Delirium Confusional State
Conditions
Keywords
Emergency Intensive Care Unit, Family intervention, Intelligent Audiovisual, Middle-aged and Older Adults
Brief summary
The goal of this nonrandomized, quasi-experimental clinical trial is to evaluate whether an intelligent audiovisual intervention can prevent delirium and reduce delirium severity, agitation, and pain among adults aged 55 years or older admitted to an emergency intensive care unit (EICU). The main questions it aims to answer are: Does the intelligent audiovisual intervention reduce the incidence and severity of delirium compared with routine care? Does the intervention improve agitation and pain scores compared with routine care? Researchers will compare participants receiving the intelligent audiovisual intervention plus routine care with participants receiving routine care alone. Participants will be assigned according to the week of EICU admission: those admitted during odd-numbered weeks will receive the intervention, while those admitted during even-numbered weeks will receive routine care. Participants in the intervention group will: View a structured audiovisual program containing a prerecorded message from a family member, current date and weather information, and images of the area surrounding the hospital. Receive the intervention for 2 minutes per session, 3 times daily for 2 consecutive days, beginning within 24 hours after EICU admission. Participants in both groups will undergo assessments of delirium, agitation, and pain 3 times daily for 2 consecutive days. Delirium incidence and severity will be assessed using the Confusion Assessment Method for the Intensive Care Unit-7 (CAM-ICU-7). Agitation will be evaluated using the Richmond Agitation-Sedation Scale (RASS), and pain will be assessed using either the Numerical Rating Scale (NRS) or the Face, Legs, Activity, Cry, and Consolability (FLACC) scale.
Interventions
BEHAVIORALIntelligent Audiovisual Intervention
A structured, personalized audiovisual intervention designed to provide cognitive reorientation and emotional support. The program incorporates person, time, and place orientation cues, including a prerecorded message from a family member using the participant's name and familiar language; current date, weather, and temperature information presented through automated audiovisual content; and images of the area surrounding the hospital. Participants will receive the intervention for 2 minutes per session, 3 times daily (at 7:00 AM, 5:00 PM, and 9:00 PM) for 2 consecutive days, beginning within 24 hours after admission to the emergency intensive care unit. The intervention will be provided in addition to routine care.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 55 years or older. 2. Admitted to the emergency intensive care unit within the previous 24 hours. 3. No delirium at baseline, defined as a negative Confusion Assessment Method for the Intensive Care Unit assessment and a CAM-ICU-7 score of 0-2. 4. Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥14. 5. Sufficiently alert to communicate, with a Glasgow Coma Scale score of E4V4-5M6 or E4VTM6. 6. Diagnosed with an infection or an infection-related critical illness, such as sepsis, urinary tract infection, or pneumonia.
Exclusion criteria
1. Diagnosed visual or hearing impairment that would interfere with receiving the audiovisual intervention. 2. History of substance abuse. 3. History of psychiatric illness. 4. Moribund status, receipt of a palliative care consultation, or an expected survival of 7 days or less. 5. Unable to communicate in Mandarin Chinese or Taiwanese Hokkien. 6. No family caregiver available to participate in preparation of the audiovisual intervention. 7. History of surgery within the previous 7 days. 8. Montreal Cognitive Assessment (MoCA) score \<23.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium Assessed Using the CAM-ICU-7 | From baseline through the end of Day 2; assessed 3 times daily | Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU-7). The outcome will be reported as the percentage of participants with at least one positive CAM-ICU-7 assessment during the 2-day assessment period. |
| Change From Baseline in Delirium Severity Assessed Using the CAM-ICU-7 | Baseline through the end of Day 2; assessed 3 times daily | Delirium severity will be measured using the CAM-ICU-7. Total scores range from 0 to 7, with higher scores indicating greater delirium severity. Scores of 0 to 2 indicate no delirium, 3 to 5 indicate mild to moderate delirium, and 6 to 7 indicate severe delirium. Changes from baseline will be evaluated across the scheduled assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Richmond Agitation-Sedation Scale Score | Baseline through the end of Day 2; assessed 3 times daily | Agitation and sedation will be assessed using the Richmond Agitation-Sedation Scale (RASS). Scores range from -5 to +4. A score of 0 indicates that the participant is alert and calm, positive scores indicate increasing agitation, and negative scores indicate increasing levels of sedation. |
| Change From Baseline in Pain Intensity Score | Baseline through the end of Day 2; assessed 3 times daily | Pain intensity will be assessed using the 11-point Numerical Rating Scale (NRS) for participants able to self-report or the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for participants unable to communicate reliably. Both scales range from 0 to 10, with higher scores indicating greater pain intensity. |
Contacts
CONTACTLi Fang-Yu
Outcome results
None listed