Decreasing Delirium Through Music in Critically Ill Older Adults

Pain Clinical Trial

— DDM  

Official title:

Decreasing Delirium Through Music in Critically Ill Older Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04182334
• Other study ID #: 1906664366
• Secondary ID: 5R01AG067631-03
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 31, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Age 50 years or older.

2. English speaking.

3. Admitted to the intensive care unit (medical or surgical).

4. Expected mechanical ventilator support for =48 hours.

5. Consentable through a legally authorized representative.

6. Have access to a telephone.

Exclusion Criteria:

1. History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.

2. Psychiatric illness which is not well controlled.

3. Alcohol withdrawal symptoms/concern for withdrawal.

4. Suspected or confirmed drug intoxication/overdose

5. Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.

6. Uncorrected hearing or vision impairment including legal blindness.

7. Incarcerated at the time of study enrollment.

8. Enrolled in another clinical trial which does not permit co-enrollment.

9. Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.

Related Conditions & MeSH terms

• Anxiety
• Delirium
• Intensive Care Acquired Cognitive Impairment
• Intensive Care Unit Delirium
• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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