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Table 1 Schedule of enrollment, interventions and assessments (using the SPIRIT template [60]) for the melatonin feasibility study

From: The preventative role of exogenous melatonin administration to patients with advanced cancer who are at risk of delirium: study protocol for a randomized controlled trial

  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
  1. Abbreviations: AE/SAE adverse event/serious adverse event, BRP-DICT Baseline Risk Profile for Delirium in the Cancer Trajectory, CAM Confusion Assessment Method, CCI Charlson Co-morbidity Index, CGR Clinical Global Rating Scale, ESAS-r Edmonton Symptom Assessment System-revised, GOC goals of care, HCP health care professional, ISI Insomnia Severity Index, MDAS Memorial Delirium Assessment Scale, NHP Natural Health Product, Nu-DESC Nursing Delirium Screening Scale, PCU palliative care unit, PP-DICT Precipitant Profile for Delirium in the Cancer Trajectory, PPS Palliative Performance Scale, SOMCT Short Orientation Memory Concentration Test