Clinical trial NCT06997822: Integrated Recovery Program for Critical Illness
Official title: Integrated Critical Illness Aftercare and Recovery Enhancement (I-CARE) Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ICU Survivors
Keywords: ICU survivors
Physical function
Cognitive
Weight loss
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* ICU survivors who had experienced endotracheal intubation and mechanical ventilation treatment.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of unplanned hospital readmissions
timeFrame: 1, 2, 3, 4, 5, and 6 months after discharge
measure: Incidence of emergency department visits
timeFrame: 1, 2, 3, 4, 5, and 6 months after discharge
Secondary outcomes:
measure: Barthel Index
timeFrame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
measure: Maximal inspiratory pressure
timeFrame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
measure: Grip strength
timeFrame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
measure: Modified 30-second sit-to-stand test
timeFrame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
measure: Montreal Cognitive Assessment
timeFrame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
measure: Confusion assessment methods
timeFrame: Immediately after ICU discharge and 0, 3, and 6 months after discharge
measure: Body weight
timeFrame: Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge
measure: Calf circumference
timeFrame: Immediately after ICU discharge and 0, 1, 2, 3, 4, 5, and 6 months after discharge
measure: Maslach Burnout Inventory - Human Services Survey (MBI-HSS)
timeFrame: 0, 6, 12, 18, and 24 months after I-CARE program start
measure: Intention to leave
timeFrame: 0, 6, 12, 18, and 24 months after I-CARE program start
measure: Mortality rate
timeFrame: 1, 2, 3, 4, 5, and 6 months after discharge
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: