Integrated Recovery Program for Critical Illness
- Conditions
- ICU Survivors
- Registration Number
- NCT06997822
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
This study aims to investigate the effects of the Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) program on reducing healthcare burden and improving functional outcomes in ICU survivors. The I-CARE program combines remote support via LINE Bot Care with in-person post-ICU recovery clinic visits. The study will assess whether this integrated care model reduces unplanned hospital readmissions and emergency department visits within six months after discharge, and improves physical and cognitive outcomes at 3 and 6 months post-discharge. Additionally, the study will evaluate the impact of a built-in patient-nurse interaction feature on ICU nurses' burnout and intention to leave, measured every six months over a two-year period.
- Detailed Description
This randomized clinical trial is designed to evaluate the effectiveness of the Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) program for survivors of critical illness discharged from the intensive care unit (ICU). The I-CARE program integrates a LINE Bot-based remote monitoring and support system with structured, in-person post-ICU recovery clinic visits. The primary objective is to determine whether this comprehensive care model can reduce the incidence of unplanned hospital readmissions and emergency department visits within six months after hospital discharge.
Secondary outcomes focus on functional recovery and include assessments of physical mobility (e.g., ability to transition from sit to stand), inspiratory muscle strength, body weight changes, presence of dysphagia, and cognitive function at 3 and 6 months post-discharge.
In addition, the LINE Bot Care system incorporates an interactive feature titled "Thanks to Nurses," which enables ICU survivors to share personal reflections, such as short messages, photos, diary entries, stickers, and audio clips, with their ICU care team. This bidirectional communication channel is intended to enhance emotional support and foster a sense of connection between patients and healthcare providers. The study will evaluate the impact of this feature on ICU nurses' professional well-being, specifically measuring levels of burnout and intention to leave the profession at 6, 12, 18, and 24 months after implementation, using a pre-post intervention design.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 240
- ICU survivors who had experienced endotracheal intubation and mechanical ventilation treatment.
- ICU survivors who are unable to walk independently before admission
- ICU survivors who are unable to receive assessment (e.g., dementia or mental retardation)
- ICU survivors who don't have a smartphone.
- ICU survivors were discharged to institutional care facilities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of unplanned hospital readmissions 1, 2, 3, 4, 5, and 6 months after discharge Incidence of emergency department visits 1, 2, 3, 4, 5, and 6 months after discharge
- Secondary Outcome Measures
Name Time Method Barthel Index Immediately after ICU discharge and 0, 3, and 6 months after discharge The Barthel Index is a validated instrument used to assess functional independence in activities of daily living (ADLs). It evaluates a person's ability to perform ten basic self-care and mobility tasks, such as feeding, bathing, dressing, grooming, bowel and bladder control, toileting, chair/bed transfers, ambulation, and stair climbing. Scores range from 0 to 100, with higher scores indicating greater independence.
Maximal inspiratory pressure Immediately after ICU discharge and 0, 3, and 6 months after discharge Maximal Inspiratory Pressure (MIP) is a measure of respiratory muscle strength, specifically the strength of the diaphragm and other inspiratory muscles. It is assessed by having the individual inhale as forcefully as possible against an occluded airway, typically measured in centimeters of water pressure (cmH₂O). MIP is a key indicator of ventilatory muscle function and is commonly used in critical care, pulmonary rehabilitation, and neuromuscular disease assessment.
Grip strength Immediately after ICU discharge and 0, 3, and 6 months after discharge Grip strength is a simple and reliable measure of overall muscle strength, particularly of the upper extremities. It is commonly used as a proxy for general physical function and is strongly associated with mobility, nutritional status, and overall health outcomes. Lower grip strength has been linked to increased risk of disability, hospitalization, and mortality.
Confusion assessment methods Immediately after ICU discharge and 0, 3, and 6 months after discharge The Confusion Assessment Method (CAM) is a widely used, validated tool for the detection of delirium in clinical settings. It allows non-psychiatric clinicians to identify delirium quickly and accurately based on four key diagnostic features: (1) Acute onset and fluctuating course; (2) Inattention; (3) Disorganized thinking; (4) Altered level of consciousness. A diagnosis of delirium using CAM requires the presence of features 1 and 2, plus either feature 3 or 4.
Body weight Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge Body weight refers to the total mass of an individual and is typically measured in kilograms (kg) using a calibrated digital or mechanical scale. It is a key parameter in clinical assessments, nutritional evaluations, and outcome monitoring.
Calf circumference Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge Calf circumference is a simple and non-invasive anthropometric measurement used to assess muscle mass and nutritional status, particularly in older adults. Calf circumference was measured at the widest point of the non-dominant leg using a flexible, non-elastic tape measure, with participants in a seated position and knees at 90 degrees. Measurements were recorded to the nearest 0.1 cm. Cut-off values of \<34 cm for men and \<33 cm for women were used to identify low muscle mass, according to the AWGS 2019 criteria.
Modified 30-second sit-to-stand test Immediately after ICU discharge and 0, 3, and 6 months after discharge The Modified 30-Second Sit-to-Stand Test (m30STS) is a functional performance test used to assess lower limb muscle strength and endurance. It measures the number of times an individual can rise from a seated to a standing position in 30 seconds. In the modified version, participants are allowed to use their upper limbs (e.g., pushing off from the chair or armrests) to complete the movement, making it more suitable for frail or physically limited individuals, such as older adults or ICU survivors.
Montreal Cognitive Assessment Immediately after ICU discharge and 0, 3, and 6 months after discharge The Montreal Cognitive Assessment (MoCA) is a brief, standardized screening tool designed to detect mild cognitive impairment. It evaluates multiple cognitive domains, including attention, executive function, memory, language, visuospatial ability, abstract thinking, calculation, and orientation. The test is scored out of 30 points, with a score of 26 or above generally considered normal.
Maslach Burnout Inventory - Human Services Survey (MBI-HSS) 0, 6, 12, 18, and 24 months after I-CARE program start The MBI-HSS is a widely used psychological assessment tool designed to measure burnout specifically in professionals working in human services and healthcare, such as nurses, doctors, social workers, and therapists. The survey consists of 22 items (questions). It measures three key dimensions of burnout: (1)Emotional Exhaustion; (2)Depersonalization; (3)Personal Accomplishment. Respondents rate the frequency of experiencing each feeling or attitude on a 7-point Likert scale ranging from 0 (never) to 6 (every day). Higher scores in Emotional Exhaustion and Depersonalization, along with lower scores in Personal Accomplishment, indicate greater levels of burnout.
Intention to leave 0, 6, 12, 18, and 24 months after I-CARE program start Intention to leave is measured by the level of agreement with the following three statements: (1) I plan to leave my job within the next year; (2) I am actively looking for other job opportunities; (3) I want to continue working in this job. Nurses rate these statements using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores on the first and second statements, as well as lower scores on the third statement, indicate a higher intention to leave.
Mortality rate 1, 2, 3, 4, 5, and 6 months after discharge Mortality rate is a statistical measure that represents the number of deaths in a specific population during a given period of time.
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan