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Table 2 Schedule of enrolment, interventions, and assessments

From: A study protocol for a randomized controlled trial of family-partnered delirium prevention, detection, and management in critically ill adults: the ACTIVATE study

Activity / assessment

CRF (Yes/No)

Staff Member

-1

Prescreening / consent

0

Baseline / Randomization

T1

Immediately post-randomization

T2

Daily for Remainder of ICU stay

F1

Follow-up 1-month

F2

Follow-up 3-months

Prescreening consent

No

Nurse unaffiliated with study

X

     

Screening log

No

Research Assistant

X

     

Consent form

No

Research Assistant

X

     

Inclusion/Exclusion form

Yes

Research Assistant

X

     

Randomization

No

Biostatistician unaffiliated with study

 

X

    

Patient demographics form

Yes

Research Assistant

 

X

    

Family member demographics form

Yes

Research Assistant

 

X

    

Educational video/booklet

No

Research Assistant

  

X

   

Delirium prevention and management

Yes

Research Assistant

   

X

  

Delirium detection (Sour Seven)

Yes

Research Assistant

   

X

  

CIDKQ

Yes

Research Assistant

 

X

 

X

X

X

GAD-7

Yes

Research Assistant

 

X

 

X

X

X

PHQ-9

Yes

Research Assistant

 

X

 

X

X

X

K-10

Yes

Research Assistant

 

X

 

X

X

X

DEL-B

Yes

Research Assistant

 

X

 

X

  

ICDSC

No

Research Assistant

 

X

 

X

  

RASS

No

Research Assistant

 

X

 

X

  

CCFNI

Yes

Research Assistant

 

X

    

BCQ

Yes

Research Assistant

 

X

    

CSS

Yes

Research Assistant

 

X

    
  1. Abbreviations: BCQ Barriers to Care Questionnaire in the ICU, CIDKQ Caregiver ICU Delirium Knowledge Questionnaire, CCFNI Critical Care Family Needs Inventory, CSS Caregiver Coping Strategies, DEL-B Delirium Burden, GAD-7 Generalized Anxiety Disorder 7, ICU Intensive Care Unit, K-10 Kessler Psychological Distress Scale, PHQ-9 Patient Health Questionnaire 9, RASS Richmond Agitation Sedation Scale