| Study period | ||||||||
---|---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | ||||||
Timepoint | At admission | Within 72 h of admission | Day 1 to Day 28 | Day 29 and Day 30 | At suspicion of delirium | Delirium diagnosis confirmed | 24 (16–32) h after delirium diagnosis | Within 3 days after delirium diagnosis | 30-day period after stop of trial product |
 |  |  | (D1–D28) | (D29 + 30) |  |  |  |  |  |
Enrollment: | |||||||||
 Eligibility screen: verbal consent to be contacted by research team member | X |  |  |  |  |  |  |  |  |
 Informed consent |  | X |  |  |  |  |  |  |  |
 Allocation |  | X |  |  |  |  |  |  |  |
Interventions: | |||||||||
 Administer melatonin/placebo |  |  | X Daily: @ 21:00 ± 1 h |  |  | Discontinue trial product (trial product return/count) |  |  |  |
Assessments: | |||||||||
 Medical history | X |  |  |  |  |  |  |  |  |
 GOC | X |  |  |  |  | X |  |  |  |
 PPS | X |  |  |  |  |  |  |  |  |
 ECS-CP | X |  |  |  |  |  |  |  |  |
 CAM | X |  |  |  | X |  |  |  |  |
 SOMCT | X |  |  |  |  |  |  |  |  |
 Nu-DESC | X |  | X |  |  |  |  |  |  |
 ESAS-r | X |  | X |  |  |  |  |  |  |
 Concomitant medications/NHP | X |  | X |  |  |  |  |  |  |
 AE data collection |  | X | X | X | X | X | X | X |  |
 BRP-DICT |  |  | X D1 only |  |  |  |  |  |  |
 CCI |  |  | X D1 only |  |  |  |  |  |  |
 ISI |  |  | X D1, 14, 28 ± 2 days |  |  |  |  |  |  |
 PCU physician CGR |  |  |  |  |  | X |  |  |  |
 MDAS |  |  |  |  |  |  | X |  |  |
 PP-DICT |  |  |  |  |  |  |  | X |  |
 Contact HCP for SAE outcome/death |  |  |  |  |  |  |  |  | X |