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

Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for the DDM 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
Enrollment:
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
Interventions:
Slow tempo music		2x	2x
Attention control		2x	2x
Assessments:
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

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

ISSN: 1745-6215