Post Intensive Care Syndrome-Family Post Intensive Care Syndrome
Conditions
Interventions
Participants randomized to the intervention group will receive, in addition to usual ICU care, a complex intervention termed family involvement related to mobilization. In this study, "
mobilization"
refers to interventions aimed at restoring physical and social functioning in ICU patients, including early mobilization, exercise therapy, and respiratory training, delivered by physiotherapists, occ
Family Involvement in Mobilization Program"
, developed and shared among rehabilitation staff before trial initiation. The intervention also includes increased opportunities for family contact, visitation, and communication with healthcare pr
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: <Inclusion criteria for family participants> Age >=18 years Within the second degree of kinship with the patient participant or partner Independent in activities of daily living (ADL) Able to provide informed consent within 72 hours after the patient participant's ICU admission <Inclusion criteria for patient participants> Age >=18 years Emergency admission to the ICU Expected to require mechanical ventilation for >=48 hours Not expected to die prematurely The prediction of >=48 hours of ventilation and non-early death will be made by a physician with at least six months of ICU experience.
Exclusion criteria
Exclusion criteria: <Exclusion criteria for family participants> Receiving psychiatric treatment Native language other than Japanese Anticipated difficulty visiting the hospital Anticipated difficulty completing web-based questionnaires Judged inappropriate by the attending physician <Exclusion criteria for patient participants> Previous enrollment in this trial Native language other than Japanese
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Family satisfaction at ICU discharge, assessed with the Japanese version of the FS-ICU 24R overall satisfaction score (0-100 scale; higher scores indicate greater satisfaction) | — |
Secondary
| Measure | Time frame |
|---|---|
| <Family participant outcomes> PICS-F at 3, 6, and 12 months after randomization, defined as the presence of any of the following: IES-R >=25, HADS-A >=8, HADS-D >=8, or ICG >=25 (The ICG assessed only for bereaved family members whose patient died before or at hospital discharge). All assessments of the IES-R, HADS, and ICG will be conducted using the validated Japanese versions of these instruments. IES-R at 3, 6, and 12 months. IES-R >=25 at 3, 6, and 12 months. Change in IES-R from baseline to 3, 6, and 12 months. HADS-A at 3, 6, and 12 months. HADS-A >=8 at 3, 6, and 12 months. Change in HADS-A from baseline to 3, 6, and 12 months. HADS-D at 3, 6, and 12 months. HADS-D >=8 at 3, 6, and 12 months. Change in HADS-D from baseline to 3, 6, and 12 months. ICG >=25 at 3, 6, and 12 months. EQ-5D at 3, 6, and 12 months. Change in EQ-5D from baseline to 3, 6, and 12 months. FS-ICU 24R domain scores for Satisfaction with Care and Satisfaction with Decision-Making. FS-ICU 24R item-level scores. Number of family visits. <Patient participant outcomes> ICU discharge disposition. ICU length of stay. Duration of invasive mechanical ventilation. Ventilator-free days to day 28, defined as 28 minus the number of days on invasive ventilation between randomization and day 28; assigned 0 for deaths before day 28. Hospital discharge disposition. Hospital length of stay. Incidence of delirium during the ICU stay. Mean Mobilization Quantification Score (MQS) across ICU stay. Mean rehabilitation time per session during ICU stay. Number of days rehabilitation was performed. Patient-reported EQ-5D at 3, 6, and 12 months for survivors. Change in patient EQ-5D from baseline to 3, 6, and 12 months for survivors. Barthel Index (BI) at 3, 6, and 12 months for survivors. Change in BI from baseline to 3, 6, and 12 months for survivors. HABC-M SR at 3, 6, and 12 months for survivors. | — |
Countries
Japan
Contacts
Public ContactTakefumi Tsunemitsu
Graduate School of Medicine, Kyoto University Department of Preventive Services, School of Public Health
Outcome results
None listed