Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03471520
Eligibility Criteria:
Inclusion Criteria:
* Admitted to General Medicine (units 8100 and 8300 only) from the Duke University Hospital (DUH) Emergency Department
* Age \>= 65
Exclusion Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT03471520
Study Brief:
Protocol Section:
NCT03471520