Decreasing Delirium Through Music in Critically Ill Older Adults

Study Overview
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Brief Summary
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Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.

Detailed Description
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One million adults in the United States receive mechanical ventilation for acute respiratory failure in the intensive care units (ICUs) annually and up to 80% of them develop delirium during their ICU stay. Presence of delirium predisposes older adults to immediate in-hospital complications including a longer length of ICU and hospital stay, increased risk of in-patient mortality and elevated costs of care. In addition, ICU delirium is associated with long-term post-discharge complications such as development of cognitive impairment and dementia. Recent research studies exploring pharmacological strategies to manage ICU delirium have not demonstrated efficacy; a limitation also acknowledged in the Society of Critical Care Medicine 2018 Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption guidelines. Music listening is a non-pharmacological intervention that has shown to decrease over-sedation, anxiety and stress in critically ill patients, factors that could predispose to ICU delirium. Our team is now proposing to conduct a large randomized clinical trial called Decreasing Delirium through Music (DDM) in Critically Ill Older Adults to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically-ventilated older adults admitted to the ICU.

Official Title
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Decreasing Delirium Through Music in Critically Ill Older Adults

Conditions
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Intensive Care Unit Delirium, Pain, Anxiety, Intensive Care Acquired Cognitive Impairment

Intervention / Treatment
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* Other: Slow Tempo Music
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 years or older. English speaking. Admitted to the intensive care unit (medical or surgical). Expected mechanical ventilator support for ≥48 hours. Consentable through a legally authorized representative. Have access to a telephone. Exclusion Criteria: History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia. Psychiatric illness which is not well controlled. Alcohol withdrawal symptoms/concern for withdrawal. Suspected or confirmed drug intoxication/overdose Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery. Uncorrected hearing or vision impairment including legal blindness. Incarcerated at the time of study enrollment. Enrolled in another clinical trial which does not permit co-enrollment. Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Slow Tempo Music vs Attention Control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Slow Tempo Music<br>Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad. | Other: Slow Tempo Music<br>* For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.<br>|
| Sham Comparator: Attention Control<br>One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days. | Other: Attention Control<br>* Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days free of delirium and coma | Days free of delirium and coma will be the primary outcome for the trial. Days free of delirium and coma are the number of days after randomization patient is alive free of delirium and not in coma during the seven-day study intervention phase. | Subjects will be followed up to 28 days post randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium Severity | Delirium severity will be assessed twice daily by trained research assistants using the CAM-ICU-7. CAM-ICU-7 is a seven point scale (0-7), derived from the RASS and the CAM-ICU. | Subjects will be followed up to 28 days post randomization | 
| Pain intensity | Pain will be assessed by trained research assistants utilizing the Critical Care Pain Observation Tool (CPOT), a valid and reliable instrument in critically ill patients with and without delirium.. Scale range 0-8, higher score indicates worse pain. | 4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization | 
| Anxiety | Anxiety intensity defined as a heightened state of apprehension, agitation, and arousal, will be measured four times daily before and after assigned intervention using a 100-mm Visual Analog Scale-Anxiety (VAS-A). Scale range 0-100, higher score indicates worse anxiety. | 4 times daily, before and after each intervention for up to 7 days while in the ICU and then twice daily up to 28 days post randomization | 
| Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Auditory Verbal Learning Test [AVLT] will be administered using a phone-based format. Score ranges, sum of learning trials 0-75, 30-minute delay 0-15, a lower score indicates a worse outcome. | 3 months post hospital discharge | 
| Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Wechsler Adult Intelligence Scale- III Digit Span test will be administered using a phone-based format. Score range 0-30, a lower score indicates a worse outcome. | 3 months post hospital discharge | 
| Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Symbol Digit Modalities Test will be administered using a phone-based format. Score range 0-110, a lower score indicates a worse outcome. | 3 months post hospital discharge | 
| Cognition | Cognition will be measured by objective tests of memory, attention, information processing speed and executive cognitive function. The Multilingual Aphasia Examination Controlled Oral Word Association test will be administered using a phone-based format. Score range 0-no max score, a lower score indicates a worse outcome. | 3 months post hospital discharge | 
| Depression | We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood. Scale range 0-27, higher score indicates worse depression. | 3 months post hospital discharge | 
| Anxiety | We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety. Scale range 0-21, higher score indicates worse anxiety. | 3 months post hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Music, Pain, Anxiety, Cognition