Decreasing Delirium Through Music in Critically Ill Older Adults

Not Applicable

Completed

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

Registration Number: NCT04182334

Lead Sponsor: Indiana University

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Days Free of Delirium and Coma	Seven day study intervention phase	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.

Secondary Outcome Measures

Name	Time	Method
Delirium Severity	Subjects will be followed up to 28 days post randomization. The first 7 days were used for analysis per the protocol statistical plan.	Delirium severity was assessed twice daily by trained research assistants by the CAM-ICU-7, a seven point rating scale (0-7) where higher scores reflect higher delirium severity (worse outcomes). The CAM-ICU-7 score are categorized as 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium. For the twice daily assessments, the mean of the two assessments was used.
Pain Intensity	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. The first 7 days were used for analysis per the protocol statistical plan.	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. For the 4 times daily assessments, the mean of the 2 post intervention assessments was used.
Anxiety	3 months post hospital discharge	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.
Cognition	3 months post hospital discharge	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.
Depression	3 months post hospital discharge	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.

Trial Locations

Locations (5): IU Health West Hospital
🇺🇸
Avon, Indiana, United States
Eskenazi Hospital
🇺🇸
Indianapolis, Indiana, United States
IU Health University Hospital
🇺🇸
Indianapolis, Indiana, United States
Methodist Hospital
🇺🇸
Indianapolis, Indiana, United States
Mayo Clinic Rochester
🇺🇸
Rochester, Minnesota, United States
IU Health West Hospital
🇺🇸Avon, Indiana, United States