Status:
COMPLETED
Earplugs and Eye Masks for Reducing Delirium
Lead Sponsor:
Duke University
Conditions:
Delirium
Hospital Acquired Condition
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
There has been some recent evidence to support the use of earplugs and eye masks to prevent delirium, but the existing studies have been small, have not been thoroughly replicated, and have only been ...
Eligibility Criteria
Inclusion
- Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department
- Age \>= 65
Exclusion
- Admitted from outside hospitals, clinics (i.e., direct admissions), or transferred from another department
- Admitted as "observation" (i.e., expected length of stay \< 2 nights)
- Admitted \> 24 hours prior to time of enrollment
- Non-English-speaking patients will be excluded because a language barrier would introduce inaccuracy into the CAM measurement and for feasibility reasons (e.g., availability of translator services)
- Blind or deaf patients will be excluded because they are unlikely to benefit from the intervention, but sensory-impaired patients will be included
- Patients lacking decision-making capacity for whom no Legally Authorized Representative (LAR) is available
- Primary reason for admission "altered mental status", drug withdrawal, stroke, or seizure
- Patients for whom a withdrawal pathway has been preemptively initiated based on their substance use history (e.g., the alcohol withdrawal pathway order set or other as needed ("PRN") orders for the indication of withdrawal)
- Delirium present at time of enrollment
- Glasgow Coma Scale (GCS) \< 10 at time of enrollment
- Enrolled in this trial during a previous admission (i.e., we will not resample)
- Enrolled in a separate trial this admission
- Contraindication to using earplugs or an eye mask (e.g., facial trauma or other safety concern)
- Significant fall risk per nursing assessment
Key Trial Info
Start Date :
August 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03471520
Start Date
August 6 2018
End Date
December 8 2018
Last Update
November 5 2021
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710