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Table 1 Time schedule of Pro-MEDIC enrolment, interventions and assessments

From: Prophylactic Melatonin for Delirium in Intensive Care (Pro-MEDIC): study protocol for a randomised controlled trial

 

Day 1

Day 2

Day 3

Day 4

Days 5–14

Days 2–14 post-ICU discharge

Hospital discharge

Days 28 and 90

Inf`ormed consent

X

       

Demographic information

X

       

Medical co-morbidities

X

       

Psychiatric history

X

       

Liver function tests

X

   

X (days 0, 5 and 10)

   

CAM-ICU score

X

X

X

X

X

   

CAM-S test (for patients found to be delirious)

X

X

X

X

X

   

Record daily ICU interventions

X

X

X

X

X

   

Record daily anti-psychotic and sedation use

X

X

X

X

X

   

Record daily sleep aid measures

X

X

X

X

X

   

RCSQ

X

X

X

X

X

   

Use of physical restraints

X

X

X

X

X

   

Physiotherapy participation

X

X

X

X

X

   

Polysomnography

 

X

  

X

   

Assessment of sleep quality

     

X

  

ICU and hospital LOS

      

X

 

Hospital discharge destination

      

X

 

Mortality at 28 and 90 days

       

X

  1. Abbreviations: CAM-ICU Confusion Assessment Method for the ICU, CAM-S Confusion Assessment Method for delirium severity, ICU Intensive care unit, LOS Length of stay, Pro-MEDIC Prophylactic Melatonin for Delirium in Intensive Care, RCSQ Richards-Campbell Sleep Questionnaire