-efficacy, and quality of life over 6 months post-discharge. 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: * PICS Symptom Questionnaire (PICSQ) * Pittsburgh Sleep Quality Index (PSQI) * Anxiety (GAD-7) and Depression (PHQ-9) scales * Self-Management Ability Scale (AHSMSRS) * Attend semi-structured interviews (Group C only) at 3 and 6 months to share experiences with LLM use.
Interventions
BEHAVIORALRoutine Care
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.
BEHAVIORALHealth Promotion Model-Based Optimized Program
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 .
BEHAVIORALLLM-Enhanced Optimized Program
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 .
Sponsors
The Affiliated Hospital Of Guizhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* ICU hospitalization duration \> 24 hours. * Age ≥ 18 years. * Conscious at ICU discharge, able to communicate without barriers. * Provide informed consent to participate. * Regular access to and usage of smart electronic devices.
Exclusion criteria
* Previous ICU admission (≥24h) within 3 months before the current hospitalization. * Transferred to another ICU during the current hospitalization. * Pre-existing cognitive impairment (Blessed Dementia Rating Scale \[BDRS\] score \>4 before ICU admission). * Severe communication barriers: Hearing impairment Dysarthria Other conditions preventing follow-up assessments. * Critically unstable condition preventing questionnaire completion. * Infrequent/no experience using smart electronic devices (e.g., smartphones, tablets).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-Intensive Care Syndrome (PICS) Symptom Severity | Measured at baseline (pre-discharge), 1 month, 3 months, and 6 months post-discharge. | \- 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. * Total score of the Pittsburgh Sleep Quality Index (PSQI). Scoring: 7 components × 0-3 points = 0-21 total; higher scores = poorer sleep. * Recall experiences measured by the Chinese ICU Memory Tool (ICUMT). Format: 14-item mixed open/closed questions about ICU admission, treatment, and discharge memories. * Anxiety: GAD-7 score (0-21; higher = worse anxiety). Depression: PHQ-9 score (0-27; higher = worse depression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Management Ability | 1m, 3m, 6m post-discharge. | \- 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. |
| Patient Experience with LLMs | 3 months and 6 months post-discharge (Group C only). | Qualitative insights from semi-structured interviews based on the Technology Acceptance Model (TAM). |
Countries
China
Outcome results
None listed