Table 2 Participant timeline
Task/study period | Admission to ICU | Screening | Informaiton | ICF | Baseline assessment (T0) | FU 1 to discharge from ICU (T1) | EOT and FU 2–3 months (T2) | FU 3–6 months (T3) | FU 4–12 months (T4) = EOS |
|---|---|---|---|---|---|---|---|---|---|
Time point | 0–24 h | 0–48 h | 0–72 h | 0–96 h | 0–96 h | Y (− 24 h/+ 14 days) | Y + 90 days (± 14 days) | Y + 180 days (± 14 days) | Y + 365 days (± 14 days) |
Enrollment | |||||||||
Eligibility screen of patient | X | ||||||||
Identification of eligible family member | X | ||||||||
Information of family member | X | ||||||||
Informed consent | X | ||||||||
Interventions | |||||||||
Intervention arm: family support intervention including intervention log | X | X | X | ||||||
Usual care | X | X | X | X | X | X | |||
Assessments | |||||||||
Patient demographics, health and functional status, care utilizationa | X | X | X | X | X | X | |||
Family member demographics, self-perceived health, care utilization | X | X | X | X | X | ||||
Satisfaction with care (FS-ICU-24R) (primary endpoint) | X | ||||||||
Quality of communication (QQPPI-14) | X | ||||||||
Nurse support (ICE-FPSQ-14) | X | ||||||||
Family functioning (FAD-GF-12) | X | X | X | X | X | ||||
Family resilience (BRS-6) | X | X | X | X | X | ||||
Distress Thermometer (DT) | X | X | X | X | X | ||||
Depression and anxiety (HADS-14) | X | X | X | X | X | ||||
Posttraumatic stress (IES-6) | X | X | X | X | X | ||||
Life satisfaction (SWLS-5) | X | X | X | X | X | ||||
Well-being (WHO-5, QoL-VAS) | X | X | X | X | X | ||||