DDM: Decreasing Delirium Through Music in Critically Ill Older Adults

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04182334

Collaborator

(none)

160

Enrollment

Locations

Arms

57.9

Anticipated Duration (Months)

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intensive Care Unit Delirium Pain Anxiety Intensive Care Acquired Cognitive Impairment	Other: Slow Tempo Music Other: Attention Control	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Slow Tempo Music vs Attention ControlSlow Tempo Music vs Attention Control

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Only the unblinded study coordinator is aware of randomization. Outcomes assessors are blinded

Primary Purpose:

Treatment

Official Title:

Decreasing Delirium Through Music in Critically Ill Older Adults

Actual Study Start Date :

Mar 5, 2020

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Slow Tempo Music 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 For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.
Sham Comparator: Attention Control One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.	Other: Attention Control 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.

Arm

Intervention/Treatment

Experimental: Slow Tempo Music

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

For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.

Sham Comparator: Attention Control

One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.

Other: Attention Control

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.

Outcome Measures

Primary Outcome Measures

Days free of delirium and coma [Subjects will be followed up to 28 days post randomization]
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

Delirium Severity [Subjects will be followed up to 28 days post randomization]
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.

Other Outcome Measures

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]
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.
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]
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).
Cognition [3 months post intervention]
Cognition will be measured by 4 objective tests of memory, attention, information processing speed, and executive cognitive function (Auditory Verbal Learning Test [AVLT], Digit Span, and Symbol Digit Modalities Test [SDMT], and Controlled Oral Word Association test [COWA]) using a telephone-based administration format, the Indiana University Telephone-Based Assessment of Neuropsychological Status (IU- TBANS) at 3-months post hospital discharge.
Depression [3 months post intervention]
We will use the Patient Health Questionnaire-9 (PHQ-9) to determine the impact of the music intervention on ICU survivor's mood.
Anxiety [3 months post intervention]
We will use the Generalized Anxiety Disorder Scale (GAD-7) to determine the impact of the music intervention on ICU survivor's anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IU Health West Hospital	Avon	Indiana	United States	46123
2	Eskenazi Hospital	Indianapolis	Indiana	United States	46202
3	IU Health University Hospital	Indianapolis	Indiana	United States	46202
4	Methodist Hospital	Indianapolis	Indiana	United States	46202
5	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905