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Table 2 Participant timeline

From: A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial)

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)
 Eligibility screen of patient X         
 Identification of eligible family member   X        
 Information of family member    X       
 Informed consent     X      
 Intervention arm: family support intervention including intervention log      X X X   
 Usual care X X X X X X    
 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
  1. ICF informed consent form, FU follow-up, EOT end of treatment, EOS end of study, Tx assessment time point
  2. aT0–T1 from clinical record, T2–T4 family member reported