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Table 1 Schedule of activities

From: Use of olanzapine to treat agitation in traumatic brain injury: study protocol for a randomised controlled trial

Study phase

Screening/consent

Baseline/randomisation

Treatment period (PTA)

Post-PTA

Discharge

Three-month follow-up

ACD/ MTDM identification

X

     

Trial introduction

X

     

MTDM consent

X

     

Screening

X

     

Participant consent

   

X

  

Randomisation

 

X

    

Demographicsa

 

X

 

X

  

Medical recordb

 

X

X

 

X

 

Medical informationc

 

X

X

X

  

Blood test(s)d

 

X

X

X

  

WPTAS

 

X

X

   

ABS

 

X

X

X

X

 

Simpson-Angus Scale

 

X

X

   

Administer treatment

  

X

   

Treatment log

  

X

   

AE monitoringe

  

X

   

RAVLT

   

X

  

SDMT

   

X

  

SF-12

   

X

X

X

FIM

   

X

X

 

MPAI-4

     

X

PDHSUQ

     

X

  1. aAge, gender, years of education, marital status, pre-injury employment/study status, drug and alcohol history, psychiatric history
  2. bOne or more of date and cause of injury, Glasgow Coma Scale, PTA duration, imaging results, surgical intervention, other injuries, Injury Severity Score, therapy hours and number of sessions, special nursing care, medication details, number of patients on ward
  3. cWeight, BP, HR, WC
  4. dAssessing fasting lipids, fasting glucose, HBA1C, creatinine
  5. eRespiratory issues, lethargy, nausea, vomiting, difficulty swallowing, constipation, urinary retention, dizziness, seizures