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Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for the DDM trial

From: Decreasing delirium through music listening (DDM) in critically ill, mechanically ventilated older adults in the intensive care unit: a two-arm, parallel-group, randomized clinical trial

Timepoint Study period
Enrollment Allocation Post-allocation Close-out
 − t 0 Day 1–7 Day 8–14 Day 15–21 Day 21–28 Day 90
Eligibility screen x       
Informed consent x       
Demographics, comorbidities, functional status, clinical data, baseline cognitive function (IQCODE), diagnoses, severity of illness, functional status, medications x       
Allocation   x      
Slow tempo music   2x 2x     
Attention control   2x 2x     
ICU assessments: RASS, CAM-ICU, CAM-ICU7, CPOT, VAS-A x x 2x 2x 2x 2x  
IUTBANS, PHQ-9, GAD-7        x
Other assessments:
Clinical data x   x     
Discharge disposition    x x x x  
Intervention fidelity    x     
Physiologic parameters x   4x x x x  
Length of stay and healthcare utilization        x
  1. Abbreviations: CAM-ICU Confusion Assessment Method for the Intensive Care Unit, CPOT Critical Pain Observation Tool, RASS Richmond Agitation-Sedation Scale, VAS-A visual analog scale-anxiety, IUTBANS Indiana University Telephone-Based Assessment of Neuropsychological Status, PHQ-9 Patient Health Questionnaire, GAD-7 Generalized Anxiety Disorder Scale