Live and recorded music interventions for management of delirium symptoms in acute geriatric patients: Protocol for a randomized feasibility trial

Figures & data

Figure 1. Shared therapeutic mechanisms of PRM and PLM.

Figure 2. Rationale for comparison.

Figure 3. CONSORT study flow diagram.

Table 1. Diagnostic algorithm for DSM-5 delirium evaluation.

DSM-5 Criteria	Tests to be performed and information to be collected			Is DSM-criteria fulfilled?
				YES	NO
A. Disturbance in attention (i.e. reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment	Evaluation	Attention-tests	Cut off (definition of inattention)
	Daily	SAVEAHAART/KATAMARAAN	2 or more errors
		Days of the week in reversed order	Any error
		Months of the year in reverse order	Unable to reach July
		Count backwards from 20 to 1	Any error
		Digit span forward	Less than 5 forward
	Observation: Easily distracted? Collaborative? Has a tendency to “loose thread” in the conversation?
	Arousal: OSLA>3 and/or mRASS other than 0?
B. The disturbance develops over a short period of time (usually hours to a few days), represents a change from baseline attention and awareness, and tends to fluctuate in severity during a day.	Informant history from patient’s carers and nursing staff. Questions to carer/nursing staff or derived from clinical notes: Has there been a sudden change in the patient’s mental state? Does the patient seem to be better at any period in the day compared to other times? Has the level of consciousness been altered (drowsy/not responsive, or agitated)? Sleep-wake cycle disturbances?
C. An additional disturbance in cognition (e.g. memory deficit, disorientation, language, visuospatial ability, or perception).	Questions to the patients: Orientation-tests: Orientation to time, place, and person; Why are you in hospital? Will a stone float in water? Are there fish in the sea? (Any error = disorganized thinking) Recall (3 words) Questions to carers/nursing staff/clinical notes: Has there been any … Perceptual disturbances? Sleep-wake cycle disturbances? Memory disturbances? Psychotic episodes? Psychomotor disturbances?
D. The disturbances in Criteria A and C are not explained by another pre-existing, established, or evolving neurocognitive disorder and do not occur in the context of a severely reduced level of arousal, such as coma.	Information from history/chart/clinical assessment.
E. There is evidence from the history, physical examination, or laboratory findings that the disturbance is a direct physiological consequence of another medical condition, substance intoxication or withdrawal (i.e. due to a drug of abuse or to a medication), or exposure to a toxin, or is due to multiple aetiologies.
Delirium, based on the tests and information above?	All DSM-5 criteria are fulfilled
Subsyndromal delirium, based on the tests and information above?	Defined as evidence of change, in addition to any of the following: (a) altered arousal, (b) attention deficits, (c) other cognitive change, (d) delusions or hallucinations. Criteria D and E must be fulfilled.

DSM-5 – Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; OSLA – Observational Scale of Level of Arousal; mRASS – Modified Richmond Agitation and Sedation Scale.

Table 2. Schedule of clinical activities.

Procedure	Screening (Day 0)	Baseline, Enrolment, Randomization (Day 0)	Intervention period		End of treatment (Registration during hospital stay)
			Before intervention (Day 1, 2, 3)	After intervention (Day 1, 2, 3)
Assessment of eligibility (inclusion and exclusion criteria)	X
4AT	X
Informed Consent	X
Enrolment/Randomization	X
DSM-5 delirium diagnosing	X	X	X	X
DMSS-4 delirium subtyping		X	X	X
Sociodemographic data		X
Past and current medical conditions		X			X
Prescribed Medications		X			X
IQCODE		X
NEWS II		X	X	X	X
Assessment of Personal Music Preference (family version)		X
MAT (participant version)		X
OSLA		X	X	X
mRASS		X	X	X
Attention tests		X	X	X
Cognitive tests		X	X	X
CFS		X
MMSE-NR					X
Length of hospital stay					X
Discharge information (home, nursing home)					X
Adverse Events			X	X	X

4AT – Alertness, Abbreviated Mental Test-4; DSM-5 – Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; DMSS – Delirium Motor Subtype Scale; IQCODE – Informant Questionnaire on Cognitive Decline in the Elderly; NEWS II – National Early Warning Score II; MAT – Music Assessment Tool; OSLA – Observational Scale of Level of Arousal; mRASS – Modified Richmond Agitation and Sedation Scale; CFS - Clinical Frailty Scale; MMSE-NR – Norwegian Revised Mini-Mental Status Evaluation.